what is study subject in research

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Research Is an Activity and a Subject of Study: A Proposed Metaconcept and Its Practical Application

Allison Hosier *

Information literacy instruction based on the ACRL Information Literacy Competency Standards for Higher Education tends to focus on basic research skills. However, research is not just a skill but also a subject of study. The ACRL Framework for Information Literacy for Higher Education opens the door to integrating the study of research into information literacy instruction via its acknowledgement of the contextual nature of research. This article introduces the metaconcept that research is both an activity and a subject of study. The application of this metaconcept in core LIS literature is discussed and a model for incorporating the study of research into information literacy instruction is suggested.

Introduction

Studies have shown that students’ confidence in their research skills often does not match their proficiency with those skills. 1 Students seem to believe that their facility with search engines is sufficient for any research-related task they may be faced with. In believing this, what students fail to realize is that while the information-seeking skills they have developed are certainly valuable in some situations, they are less so in others.

Instructors of composition courses face a similar dilemma. Students believe that writing is nothing more than a basic skill and often fail to appreciate the importance of rhetorical context to the writing process. In an effort to resolve this, instructors help students familiarize themselves with different genres of writing via the study of writing itself. As a result, students may begin to recognize that basic skills are not enough to meet the expectations for writing in every context. The most successful student writers are ones who are able to recognize themselves as novices in some of these contexts. 2 These student writers will also begin to see that writing is not just an activity but also a subject of study. 3

Students who learn about research through information literacy instruction may not have the opportunity to experience a similar epiphany about the research process. This is because common models of information literacy instruction are primarily skills-based with a particular focus on application. There is little if any time to devote to teaching students about the contextual nature of research or how to study a research product for evidence of conventions related to these contexts.

If information literacy instruction is typically skills-based, it is likely because the ACRL Information Literacy Competency Standards for Higher Education (the Standards ) is a skills-based document, as are similar documents that have shaped how information literacy has been taught until now. The Standards guidelines in particular fail to address the contextual nature of research in a meaningful way, thus limiting opportunities to introduce this important concept in the classroom.

The advent of the ACRL Framework for Information Literacy for Higher Education (the Framework ) marks a shift from skills-based thinking about information literacy to concept-based thinking. Because of this shift, information literacy instructors now have the option to expand their teaching beyond the application of basic research skills. The Framework ’s attention to context in particular can be used to create a model of instruction that involves the study of research in addition to the application of research skills. In this way, students will better recognize that research, like writing, is both an activity and a subject of study.

The purpose of this article is threefold. The first is to propose the metaconcept that research is both an activity and a subject of study. This metaconcept has long been present in the literature in the library and information science field but has been largely absent from information literacy instruction. The second goal of this study is dto discuss how the influence of the Standards led to the skills-based model of information literacy instruction while suggesting that the Framework ’s attention to context provides a path for reshaping such instruction around the study of research. Third, a model for integrating this metaconcept into information literacy instruction will be presented.

These ideas were initially inspired by Adler-Kassner and Wardle’s edited volume Naming What We Know: Threshold Concepts of Writing Studies . Just as Adler-Kassner and Wardle and their collaborators aimed to articulate what writing studies experts know about their subject to improve conversations with students and other nonexperts, the application of the ideas in the present study can lead to better discussions about information literacy with those who in the past may not have fully understood its value.

Defining Research

Before getting to the heart of this paper’s argument, it may be helpful to first establish more clearly what, exactly, is meant by “research.”

In their “Policy for Protection of Human Research Subjects,” the Office for Human Research Protections defines research as a systematic investigation intended to contribute to generalizable knowledge. 4 Institutional Review Boards commonly use this definition to guide researchers applying for approval to pursue research involving human subjects.

The Standards also portrays research as an investigation, one that likely involves the use of library resources. The prescribed steps for the research process include the identification of a gap in knowledge, the identification and evaluation of relevant sources, and the ethical use of those sources. 5

In the Framework , research is alluded to as a “reflective discovery of information” in the expanded definition of information literacy. 6 This journey of reflective discovery is intended to lead to the creation of new knowledge.

Information-seeking is a concept related closely to research that takes into consideration contexts beyond the scientific and academic ones that are the primary concern of the above definitions. Wilson describes information-seeking as a behavior that “arises as a consequence of a need perceived by an information user who…makes demands upon formal or informal information sources or services, which result in success or failure to find relevant information.” 7

It is necessary to define research broadly in a discussion of research as both an activity and a subject of study, because the study of research can take many forms and context is always a consideration. For this reason, the understanding of research in this paper will encompass the following:

• Research is any formal or informal process that is undertaken to fill a gap in knowledge, build on existing knowledge, or create new knowledge.
• Goals of research include but are not limited to answering a research question, testing a hypothesis, or satisfying curiosity.
• Research involves investigation of some kind. This investigation may be formal, such as an exhaustive literature review or the careful implementation of the scientific method, or it may be informal, such as a brief Google search. More formal research investigations may be qualitative or quantitative in nature.
• The research process is often iterative rather than linear.
• The results of research may be captured in a research product or a set of research products. The products of research can take many forms, including but not limited to: formally published research studies, dissertations, conference proceedings, creative works, presentations, speeches, news and magazine articles, and blog posts.
• Research products often include evidence of research in some way, whether it is a list of citations, a detailed description of methodology, a quote from an interview subject, a list of acknowledgements, a verbal allusion to a source of information (as in a speech), or contextual links (as in an online blog post).

Research envisioned through an information literacy lens is often academic in nature. This type of research will be referred to as “academic research” throughout this paper. Table 1 outlines additional terms that will be used to refer to different types of research where necessary. This is not intended as a definitive list of research genres but rather a guide that will serve to clarify certain points. Note that some types of research may overlap with others.

Research Is a Subject of Study

A study of research is one in which the products or processes of research are analyzed to better understand some aspect of research itself. This is most directly seen in studies that observe actual research behaviors or evaluate specific research products. The study of research also has an influence on other areas of inquiry. Context is often key to studies of research.

The study of research is most prevalent in literature found in the library and information science (LIS) field. However, it also has relevant applications in other fields. This section will first summarize areas of inquiry directly and indirectly related to the study of research that can be found in LIS literature. A few relevant examples from the related field of writing studies will also be mentioned. Brief consideration will then be given to a relevant example from the field of psychology.

The Study of Research in Library and Information Science

Researchers in library and information science study the processes and products of research to improve systems and services, to understand how those systems and services are used, to analyze collections, to measure the impact of research-related instruction, to trace the development of a research topic over time, and more. These areas of inquiry are studied in a variety of contexts using a range of methods and populations. The study of research is relevant to virtually every specialization in library and information science. It is not an exaggeration to say that if you open any of the core journals in this field, such as those identified in a 2014 study by Nixon, 8 you are likely to find at least one article that is concerned directly or indirectly with the study of research in some way, shape, or form.

The study of research is a theme that has long been present in LIS literature but can be difficult to locate because until now it has not generally been named as such. The metaconcept introduced here gives us a novel lens through which to view our work and begin to articulate what we know about research as both an activity and a subject of study in a new way. When this lens is applied to content analyses and literature reviews, which are fairly common in LIS literature 9 and are themselves an example of the study of research, these works can serve as a valuable proxy for identifying topics related to the study of research in our field. An analysis by Tuomaala, Jarvelin, & Vakkari from 2014 may be most useful in this respect for the present discussion. 10 The breakdown of topics and subtopics the authors created for their study is specific enough to begin to see shades of the research-as-subject metaconcept. In their analysis, the authors found that information seeking, which includes subtopics such as information use and information management, accounted for 12.3 percent of the LIS literature in 2005, the most recent year considered for the study. The study of research also has applications related to studies of information storage and retrieval, a separate topic that includes subtopics such as cataloging and the testing of retrieval systems. More than 30 percent of the articles published that year related to this topic. Other potentially relevant areas from Tuomaala, Jarvelin, and Vakkari’s study include research on user education (1.7%), citation patterns (6.5%), and webometrics (2.9%).

What does the study of research in LIS look like? For one, it is often concerned with context. Researchers seek to gain important insights into how different populations seek or use information in different contexts. Some of the populations studied in recent issues of core LIS journals include disadvantaged adolescents, Catholic clergy, linguists, and poultry farmers, to name just a few. 11 Contexts of interest found in recent literature include not just academic or scholarly ones 12 but also personal, as in studies of everyday life information seeking, 13 and professional, as in studies of how information is accessed and used in various workplace environments. 14 Those who study the products of research may be interested in understanding how researchers cite data, what common themes can be found in the research on a particular subject, or how the content of one type of research product might distinguish it from another type of research product. 15 In all of these cases, context matters to the researcher.

Context also matters to those whose work may be informed by the study of research though research itself is not the direct object of study. For example, the work of collection management researchers must be informed at least in part by how a particular population uses the collection in question. 16 Usability studies may be primarily concerned with issues of design, but the researcher must also take into account the context in which the resource being tested will actually be used. 17 A study of a library’s physical space must include some consideration for the research and information-seeking activities that users conduct in that space, which will be different depending on details such as the type and size of the library as well as the population it serves. 18 Researchers who create algorithms or implement other methods to improve the effectiveness of information retrieval systems must have some understanding of the needs and behaviors of the system’s front-end users. 19 Though the examples cited are all from recent literature, they represent areas of inquiry that have developed over a long period of time.

In the past, the study of academic research as conducted by students has been of particular concern to those who teach information literacy. Leckie, for example, comments on how typical research assignments reflect an expert approach to research that may be inaccessible to novice student researchers. 20 Information literacy instruction is also often informed by studies that establish an understanding of students’ research behavior, including their method of strategic satisficing, 21 why they prefer certain resources and tools over others, 22 and why their choices do not always match expert expectations of quality and reliability. 23 Understanding gaps between the research skills librarians teach and the ones that are actually used in the workplace, as in Head, Van Hoeck, Eschler, and Fullerton, is another area of inquiry that has gained importance over time. 24

Among these studies of the products and processes of academic research are arguments for teaching students about the contextual nature of research. Fister advocates for creating a better awareness of the rhetorical aspects of research, 25 an idea that was later put into action by Davidson and Crateau. 26 Simmons proposes applying genre theory and critical information literacy to research instruction so that librarians can position themselves as discourse mediators, studying and teaching the conventions of research in different disciplines as anthropologists study and teach the practices of different cultures. 27 Harris makes a similar argument: “Before we make assumptions about how to assist communities of learning, we may also need to define and navigate the social, political, and cultural characteristics of that community.” 28

The study of research touches nearly every aspect of the library and information science field, in one form or another. But, as Faix points out, experts in other fields also take part in scholarly conversations about research. 29 This includes related fields such as writing studies, where authors like Brent and North approach the study of research from a composition perspective. 30 However, the study of research is also relevant to researchers in more scientific fields, which are often considered outside the scope of information literacy instruction. Though this paper focuses primarily on information literacy instruction, the overall argument is that such instruction would be more effective if it involved the study of research to help students appreciate the contextual nature of the research process. This means expanding our thinking about research beyond the library-based academic notions we have favored so far. For this reason, a relevant example of the study of research in psychology is provided in the next section.

The Study of Replicability and Reproducibility in Psychology

The methods, goals, and motivations of scientific research are considered to be distinct from the ones described by documents such as the Standards and the Framework . That this is the case serves as further evidence in support of the importance of context to the research process. However, scientific researchers have also been known to turn inward and examine the processes and products of research as it is represented in their fields.

In the field of psychology, the work done as part of the Reproducibility Project is particularly relevant to the present discussion. As part of this project, a team of researchers attempted to replicate the results of 100 psychological studies. 31 Their findings led them to create a set of recommendations for how to improve the research and publication process in their field to better promote replicability. One of these recommendations was to teach students to study research publications in their fields to evaluate the evidence used and learn to see potential methodological flaws.

The findings of this project inspired a number of responses. Some researchers studied the methods undertaken by those who worked on the project and used these analyses to question or criticize the results. 32 Others turned to conversations about whether replicability and reproducibility should be goals of psychological research in the first place. 33 There are also studies, 34 published since then, that seek to establish whether there are methods that can be used to improve the replicability of a study and others 35 that recommend new approaches to evaluating replicability itself. A similar study to investigate the reproducibility of cancer biology research is also being undertaken. 36

From these discussions, it becomes clear that research is not just an activity but also a subject of study for researchers in LIS and other fields. This metaconcept has important connections to the contextual nature of research. Both ideas are essential to learning about research in a meaningful way. Despite this, information literacy instruction tends to be generally skills-based with little or no discussion of these ideas. The reason for this may be that, for many, models of information literacy instruction have been built around the Standards , a document that places priority on teaching research skills over research-related concepts.

The Importance of Context: Limitations of the Standards and New Opportunities

As stated earlier, the Standards is a skills-based document. When considering the historical context of this document, its focus on the activity of research makes sense. Information literacy had developed over time from a job skill to one that was more closely related to research. Meanwhile, bibliographic instruction had also shifted from the original concept-based approaches to ones that focused more on teaching students basic access skills. 37 The Standards simply reflected these ways of thinking.

The Standards was also developed at a time when academic librarians were seeking to stake a place for themselves in the missions of their institutions, which had become more closely tied to the employability of their graduates. 38 For such institutions, learning outcomes became the favored way of gauging the success of a particular program. One of the Standards ’ stated goals is to provide measurable learning outcomes for information literacy. 39 To be measurable, learning outcomes must be based on what can be observed. It is much easier to measure the development of skills than it is to measure changes in a student’s worldview.

The limitations of the Standards have been well documented over time. 40 One of the main shortcomings of the Standards has always been in its failure to acknowledge the importance of context to the research process. More accurately, the Standards assume a single research context: that of library-based academic research. The closest the document comes to referencing the contextual nature of research is the occasional gesture toward discipline-specific research, which is still a highly academic notion (see table 2). Despite the aspiration of the Standards toward transferability, 41 research studies that have tested this idea tend to have mixed results. 42 In other words, despite its stated intentions, what the document is really doing is, as Mark points out, reflecting a tendency in the academy to measure expertise by one’s ability to adopt the conventions of academia. 43

Because the Standards does not adequately take into account the contextual nature of research, neither does Standards -based information literacy instruction. Instead, such instruction focuses primarily if not exclusively on teaching students the basic skills associated with library-based academic research. We know this because influential tools created to standardize the assessment of information literacy learning, such as the Information Literacy VALUE rubrics and the learning goals suggested by the Middle States Commission of Higher Education, reflect it. 44 We also know this because studies of syllabi for credit-bearing information literacy courses show that the most common topics taught as part of these courses are skills-based. 45

The influence of the Standards has had a noticeable effect on the way librarians think about teaching information literacy. When asked by Hofer, Townsend, and Brunetti about the most common “stuck places” students encountered when learning about research, the answers given by the librarians who participated in the study were concerned almost exclusively with academic research skills. 46 One place where a more contextual view of research shows through is in the respondents’ stated desire to help students better understand how the process of information creation might differ from one discipline to another.

The Standards has also had an effect on how information literacy is perceived by those outside the library field. When Gullikson asked nonlibrary faculty at what academic level they would expect students to have achieved individual learning outcomes from the Standards , the majority of those who responded indicated that they would expect students to have mastered these skills in the early part of their careers in higher education, if not before. 47 Standards- based information literacy, in the eyes of nonlibrarians, is at best seen as what Norgaard calls “a mere look up skill.” 48

The Standards provides no path to introducing students to the contextual nature of research. Because of this, the idea that research is both an activity and a subject of study became lost in our information literacy instruction and our thinking about information literacy instruction despite the fact that it remained a prevalent theme in our professional literature. In insisting on the importance of context to the research process, 49 the Framework gives us a way to change our thinking and our instruction.

Each of the Framework ’s six frames is infused with implicit and explicit references to the contextual nature of research (see table 3). In fact, the only frame in which the word “context” does not appear in one form or another is “Research as Inquiry,” which still manages to highlight the importance of distinguishing between processes of inquiry intended to meet different needs.

Of course, the Framework, like the Standards , is also a product of ACRL and so, as Foasberg points out, its contexts of interest are still primarily academic in nature. 50 No doubt research is currently underway to test the transferability of the Framework . In the meantime, it is not difficult to imagine how the six frames could apply to nonacademic forms of research. For example, negotiating a meaning from varying perspectives, as described in the “Scholarship as Conversation” frame, is as of much concern to those conducting personal, professional, or creative research as it is to those conducting academic research. Those who follow the investigative steps of the scientific method can likely find relevance in the idea of “Research as Inquiry.”

It may be true that not every threshold concept will apply to every research context. For some, that might be seen as a shortcoming of the present argument. However, it is worth remembering that the Framework is intended to be a flexible document, making it clear that there is room for more threshold concepts than those identified in the original version. 51 Further, in establishing a set of threshold concepts related to writing studies, Adler-Kassner and Wardle and their collaborators identified 37 threshold concepts, some of which may be more applicable to the study and activity of certain genres of writing than others. Granted, this work is not intended for broad implementation the way the Framework is, but both documents are of a similar spirit. 52

As stated earlier, students often enter the information literacy classroom unable to recognize that, while the skills and knowledge they have developed are valuable in some research contexts, they may be less so in others. For information literacy instructors, this has been a significant barrier, one that the Standards provided no meaningful way to overcome. The metaconcept that has been established here gives us a lens through which to understand research as not just an activity but also a subject of study. The Framework provides a path to pass on this knowledge to students by introducing them to the importance of context to the research process. The next section describes how a common model for composition instruction could be adapted for this purpose.

A Suggested Model for Practical Application

In Standards -based information literacy instruction, students are introduced to the conventions of academic research at the same time that they are expected to apply those conventions. They are expected to do this correctly without ever having seen or studied an example of such research, except perhaps one provided by their instructor for informational purposes. Badke criticizes this approach, colorfully stating, “teaching application without teaching method and philosophy is akin to showing someone how to steer and use the brakes on a car without teaching overall driving technique and the rules of the road.” 53

In writing studies, there is a similar expectation that, as Sommers and Saltz put it, students will “become master builders while they are still apprentices.” 54 However, composition instruction does not generally begin and end with application the way information literacy instruction does. Instead, students first study a selected example of a genre of writing to learn about the conventions of that genre and then attempt to apply those conventions in their own work. Information literacy instruction could benefit from emulating this structure.

Rather than organizing an information literacy course around units based on skills, sources, or tools, the course could be organized instead around different research contexts. More work may need to be done to determine what exactly those contexts can or should be or whether the conventions, goals, and motivations of those contexts can be said to represent “genres” as the term is understood by researchers of genre theory. 55 However, a general information literacy course could conceivably be organized around units on academic research, personal research, professional research, creative research, scientific research, and more.

In this approach, research skills like those described by the Standards would still be valuable but would only be taught after students first had the opportunity to study an example piece of research. Similar to the work of some professionals who study research, students could closely examine the types of sources used and think about the roles those sources play in the author’s research. They might also study the way the author gives credit to those sources, perhaps noticing that, in some research contexts, credit is given through formal citation while in others it is done through contextual links, quotes from interview subjects, or some other way. By doing this, students would learn how the conventions of research change from context to context. They may begin to develop a more realistic view of how much more there is to learn beyond the skills they already have and why it is worth learning.

As an illustration of how a unit in a course designed like this would work, consider that in a composition course students might first be given Letter from a Birmingham Jail by Martin Luther King Jr. as an example of persuasive writing. They would study this piece before trying to emulate King’s rhetorical moves in their own work.

In a unit on academic research in an information literacy course, students might first be given an example research essay or scholarly article. Rather than studying the writing, they would look at the evidence of research in the source. They might be asked to notice how the author uses citations or footnotes and includes a list of sources at the end. Attention might be drawn to the nature of the sources the author used, and critical thought might be given to why he or she made those choices. A student could also be asked to comment on how each source was used in the example piece: to add new information, to present and answer a contradicting view, to pull a quote, and so on.

The same could be done with units on other types of research. In a different unit, a personal blog post could be used as an example of personal research in which the evidence of research might appear as contextual links rather than formal citations. Or a news article could be studied as an example of journalistic or professional research in which quotes from sources with firsthand knowledge of an event are privileged over other types of sources. Even King’s Letter could be used as an example of research. In this piece, King borrows ideas from and makes reference to Socrates and the Bible to support his ideas. He also relies on the authority granted to him by his own personal experience with the issues he is discussing. 56

After studying the conventions of a genre of research through an example piece, students could then be taught the skills needed to complete the type of research each product represents. As a culminating project, students could be required to create a research product of their own that follows the conventions they learned about and then reflect on the ways that they used or challenged those conventions in their own work.

What is described above would be most appropriate for a general information literacy course taught at the undergraduate level. Instructors who teach more advanced or discipline-based information literacy could adapt this approach to suit their students’ needs and interests. For example, such instruction could focus more closely on the evaluation of research as it is most often represented in a field of study or profession. Students could be taught to see flaws in an author’s methodology, reasoning, or use of sources. They might also benefit from reviewing studies of information behavior of relevant populations to gain an understanding of how these populations interact with and create information in various settings. Instructors could invite students to think critically about the research practices in their fields and reflect on areas of potential improvement.

Caveats and Potential Concerns

It is necessary at this point to acknowledge that the common model for teaching composition described earlier is not without its critics in that field. Connors, for example, argues that using genres and modes to teach writing is more of a convenience to the instructor than a reflection of how writing actually works. 57 Hillocks makes the case that using genre and form to teach composition neglects the importance of inquiry and teaching students how to work with content. 58

In implementing a similar model for information literacy instruction, information literacy instructors may also have concerns. Foremost among these may be a reluctance to teach research outside the discipline-agnostic academic context of past Standards -based instruction. To do so, it has been argued in the past, would be to tread on the toes of disciplinary faculty who are the rightfully recognized experts on research in their fields of study and also perhaps to stray outside our professional strengths. 59 In response to this, it must be acknowledged that disciplinary faculty have been valuable partners in teaching information literacy in the past and could continue to be so in this new approach. As far as professional strengths, the Standards may have been limited to library-based academic research but the study of research in the LIS field is not, showing that contexts outside academia are, in fact, within our professional domain. Even if they were not, librarians tend to portray themselves as research experts as a way of communicating their value to their institutions. Taking advantage of the ways in which researchers in our own field have cultivated an understanding of how research works in a variety of contexts can only enhance our ability to label ourselves this way.

Another possible area of concern might be one anticipated by Townsend, Brunetti, and Hofer who acknowledge that threshold concepts like the ones found in the Framework tend to privilege certain ways of thinking. 60 Information literacy instructors may feel that the study of research is for professionals only and that teaching it to students would set up an expectation that, to be successful researchers, they need to become junior librarians or junior professors. However, it is worth noting that the goal of composition instruction, which involves both the study and practice of writing, is to teach students to be competent writers with an appreciation for rhetorical context. They are introduced to expert ways of thinking as a way of expanding their worldview but are not expected to become published (or even publishable) authors as a result of what they learn.

Finally, there may be some question of whether teaching students the conventions associated with different research contexts and then expecting them to follow those conventions stifles creativity by inviting conformity to existing systems. In answer to this, it could be argued that using the conventions of research as a teaching tool opens the door to conversations about why those conventions exist in the first place and in what ways they uphold what Beilin refers to as the “knowledge regime.” 61 Teaching students to think critically about the research that goes into creating a particular research product would enable them to more clearly see how the recontextualization process that is part of all research is subject to the inherent biases and worldviews of the author. 62 Even more important, as observed by Simmons, when students learn about generic conventions, they may learn to see themselves as having “the potential to effect changes in the conventions instead of simply learning to conform to the established patterns.” 63 In other words, learning “the rules” is also the first step in learning how to break those rules and challenge the systems that created them in meaningful and interesting ways.

Current models of information literacy instruction that treat research as nothing more than a basic skill do not serve students well. They also do not serve information literacy well. Research is not a basic skill that can be mastered for a lifetime in the space of a single instruction session. It is an activity that relies heavily on rhetorical context. It is also a subject of study with areas of inquiry in which context is often a large consideration. To paraphrase Wardle and Adler-Kassner, 64 a successful researcher is someone who cultivates an understanding of the expectations associated with research in a given context and then meaningfully engages with those expectations. Such a researcher is both a consumer and a creator of information.

The metaconcept introduced in this article, that research is both an activity and a subject of study, is an attempt to name something that has been present in LIS literature all along but for which there has been no room in information literacy instruction in the past. Future work to identify the ways in which this metaconcept has manifested itself in the literature in our field will be valuable in helping us to articulate the value of our work in a new way. In the meantime, it could serve as a useful frame for transforming information literacy instruction and enhancing the reputation of information literacy as something more than a basic skill.

1. Valeria E. Molteni and Emily K. Chan, “Student Confidence/Overconfidence in the Research Process,” Journal of Academic Librarianship 41, no. 1 (2015): 2–8.

2. Nancy Sommers and Laura Saltz, “The Novice as Expert: Writing the Freshman Year,” College Composition and Communication 56, no. 1 (2004): 124–49.

3. Elizabeth Wardle and Linda Adler-Kassner, “Metaconcept: Writing Is an Activity and a Subject of Study,” in Naming What We Know: Threshold Concepts of Writing Studies , eds. Linda Adler-Kassner and Elizabeth Wardle (Boulder: University Press of Colorado, 2015), 15–16.

4. Office for Human Research Protection, “Basic HHS Policy for Protection of Human Research Subjects” (2009), available online at https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html [accessed 23 January 2018].

5. ACRL Information Literacy Competency Standards for Higher Education , “Information Literacy Defined” (2000), available online at www.ala.org/acrl/standards/informationliteracycompetency [accessed 23 January 2018].

6. ACRL Framework for Information Literacy for Higher Education , “Introduction” (2015), available online at www.ala.org/acrl/standards/ilframework [accessed 23 January 2018].

7. T.D. Wilson, “Models in Information Behaviour Research,” Journal of Documentation 55, no. 3 (1999): 251.

8. Judith M. Nixon, “Core Journals in Library and Information Science: Developing a Methodology for Ranking LIS Journals,” College & Research Libraries 75, no. 1 (2014): 66–90.

9. Examples include: Stephen E. Atkins, “Subject Trends in Library and Information Science Research, 1975–1984,” Library Trends 36, no. 4 (Spring 1988): 633–58; Lois Buttlar, “Analyzing the Library Periodical Literature: Content and Authorship,” College & Research Libraries 52, no. 1 (Jan. 1991): 38–53; Gloria S. Cline, ” College & Research Libraries : Its First Forty Years,” College & Research Libraries 43, no. 3 (1982): 208–32; Gregory A. Crawford, ”The Research Literature of Academic Librarianship: A Comparison of College & Research Libraries and Journal of Academic Librarianship ,” College & Research Libraries 60, no. 3 (1999): 224–30; Amy VanScoy and Cady Fontana, “How Reference and Information Services is Studied: Research Approaches and Methods,” Library & Information Science Research 38, no. 2 (2016): 94–100.

10. Otto Tuomaala, Kalervo Jarvelin, and Pertti Vakkari, “Evolution of Library and Information Science, 1965–2005: Content Analysis of Journal Articles,” Journal of the Association for Information Science & Technology 65, no. 7 (2014): 1446–62.

11. Steven Buchanan and Lauren Tuckerman, “The Information Behaviours of Disadvantaged and Disengaged Adolescents,” Journal of Documentation 72, no. 3 (2016): 527–48; Jacob Dankasa, “Mapping the Everyday Life Information Needs of Catholic Clergy: Savolainen’s ELIS Model Revisited,” Journal of Documentation 72, no. 3 (2016): 549–68; Maja Krtalic, Sanjica Faletar Tanackovic, and Damir Hasenay, “Linguists as Newspaper Users: Perceptions and Experiences,” Library and Information Science Research 38, no. 2 (2016): 108–16; Grace Msoffe and Patrick Ngulube, “Farmers’ Access to Poultry Management Information in Selected Areas of Tanzania,” Library and Information Science Research 38, no. 3 (2016): 82–90.

12. Examples include: Nancy Falciani-White, “Understanding the ‘Complexity of Experience’: Modeling Faculty Research Practices,” Journal of Academic Librarianship 42, no. 2 (2016): 118–26; Christopher V. Hollister, “An Exploratory Study on Post-tenure Research Productivity Among Academic Librarians,” Journal of Academic Librarianship 42, no. 4 (2016): 368–81; Sloan Komissarov and James Murray, “Factors That Influence Undergraduate Information-seeking Behavior and Opportunities for Student Success,” Journal of Academic Librarianship 42, no. 4 (2016): 423–49; Carol Sabbar and Iris Xie, “Language in the Information-Seeking Context: A Study of U.S. Scholars Using Non-English Sources,” Journal of Documentation 72, no. 1 (2016): 103–26.

13. Examples include: Lisa M. Given et al., “Watching Young Children ‘Play’ with Information Technology: Everyday Life Information Seeking in the Home,” Library and Information Science Research 38, no. 4 (2016): 344–52; Helena Känsäkoski and Maija-Leena Huotari, “Applying the Theory of Information Worlds Within a Health Care Practise in Finland,” Journal of Documentation 72, no. 2 (2016): 321–41; Reijo Savolainen, “Approaches to Socio-Cultural Barriers to Information Seeking,” Library and Information Science Research 38, no. 1 (2016): 52–59.

14. Examples include: Elham Sayyad Abdi, Helen Partridge, and Christine Bruce, “Web Designers and Developers’ Experience of Information Literacy: A Phenomenographic Study,” Library and Information Science Research 38, no. 4 (2016): 353–59; Rebecca Lea French and Kirsty Williamson, “The Information Practices of Welfare Workers: Conceptualizing and Modelling Information Bricolage,” Journal of Documentation 72, no. 4 (2016): 737–54; Ayse Göker et al., “Expeditions Through Image Jungles: The Commercial Use of Image Libraries in an Online Environment,” Journal of Documentation 72, no. 1 (2016): 5–23.

15. Examples related to each theme mentioned include: Nicolas Robinson-Garcia, Evaristo Jimenez-Contreras, and Daniel Torres-Salinas, “Analyzing Data Practices Using the Data Citation Index,” Journal of the Association for Information Science & Technology 67, no. 12 (2016): 2964–75; Angela Dresselhaus, “Literature of Acquisitions in Review, 2012–2013,” Library Resources & Technical Services 60, no. 3 (2016): 169–81; and Dian Walster, Deborah H. Charbonneau, and Kafi Kumasi, “Finding and Reading Reports of Research: How Academic Librarians Can Help Students Be More Successful,” Journal of Academic Librarianship 42, no. 6 (2016): 732–38.

16. Examples include: Cheryl D. Bain et al., “Using WorldShare Collection Evaluation to Analyze Physical Science and Engineering Monograph Holdings by Discipline,” Collection Management 41, no. 3 (2016): 133–51; Michael Hughes, “A Long-Term Study of Collection Use Based on Detailed Library of Congress Classification, a Statistical Tool for Collection Management Decisions,” Collection Management 41, no. 3 (2016): 152–67; Blanca Rodriguez-Bravo and Francisco Rodriguez-Sedano, “Trends in Library Collection Circulation in Spanish Universities,” Library Resources & Technical Services 60, no. 4 (2016): 248–58.

17. Examples include: Kelsey Renee Brett, Ashley Lierman, and Cherie Turner, “Lessons Learned: A Primo Usability Study,” Information Technology and Libraries 35, no. 1 (2016): 7–25; Reese Hoi Yin Fung, Dickson K.W. Chiu, Eddie H.T. Ko, Kevin K.W. Ho, and Patrick Lo, “Heuristic Usability Evaluation of University of Hong Kong Libraries’ Mobile Website,” Journal of Academic Librarianship 42, no. 5 (2016): 581–94; Joanne Oud, “Accessibility of Vendor-Created Database Tutorials for People with Disabilities,” Information Technology and Libraries 35, no. 4 (2016): 7–18; Kyunghye Yoon et al., “An Exploratory Study of Library Website Accessibility for Visually Impaired Users,” Library & Information Science Research 38, no. 3 (2016): 250–58.

18. Examples include: Çağrı Imamoğlu and Meltem Ö. Gürel, “‘Good Fences Make Good Neighbors’: Territorial Dividers Increase User Satisfaction and Efficiency in Library Study Spaces,” Journal of Academic Librarianship 42, no. 1 (2016): 65–73; Vera Lux, Robert J. Snyder, and Colleen Boff, “Why Users Come to the Library: A Case Study of Library and Non-Library Units,” Journal of Academic Librarianship 42, no. 2 (2016): 109–17; Silas M. Oliveira, “Space Preferences at James White Library: What Students Really Want,” Journal of Academic Librarianship 42, no. 4 (2016): 355–67.

19. Examples include: Edward Kai Fung Dang, Robert W.P. Luk, and James Allan, “A Context-Dependent Relevance Model,” Journal of the Association for Information Science & Technology 67, no. 3 (2016): 582–93; Bo Xu, Hongfei Lin, and Yuan Lin, “Assessment of Learning to Rank Methods for Query Expansion,” Journal of the Association for Information Science & Technology 67, no. 6 (2016): 1345–57.

20. Gloria J. Leckie, (1996). “Desperately Seeking Citations: Uncovering Faculty Assumptions About the Undergraduate Research Process,” Journal of Academic Librarianship 22, no. 3 (1996): 201–08.

21. Claire Warwick et al., “Cognitive Economy and Satisficing in Information Seeking: A Longitudinal Study of Undergraduate Information Behavior,” Journal of the American Society for Information Science & Technology 60, no. 12 (2009): 2402–15.

22. James P. Purdy, “Why First-Year College Students Select Online Research Resources as Their Favorite,” First Monday 17, no. 9 (2012).

23. Kyung-Sun Kim and Sei-Ching Joanna Sin, “Selecting Quality Sources: Bridging the Gap Between the Perception and Use of Information Sources,” Journal of Information Science 37, no. 2 (2011): 178–88.

24. Allison J. Head, Michele Van Hoeck, Jordan Eschler, and Sean Fullerton, “What Information Competencies Matter in Today’s Workplace?” Library and Information Research 37, no. 114 (2013): 75–104.

25. Barbara Fister, “Teaching the Rhetorical Dimensions of Research,” Research Strategies 11, no. 4 (1993): 211–19.

26. Jeanne R. Davidson and Carole Anne Crateau. “Intersections: Teaching Research Through a Rhetorical Lens,” Research Strategies 16, no. 4 (1998): 245–57.

27. Michelle Holschuh Simmons, “Librarians as Disciplinary Discourse Mediators: Using Genre Theory to Move toward Critical Information Literacy,” portal: Libraries and the Academy 5, no. 3 (2005): 297–311.

28. Benjamin R. Harris, “Communities as Necessity in Information Literacy Development: Challenging the Standards,” Journal of Academic Librarianship 34, no. 3 (2008): 250.

29. Allison Faix, “Assisting Students to Identify Sources: An Investigation,” Library Review 53, no. 8/9 (2014): 624–36.

30. Doug Brent, “Crossing Boundaries: Co-Op Students Relearning to Write,” College Composition and Communication 63, no. 4 (2012): 558–92; Sarah North, “Different Values, Different Skills? A Comparison of Essay Writing by Students from Arts and Science Backgrounds,” Studies in Higher Education 30, no. 5 (2005): 517–33.

31. Jens B. Asendorpf et al., “Recommendations for Increasing Replicability in Psychology,” European Journal of Personality 27, no. 2 (2013): 108–19.

32. Examples include: Shane W. Bench et al., “Does Expertise Matter in Replication? An Examination of the Reproducibility Project: Psychology,” Journal of Experimental Social Psychology 68 (2017): 181–84; and Alexander Etz and Joachim Vandekerckhove, “A Bayesian Perspective on the Reproducibility Project: Psychology,” Plos One 11, no. 2 (2016): 1–12.

33. Wolfgang Stroebe, “Are Most Published Social Psychological Findings False?” Journal of Experimental Social Psychology 66 (2016): 134–44.

34. Examples include: Mark J. Brandt et al., “The Replication Recipe: What Makes for a Convincing Replication?” Journal of Experimental Social Psychology 50 (2014): 217–24; and Sean Grant, Lukasz Cybulski, and Evan Mayo-Wilson, “Improving Transparency and Reproducibility through Registration: The Status of Intervention Trials Published in Clinical Psychology Journals,” Journal of Consulting and Clinical Psychology 84, no. 9 (2016): 753–67.

35. Uri Simonsohn, “Small Telescopes: Detectability and the Evaluation of Replication Results,” Psychological Science 26, no. 5 (2015): 559–69.

36. Timothy M. Errington et al., “Science Forum: An Open Investigation of the Reproducibility of Cancer Biology Research,” eLife 3 (2014).

37. Shirley J. Behrens, “A Conceptual Analysis and Historical Overview of Information Literacy,” College & Research Libraries 55, no. 4 (1994): 309–22; Frances L. Hopkins, “A Century of Bibliographyic Instruction: The Historical Claim to Professional and Academic Legitimacy,” College & Research Libraries 43, no. 3 (1982): 192–98; Mary F. Salony, “The History of Bibliographic Instruction: Changing Trends From Books to the Electronic World,” Reference Librarian 24, no. 51 (1995): 31–51.

38. Emily Drabinski, “Toward a Kairos of Library Instruction,” Journal of Academic Librarianship 40, no. 5 (2014): 480–85; Heidi L.M. Jacobs, “Information Literacy and Reflective Pedagogical Praxis,” Journal of Academic Librarianship 34, no. 3 (2008): 256–62.

39. ACRL Standards , “Information Literacy and Assessment.”

40. Notable examples of such thinking include: James Elmborg, “Critical Information Literacy: Implications for Instructional Practice,” Journal of Academic Librarianship 32, no. 2 (2006): 192–99; Edward K. Owusu-Ansah, “Information Literacy and the Academic Library: A Critical Look at a Concept and the Controversies Surrounding It,” Journal of Academic Librarianship 29, no. 4 (2003): 219–30; Troy A. Swanson, “Applying a Critical Pedagogical Perspective to Information Literacy Standards,” Community & Junior College Libraries 12, no. 4 (2004): 65–78: Eamon Tewell, “A Decade of Critical Information Literacy: A Review of the Literature,” Communications in Information Literacy 9, no. 1 (2015): 24–43.

41. ACRL Standards , “Information Literacy Defined”; ACRL Standards , “Information Literacy and Higher Education.”

42. Examples include: Brent, “Crossing Boundaries”; Jason Eyre, “Context and Learning: The Value and Limits of Library-Based Information Literacy Teaching,” Health Information and Libraries Journal 29, no. 4 (2012): 344–48; and Kaye Towlson and Nathan Rush, “Carving the Information Literacy Niche Within Graduate Employability ,” New Review of Academic Librarianship 19, no. 3 (2013): 300–15.

43. Amy E. Mark, “Privileging Peer Review: Implications for Undergraduates ,” Communications in Information Literacy 5, no. 1 (2011): 4–8.

44. Association of American Colleges & Universities, “Information Literacy VALUE Rubric” (2010), available online at https://www.aacu.org/value/rubrics/information-literacy [accessed 23 January 2018]; Middle States Association of Colleges and Schools Commission on Higher Education, Developing Research & Communication Skills: Guidelines for Information Literacy Instruction (Philadelphia: Middle States Commission on Higher Education, 2003).

45. Paul L. Hrycaj, “An Analysis of Online Syllabi for Credit-Bearing Library Skills Courses,” College & Research Libraries 67, no. 6 (2006): 525–35; Rachael E. Elrod, Elise D. Wallace, and Cecilia B. Sirigos, “Teaching Information Literacy: A Review of 100 Syllabi,” Southeastern Librarian 60, no. 3 (2012): 8–15.

46. Amy R. Hofer, Lori Townsend, and Korey Brunetti, “Troublesome Concepts and Information Literacy: Investigating Threshold Concepts for IL Instruction,” portal: Libraries and the Academy 12, no. 4 (2012): 387–405.

47. Shelley Gullikson, “Faculty Perceptions of ACRL’s Information Literacy Competency Standards for Higher Education,” Journal of Academic Librarianship 32, no. 6 (2006): 583–92.

48. Rolf Norgaard, “Writing Information Literacy: Contributions to a Concept,” Reference & User Services Quarterly 43, no. 2 (2003): 126.

49. ACRL Framework , “Introduction.”

50. Nancy M. Foasberg, “From Standards to Frameworks for IL: How the ACRL Framework Addresses Critiques of the Standards ,” portal: Libraries and the Academy 15, no. 4 (2015): 708.

51. ACRL Framework , “Introduction.”

52. Elizabeth Wardle and Linda Adler-Kassner, “Naming What We Know: The Project of This Book,” in Naming What We Know: Threshold Concepts of Writing Studies, eds. Linda Adler-Kassner and Elizabeth Wardle (Boulder: University Press of Colorado, 2015), 8.

53. William Badke, “A Rationale for Information Literacy as a Credit-Bearing Discipline ,” Journal of Information Literacy 2, no. 1 (2008).

54. Sommers and Saltz, “The Novice as Expert,” 132.

55. Amy J. Devitt, Writing Genres (Carbondale: Southern Illinois University Press, 2004).

56. Martin Luther King, Jr., Letter from a Birmingham Jail , available online at https://kinginstitute.stanford.edu/king-papers/documents/letter-birmingham-jail [accessed 23 January 2018].

57. Robert J. Connors, “The Rise and Fall of the Modes of Discourse,” College Composition and Communication 32, no. 4 (1981): 444–55.

58. George Hillocks, Jr., “The Focus on Form vs. Content in Teaching Writing,” Research in the Teaching of English 40, no. 2 (2005): 238–48.

59. Richard Feinberg and Christine King, “Short-Term Library Skill Competencies: Arguing for the Achievable,” College & Research Libraries 49, no. 1 (1988): 24–28.

60. Lori Townsend, Korey Brunetti, and Amy R. Hofer, “Threshold Concepts and Information Literacy,” portal: Libraries and the Academy 11, no. 3 (2011): 853–69.

61. Ian Beilin, “Beyond the Threshold: Conformity, Resistance, and the ACRL Information Literacy Framework for Higher Education,” In the Library with the Lead Pipe (Feb. 25, 2015), available online at www.inthelibrarywiththeleadpipe.org/2015/beyond-the-threshold-conformity-resistance-and-the-aclr-information-literacy-framework-for-higher-education/ [accessed 26 October 2018].

62. Christine Pawley, “Information Literacy: A Contradictory Coupling,” Library Quarterly 73, no. 4 (2003): 422–52.

63. Simmons, “Librarians as Disciplinary Discourse Mediators,” 302.

64. Wardle and Adler-Kassner, “Metaconcept,” 16.

* Allison Hosier is Information Literacy Librarian in the University Libraries at the University at Albany, State University of New York; email: [email protected] . ©2019 Allison Hosier, Attribution-NonCommercial ( http://creativecommons.org/licenses/by-nc/4.0/ ) CC BY-NC.

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Defining Research with Human Subjects

A study is considered research with human subjects if it meets the definitions of both research AND human subjects, as defined in the federal regulations for protecting research subjects.

Research.  A systematic inquiry designed to answer a research question or contribute to a field of knowledge, including pilot studies and research development.

Human subject:  A living individual about whom an investigator (whether professional or student) conducting research:

• Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
• Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

The following sections will explain some of the words in the previous definitions.

The regulatory language:

A systematic inquiry designed to answer a research question or contribute to a field of knowledge, including pilot studies and research development.

The explanation:

Understanding what constitutes a systematic inquiry varies among disciplines and depends on the procedures and steps used to answer research questions and how the search for knowledge is organize and structured.

Pilot Studies and Research Development

Pilot studies are designed to conduct preliminary analyses before committing to a full-blown study or experiment.

Research development includes activities such as convening a focus group consisting of members of the proposed research population to help develop a culturally appropriate questionnaire.

Practical applications:

• You are conducting a pilot study or other activities preliminary to research; or
• You have designed a study to collect information or biospecimens in a systematic way to answer a research question; or
• You intend to study, analyze, or otherwise use existing information or biospecimens to answer a research question.

Human Subjects

Human subjects are living individuals about whom researchers obtain information or biospecimens through interaction, intervention, or observation of private behavior, to also include the use, study, and analysis of said information or biospecimens.

Obtaining, using, analyzing, and generating identifiable private information or identifiable biospecimens that are provided to a researcher is also considered to be human subjects.

To meet the definition of human subjects, the data being collected or used are about people. Asking participants questions about their attitudes, opinions, preferences, behavior, experiences, background/history, and characteristics, or analyzing demographic, academic or medical records, are just some examples of human subjects data.

• Interacting with people to gather data about them using methods such as interviews, focus groups, questionnaires, and participant observation; or
• Conducting interventions with people such as experiments or manipulations of subjects or subjects' environments; or
• Observing or recording behavior, whether in-person and captured in real time or in virtual spaces, like social media sites (e.g., Twitter) or online forums (e.g., Reddit); or
• Obtaining existing information about individuals, such as students’ school records or patients’ health records, or data sets provided by another researcher or organization.

Interactions and Interventions

Interventions are manipulations of the subject or the subject's environment, for example is a behavioral change study using text messages about healthy foods.

Interactions include communication or interpersonal contact between investigator and participant.

A study may include both interventions and interactions.

Interactions and interventions do not require in-person contact, but may be conducted on-line.

Private Information

Private information  includes information or biospecimens: 1) about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place; 2) that has been provided for specific purposes by an individual; and 3) that the individual can reasonably expect will not be made public (for example, a medical record).

Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for the information to constitute research involving human subjects.

The regulations are clear that it is the subjects’ expectations that determine what behaviors, biospecimens, and identifiable information must be considered private. Subjects’ understanding of what privacy means are not universal, but are very specific and based on multiple interrelated factors, such as the research setting, cultural norms, the age of the subjects, and life experiences. For example, in the United States, health records are considered private and protected by law, but in some countries, health information is not considered private but are of communal concern. 

Identifiable Information

The identity of the subject is associated with the data gathered from the subject(s) existing data about the subjects. Even if the data (including biospecimens) do not include direct identifiers, such as names or email addresses, the data are considered identifiable if names of individuals can easily be deduced from the data.

If there are keys linking individuals to their data, the data are considered identifiable.

Levels of Review

Not all projects that meet the definition of research with human subjects need review by the actual committee. For example, projects that pose  negligible risk to participants may be reviewed and recommended for approval by IRB staff ; other projects may need to undergo review and approval by at least one member of the IRB committee or a quorum of the full board. Determination as to the need for review should always be made by the IRB staff.

Examples of Studies That MAY Meet the Definition of Research with Human Subjects

The following examples will likely require further consultation with an IRB staff member.

Analysis of existing information with no identifiers

If researchers have no interaction with human subjects, but will be conducting a secondary analysis of existing data without individual identifiers, the analysis of those data may not be research with human subjects. 

Expert consultation

Key words in the definition of a human subject are "a living individual about whom" a researcher obtains, uses, studies, analyzes, or generates information. People can provide you information that is not about them but is important for the research. For example, a researcher may contact non-governmental organizations to ask about sources of funding.

Program evaluations and quality improvement studies

Program evaluations are generally intended to query whether a particular program or curriculum meets its goals. They often involve pre- and post-surveys or evaluations.

Some program evaluations include a research component. If data are collected about the characteristics of the participants to analyze the relationship between demographic variable and success of the program, the study may become research with human subjects.  Research question:  Are there different learning outcomes associated with different levels of participant confidence?

Classroom research

Classes designed to teach research methods such as fieldwork, statistical analysis, or interview techniques, may assign students to conduct interviews, distribute questionnaires, or engage in participant observation. If the purpose of these activities is solely pedagogical and are not designed to contribute to a body of knowledge, the activities do not meet the definition of research with human subjects. 

Vignettes: Applying the Definitions

Art in Cambodia

An art history student wants to study art created by Cambodians in response to the massacres committed by the Khmer Rouge. The art she will study includes paintings, sculpture, video, and the performing arts.

Much of the research will be archival, using library and online resources. In addition, she will visit Cambodia. While there, she will speak with several museum curators for assistance locating and viewing art collections related to the massacres.

Is this research with human subjects?

No. Although the student will speak with curators, they are not the subjects of her research and she is not interested in learning anything about them. They will, in effect, serve as local guides.

What would make the study research with human subjects?

The student interviews people as they interact with art to understand the role of the arts in evoking and/or coming to terms with traumatic past events. She interviews people who view the art, such as visitors to museums, and discusses what the art means to them. She may collect information about their experiences during the genocide and compare those experiences with their reactions to the art. 

Bank-Supported Micro-Finance in Chile

A researcher is interested in the practice of microfinance in the Chilean Mapuche community. She meets with bankers and asks about the criteria for granting loans, the demographics of the people who receive loans, the types of businesses to which the bank prefers to grant loans, how many loans they give, the payback rates, and other data about the bank’s loan practices.

No. Although the researcher is interviewing bankers, the bankers are only providing information about their banking practices and are not providing any information about themselves. The questions are about “what” rather than “about whom.” The bankers are not human subjects. This type of interview is sometimes referred to as expert consultation.

The researcher explores the impact of small loans, both intended and unintended, on the recipients of the loans. The researcher interviews the recipients of the loans and gathers information from them about their lives before and after they received funding, how the loans affected their relationships with family members and other community members, the impact of the loans on their aspirations, and so on. He asks “about whom” questions designed to understand the impact of micro-loans.

Developing Teaching Materials

A researcher goes to a country in which the infrastructure has been severely damaged to help rebuild schools. The student interviews community members about what curricular materials they need, develops some materials, and teaches a math class.

No. Although interviews are conducted, the intent of interviewing is to assist in resource development rather than answer a research question designed to contribute to a field of knowledge.

If the researcher does pre- and post-testing to assess student learning in his class, is this research with human subjects?

No. The intent is to find out if the materials are effective. This is sometimes referred to as program assessment.

What would make this research with human subjects?

The researcher studies the impact of nutrition and personal variables on learning. He assesses the nutritional composition of the local diet, assesses students’ general health, and compares those data with test scores. He also measures motivation, family composition, and other characteristics of the students using written questionnaires.

Water Conservation

A researcher wants to find out if the campus water conservation program is effective. She will gather some information about water volume usage from the University engineering department. She will also survey residential students about their water usage habits over the last six months, their perceptions of the campus drought education program, and their reactions to the incentives offered by the program (water-saving competitions, free water-saving devices, etc.) She will report her findings to the program’s steering committee and administrators.

No. Although the researcher will systematically survey other students and will be collecting information about them, her intention is to assess the effectiveness of the conservation program.

The researcher designs an online survey to collect information that may help understand factors that influence the residential students’ responses to the conservation program. She asks questions about green attitudes and behaviors, positions on social and political issues, as well as motivation and narcissism.

Campus IRB Guides

Research vs. Study

What's the difference.

Research and study are two essential components of the learning process, but they differ in their approach and purpose. Research involves a systematic investigation of a particular topic or issue, aiming to discover new knowledge or validate existing theories. It often involves collecting and analyzing data, conducting experiments, and drawing conclusions. On the other hand, study refers to the process of acquiring knowledge or understanding through reading, memorizing, and reviewing information. It is typically focused on a specific subject or discipline and aims to deepen one's understanding or mastery of that subject. While research is more exploratory and investigative, study is more focused on acquiring and retaining information. Both research and study are crucial for intellectual growth and expanding our knowledge base.

Further Detail

Introduction.

Research and study are two fundamental activities that play a crucial role in acquiring knowledge and understanding. While they share similarities, they also have distinct attributes that set them apart. In this article, we will explore the characteristics of research and study, highlighting their differences and similarities.

Definition and Purpose

Research is a systematic investigation aimed at discovering new knowledge, expanding existing knowledge, or solving specific problems. It involves gathering and analyzing data, formulating hypotheses, and drawing conclusions based on evidence. Research is often conducted in a structured and scientific manner, employing various methodologies and techniques.

On the other hand, study refers to the process of acquiring knowledge through reading, memorizing, and understanding information. It involves examining and learning from existing materials, such as textbooks, articles, or lectures. The purpose of study is to gain a comprehensive understanding of a particular subject or topic.

Approach and Methodology

Research typically follows a systematic approach, involving the formulation of research questions or hypotheses, designing experiments or surveys, collecting and analyzing data, and drawing conclusions. It often requires a rigorous methodology, including literature review, data collection, statistical analysis, and peer review. Research can be qualitative or quantitative, depending on the nature of the investigation.

Study, on the other hand, does not necessarily follow a specific methodology. It can be more flexible and personalized, allowing individuals to choose their own approach to learning. Study often involves reading and analyzing existing materials, taking notes, summarizing information, and engaging in discussions or self-reflection. While study can be structured, it is generally less formalized compared to research.

Scope and Depth

Research tends to have a broader scope and aims to contribute to the overall body of knowledge in a particular field. It often involves exploring new areas, pushing boundaries, and generating original insights. Research can be interdisciplinary, involving multiple disciplines and perspectives. The depth of research is often extensive, requiring in-depth analysis, critical thinking, and the ability to synthesize complex information.

Study, on the other hand, is usually more focused and specific. It aims to gain a comprehensive understanding of a particular subject or topic within an existing body of knowledge. Study can be deep and detailed, but it is often limited to the available resources and materials. While study may not contribute directly to the advancement of knowledge, it plays a crucial role in building a solid foundation of understanding.

Application and Output

Research is often driven by the desire to solve real-world problems or contribute to practical applications. The output of research can take various forms, including scientific papers, patents, policy recommendations, or technological advancements. Research findings are typically shared with the academic community and the public, aiming to advance knowledge and improve society.

Study, on the other hand, focuses more on personal development and learning. The application of study is often seen in academic settings, where individuals acquire knowledge to excel in their studies or careers. The output of study is usually reflected in improved understanding, enhanced critical thinking skills, and the ability to apply knowledge in practical situations.

Limitations and Challenges

Research faces several challenges, including limited resources, time constraints, ethical considerations, and the potential for bias. Conducting research requires careful planning, data collection, and analysis, which can be time-consuming and costly. Researchers must also navigate ethical guidelines and ensure the validity and reliability of their findings.

Study, on the other hand, may face challenges such as information overload, lack of motivation, or difficulty in finding reliable sources. It requires self-discipline, time management, and the ability to filter and prioritize information. Without proper guidance or structure, study can sometimes lead to superficial understanding or misconceptions.

In conclusion, research and study are both essential activities in the pursuit of knowledge and understanding. While research focuses on generating new knowledge and solving problems through a systematic approach, study aims to acquire and comprehend existing information. Research tends to be more formalized, rigorous, and contributes to the advancement of knowledge, while study is often more flexible, personalized, and focused on individual learning. Both research and study have their unique attributes and challenges, but together they form the foundation for intellectual growth and development.

Comparisons may contain inaccurate information about people, places, or facts. Please report any issues.

How to appropriately choose research subjects

Affiliation.

• 1 Consulting Center of Biomedical Statistics, Academy of Military Medical Sciences, Beijing 100850, China. [email protected]
• PMID: 21419075
• DOI: 10.3736/jcim20110303

The research subject is the first key element of the three key elements in the research design. An appropriate selection of research subjects is crucial to the success of the research. This article summarizes the general principles for the selection of research subjects, the types and numbers of research subjects and the common mistakes that researchers tend to make in the selection of the research subjects. This article also provides the methodology suggestions for the selection of research subjects.

• Patient Selection*
• Research Design*

Information for Research Subjects

Learn about becoming a research participant at the University of Rochester

True to the University of Rochester’s Mission Statement, ‘Learn, Discover, Heal, Create—and Make the World Ever Better’, research has been a long-standing tradition at the University of Rochester . Our researchers are among the nation’s leaders across a wide range of fields, including medicine, human behavior, education, politics, optics and economics.

Find an open research study

Faqs: participating in research.

Participating in research can be a fun and exciting way to give back to your community, but it doesn’t necessarily come without risk. Becoming a research participant is an important decision that should be taken seriously.

Background and overview

Research studies are done to discover new information or to answer a question about how we learn, behave, and function. Some studies might involve simple tasks like completing a survey, being observed among a group of people, or participating in a group discussion. Other studies, sometimes called clinical trials, involve more risky procedures like testing a new drug or medical device.

Each research study has its own set of criteria to determine who can participate. This depends on the research question being asked and may include restrictions based on age, behaviors, health status, or other traits.

Deciding to participate

Research is designed to benefit society. This might include learning how to live healthier lives, how to better treat conditions or diseases, why we do the things we do, or how we learn and develop. And while there are several reasons why people choose to participate in research, most people participate based on the possibility of helping themselves or others.

It’s important to understand that you may not directly benefit from participating in research. In fact, with a lot of research, you will not receive any benefit. For some types of research however, there may be a possibility that you could receive benefit, but there is no guarantee.

Most studies involve some risk, though the risks can range from very small to very serious. Some examples of risks include:

• side effects or reactions to experimental drugs, treatments, or procedures
• feeling anxious or uncomfortable
• breach in confidentiality or invasion of privacy.

Side effects or other risks you might experience may be temporary or go away with treatment, but in rare cases they may be permanent, cause disability, or be life threatening. There may also be risks in participating that we don’t know about.

To start, you will be given information about the study so that you can make an informed decision about whether or not to participate. You will also be given an opportunity to ask questions about the study. This process is called informed consent . Before you can start the study, you need to agree to participate (i.e., consent). Participation is always voluntary.

Once you provide consent, the specific procedures or activities you’ll be asked to complete can vary widely and depend on what is being studied. Regardless, all the activities you will be asked to complete will be described during the consent process.

Before you agree to be in the study, make sure you have a solid understanding of the following:

• the voluntary nature of the study
• why the study is being done
• who is doing the study
• the procedures, activities, tests, or treatments involved (including how long they will take, how often they have to be completed, and whether there are any other treatment options available rather than being in the study)
• potential risks, discomforts, or side effects
• potential benefits to participating, if any
• how your privacy will be protected
• how long your participation will last
• what will happen if you are injured while participating
• the costs to you, if any
• what to do if you change your mind about participating
• whom to contact with questions, concerns, or problems

Each study is different, so time requirements will vary. Some may require very little of your time, perhaps only 5–10 minutes, while others may require multiple visits over an extended period of time, sometimes up to several years. Your time commitment for a particular study will be described during the consent process.

informed consent

Informed consent is the process of telling interested individuals what is involved in taking part in a specific research study. Typically, this includes:

• reviewing written information
• giving the potential volunteer time to review this information while considering participation (taking it home to review with friends or family, if desired)
• discussing the information verbally
• answering any questions

Once all of the information is provided to you and your questions are answered, you will then be asked to decide whether or not to take part in the study.

All decisions are voluntary, and you must provide your agreement (i.e., consent) before any study activities can begin. Usually, this involves signing a consent form. Although, for some studies, verbally agreeing to participate may be sufficient.

Once you provide consent to be in the study, you will continue to receive important information about your participation throughout the study.

It’s important to understand what is involved in taking part in a research study and to carefully consider what that means for you. Research can pose risks to your health, safety, and welfare, so it’s important to understand exactly what those risks are.

It’s also important to understand that taking part in research is voluntary. You make the decision about whether or not to participate, and if you agree to take part, you can always change your mind later.

State law determines who can provide consent. In New York State, only individuals 18 years of age and older can provide consent. Minors, based on their age and ability, are usually asked for their agreement to participate in research, but their parent or legal guardian must also provide their permission to participate. Other special considerations are also made when a minor is a ward of the state or adults are unable to make decisions for themselves.

If you have questions about who can or cannot provide consent, be sure to ask the study team.

The following key points are most important about informed consent:

• Being in a study is voluntary—it is your choice.
• If you join a study, you can change your mind and stop at any time.
• If you have questions about anything that is not clear to you, you can ask them at any point of time before, during, or after the study.
• If you feel you need more time or information to make an informed decision about whether or not to take part in the study, do not hesitate to ask for it.

Subject Protections

Research studies involving humans must be approved and monitored by an Institutional Review Board (IRB). An IRB is a committee of individuals responsible for reviewing research to ensure adequate protections are in place to protect the people who take part.

For each study reviewed, the IRB checks to see that:

• there is a good reason to conduct the study
• the risks related to participating are the least possible
• the risks related to participating are reasonable given the knowledge that will be gained from conducting the study
• the plan for selecting subjects to participate is fair
• subjects will be provided enough information about the study

Protecting the information you provide to researchers is a high priority, particularly if you provide health-related or sensitive information.

As part of the IRB approval process described above, all researchers must provide a plan to adequately protect the information they plan to collect in order for the study to be approved. This might include assigning a code to the information collected instead of using your name or other identifiable information and storing the information in a secure manner.

You are free to withdraw from a research study at any time, for any reason. Your relationship with the hospital, clinic, academic institution, or employer will not be affected and you will not lose any benefits to which you are entitled.

Note that in some cases, a researcher may decide to end your participation in the study early. This may happen if the study is no longer in your best interest, if you can no longer complete study activities, or if the study ends early for some other reason.

Additional participant resources

Downloadable information.

• Participating in Research Overview
• Informed Consent

External resources

• About Research Participation (Department of Health & Human Service)
• Children & Clinical Studies (National Heart, Lung & Blood Institute)
• Clinical Research Trials and You (National Institutes of Health)

University research studies

• Search UR Health Research
• Join the UR Health Research Volunteer Registry to be contacted for future studies
• Follow UR Health Research on Facebook
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How to print from a samsung tablet, how to fix a frozen samsung tablet.

Object And Subject Of Research — What Is The Difference?

In the process of studying, students will have to devote a lot of time to research essays. After all, this allows you to deepen knowledge, teach you to analyze and systematize information, to engage in independent work. However, getting assistance from thesis helper will definitely save your time.

But first, you need to understand such concepts as the object and subject of research. Otherwise, you will not be able to make successful research and get results. Everything is quite simple: the object is what you are studying, and the subject is properties and functions.

Even though it seems to be quite simple, many students still experience difficulties while defining an object and the subject.

A good option is to address the EssaysMatch website and get professional help there. The experienced authors know exactly how to write a perfect paper so that you will get the highest grade.

Object Of Study

If you want your scientific work to be successful and correct, you need to immediately determine the main ideas.

Although the meaning of the terms necessary for your research can be found in the dictionary, in practice, it is quite difficult to apply it. An object is a rather broad concept, it includes many properties, therefore, it is easier to define it in your own research than an object.

Speaking in the language of science: The object of research is an object or phenomenon that exists in the material world and is not affected by human activity. It is also part of the knowledge that a scientist (or student) is working on. Often the object is tightly connected with the topic but does not duplicate it.

Subject Of Study

It is worth saying that in the current terminology there are no clear differences between the subject and the object. But for convenience, the subject is used to mean certain properties of an object. The analysis cannot include all aspects of the object, so you need to immediately choose a specific one and devote all research to it.

When determining the subject, it is better to ask yourself the question “what will be studied?” These are phenomena, relations, and everything that specifies and separates the object from the rest of the information.

Examples And Differences

Remember that the subject of research is tightly connected to the topic of research, therefore it is often duplicated. The object is a larger area that can be explored from different angles. Moreover, the subject is a secondary concept, and the object is a primary one, as it relates to a part of the system. 

When talking about the subject, you can devote a lot of time to the description and it is correct. At the same time, the object can be described in a couple of words or sentences.

If you initially make the right questions and share concepts, you will not have problems with the formulation and writing of scientific work. This is precisely the purpose of the study — to teach the student to share and systematize.

Scientific terms and concepts are sometimes difficult to understand to see important differences. But it depends on how successful the study will be and what you will be able to identify. So, before you start the analysis, you need to study the concepts and choose an interesting direction or area.

The maximum of facts and interesting information, skillful use of terms, and clear presentation will make your work better! And remember, your professors are always ready to help and explain the essence of each concept.

Daniel with his strong cybersecurity analyst background, unfold intricate digital privacy realms, offering readers strategic pathways to navigate the web securely. A connoisseur of online security narratives, specializing in creating content that bridges technological know-how with essential business insights.

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• Human Subjects

Definition of Human Subjects Research

• Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
• Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens."

Decision Tool: Am I Doing Human Subjects Research?  

The questionnaire is a tool to assist you with determining whether your project involves non-exempt human subjects research, meets the criteria for exempt human subjects research, or does not involve human subjects research. 

Human Subjects Research Infographic

This resource summarizes the definition of human subjects research and provides examples of human subjects research projects. It also describes what you will need when you are preparing your NIH application and what is required if you are funded.

Exempt Human Subjects Research Infographic

This resource is a guide to simplify the understanding of the exemptions from the federal regulations for the protection of human subjects research. It summarizes Exemptions 1, 2, 3, 4, 5, 6, 7 and 8, providing basic definitions, examples of studies that meet and do not meet the criteria of the exemption, and aspects one must consider when engaged in exempt or non-exempt human subjects research. 

Research Involving Private Information or Biospecimens Flowchart

Studies involving the use of human specimens or data may or may not be considered to be research involving human subjects, depending on the details of the materials to be used. Use this flowchart to help determine if studies involving private information or biospecimens may meet the definition of human subjects research.

Public Health Surveillance Exclusions

Learn about research activities which may qualify for a public health surveillance exclusion. Find useful information, key resources, and instructions for NIH applicants and offerors.

This page last updated on: January 13, 2020

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10.1 Overview of Single-Subject Research

Learning objectives.

• Explain what single-subject research is, including how it differs from other types of psychological research.
• Explain what case studies are, including some of their strengths and weaknesses.
• Explain who uses single-subject research and why.

What Is Single-Subject Research?

Single-subject research is a type of quantitative research that involves studying in detail the behavior of each of a small number of participants. Note that the term single-subject does not mean that only one participant is studied; it is more typical for there to be somewhere between two and 10 participants. (This is why single-subject research designs are sometimes called small- n designs, where n is the statistical symbol for the sample size.) Single-subject research can be contrasted with group research , which typically involves studying large numbers of participants and examining their behavior primarily in terms of group means, standard deviations, and so on. The majority of this book is devoted to understanding group research, which is the most common approach in psychology. But single-subject research is an important alternative, and it is the primary approach in some areas of psychology.

Before continuing, it is important to distinguish single-subject research from two other approaches, both of which involve studying in detail a small number of participants. One is qualitative research, which focuses on understanding people’s subjective experience by collecting relatively unstructured data (e.g., detailed interviews) and analyzing those data using narrative rather than quantitative techniques. Single-subject research, in contrast, focuses on understanding objective behavior through experimental manipulation and control, collecting highly structured data, and analyzing those data quantitatively.

It is also important to distinguish single-subject research from case studies. A case study is a detailed description of an individual, which can include both qualitative and quantitative analyses. (Case studies that include only qualitative analyses can be considered a type of qualitative research.) The history of psychology is filled with influential cases studies, such as Sigmund Freud’s description of “Anna O.” (see Note 10.5 “The Case of “Anna O.”” ) and John Watson and Rosalie Rayner’s description of Little Albert (Watson & Rayner, 1920), who learned to fear a white rat—along with other furry objects—when the researchers made a loud noise while he was playing with the rat. Case studies can be useful for suggesting new research questions and for illustrating general principles. They can also help researchers understand rare phenomena, such as the effects of damage to a specific part of the human brain. As a general rule, however, case studies cannot substitute for carefully designed group or single-subject research studies. One reason is that case studies usually do not allow researchers to determine whether specific events are causally related, or even related at all. For example, if a patient is described in a case study as having been sexually abused as a child and then as having developed an eating disorder as a teenager, there is no way to determine whether these two events had anything to do with each other. A second reason is that an individual case can always be unusual in some way and therefore be unrepresentative of people more generally. Thus case studies have serious problems with both internal and external validity.

The Case of “Anna O.”

Sigmund Freud used the case of a young woman he called “Anna O.” to illustrate many principles of his theory of psychoanalysis (Freud, 1961). (Her real name was Bertha Pappenheim, and she was an early feminist who went on to make important contributions to the field of social work.) Anna had come to Freud’s colleague Josef Breuer around 1880 with a variety of odd physical and psychological symptoms. One of them was that for several weeks she was unable to drink any fluids. According to Freud,

She would take up the glass of water that she longed for, but as soon as it touched her lips she would push it away like someone suffering from hydrophobia.…She lived only on fruit, such as melons, etc., so as to lessen her tormenting thirst (p. 9).

But according to Freud, a breakthrough came one day while Anna was under hypnosis.

[S]he grumbled about her English “lady-companion,” whom she did not care for, and went on to describe, with every sign of disgust, how she had once gone into this lady’s room and how her little dog—horrid creature!—had drunk out of a glass there. The patient had said nothing, as she had wanted to be polite. After giving further energetic expression to the anger she had held back, she asked for something to drink, drank a large quantity of water without any difficulty, and awoke from her hypnosis with the glass at her lips; and thereupon the disturbance vanished, never to return.

Freud’s interpretation was that Anna had repressed the memory of this incident along with the emotion that it triggered and that this was what had caused her inability to drink. Furthermore, her recollection of the incident, along with her expression of the emotion she had repressed, caused the symptom to go away.

As an illustration of Freud’s theory, the case study of Anna O. is quite effective. As evidence for the theory, however, it is essentially worthless. The description provides no way of knowing whether Anna had really repressed the memory of the dog drinking from the glass, whether this repression had caused her inability to drink, or whether recalling this “trauma” relieved the symptom. It is also unclear from this case study how typical or atypical Anna’s experience was.

Figure 10.2

“Anna O.” was the subject of a famous case study used by Freud to illustrate the principles of psychoanalysis.

Wikimedia Commons – public domain.

Assumptions of Single-Subject Research

Again, single-subject research involves studying a small number of participants and focusing intensively on the behavior of each one. But why take this approach instead of the group approach? There are several important assumptions underlying single-subject research, and it will help to consider them now.

First and foremost is the assumption that it is important to focus intensively on the behavior of individual participants. One reason for this is that group research can hide individual differences and generate results that do not represent the behavior of any individual. For example, a treatment that has a positive effect for half the people exposed to it but a negative effect for the other half would, on average, appear to have no effect at all. Single-subject research, however, would likely reveal these individual differences. A second reason to focus intensively on individuals is that sometimes it is the behavior of a particular individual that is primarily of interest. A school psychologist, for example, might be interested in changing the behavior of a particular disruptive student. Although previous published research (both single-subject and group research) is likely to provide some guidance on how to do this, conducting a study on this student would be more direct and probably more effective.

A second assumption of single-subject research is that it is important to discover causal relationships through the manipulation of an independent variable, the careful measurement of a dependent variable, and the control of extraneous variables. For this reason, single-subject research is often considered a type of experimental research with good internal validity. Recall, for example, that Hall and his colleagues measured their dependent variable (studying) many times—first under a no-treatment control condition, then under a treatment condition (positive teacher attention), and then again under the control condition. Because there was a clear increase in studying when the treatment was introduced, a decrease when it was removed, and an increase when it was reintroduced, there is little doubt that the treatment was the cause of the improvement.

A third assumption of single-subject research is that it is important to study strong and consistent effects that have biological or social importance. Applied researchers, in particular, are interested in treatments that have substantial effects on important behaviors and that can be implemented reliably in the real-world contexts in which they occur. This is sometimes referred to as social validity (Wolf, 1976). The study by Hall and his colleagues, for example, had good social validity because it showed strong and consistent effects of positive teacher attention on a behavior that is of obvious importance to teachers, parents, and students. Furthermore, the teachers found the treatment easy to implement, even in their often chaotic elementary school classrooms.

Who Uses Single-Subject Research?

Single-subject research has been around as long as the field of psychology itself. In the late 1800s, one of psychology’s founders, Wilhelm Wundt, studied sensation and consciousness by focusing intensively on each of a small number of research participants. Herman Ebbinghaus’s research on memory and Ivan Pavlov’s research on classical conditioning are other early examples, both of which are still described in almost every introductory psychology textbook.

In the middle of the 20th century, B. F. Skinner clarified many of the assumptions underlying single-subject research and refined many of its techniques (Skinner, 1938). He and other researchers then used it to describe how rewards, punishments, and other external factors affect behavior over time. This work was carried out primarily using nonhuman subjects—mostly rats and pigeons. This approach, which Skinner called the experimental analysis of behavior —remains an important subfield of psychology and continues to rely almost exclusively on single-subject research. For excellent examples of this work, look at any issue of the Journal of the Experimental Analysis of Behavior . By the 1960s, many researchers were interested in using this approach to conduct applied research primarily with humans—a subfield now called applied behavior analysis (Baer, Wolf, & Risley, 1968). Applied behavior analysis plays an especially important role in contemporary research on developmental disabilities, education, organizational behavior, and health, among many other areas. Excellent examples of this work (including the study by Hall and his colleagues) can be found in the Journal of Applied Behavior Analysis .

Although most contemporary single-subject research is conducted from the behavioral perspective, it can in principle be used to address questions framed in terms of any theoretical perspective. For example, a studying technique based on cognitive principles of learning and memory could be evaluated by testing it on individual high school students using the single-subject approach. The single-subject approach can also be used by clinicians who take any theoretical perspective—behavioral, cognitive, psychodynamic, or humanistic—to study processes of therapeutic change with individual clients and to document their clients’ improvement (Kazdin, 1982).

Key Takeaways

• Single-subject research—which involves testing a small number of participants and focusing intensively on the behavior of each individual—is an important alternative to group research in psychology.
• Single-subject studies must be distinguished from case studies, in which an individual case is described in detail. Case studies can be useful for generating new research questions, for studying rare phenomena, and for illustrating general principles. However, they cannot substitute for carefully controlled experimental or correlational studies because they are low in internal and external validity.
• Single-subject research has been around since the beginning of the field of psychology. Today it is most strongly associated with the behavioral theoretical perspective, but it can in principle be used to study behavior from any perspective.
• Practice: Find and read a published article in psychology that reports new single-subject research. (A good source of articles published in the Journal of Applied Behavior Analysis can be found at http://seab.envmed.rochester.edu/jaba/jabaMostPop-2011.html .) Write a short summary of the study.

Practice: Find and read a published case study in psychology. (Use case study as a key term in a PsycINFO search.) Then do the following:

• Describe one problem related to internal validity.
• Describe one problem related to external validity.
• Generate one hypothesis suggested by the case study that might be interesting to test in a systematic single-subject or group study.

Baer, D. M., Wolf, M. M., & Risley, T. R. (1968). Some current dimensions of applied behavior analysis. Journal of Applied Behavior Analysis , 1 , 91–97.

Freud, S. (1961). Five lectures on psycho-analysis . New York, NY: Norton.

Kazdin, A. E. (1982). Single-case research designs: Methods for clinical and applied settings . New York, NY: Oxford University Press.

Skinner, B. F. (1938). The behavior of organisms: An experimental analysis . New York, NY: Appleton-Century-Crofts.

Watson, J. B., & Rayner, R. (1920). Conditioned emotional reactions. Journal of Experimental Psychology , 3 , 1–14.

Wolf, M. (1976). Social validity: The case for subjective measurement or how applied behavior analysis is finding its heart. Journal of Applied Behavior Analysis, 11 , 203–214.

Research Methods in Psychology Copyright © 2016 by University of Minnesota is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License , except where otherwise noted.

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What Is Human Subjects Research?

Department of Philosophy, Dalhousie University

• Published: 15 December 2020
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This chapter provides an overview of the nature, scope, and practice of human subjects research. It begins by tackling the general question, “What is research?” Attempts to answer this question typically define research by its methods and/or goals, and the chapter surveys the limits of these definitions through discussion of tough boundary cases. Along the way, the chapter describes various methods (quantitative, qualitative) and types of human subjects research (clinical, social scientific, etc.). The second section of the chapter investigates who is referred to by the language of “human subjects”: which humans tend to be selected as research participants, where human subjects are located globally, and how these locations are changing. The chapter also raises questions about which subjects are considered human in this context, for instance, whether definitions include embryos, cadavers, or stem cells. Throughout, the chapter highlights the ethical issues raised by the various types of activities and subjects described.

Which of the following is human subjects research?

A clinician conducts a placebo-controlled, double-blind, randomized trial of a new treatment for depression.

A sociologist conducts a series of in-depth interviews with paramedics and firefighters about their experiences of burnout, which are then transcribed and analyzed for common themes.

On the basis of published research indicating a reduction of adverse events, a hospital administrator implements mandatory surgical checklists in one of their operating rooms and tracks the outcomes compared to the hospital’s other operating rooms; the administrator hopes that the expected positive results will help to convince reluctant hospital staff to adopt surgical checklists.

A team of economists selects three cities, sends invitation letters to all low-income citizens in those selected cities, and then partners with local government to provide a basic income to selected individuals for three years, tracking a range of health and life outcomes.

A patient seeks care from a family physician for a rare heart condition; after several unsuccessful treatments, the physician tries an unusual combination of medications, and the patient reports feeling much better.

Same as example 5, but the physician then writes up the case for publication in a peer-reviewed medical journal.

A pediatric oncologist offers patients with an otherwise untreatable form of cancer the option to try promising new treatments that are in the earliest stages of development.

Medical students manipulate human embryos in order to learn how to extract cells for genetic tests.

A geneticist analyzes and sequences the DNA from blood samples collected decades ago from the members of a marginal population.

If you found yourself struggling to decide which of these counts as human subjects research, you are not alone: experts and newcomers to research ethics alike find this task difficult. In fact, even highly respected regulatory bodies and authors of codes of ethics struggle to articulate clear and consistent answers to this question (for examples, see the opening chapters in this handbook). And because an affirmative answer to the question is thought to determine which activities are in need of prospective ethics review, the stakes of this debate are thought to be quite high.

The difficulty of this task persists for many reasons but, in particular, because both key concepts in the question—“research” and “human subjects”—are hard to define and plagued by tough, and ever-evolving, boundary cases. In what follows, I will outline these controversies and investigate whether there might be a clear sorting mechanism for the kinds of cases just outlined. For both concepts (“research” and “human subjects”), I will show that a clear definition is hard, if not impossible, to find. But this may not be as big a problem as it seems. In order to explain why not, I will explore a common underlying assumption about the high stakes of this assessment: the presumed connection between ethics and a particular type of regulatory review in human subjects research. Clarifying this relationship will help to defuse the worry about demarcation criteria for these concepts.

What is research? This is a harder question to answer than one might expect: any answer is in danger of being either underinclusive (for instance, by focusing narrowly on medical research when similar activities are carried out by researchers in other disciplines or professions) or overinclusive (labeling everything vaguely experimental or involving human interaction as research). The Tri-Council Policy Statement (TCPS 2) in Canada begins with a reflection on the broad range of practices and activities that qualify as research, before proposing a definition:

The scope of research is vast. On the purely physical side, it ranges from seeking to understand the origins of the universe down to the fundamental nature of matter. At the analytic level, it covers mathematics, logic and metaphysics. Research involving humans ranges widely, including attempts to understand the broad sweep of history, the workings of the human body and the body politic, the nature of human interactions and the impact of nature on humans—the list is as boundless as the human imagination. For the purposes of this Policy, research is defined as an undertaking intended to extend knowledge through a disciplined inquiry and/or systematic investigation . (Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, and Social Sciences and Humanities Research Council of Canada 2018 , 5, emphasis added)

The ethical guidelines provided by the Council for International Organizations of Medical Sciences (CIOMS) provide a similar (though health-focused) definition and some examples of common research methods:

The term “health-related research” in these Guidelines refers to activities designed to develop or contribute to generalizable health knowledge within the more classic realm of research with humans, such as observational research, clinical trials, biobanking and epidemiological studies. Generalizable health knowledge consists of theories, principles or relationships, or the accumulation of information on which they are based related to health, which can be corroborated by accepted scientific methods of observation and inference . (2016, xii, emphasis added)

Likewise, according to the original Belmont Report in the United States, “the term ‘research’ designates an activity designed to test a hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge ” (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1978, emphasis added).

Note first that each of these definitions would lead to a slightly different assessment of the cases outlined at the beginning of this chapter, so we can’t simply point to regulations to answer our question for us without engaging in further discussion about which regulations are correct. More to the point here, though, we can see that the following concepts tend to arise in definitions of research: scientific methods (observation, hypothesis testing, and/or inference), systematic and/or disciplined inquiry, generalizability, and contributing to knowledge. Research, it seems, is implicitly scientific research . Research is something that scientists do (as contrasted with journalists or celebrities, for instance). This qualification is supported by landmark ethical guidelines such as the original Nuremberg Code, Article 8 of which states, “The experiment should be conducted only by scientifically qualified persons” (Nuremberg Code 1949 , 182). And scientific research involves certain systematic and disciplined methods , which when used properly provide some assurance about the generalizability of results.

Does a focus on the scientific method help to sort the test cases? This seems a promising route since the scientific method is thought to be what makes results more reliable than unsystematic observation and inference, which connects to the aim of producing knowledge. The difficulty is that there are many different methods used by researchers in a range of disciplines. Each research method aims to answer a different question—some are comparative, while others try to find out why someone holds a position or acts a certain way.

Qualitative research methods involving human subjects range from those involving close contact and communication between researchers and individual subjects, which are often open-ended and dynamic, such as ethnographic studies, oral histories, narrative inquiries, focus groups, and minimally structured interviews, to more structured and less dynamic methods such as large-scale surveys and structured interviews. Qualitative research is excellent at answering “why” and “how” questions and much less focused on reporting numerical results than quantitative research. As such, it plays an important and complementary role to quantitative research: a quantitative study may determine that some percentage of elementary school teachers report feeling burned out, for instance, while a qualitative study can investigate why this occurring and how it is experienced or understood by those who self-report.

Quantitative research methods involving human subjects include case studies, case series, and n -of-1 studies, all of which focus on the description and analysis of individual cases. They include observational methods such as case–control and cohort studies, which track and compare groups of people over time (either prospectively or retrospectively). In these types of studies, subjects are not assigned to different groups but rather self-select or are otherwise independently sorted into groups (for instance, a study might follow cyclists and non-cyclists). And then there are interventional methods such as randomized controlled trials (RCTs), in which participants are assigned to intervention and control groups randomly, and, when double-blind, neither they nor the researchers involved know which group they were assigned to until the study is completed. In many domains, including economics, public policy, and medicine, the RCT design is regarded as the gold standard of quantitative methods because of its rigorous comparative design and perceived objectivity.

Quantitative clinical research, in particular, proceeds on the basis of positive results in earlier animal studies and then is carried out in phases. Phase I clinical research typically enrolls a small number of healthy subjects (20–80) and aims to determine whether a proposed intervention is safe in humans and at what approximate dose or intensity. Phase II clinical research enrolls a somewhat greater number of subjects (100–300)—this time those with the health condition the intervention aims to treat—and aims to assess both safety and efficacy (the effect under near-ideal conditions). Phase III clinical research enrolls large numbers of subjects (1,000+) and aims to determine whether an intervention is effective. This phase of research is typically the basis for national regulatory approval, meaning that the treatment can be prescribed and sold to patients in some jurisdiction once it has the support of (typically at least two) well-designed phase III trials. Phase IV, or post-marketing trials, track outcomes in the general population once a treatment is widely available.

In both qualitative and quantitative domains, there are meta-level research methods designed to amalgamate the results of research. These include literature reviews, systematic reviews, and meta-analyses. In an effort to reach busy audiences, there are also summaries and syntheses which aim to bring together all research on a given topic and provide an overall assessment. Guidelines for practitioners in medicine often draw upon these meta-level studies, as well as expert opinion, in recommending standards of practice. And the range of methods is always expanding: some newer methods, such as cluster RCTs and umbrella trials, are discussed by Hey and Weijer in this handbook.

Generalizable Knowledge

What this wide range of scientific methods, from in-depth interviews to RCTs, have in common is that they involve a systematic or disciplined effort to produce results that contribute not just to knowledge but to generalizable knowledge —a standard interpretation of this term is “the use of information to draw conclusions that apply beyond the specific individuals or groups from whom the information was obtained” (Coleman 2019 , 248). This brings us to the aims of research, which were a common component of the definitions of research offered earlier. Each of the methods described might be thought of as contributing to generalizable knowledge, while something like trial and error in clinical practice might be aimed only at benefiting an individual patient. In order to figure out whether quality improvement efforts—such as instituting a surgical checklist in one operating room and comparing with others—count as generating generalizable knowledge, we would look to their aim. In the case as I described it at the outset, the administrator believed that they already knew the intervention would be successful at reducing rates of adverse events, based on the research evidence. The aim was to convince the healthcare team in the hospital that these results applied locally so that they would adopt the practice. This seems to be a case where the primary aim is changing local behavior rather than adding to general knowledge. This way of separating quality improvement activities from research proper has become quite popular in recent years. Scholars take different positions on whether this way of settling the matter is successful or not. This debate turns on, among other things, different ideas of what is meant by “generalizable knowledge.”

Most interpretations of “generalizable” focus on the applicability of results to people who were not in a study. But this can be tricky. An RCT with strict criteria for who is included, that tests an intervention against placebo, and that strictly controls the context in which treatment is administered (for instance, only by specialists in a highly resourced urban hospital) may produce results indicating that a particular medical treatment is effective. This sort of clean explanatory RCT is thought by many scholars to be the exemplar of a study design yielding generalizable results. But a rural physician in a low-resource area dealing primarily with elderly patients who have multiple health conditions might not regard the results of the study just described as generalizable to their patients. (And they would probably be right about this—the gap between research evidence and individual patient care is a real one, and closing or narrowing that gap is something researchers have been working on for decades. The advance of pragmatic trials is one attempt to solve this problem, for instance.) Through this example, we see some of the challenges inherent in claims made about generalizability, particularly when interpretations focus on applicability. Not all areas of scientific investigation lend themselves to the production of law-like generalizations of the sort (ostensibly) found in physics or chemistry. And very few medical interventions work for all patients, without qualification. To return to the quality improvement case, there is a sense in which knowledge is gained through the investigation—something new is learned about whether surgical checklists work in this specific location—and the knowledge is intended to generalize—for instance, across other operating rooms in that facility. Is this not (at least locally) generalizable knowledge, then? Many people seem to want to say “no” here but struggle to find a clear rationale for their position.

The challenges encountered thus far in our efforts to define research indicate that a new strategy is in order; accordingly, let’s turn back to our original question—“What is human subjects research?”—and ask why we are seeking an answer to this question. Perhaps the question is ill-conceived, or perhaps our aims will help guide us toward one of these imperfect options or even something better. What are the stakes here? Why does it matter what counts as human subjects research? Why would anyone resist having their actions labeled “research”?

The common answer to this question—the one potential researchers themselves would likely be quick to offer—is that it matters because activities that are considered research involving human subjects must undergo review by a research ethics committee (REC) and secure approval before recruiting any participants. 1 In other words, there are regulations in most jurisdictions requiring that certain types of activities are subject to independent oversight. According to the TCPS 2 in Canada, for instance, “A determination that research is the intended purpose of the undertaking is key for differentiating activities that require ethics review by an REB and those that do not” (Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, and Social Sciences and Humanities Research Council of Canada 2018 , 14). 2 A common rationale for this is that the primary aim of research is to gather knowledge to benefit people other than those in the study itself. By contrast, clinical practice, which also involves human subjects, is regulated differently (and with much less direct oversight)—by expectations that professionals will adhere to professional norms and guidelines. Because the aim of practice is benefit for the particular patient, it is thought that fewer or at least different ethical concerns arise. Similarly, other professions, like journalism, have their own sets of norms and rules guiding their activities, tied to their specific aims. The special ethical oversight of research activities is relatively new, in historical terms, since national regulations on human subjects research were enacted in most jurisdictions, in response to the public outcry over publicized cases of abuse of research subjects (for more on this, see the opening chapters of this handbook). When these regulations were proposed, those who drafted the regulations were acutely aware of the need to avoid encroaching on other domains of professional activity—particularly clinical practice (Beauchamp and Saghai 2012 ).

From the earliest attempts to offer a research–practice distinction it was clear that there would be troublesome boundary cases. 3 Phase I (or “first in human”) clinical trials—famously, those in pediatric oncology—tend to enroll patients who have cancer (not healthy subjects), and when there is no other treatment option available for that form of cancer, the research looks pretty much identical to practice (Kass et al. 2013 ). These sorts of activities might be thought of as “therapeutic research,” “innovative therapy,” or “unvalidated practice” depending on one’s orientation to the research–practice distinction. Other boundary cases recognized by early scholarship in this area included what would now be considered a type of comparative effectiveness research, in which two widely available treatments are compared to see which performs better, and quality improvement activities, in which healthcare systems experiment with new rules or guidelines in order to see how well they work in local settings (Beauchamp and Saghai 2012 , 49). Note that it is a necessary, not merely accidental, feature of such activities that they are in some sense both research and practice simultaneously. Phase IV studies are also often ambiguous—depending on how rigorously they are designed, they may also look simply like tracking adverse events in clinical practice. So while research has been defined in terms of its distinctive aim, the distinction is fuzzy and contested; and it continues to be plagued by borderline cases. 4

Note also that the way research was defined for regulatory purposes—against medical practice in particular—meant that the resulting distinction tracked the activities of greatest ethical concern in the medical context specifically. But human subjects research is a much broader category than simply medical research: there are a range of ways in which human subjects may be subjects of studies, including, for instance, in social scientific research. Because this type of research is helpful for understanding the stakes of getting the answer to the title question right, I will outline briefly the social scientific backlash to research ethics oversight, which typically involves delays associated with the prospective review of proposed research and some of the ways that ethics regulation has adjusted to accommodate the range of different types of investigations involving human subjects.

Cases from the social sciences are among the more prominent examples of controversial research in the twentieth century: the Milgram experiment on obedience to authority and Zimbardo’s prison experiment with students assigned to the role of prisoner or guard might come to mind (Haggerty 2004 ). Given that the outcry about the abuse of human subjects in medical research happened around the same time in many jurisdictions (roughly the 1970s), it is no surprise that ethics regulations were developed and applied across all domains of research with human subjects, including social science research. Resistance to these regulations is common, particularly (though not uniformly) in the social sciences, where being lumped in with medical researchers strikes many as bizarre overreach: “What began years ago as a sort of safeguard against doctors injecting cancer cells into research patients without first asking them if that was OK has turned into a serious, ambitious bureaucracy with interests to protect, a mission to promote, and a self-righteous and self-protective ideology to explain why it’s all necessary” (Becker 2004 , 415). Becker is referring here to what he calls “ethics creep,” which involves “a dual process whereby the regulatory system is expanding outward to incorporate a host of new activities and institutions, while at the same time intensifying the regulation of activities deemed to fall within its ambit” (Haggerty 2004 , 391).

A common critique raised by social scientists hinges on the inconsistency between the way different professionals, for instance, journalists and academic social scientists, are treated under current regulatory schemes. The very same activity—interviewing people, for instance—seems to trigger extensive and burdensome oversight when conducted by social scientists even though journalists proceed much more freely. In locating the problem with this arrangement, Haggerty draws attention to precisely the problem identified in this chapter, namely that central concepts like research are poorly defined in documents regarding the ethical regulation of research; they are “empty signifiers, capable of being interpreted in a multitude of ways, and occasionally serving as sites of contestation” (2004, 411). Interpretation is required, and because members of RECs feel responsible for protecting people, they tend to take what he calls a “just in case” approach, in which research is interpreted inclusively (and over-broadly) (2004, 411). This means that social scientists may be subject to extensive oversight.

In 2004, Haggerty articulated his concern as follows: “Over time, I fear that the [REC] structure will follow the pattern of most bureaucracies and continue to expand, formalizing procedures in ways that increasingly complicate, hamper, or censor certain forms of non-traditional, qualitative, or critical social scientific research” (pp. 392–393). This has also been referred to as part of the expansion of neoliberal audit culture and identified as part of the increasing bureaucratization of academia (Taylor and Patterson 2010 ). In response to this perceived ethics creep, some social scientists have called for “creative compliance” or even outright resistance to ethics regulations. One option—reclassifying one’s research as performance art (or some other unregulated activity) is offered with a wink, but behind closed doors researchers will sometimes admit using such tactics (Haggerty 2004 , 408). These efforts have in some cases been met with further regulation: “As some of us have tried new dodges to skirt the requirements, the [RECs] have wised up and closed loopholes” (Becker 2004 , 415).

Yet against these dire predictions and in response to the outcry and backlash generated by social scientists in the wake of early, more heavy-handed and medically oriented regulatory approaches, regulations (and their interpretation) have shifted in the opposite direction in many jurisdictions (for an overview of international regulations, see the chapter by Nelson and Forster in this handbook). In Canada, for instance, the most recent version of the TCPS 2 takes a proportionate approach to the review of research:

Given that research involving humans spans the full spectrum of risk, from minimal to significant, a crucial element of REB review is to ensure that the level of scrutiny of a research project is determined by the level of risk it poses to participants. … A reduced level of scrutiny applied to a research project assessed as minimal risk does not imply a lower level of adherence to the core principles. Rather, the intention is to ensure adequate protection of participants is maintained while reducing unnecessary impediments to, and facilitating the progress of, ethical research. (Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, and Social Sciences and Humanities Research Council of Canada 2018 , 9)

As this statement indicates, while all research is held to the same high ethical standard, research of minimal risk is thought to require a lower degree of oversight. Ethics review in Canada begins with a determination that the activity is in fact research with human subjects; activities described as falling outside of the definition of research include the sorts of quality improvement activities outlined in the hospital administrator case and “creative practice activities” such as those undertaken by artists (p. 19). 5 Next, some activities that meet the definition of human subjects research are automatically exempt from review, including 1) research that relies entirely on legally accessible, publicly available information where the individuals have no reasonable expectation of privacy and 2) exclusively observational qualitative research conducted in public places where there is no reasonable expectation of privacy and individuals are not identified in the written report (pp. 15–18). This will cover much of the research conducted by historians and some observational studies conducted by social scientists, educators, etc.

At this point, if an activity is considered research and not exempt, it may still be afforded an expedited (“delegated”) review if it is low-risk: according to Article 6.12, “In keeping with a proportionate approach to research ethics review, the selection of the level of REB review shall be determined by the level of foreseeable risks to participants: the lower the level of risk, the lower the level of scrutiny (delegated review); the higher the level of risk, the higher the level of scrutiny (full board review)” (p. 79). In delegated review, the committee assigns one member (or some equivalently qualified person) to assess the proposal rather than assessing it all together. A negative assessment at this stage refers the study back to the full committee for review. Because social scientific research is more likely to be minimal-risk than medical research, it is well positioned to benefit from delegated review. Canada is not unique here: similar exclusions and exemptions typically exist in other national regulatory systems. And in some jurisdictions they are even broader: in the United States, for instance, public health surveillance, criminal justice, and intelligence activities are all excluded from the domain of “research” and exemptions (activities requiring only “limited review”) are offered for most interview- and survey-based research, secondary research even when it uses identifiable private information or biospecimens, and “benign behavioral interventions” (Coleman 2019 , 248). This is a more permissive approach, overall, than the one found in Canada, and the trajectory seems to be generally in the more permissive direction over time.

At this point, we have enough background about the relationship between research and regulation to return to our question about the stakes of this discussion: why would someone wish to avoid having their activity labeled research? The answer given by some investigators is that they might resist if they think there are immediate, and burdensome, regulatory implications. A few things can now be said about this. First, it may be the case that there were times and places where the burdens of regulatory oversight were heavy even in the face of minimally risky activities or where the interpretation of regulations was overzealous. But it is unlikely to be true today—most systems have built-in exemptions and expedited processes for these sorts of cases, as the Canadian example makes clear, and discrepancies in interpretation between RECs have had time to resolve. In the face of complaints from researchers, it is good to look closely at the current local regulations and the way they are implemented. Second, in some jurisdictions today there are known inefficiencies in the regulatory oversight system—this occurs for a wide range of reasons but particularly because the process typically relies on volunteer labor and can involve reading hundreds of pages of detailed, technical proposals at a time. As a result, there are sometimes long delays, and researchers are entirely within their rights to complain about this, though they should be careful about selecting an appropriate target of criticism, whether that’s the local REC or the system within which RECs operate. Further, instantaneous processing of files would be unreasonable on the part of researchers, so negotiation will be needed to find a reasonable timeline, given shared goals. 6 Finally, some of the resistance likely arises from a misunderstanding about what ethics is and how it operates in the world. This requires some attention.

For many researchers, regulatory oversight has become synonymous with ethical assessment. You might hear a hint of this when researchers talk about “getting through ethics,” “waiting for ethics,” or claiming to have “completed ethics” once they have received approval from an ethics board for their study. A similar sort of reduction of ethics to a formal process sometimes occurs in contexts where healthcare providers seek informed consent: they may talk about “consenting the patient” in advance of a procedure, for instance, which is typically reduced to having the patient sign a legal document. It is important to appreciate why this position is indefensible—why legal paperwork or regulatory approval isn’t in any meaningful way a substitute for ethics, understood properly.

To begin, consider a study that has received ethics approval and yet which, when it is actually carried out, has risks that are unreasonably high (perhaps most subjects enrolled will die) a flawed design (perhaps it is not possible to achieve statistically significant or otherwise meaningful results), subjects are told they can’t leave the study once enrolled (violating the voluntariness of their ongoing consent), or the particular individuals in the study are easily identifiable in the published final report (violating their privacy). That study is unethical, in spite of having received approval from an ethics committee. Any number of things may have gone wrong here. First, like all human activities, review is fallible, and sometimes committee members will make mistakes. Sometimes the mistake will be in applying the rules, but at other times the mistake might be in the rules themselves. The particular rules applied by any ethics committee are open to debate, discussion, and revisions in light of new developments in scientific or ethical domains. The regular updates to codes of ethics such as the “Declaration of Helsinki,” currently in its seventh revision since 1975, provide some indication of the rate of change in these domains. Second, the researchers may have provided only a general description of certain activities (such as the trial design or informed consent process) in their application to the ethics committee and then, in specifying these matters later on, made poor choices. Third, researchers may simply have deviated from what they promised to do in their application to the ethics board. The research process relies on a certain amount of trust and good will between reviewers and researchers, and this can be violated by unethical or incompetent researchers. Approval by an ethics committee, then, is not all there is to an assessment of whether some activity is actually ethical .

Awareness of this simple fact helps us to see the dangers of thinking that classifying something as research means a particular set of ethical rules applies that wouldn’t otherwise. Codes of ethics aim to identify and articulate ethical principles or rules, and ethics committees do their best to interpret and apply these general principles to particular cases. But whether those committees existed in the middle ground between principles and action or not (and until recently, they didn’t), ethical principles would still apply to certain activities whenever those activities had certain features. Research with human subjects, as noted, aims at generalizable knowledge, and it typically “uses” those subjects to get knowledge. Along the way, the subjects may be made better or worse off, and any interaction where people make others worse off raises ethical concerns about harms such as exploitation and disrespect. Think about the contrast between paradigmatic cases of medical practice and medical research here—in practice, a healthcare provider aims primarily to benefit the patient, while in research, they aim primarily to generate new knowledge. When getting new knowledge requires the use of another person’s body, it seems clear that we’re in risky ethical territory.

Another way of appreciating the scope of ethics as something far bigger than ethics regulations is to think about the fact that regulations won’t specifically state things like “don’t murder your subjects” or “don’t steal the personal belongings of your subjects” because these ethical prohibitions are thought to be covered by existing criminal laws and not in need of restating. There are many ways to be unethical beyond those listed in codes of ethics because those codes are only part of a larger social system.

Further, some of the ethical rules present in codes and guidelines arise because of the place of research within society and not merely because it is a transaction between individuals. Research proceeds only with the cooperation and support of the societies in which it is conducted, which provide funding, regulation, legal protections, social and physical infrastructure, potential subjects, and more. The requirement that research is socially valuable—that it contribute to knowledge on the topic and directly or indirectly benefits society—is one such rule imposed on research with human subjects (you can read more about this requirement elsewhere in this handbook). The requirement that research is scientifically valid—including the expectation that methods are rigorous and results are meaningful—draws on norms of science developed independently by scientists, which prioritize epistemic values such as fruitfulness, scope, and accuracy in theory construction. Scientists are also held to ethical restrictions around activities considered research misconduct, such as plagiarism, fabrication, and falsification, even though these activities aren’t listed explicitly in codes of ethics for research with human subjects.

Professional Ethics

We’ve been discussing, and trying to articulate the problems with, a particular resistance to being labeled research that results from a misunderstanding about how ethics operates in the world. Hopefully the responses to this argument have been convincing thus far. There is, however, a more nuanced version of the position remaining: some investigators might resist the research label because they believe they are governed by codes of ethics developed prior to current codes and articulated within their professions and see the bureaucracy associated with contemporary ethics review as a less nuanced and perhaps even misleading way to go about thinking through the ethical dimensions of their work. They see a perfectly functional self-regulating profession taken over by people with little or no understanding of the nature of their work or the subtle and precise responses to ethical dilemmas they’ve developed over time.

For example, journalists have ethical norms prioritizing the protection of sources—these norms evolved because of social-historical cases where harm arose (in the extreme, people who were killed when they were identified after a story was published) and a recognition of the need to avoid those harms going forward. This ethical rule for journalists is tied to what is valuable about the activity (here: truth) and a recognition of particular harms that could arise in telling the truth (here: people who assisted in exposing the truth could be killed). If you want to proceed with an activity that involves interaction with other people (maybe even in some sense “uses” them to gain knowledge) but in that interaction, or afterward, those people might be harmed, you should probably ask how that harm can be minimized. Responsible professionals in a range of domains have engaged in this thoughtful work for decades and even centuries. Anthropologists, for instance, have been reflecting about the particular ethical duties arising from ethnography since the method was developed, such as the shifting loyalties that result from the close relationships formed during fieldwork, and the desire of state entities to access and direct their research to secure information from enemies during wartime (Fluehr-Lobban 2002 ).

A decisive response to these concerns is unnecessary here: it is sufficient for the purpose of this chapter that we are aware of them. It is a matter of ongoing discussion in a range of human domains whether certain activities should be regulated or not or whether they should be regulated using one set of rules or another. In general, the position taken by liberal democratic states is that professions and industries with a history of serious harm to citizens have forfeited their right to self-regulation. Research on human subjects has a sufficiently sordid history to qualify here. Whether this inappropriately covers social scientists or others will likely be a matter for further debate. For our purposes, what is important is that we recognize that ethical rules apply regardless of which set of regulations is in force (state-imposed external ethics review, professional codes of ethics, or novel alternative oversight mechanisms). So while the stakes of the discussion are high in the sense that they determine this regulatory path, they are not as high as people tend to think because the ethical rules will apply regardless. Being labeled performance art rather than research might mean you avoid filling out some forms, but it won’t on its own change the nature of your ethical obligations since those arise out of the type of activity planned and its aims and consequences.

In sum, the best response we have to the question “What is research?” is probably that research aims to produce generalizable knowledge, but it is important to recognize that this is an imperfect definition and leaves open a range of debates, including those related to the correct interpretation of “generalizability.” It is also important to recognize that answering this question may not be the best way to decide what systems of accountability ought to track the ethical issues that arise in knowledge-gathering activities; it is worth always keeping in mind that a range of regulatory mechanisms are possible. We have also defused some of the anxiety around responses to this question by tracing and responding to some of the reasons for resistance to the label. The ethical principles arising from an activity aren’t invented and dictated by RECs—they apply whether an activity is labeled research or not and whether it is regulated as such or not. There is room for critical engagement here, but at the end of the day there’s just no escaping ethics.

Human Subjects

I have indicated that there is debate over not only what counts as research, as we’ve just seen, but also who is included in our discussions of human subjects. There are two versions of the question “Who are human subjects?,” each of which raises distinct ethical issues. First, we might wonder which humans end up being research subjects. Is there a paradigm or “model human” researchers have in mind? Are there some humans on whom research is forbidden or significantly restricted? Where are human subjects located globally, and how is this changing? Is there a shortage or surplus of human subjects available for research? How many people are research subjects annually? Depending on the answers to these questions, how might we assess the fairness of the burdens and benefits of research participation? This version of the question raises issues about representation in research as well as more general concerns of distributive and social justice.

Second, we might wonder which subjects are included in discussions of human subjects research. Are any of the following included, for instance: fetuses, embryos, brain-dead humans, cadavers, human organs or tissues, reproductive tissues, or stem cells? And, particularly if some of these items are included, why stop at the boundary of the human species? What lies behind the strict demarcation between human and nonhuman animals as subjects of research? Thinking more broadly, what are the implications of various positions on this matter for research on (hypothetical) conscious, sentient robots or aliens? This version of the question raises issues of moral status. I’ll outline both of these sets of issues.

Which Humans?

The human subjects of research have not always been representative of the diversity of humanity or even of the local populations within which research was conducted. The tendency of Western researchers (white men, for the most part), prior to ethics regulations, to seek out vulnerable populations such as prisoners, children at boarding schools, hospital patients, sex workers, citizens of other countries, racial minorities, and impoverished persons (and especially people at the intersection of these categories) for inclusion in research is well documented. The attraction of these groups was precisely their vulnerability—the fact that it was difficult or impossible for them to refuse involvement, for instance. Early responses to this situation focused on protections for variously identified vulnerable populations. While these concerns persist, and took on new life when multinational research became more common in the 1990s, another concern about representation has arisen more recently: the underrepresentation of certain groups in research. While the first set of concerns track disproportionate burdens of research participation, the second set tracks the lost benefits of research participation. The ethical assessment of the former actions—essentially, preying on the vulnerable—is more easily appreciated, so I’ll say a bit about the latter problem. Failing to ensure that subjects are representative of particular groups can lead not only to missed opportunities to benefit those populations but also to direct harm when research is falsely generalized across that group, as when a drug with positive results in one group is dangerous or toxic to another.

Women were underrepresented in clinical research in the United States (and elsewhere) until at least the 1990s. As a result of improved regulations, the United States has shifted toward more equitable inclusion of women in publicly funded clinical trials, though most studies still fail to analyze results by sex/gender in spite of the recognized benefits of doing so (cf. Geller et al. 2018 ). This is a development worth noting, but it is important to keep in mind that this tracks only clinical research, funded publicly, in one country. We shouldn’t assume the underrepresentation of women in human subjects research has been resolved or even that sensible extension to related domains has been made—the selection of exclusively male mice for animal research continued for many years after these changes were made to human subjects regulation and is still the status quo in many countries and contexts (Shansky 2019 ). The attempted justification for these exclusions has been decisively refuted in the literature dozens of times. Addressing one common mistake clearly driven by outdated gender norms, Shansky reminds us, “Women, but not men, are still pejoratively described as hormonal or emotional, which curiously neglects the well-documented fact that men also possess both hormones and emotions” (2019, 825). The resulting imbalance has affected research in many fields that continue to rely on animal studies such as neuroscience, endocrinology, physiology, and pharmacology. As a result of the exclusion of female mice from neuroscience research, and because research in animals provides the foundation for clinical trials, “the current understanding of how to most effectively treat disease in humans is similarly unbalanced” (Shansky 2019 , 825).

Over the past five years, Canadian and American funding bodies have introduced new requirements for researchers to consider sex as a biological variable in animal studies, and similar efforts have been made by the European Commission (Shansky 2019 ). Of course, sex/gender is not the only characteristic that has been unequally distributed in research studies. The same arguments offered in support of ending the exclusion of female animals from animal research and women from clinical research have been marshaled in favor of improving the inclusion of children, pregnant women, and specific ethnic minority groups (for instance, particular indigenous groups in Canada) with limited success. As mentioned, these exclusions have the potential to lead to significant harm to these populations, particularly in clinical practice since interventions never tested on a population may turn out to have more harms than benefits, and the lack of information about effects of treatments in that population might leave clinicians and others uncertain about how best to act even when acting quickly is critical. It may also simply be unjust in its own right to exclude people from research that might benefit them.

In addition to the explicit long-standing exclusion of particular identifiable groups, such as women, researchers have excluded populations indirectly by, for instance, preferring subjects who are healthier, are younger, and have fewer comorbid conditions. One result of these exclusions has been an underrepresentation of elderly people in clinical research. Because underrepresentation in research means the bench-to-bedside knowledge translation gap is bigger, this likely means elderly people are missing out on certain health benefits. And they aren’t the only ones losing out on benefits: clinical research subjects are not generally representative of a large percentage of the patient population for whom the interventions are intended. For instance, Humphreys and colleagues found that “highly cited trials do not enroll an average of 40.1% of identified patients with the disorder being studied, primarily owing to eligibility criteria” (2013, 1030). Other identifiable groups who may be affected by exclusions indirectly are people whose immigration status is uncertain, people who don’t speak the local language, and people who live far from the urban centers where much research occurs. Who is overrepresented in studies, then? People from “Western, Educated, Industrialized, Rich, and Democratic . . . societies” (Henrich, Heine, and Norenzayan 2010 , 61). The 2019 World Health Organization’s World RePORT , drawing on data from 2016, indicates that the recipients of research funding from the top 10 funders globally continue to be mostly institutions and investigators in North America and Europe working on non-communicable diseases (World Health Organization 2019 ).

While this is true today, some things are changing. Though most clinical research (approximately 70 percent) is still conducted in North America and Europe, “significant West-to-East and North-to-South shifts appear to be underway” with researchers looking increasingly to Asia, Africa, South America, and eastern Europe (Sismondo 2018 , 55). One reason this is thought to be happening is that researchers are keen to find countries where the medical system is advanced enough to locate their trials, with access to a large population, but at the lowest cost possible. According to Sismondo, costs per subject in clinical trials are estimated to be 30–50 percent lower in India than in North America or western Europe (2018, 55). Researchers are also interested in finding populations where individuals are not already taking other medications, and countries like India may have a greater proportion of subjects like this (Sismondo 2018 , 54). There are also more altruistic motives: low- and middle-income countries (LMICs) have particular health problems, and some researchers in high-income countries (HICs) may have an interest in helping to alleviate those problems, such as high rates of HIV transmission, epidemics such as the recent Ebola outbreaks, neonatal disorders, and neglected tropical diseases. Research in developmental economics suggests that these motives and effects can also be mixed in quite complicated ways: for instance, aid organizations may seek to alleviate global poverty and design studies to inform this effort but, in doing so, also reinforce the continued existence of their organization, create cycles of dependency, or perpetuate assumptions about the lack of knowledge or expertise in targeted populations.

Another reason for this global shift is that researchers often report difficulty recruiting subjects in HICs. For example, according to McDonald and colleagues ( 2006 , np), for multi-center RCTs funded by two UK funding agencies, “Less than a third (31%) of the trials achieved their original recruitment target and half (53%) were awarded an extension. The proportion achieving targets did not appear to improve over time. The overall start to recruitment was delayed in 47 (41%) trials and early recruitment problems were identified in 77 (63%) trials.” In general, “Recruitment is often slower or more difficult than expected, with many trials failing to reach their planned sample size within the timescale and funding originally envisaged” (McDonald et al. 2006 , np). This shortage of (appropriate) research subjects is of interest to research ethics because it can drive the demographic shifts just described, which raises concerns about potential exploitation of subjects in multinational studies. It also arguably lends further support to the social value requirement of research since a resource shared by all researchers (including industry researchers) is in limited supply: human research subjects. Perhaps this means lower-value research ought not to be conducted, or the bar for what counts as a sufficiently socially valuable study should be raised (Borgerson 2016 ).

The relationship between funders, researchers, and subjects is also of interest to bioethicists. One of the reasons ethical concerns arise in LMICs is that the research is often funded and designed in HICs, and this raises worries about potential exploitation. Another concern arises when the results of the research conducted in LMICs won’t benefit other people in those same populations. One of the reasons given for the increased interest in conducting research in LMICs is that populations are “treatment-naive”—this means in general they don’t have access to healthcare, and they are likely to be unable to afford whatever treatment emerges from the research if it is successful. This feature of multinational research has generated extensive discussion among bioethicists, many of whom now agree that research should be responsive to the health needs of local populations if it is to avoid charges of exploitation. Yet this worrisome overview of the global situation was provided in 2013:

Total global investments in health R&D (both public and private sector) in 2009 reached US$240 billion. Of the US$214 billion invested in high-income countries, 60% of health R&D investments came from the business sector, 30% from the public sector, and about 10% from other sources (including private non-profit organisations). Only about 1% of all health R&D investments were allocated to neglected diseases in 2010. Diseases of relevance to high-income countries were investigated in clinical trials seven-to-eight-times more often than were diseases whose burden lies mainly in low-income and middle-income countries. (Røttingen et al. 2013 , 1286)

Dandona et al. also found that research priorities were misaligned with the health needs of the local population in India specifically: “funding for some of the leading causes of disease burden, including neonatal disorders, cardiovascular disease, chronic respiratory disease, mental health, musculoskeletal disorders and injuries was substantially lower than their contribution to the disease burden” (2017, 309). The gap between funding priorities and disease burden has been of interest to economists, political scientists, and bioethicists alike for many years.

A roughly 70/30 split between industry funding and other sources is common in clinical research. Of the US$1.42 billion spent on health research in India in 2011–2012, “95% of this funding was from Indian sources, including 79% by the Indian pharmaceutical industry” (Dandona et al. 2017 , 309). In the United States, “Principal research sponsors in 2003 were industry (57%) and the National Institutes of Health (28%)” (Moses et al. 2005 , 1333). Even though there seem to be shifts underway toward more industry-sponsored research in the clinical context, practicing physicians are still a vital part of research, often supplying the subjects for research:

Currently, about three-quarters of studies in the United States are conducted in the private sector by non-academic physicians who recruit their own patients or local community members into drug studies. Over 60,000 of these studies take place in the United States each year, accounting for 75 percent of the 80,000 clinical trials conducted worldwide; to execute these studies, more than 50,000 U.S. physicians registered with the Food and Drug Administration (FDA) as principal investigators on one or more clinical trials in 2001. As for the human subjects, 3.62 million Americans participated in pharmaceutical clinical trials in 2003 alone. (Fisher 2009 , 2)

The particular ethical obligations arising from the dual role of physician-investigators, such as the need to balance a commitment to doing what’s best for the patient with an interest in seeking knowledge, have received attention from bioethicists, as have the financial conflicts of interest arising when physicians play not only these two roles but a third role in their relationship to industry sponsors.

Another matter of interest to bioethicists is that there are some people who make a career out of being research subjects. Some of them self-identify as “guinea pigs for hire” and seek participation in phase I studies (on healthy subjects) (Lemmens and Elliott 2001 ). The inclusion of these people in studies raises ethical issues about appropriate compensation (whether wages and benefits or payment), undue inducement (if the payment is thought to be too high), scientific validity (whether people strongly oriented to please researchers so that they may be hired again will be more inclined to deceive researchers, for instance), upper limits of risk for studies under conditions of informed consent, and social justice and fair subject selection (since career research subjects tend to be from particular demographic groups, such as homeless people and students). For more on this issue, see the chapter by Fisher in this handbook.

Finally, a note about the number of research subjects: the research enterprise is massive and enrolls millions of human subjects every year. It is surprisingly difficult to get a clear picture of the enterprise globally (for more on why, see Young et al. 2015 ). Our best estimates come from clinical research: drawing on the 2009 CenterWatch Sourcebook, Sismondo suggests that, while estimates vary widely, there are approximately three to six million subjects involved each year (2018). And these numbers seem to be increasing. If we were able to add in figures from research in the social sciences, these numbers would skyrocket. In fact , you might be a research subject right now : there is ongoing debate over whether the tactics used by social media sites to track and manipulate their users qualify as human subjects research. If they do—and this turns partly on how we settle the issues raised in the first part of this chapter—we might find out that many of us are unwitting research subjects.

Which Subjects?

Who counts as a human subject of research? Codes of research ethics are often inclusive in their definition, for instance: “The World Medical Association (WMA) has developed the Declaration of Helsinki as a statement of ethical principles for medical research involving human subjects , including research on identifiable human material and data ” (World Medical Association, 2013 , 2191, emphasis added). Codes that initially had a narrow focus on medical research have expanded over time to cover new areas, for instance, increasing interest in the storage and use of biospecimens in research (biobanking) led CIOMS to merge its ethical guidelines for epidemiological research and biomedical research in 2016 (CIOMS, xi). Guidelines for research on human subjects are likely to be inclusive about who or what counts as a subject because many of the same ethical issues—privacy and informed consent, for instance—arise whether the subject’s body, tissues, or data are manipulated. In jurisdictions like Canada “human subjects” includes embryos and cadavers, though in the United States (ex vivo) embryos and cadavers are excluded from the definition. This doesn’t necessarily mean the use of cadavers, for instance, is unregulated but rather that it may be regulated differently. In all cases, the potential for harm to an identifiable person raises ethical concern.

If a central focus of research ethics is the prevention or minimization of harm, what then are we to make of the differences between the way humans and nonhuman animals are treated by researchers? The latter are not regarded as human subjects, even on inclusive definitions. And yet the “vast majority of biomedical research activity is conducted on animals or their tissues, cells, or even parts of cells” (Levine 2008 , 214). While research on human subjects is guided by ethical principles such as respect for persons, informed consent, fair subject selection, and a favorable risk–benefit ratio, research on nonhuman animals is typically governed by different approaches, such as the 3R framework: reduction (in numbers of animals used), refinement (improving the conditions for the animals), and replacement (using animals with lower capacity for pain or computer models when possible). Clear demarcation criteria, separating humans from other animals, have been very hard to come by, particularly as researchers discover more about the intellectual, emotional, and social capacities of a wide range of animals from crows to chimpanzees to elephants. The issue of which beings “count” morally, then, is unsettled, and as a result these divisions between the ethical principles applied in each domain rest on unsettled foundations.

It is good to keep this in mind because for many areas of research from neuroscience to immunology animal research is the basis for human research. You can’t typically propose a clinical trial on humans without convincing evidence from animal studies that the intervention might be successful. This expectation persists even though animals are never going to be ideal models for human behaviors, diseases, or functions—the ideal model for humans is humans. The reason why research doesn’t just skip over animals and start with humans, then, is ethical: it is thought to be acceptable to subject animals to risks that we find unacceptable for humans. There are deep and important issues here regarding the relative value of different lives. These issues surface in research ethics when trade-offs are proposed between human and animal studies. For instance, if “higher-level” animals like chimpanzees are no longer used in animal research (for ethical reasons), this may mean that the results from studies on the replacement animals (e.g., mice) lead to more uncertainty in the leap from animal to human studies. But this is at odds with a commitment to reduce harms to human research subjects. It will not be straightforward to find the right ethical path through these trade-offs (for one recent attempt, see Johnson and Barnard 2014 ). But if it is concern about harm to the interests of sentient beings that drives us toward research ethics oversight, we can’t proceed without attending to these difficult decisions. In the discussion of human subjects of research in section 2.1, I reviewed concerns about exploitation that arise when one group is harmed for the benefit of another. If the moral status of animals is even somewhat higher than that of inanimate objects, similar issues will arise when humans extract knowledge for our benefit from the bodies of animals.

In the future, we may have to decide how and whether to proceed with research on advanced forms of artificial intelligence or other nonhuman intelligent beings. So these gaps and unsettled foundations might matter to whether our current divisions between humans and other species are defensible in the long run.

In sum, neither “research” nor “human subjects” is easily defined, and efforts to use these concepts to draw black-and-white ethical lines around activities will struggle with a continuous and growing body of boundary cases. This is a productive realization since it helps us to see the gaps in current regulations (ethical concerns extend far beyond those captured in such regulations) and envision and work toward more efficient and nuanced systems of ethical accountability, such as those aspired to in systems aiming for the deep integration of research and practice (for more on these alternatives, see the chapter by Kim in this handbook). But it is also helpful for those of us working within current systems since it reminds us of the need to keep our focus on what we’re worried about, whether that’s exploitation, disrespect, scientific misconduct, power imbalances within relationships, conflicts of interest, violations of privacy, injustice in the selection of research participants, or opportunity costs when healthcare resources are used inefficiently. And our worries need to be responsive to an ever-changing reality: the internationalization of research, in particular, may well create new incentives (or reinforce existing incentives) that push researchers toward activities that breach different ethical principles or breach well-established principles in new ways. We will always need to be ready to provide timely, creative, and well-grounded responses to new ethical violations.

This chapter aimed to accomplish two things: 1) provide an overview of the scope and practice of research with human subjects and 2) highlight some of the philosophical issues raised by any attempt to provide such an overview. Let us return to our opening cases to see if we can apply what we’ve learned. Using the aim of generalizable knowledge as an initial sorting mechanism, it seems all cases except the family physician who “experiments” with different treatments will qualify as research. This is consistent with most regulatory assessments (keeping in mind they will then exclude and exempt some research from review). And all interventions involve human subjects directly or—in the case of blood samples—indirectly and so would likely be included because identifiable individuals raise ethical concerns about consent and privacy. Embryo research is a tough case, and different jurisdictions and different scholars handle it differently; we didn’t attempt to settle the issue here. Note that while most of the cases turn out to be human subjects research on the most common definitions, we are left with lingering worries—for instance, why does the clinical practice case change from practice to research when it is written up for publication—forget about the regulations, what changes here ethically ? Hopefully it is clear that while some things are settled in this domain, there is still much to work out. As is so often the case in philosophy, even the simplest question—"What is human subjects research?”—is harder to answer than it seems.

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Dandona, Lalit , Rakhi Dandona , G. Anil Kumar , Krycia Cowling , Pritty Titus , Vishwa Mohan Katoch , et al. 2017 . “ Mapping of Health Research Funding in India. ” National Medical Journal of India 30: 309–316.

Fisher, Jill A.   2009 . Medical Research for Hire: The Political Economy of Pharmaceutical Clinical Trials . New Brunswick, NJ: Rutgers University Press.

Fluehr-Lobban, Carolyn . 2002 . “ A Century of Ethics and Professional Anthropology. ” AAA Anthropology News 43, no. 3: 20.

Geller, Stacie E. , Abigail R. Koch , Pamela Roesch , Amarette Filut , Emily Hallgren , and Molly Carnes . 2018 . “ The More Things Change, the More They Stay the Same: A Study to Evaluate Compliance with Inclusion and Assessment of Women and Minorities in Randomized Clinical Trials. ” Academic Medicine 93, no. 4: 630–635.

Haggerty, Kevin D.   2004 . “ Ethics Creep: Governing Social Science Research in the Name of Ethics. ” Qualitative Sociology 27, no. 4: 391–414.

Henrich, Joseph , S. J. Heine , and A. Norenzayan . 2010 . “ The Weirdest People in the World? ” Behavioural and Brain Sciences 33, no. 2–3: 61–83.

Humphreys, Keith , Natalia C. Maisel , Janet C. Blodgett , Ingrid L. Fuh , and John W. Finney . 2013 . “ Extent and Reporting of Patient Nonenrollment in Influential Randomized Clinical Trials, 2002 to 2010. ” JAMA Internal Medicine 173: 1029–1031.

Johnson, Jane , and Neal D. Barnard . 2014 . “ Chimpanzees as Vulnerable Subjects in Research. ” Theoretical Medicine and Bioethics 35, no. 2: 133–141.

Kass, Nancy E. , Ruth R. Faden , Steven N. Goodman , Peter Pronovost , Sean Tunis , and Tom L. Beauchamp . 2013 . “ The Research–Treatment Distinction: A Problematic Approach for Determining which Activities Should Have Ethical Oversight.” In “Ethical Oversight of Learning Health Care Systems, ” special report, Hastings Center Report 43, no. 1: S4–S15.

Lemmens, Trudo , and Carl Elliott . 2001 . “ Justice for the Professional Guinea Pig. ” American Journal of Bioethics 1, no. 2: 51–53.

Levine, Robert J.   2008 . “The Nature, Scope, and Justification of Clinical Research.” In The Oxford Textbook of Clinical Research Ethics , edited by Ezekiel J. Emanuel , Christine Grady , Robert A. Crouch , Reidar K. Lie , Franklin G. Miller , and David Wendler , 211–221. Oxford: Oxford University Press.

McDonald, Alison M. , Rosemary C. Knight , Marion K. Campbell , Vikki A. Entwistle , Adrian M. Grant , Jonathan A. Cook , et al. 2006 . “What Influences Recruitment to Randomised Controlled Trials ? A Review of Trials Funded by Two UK Funding Agencies.” Trials 7: 9.

Moses, Hamilton , E. Ray Dorsey , David H. M. Matheson , and Samuel O. Thier . 2005 . “ Financial Anatomy of Biomedical Research. ” Journal of the American Medical Association 294, no. 11: 1333–1342.

National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. 1979 . The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research . https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html

Nuremberg Code. 1949 . “Permissible Medical Experiments.” In Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, Vol. 2, 181–182. Washington, DC: US Government Printing Office.

Røttingen, John-Arne , Sadie Regmi , Mari Eide , Alison J. Young , Roderik F. Viergever , Christine Årdal , et al. 2013 . “ Mapping of Available Health Research and Development Data: What’s There, What’s Missing, and What Role Is There for a Global Observatory? ” Lancet 382, no. 9900: 1286–1307.

Shansky, Rebecca M.   2019 . “ Are Hormones a ‘Female Problem’ for Animal Research? ” Science 364, no. 6443: 825–826.

Sismondo, Sergio . 2018 . Ghost-Managed Medicine: Big Pharma’s Invisible Hands . Manchester, UK: Mattering Press.

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World Medical Association. 2013 . “ World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. ” Journal of the American Medical Association 310, no. 20: 2191–2194.

Young, Alison J. , Robert F. Terry , John-Arne Røttingen , and Roderik F. Viergever . 2015 . “ Global Trends in Health Research and Development Expenditures—The Challenge of Making Reliable Estimates for International Comparison. ” Health Research Policy and Systems 13: 7.

I use the generic term “research ethics committee” in this chapter to refer to the committee providing prospective ethical review of research. In some jurisdictions these have other names, such as “research ethics boards” or “institutional review boards.”

The document goes on to say, “In some cases it can be difficult to make this distinction, underscoring the need to have reviewers or ad hoc advisors . . . who can assist with this determination” (p. 14). This highlights a lesson articulated in this section of the chapter: it is not easy to determine which activities are “research.”

I use the term “boundary cases” here to refer to any study designs that can’t be easily classified as “research” or “practice.” As the examples indicate, this includes “hybrid” or “overlap” activities which intentionally blend research and practice, such as those found in proposed models for learning health care systems.

This is one of the (many) reasons why scholars are so interested in the design and pursuit of learning health care systems in which the research–practice distinction is downplayed or eliminated and new mechanisms of accountability are explored. This and related issues are discussed by Kim elsewhere in this handbook.

The TCPS 2 has a very specific scope: it only covers research funded by the three federal funding agencies in Canada. Other parties, such as independent or private researchers and funders in Canada, typically agree to abide by these rules; but only researchers funded through these agencies are strictly bound by them.

A recent court decision in Newfoundland and Labrador, Canada, for instance, sets this “reasonable” window at 30 days (CBC News 2019 ).

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Lesson 2: What is Human Subjects Research?

Please note: This lesson will take approximately 1 hour and 35 minutes to complete. Use the next and previous buttons to advance through the course. You will be able to print a completion certificate for your records at the end of this training. OHRP does not collect information about who accesses it.

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Purpose of this Lesson

This lesson will explain how the Common Rule regulations define “research” and “human subjects” and explain what it means to be exempt from the regulations. This lesson focuses on the Revised Common Rule (or 2018 Requirements) that became effective in 2018.

Lesson Overview

This lesson contains four parts:

Part 1: Background of Human Subjects Research

Part 2: is the activity research, part 3: does the research involve human subjects, part 4: is the human subjects research exempt.

You will answer quiz questions throughout each part to test your knowledge. A correct response is required to advance in the lesson.

Learning Objectives

After completing this lesson, you will be able to:

• Identify if a certain activity meets the regulatory definition of research.
• Identify if research involves human subjects based on the regulatory definition.
• Determine whether a particular project is non-exempt human subjects research under the Common Rule.

Go to Section: Introduction > The Concept of Non-exempt Human Subjects Research > Identifying Non-Exempt Human Subjects Research > Quiz Questions

Introduction

The Common Rule applies to human subjects research that is supported or conducted by a Common Rule agency. For research supported or conducted by the Department of Health and Human Services (HHS), the Office for Human Research Protections (OHRP) is the office with the authority to enforce the regulations. Many research institutions choose to apply the Common Rule to all of their human subjects research regardless of funding source.

This lesson focuses on the Revised Common Rule that became effective in 2018.

The Concept of Non-exempt Human Subjects Research

Even when funded by a Common Rule agency, not all research involving humans is required to follow the Common Rule. The Rule only applies to activities that qualify as human subjects research under the regulation and that do not qualify for an exemption. This is commonly referred to as non-exempt human subjects research.

Note that, in addition to the Common Rule (subpart A), non-exempt human subjects research funded by HHS must also comply with subparts B, C, & D of the regulations at 45 CFR 46. These subparts provide additional protections for certain special populations involved in research.

This lesson explains how the regulations define research and human subjects and explains what it means to be exempt from the regulations. Understanding these concepts is important to knowing when the regulations apply and when they do not.

Identifying Non-Exempt Human Subjects Research

To figure out whether a particular activity is non-exempt human subjects research under the Common Rule, ask the following three questions, in this order :

• Is the activity research according to the regulations?
• Does the research involve human subjects based on the definition in the regulations?
• Is the human subjects research exempt?

The determination of whether a research study is non-exempt human subjects research is usually made by an institution’s Human Research Protection Program (HRPP) or IRB office. In addition to applying the Common Rule’s basic protections for human subjects in research, the HRPP or IRB office also may ensure that the activity aligns with institutional policies, ethical guidelines, and other regulations and policies that might be relevant.

What is non-exempt human subjects research?

All research involving human volunteers in the United States is required to follow the Common Rule. True or false?

An investigator plans to do a research project involving human subjects that is not funded by the Federal government. Can she proceed with her proposed project without IRB review?

In an institution, who usually determines whether a research study is non-exempt human subjects? (Select all that apply)

In deciding whether a project is non-exempt human subjects research under the Common Rule, what is the first question you should ask?

Go to Section: Defining Research > Categories of Activities Deemed Not to Be Research > Quiz Questions > Determining When the Common Rule Requirements Apply

Defining Research

Let’s start with the first question: Is the activity research according to the regulations?

Not all work that we would colloquially call ‘research’ is considered to be research under the Common Rule. The Common Rule defines research as:

“a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.”

To decide if a certain activity meets the regulatory definition of research, consider:

• It would likely involve a hypothesis, research question, and a plan to systematically collect and analyze data.
• The systematic investigation adds information and contributes to generalizable knowledge in the field.
• For example, lots of information is published that comes from activities that do not meet the Common Rule’s definition of research. And sometimes results from research that meets the Common Rule definition never get published.

Categories of Activities Deemed Not to Be Research

The revised Common Rule also lists four specific types of activities that are deemed not to be research:

• Scholarly and journalistic activities that focus on information specifically about certain individuals.
• Certain public health surveillance activities.
• Certain activities solely for criminal justice or criminal investigative purposes.
• Certain operational activities in support of national security missions.

Review the regulatory descriptions of these four categories of activities deemed to be not research under §46.102(l).

Watch the video to learn more.

The Common Rule defines research as “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalize knowledge.” True or false?

What are the criteria for the regulatory definition of research? (Select all that apply)

Select all activities deemed not to be research under the Common Rule. (Select all that apply)

Determining When the Common Rule Regulatory Requirements Apply

So, when deciding if a specific activity comes under the Common Rule,

First, ask whether it meets the regulatory definition for research—and remember to consider the four categories of activities deemed not to be research.

If the answer is “No,” then the Common Rule does not apply and, as a result, the activity does not have to be reviewed and approved by an IRB before starting. However , investigators should always check with their institution’s HRPP or IRB office to see whether there are institutional policies to follow even if the regulations don’t apply.

If, however, the answer to the first question is “ Yes ” – the activity does meet the regulatory definition of research, THEN ask the second question: Does the research involve human subjects?

Go to Section: Defining Human Subject > Living Individuals > Identifying the Subject > Interaction and Intervention > Identifiable Private Information > Quiz Questions > Determining When the Common Rule Requirements Apply

Defining Human Subject

The revised Common Rule defines human subject as:

“a living individual about whom an investigator (whether professional or student) conducting research: (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses studies, or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.”

While there is a lot of detail in the definition of human subject, it generally boils down to this:

It is important to understand the key terms in this definition to determine when a research study involves human subjects according to the regulations.

Living Individuals

Human Subject: “ a living individual about whom an investigator (whether professional or student) conducting research: (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses studies, or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.”

First of all, notice that it specifies living individuals. Therefore, for the purpose of the Common Rule, research that only involves information or biospecimens from deceased persons would not be considered human subjects research.

Identifying the Subject

Human Subject: “a living individual about whom an investigator (whether professional or student) conducting research: (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses studies, or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.”

The phrase ‘about whom’ is important. A human subject is the person that the information is about, not necessarily the person providing the information. In the case of biospecimens, the human subject is the person from whom the specimen was taken.

For example:

Interaction and Intervention

• Interactions occur when investigators communicate or have interpersonal contact with research participants, for example verbally, in writing, or electronically, to obtain information about them for the research.
• Interventions , on the other hand, include both physical procedures by which investigators collect information or biospecimens and manipulations of the subjects or the subjects’ environment for the purpose of the research.
• Examples of interventions include assigning subjects to take a particular drug in a clinical trial, asking subjects to complete a certain task for research purposes, and changing the background noise level to study how subjects’ stress levels vary.

Identifiable Private Information

Human Subject: “a living individual about whom an investigator (whether professional or student) conducting research: (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses studies, or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens .”

Note, also, that the researchers may or may not have interacted or intervened with the subject at all – for example, they might use leftover blood samples from clinical tests; but if the blood sample is identifiable, then the person is considered to be a human subject.

A proposed research project involves studying tissue samples from cadavers being used in a local medical school to train students. Personal information about the deceased individuals will be used in the research. Is this human subjects research?

Question 10

A proposed research project involves asking participants to complete a task and answer questions on a computer. No identifiable information will be recorded about participants. Is this human subjects research?

Question 11

A proposed research project will use leftover blood samples from clinical tests to check for levels of a certain metabolite. Investigators will also review patients’ identifiable medical records to obtain other necessary health information. Is this human subjects research?

Question 12

Which of the following activities, when carried out for the purpose of research, would constitute research involving human subjects under the Common Rule? (Select all that apply)

Question 13

Research that only involves specimens from deceased persons would not be considered human subjects research. True or false?

Apply this definition of “human subjects” to your research to determine whether your research study constitutes human subjects research under the Common Rule. If the answer is “no,” then the Common Rule does not apply.

If, on the other hand, the answer to this second question is “yes,” and it is human subjects research, then you go on to the third question: Is it exempt?

Go to Section: Could the Human Subjects Research Be Exempt? > Exempt Human Subjects Research > Quiz Questions > Determining When the Common Rule Requirements Apply

Could the Human Subjects Research Be Exempt?

There are eight exemption categories listed in the revised Common Rule. If all of the activities in a human subjects research study meet the criteria for one or more of these exemption categories, the study is exempt from the Common Rule requirements for oversight. This means, for example, that the research does not need to undergo initial or continuing IRB review for approval as required by the regulations.

The Common Rule does not specify who can make determinations about exemptions. Most institutions require that investigators submit proposed research to the institution’s HRPP or IRB office for the determination about whether it meets the criteria for an exemption. Additionally, certain exemptions require a “limited IRB review” to determine that specific conditions are met for the exemption to apply.

Exempt Human Subjects Research

An entire human subjects research projects that has been determined to meet the conditions for one or more exemption categories in the Common Rule can generally proceed without having to comply with the regulatory requirements.

One thing to remember, however, is that if investigators make changes to the research at a later time, they should check with their institution’s HRPP or IRB office to make sure that the research still meets the exemption criteria. If the changes cause the research study to no longer meet the criteria for exemption, then the research is no longer exempt and must comply with the regulatory requirements and undergo IRB review . Investigators should work closely with their HRPP or IRB office to avoid surprises like this that could affect the progress of their research.

Click here to watch a video explaining the exemption categories.

Question 14

What does it mean for a research project to be exempt?

Question 15

The Common Rule specifies who should make determinations about exemptions. True or false?

Question 16

Where should a researcher go to inquire whether something qualifies as an exemption? (Select all that could apply)

Question 17

Once a research study is determined to be exempt, it will always be exempt regardless of any subsequent changes that might be made to it. True or false?

Human subjects research studies that do not qualify for an exemption are referred to as non-exempt human subjects research. Unless there is a Secretarial waiver, they must comply with the Common Rule regulatory requirements, including IRB review and approval, before the research can begin. For non-exempt cooperative research studies involving multiple institutions, the review would generally be done by a single IRB.

Go to Section: Wrap Up > Completion Certificate

This lesson explained the process of determining whether a research project meets the criteria for being non-exempt human subjects research under the Common Rule. Remember that if it doesn’t satisfy the regulatory definition of either research or human subject, or if all of the activities in the human subjects research meet the criteria for one or more of the exemptions, then the Common Rule regulatory requirements do not apply to the project, but investigators may still be subject to any institutional policies that are in place. Investigators should work with their institution’s Human Research Protection Program (HRPP) or IRB office to find answers and determine how to proceed.

Congratulations!

You have completed OHRP’s learning module:

OHRP does not collect information about who completes this training. Please fill out the information below and print this page for your records.

• Clinical Trials

Effect of RBT-1 on Reducing the Risk of Post-Operative Complications in Subjects Undergoing Cardiac Surgery and Sub-Study of Clinical Protocol REN-007: A Population Pharmacokinetic (popPK) Evaluation of RBT-1

• Print details

Tab Title Description

• Observational study — observes people and measures outcomes without affecting results.
• Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
• Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

Study phase

During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

• Rochester, Minnesota: 23-004296

About this study

The purpose of this study is is to evaluate the effect of RBT-1 on reducing the risk of post-operative complications in subjects undergoing cardiac surgery on cardiopulmonary bypass (CPB).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria: 1. Male or female, ≥18 years of age at Screening. 2. Planned to undergo non-emergent CABG and/or cardiac valve surgery requiring CPB; non-emergent surgery must allow for study drug infusion ≥24 but ≤48 hours prior to surgery. 3. If female, subjects must use an effective method of birth control or abstain from sexual relations with a male partner (unless has undergone tubal ligation or hysterectomy or is at least 1 year postmenopausal) for the duration of their study participation. 4. If male, subjects must use an effective method of birth control or abstain from sexual relations with a female partner for the duration of their study participation, unless the subject has had a vasectomy ≥6 months prior to infusion with study drug. 5. Willingness to comply with all study-related procedures and assessments. Exclusion Criteria: 1. Surgery planned to occur 2. Presence of acute organ dysfunction (AKI, acute decompensated heart failure, acute respiratory failure, stroke, etc) as assessed by the Investigator at the time of Screening. 3. Surgery to be performed without CPB. 4. Chronic kidney disease (CKD) requiring dialysis. 5. Hypokalemia and/or hypomagnesemia within 24 hours prior to study drug infusion; electrolytes can be replenished if low. 6. Cardiogenic shock or requirement for inotropes, vasopressors, or other mechanical devices, such as intra-aortic balloon pump (IABP). 7. Known history of cancer within the past 2 years, except for carcinoma in situ of the cervix or breast, early-stage prostate cancer, or adequately treated non-melanoma cancer of the skin. 8. Known or suspected sepsis at time of Screening. 9. Asplenia (anatomic or functional). 10. History of hemochromatosis, iron overload, or porphyria. 11. Known hypersensitivity or previous anaphylaxis to SnPP or FeS. 12. Female subject who is pregnant or breastfeeding. 13. Participation in a study involving an investigational drug or device within 30 days prior to study drug infusion. 14. In the opinion of the Investigator, for any reason, the subject is an unsuitable candidate to receive RBT-1.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 12/14/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

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• BMC Med Res Methodol

A tutorial on methodological studies: the what, when, how and why

Lawrence mbuagbaw.

1 Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON Canada

2 Biostatistics Unit/FSORC, 50 Charlton Avenue East, St Joseph’s Healthcare—Hamilton, 3rd Floor Martha Wing, Room H321, Hamilton, Ontario L8N 4A6 Canada

3 Centre for the Development of Best Practices in Health, Yaoundé, Cameroon

Daeria O. Lawson

Livia puljak.

4 Center for Evidence-Based Medicine and Health Care, Catholic University of Croatia, Ilica 242, 10000 Zagreb, Croatia

David B. Allison

5 Department of Epidemiology and Biostatistics, School of Public Health – Bloomington, Indiana University, Bloomington, IN 47405 USA

Lehana Thabane

6 Departments of Paediatrics and Anaesthesia, McMaster University, Hamilton, ON Canada

7 Centre for Evaluation of Medicine, St. Joseph’s Healthcare-Hamilton, Hamilton, ON Canada

8 Population Health Research Institute, Hamilton Health Sciences, Hamilton, ON Canada

Associated Data

Data sharing is not applicable to this article as no new data were created or analyzed in this study.

Methodological studies – studies that evaluate the design, analysis or reporting of other research-related reports – play an important role in health research. They help to highlight issues in the conduct of research with the aim of improving health research methodology, and ultimately reducing research waste.

We provide an overview of some of the key aspects of methodological studies such as what they are, and when, how and why they are done. We adopt a “frequently asked questions” format to facilitate reading this paper and provide multiple examples to help guide researchers interested in conducting methodological studies. Some of the topics addressed include: is it necessary to publish a study protocol? How to select relevant research reports and databases for a methodological study? What approaches to data extraction and statistical analysis should be considered when conducting a methodological study? What are potential threats to validity and is there a way to appraise the quality of methodological studies?

Appropriate reflection and application of basic principles of epidemiology and biostatistics are required in the design and analysis of methodological studies. This paper provides an introduction for further discussion about the conduct of methodological studies.

The field of meta-research (or research-on-research) has proliferated in recent years in response to issues with research quality and conduct [ 1 – 3 ]. As the name suggests, this field targets issues with research design, conduct, analysis and reporting. Various types of research reports are often examined as the unit of analysis in these studies (e.g. abstracts, full manuscripts, trial registry entries). Like many other novel fields of research, meta-research has seen a proliferation of use before the development of reporting guidance. For example, this was the case with randomized trials for which risk of bias tools and reporting guidelines were only developed much later – after many trials had been published and noted to have limitations [ 4 , 5 ]; and for systematic reviews as well [ 6 – 8 ]. However, in the absence of formal guidance, studies that report on research differ substantially in how they are named, conducted and reported [ 9 , 10 ]. This creates challenges in identifying, summarizing and comparing them. In this tutorial paper, we will use the term methodological study to refer to any study that reports on the design, conduct, analysis or reporting of primary or secondary research-related reports (such as trial registry entries and conference abstracts).

In the past 10 years, there has been an increase in the use of terms related to methodological studies (based on records retrieved with a keyword search [in the title and abstract] for “methodological review” and “meta-epidemiological study” in PubMed up to December 2019), suggesting that these studies may be appearing more frequently in the literature. See Fig.  1 .

Trends in the number studies that mention “methodological review” or “meta-

epidemiological study” in PubMed.

The methods used in many methodological studies have been borrowed from systematic and scoping reviews. This practice has influenced the direction of the field, with many methodological studies including searches of electronic databases, screening of records, duplicate data extraction and assessments of risk of bias in the included studies. However, the research questions posed in methodological studies do not always require the approaches listed above, and guidance is needed on when and how to apply these methods to a methodological study. Even though methodological studies can be conducted on qualitative or mixed methods research, this paper focuses on and draws examples exclusively from quantitative research.

The objectives of this paper are to provide some insights on how to conduct methodological studies so that there is greater consistency between the research questions posed, and the design, analysis and reporting of findings. We provide multiple examples to illustrate concepts and a proposed framework for categorizing methodological studies in quantitative research.

What is a methodological study?

Any study that describes or analyzes methods (design, conduct, analysis or reporting) in published (or unpublished) literature is a methodological study. Consequently, the scope of methodological studies is quite extensive and includes, but is not limited to, topics as diverse as: research question formulation [ 11 ]; adherence to reporting guidelines [ 12 – 14 ] and consistency in reporting [ 15 ]; approaches to study analysis [ 16 ]; investigating the credibility of analyses [ 17 ]; and studies that synthesize these methodological studies [ 18 ]. While the nomenclature of methodological studies is not uniform, the intents and purposes of these studies remain fairly consistent – to describe or analyze methods in primary or secondary studies. As such, methodological studies may also be classified as a subtype of observational studies.

Parallel to this are experimental studies that compare different methods. Even though they play an important role in informing optimal research methods, experimental methodological studies are beyond the scope of this paper. Examples of such studies include the randomized trials by Buscemi et al., comparing single data extraction to double data extraction [ 19 ], and Carrasco-Labra et al., comparing approaches to presenting findings in Grading of Recommendations, Assessment, Development and Evaluations (GRADE) summary of findings tables [ 20 ]. In these studies, the unit of analysis is the person or groups of individuals applying the methods. We also direct readers to the Studies Within a Trial (SWAT) and Studies Within a Review (SWAR) programme operated through the Hub for Trials Methodology Research, for further reading as a potential useful resource for these types of experimental studies [ 21 ]. Lastly, this paper is not meant to inform the conduct of research using computational simulation and mathematical modeling for which some guidance already exists [ 22 ], or studies on the development of methods using consensus-based approaches.

When should we conduct a methodological study?

Methodological studies occupy a unique niche in health research that allows them to inform methodological advances. Methodological studies should also be conducted as pre-cursors to reporting guideline development, as they provide an opportunity to understand current practices, and help to identify the need for guidance and gaps in methodological or reporting quality. For example, the development of the popular Preferred Reporting Items of Systematic reviews and Meta-Analyses (PRISMA) guidelines were preceded by methodological studies identifying poor reporting practices [ 23 , 24 ]. In these instances, after the reporting guidelines are published, methodological studies can also be used to monitor uptake of the guidelines.

These studies can also be conducted to inform the state of the art for design, analysis and reporting practices across different types of health research fields, with the aim of improving research practices, and preventing or reducing research waste. For example, Samaan et al. conducted a scoping review of adherence to different reporting guidelines in health care literature [ 18 ]. Methodological studies can also be used to determine the factors associated with reporting practices. For example, Abbade et al. investigated journal characteristics associated with the use of the Participants, Intervention, Comparison, Outcome, Timeframe (PICOT) format in framing research questions in trials of venous ulcer disease [ 11 ].

How often are methodological studies conducted?

There is no clear answer to this question. Based on a search of PubMed, the use of related terms (“methodological review” and “meta-epidemiological study”) – and therefore, the number of methodological studies – is on the rise. However, many other terms are used to describe methodological studies. There are also many studies that explore design, conduct, analysis or reporting of research reports, but that do not use any specific terms to describe or label their study design in terms of “methodology”. This diversity in nomenclature makes a census of methodological studies elusive. Appropriate terminology and key words for methodological studies are needed to facilitate improved accessibility for end-users.

Why do we conduct methodological studies?

Methodological studies provide information on the design, conduct, analysis or reporting of primary and secondary research and can be used to appraise quality, quantity, completeness, accuracy and consistency of health research. These issues can be explored in specific fields, journals, databases, geographical regions and time periods. For example, Areia et al. explored the quality of reporting of endoscopic diagnostic studies in gastroenterology [ 25 ]; Knol et al. investigated the reporting of p -values in baseline tables in randomized trial published in high impact journals [ 26 ]; Chen et al. describe adherence to the Consolidated Standards of Reporting Trials (CONSORT) statement in Chinese Journals [ 27 ]; and Hopewell et al. describe the effect of editors’ implementation of CONSORT guidelines on reporting of abstracts over time [ 28 ]. Methodological studies provide useful information to researchers, clinicians, editors, publishers and users of health literature. As a result, these studies have been at the cornerstone of important methodological developments in the past two decades and have informed the development of many health research guidelines including the highly cited CONSORT statement [ 5 ].

Where can we find methodological studies?

Methodological studies can be found in most common biomedical bibliographic databases (e.g. Embase, MEDLINE, PubMed, Web of Science). However, the biggest caveat is that methodological studies are hard to identify in the literature due to the wide variety of names used and the lack of comprehensive databases dedicated to them. A handful can be found in the Cochrane Library as “Cochrane Methodology Reviews”, but these studies only cover methodological issues related to systematic reviews. Previous attempts to catalogue all empirical studies of methods used in reviews were abandoned 10 years ago [ 29 ]. In other databases, a variety of search terms may be applied with different levels of sensitivity and specificity.

Some frequently asked questions about methodological studies

In this section, we have outlined responses to questions that might help inform the conduct of methodological studies.

Q: How should I select research reports for my methodological study?

A: Selection of research reports for a methodological study depends on the research question and eligibility criteria. Once a clear research question is set and the nature of literature one desires to review is known, one can then begin the selection process. Selection may begin with a broad search, especially if the eligibility criteria are not apparent. For example, a methodological study of Cochrane Reviews of HIV would not require a complex search as all eligible studies can easily be retrieved from the Cochrane Library after checking a few boxes [ 30 ]. On the other hand, a methodological study of subgroup analyses in trials of gastrointestinal oncology would require a search to find such trials, and further screening to identify trials that conducted a subgroup analysis [ 31 ].

The strategies used for identifying participants in observational studies can apply here. One may use a systematic search to identify all eligible studies. If the number of eligible studies is unmanageable, a random sample of articles can be expected to provide comparable results if it is sufficiently large [ 32 ]. For example, Wilson et al. used a random sample of trials from the Cochrane Stroke Group’s Trial Register to investigate completeness of reporting [ 33 ]. It is possible that a simple random sample would lead to underrepresentation of units (i.e. research reports) that are smaller in number. This is relevant if the investigators wish to compare multiple groups but have too few units in one group. In this case a stratified sample would help to create equal groups. For example, in a methodological study comparing Cochrane and non-Cochrane reviews, Kahale et al. drew random samples from both groups [ 34 ]. Alternatively, systematic or purposeful sampling strategies can be used and we encourage researchers to justify their selected approaches based on the study objective.

Q: How many databases should I search?

A: The number of databases one should search would depend on the approach to sampling, which can include targeting the entire “population” of interest or a sample of that population. If you are interested in including the entire target population for your research question, or drawing a random or systematic sample from it, then a comprehensive and exhaustive search for relevant articles is required. In this case, we recommend using systematic approaches for searching electronic databases (i.e. at least 2 databases with a replicable and time stamped search strategy). The results of your search will constitute a sampling frame from which eligible studies can be drawn.

Alternatively, if your approach to sampling is purposeful, then we recommend targeting the database(s) or data sources (e.g. journals, registries) that include the information you need. For example, if you are conducting a methodological study of high impact journals in plastic surgery and they are all indexed in PubMed, you likely do not need to search any other databases. You may also have a comprehensive list of all journals of interest and can approach your search using the journal names in your database search (or by accessing the journal archives directly from the journal’s website). Even though one could also search journals’ web pages directly, using a database such as PubMed has multiple advantages, such as the use of filters, so the search can be narrowed down to a certain period, or study types of interest. Furthermore, individual journals’ web sites may have different search functionalities, which do not necessarily yield a consistent output.

Q: Should I publish a protocol for my methodological study?

A: A protocol is a description of intended research methods. Currently, only protocols for clinical trials require registration [ 35 ]. Protocols for systematic reviews are encouraged but no formal recommendation exists. The scientific community welcomes the publication of protocols because they help protect against selective outcome reporting, the use of post hoc methodologies to embellish results, and to help avoid duplication of efforts [ 36 ]. While the latter two risks exist in methodological research, the negative consequences may be substantially less than for clinical outcomes. In a sample of 31 methodological studies, 7 (22.6%) referenced a published protocol [ 9 ]. In the Cochrane Library, there are 15 protocols for methodological reviews (21 July 2020). This suggests that publishing protocols for methodological studies is not uncommon.

Authors can consider publishing their study protocol in a scholarly journal as a manuscript. Advantages of such publication include obtaining peer-review feedback about the planned study, and easy retrieval by searching databases such as PubMed. The disadvantages in trying to publish protocols includes delays associated with manuscript handling and peer review, as well as costs, as few journals publish study protocols, and those journals mostly charge article-processing fees [ 37 ]. Authors who would like to make their protocol publicly available without publishing it in scholarly journals, could deposit their study protocols in publicly available repositories, such as the Open Science Framework ( https://osf.io/ ).

Q: How to appraise the quality of a methodological study?

A: To date, there is no published tool for appraising the risk of bias in a methodological study, but in principle, a methodological study could be considered as a type of observational study. Therefore, during conduct or appraisal, care should be taken to avoid the biases common in observational studies [ 38 ]. These biases include selection bias, comparability of groups, and ascertainment of exposure or outcome. In other words, to generate a representative sample, a comprehensive reproducible search may be necessary to build a sampling frame. Additionally, random sampling may be necessary to ensure that all the included research reports have the same probability of being selected, and the screening and selection processes should be transparent and reproducible. To ensure that the groups compared are similar in all characteristics, matching, random sampling or stratified sampling can be used. Statistical adjustments for between-group differences can also be applied at the analysis stage. Finally, duplicate data extraction can reduce errors in assessment of exposures or outcomes.

Q: Should I justify a sample size?

A: In all instances where one is not using the target population (i.e. the group to which inferences from the research report are directed) [ 39 ], a sample size justification is good practice. The sample size justification may take the form of a description of what is expected to be achieved with the number of articles selected, or a formal sample size estimation that outlines the number of articles required to answer the research question with a certain precision and power. Sample size justifications in methodological studies are reasonable in the following instances:

• Comparing two groups
• Determining a proportion, mean or another quantifier
• Determining factors associated with an outcome using regression-based analyses

For example, El Dib et al. computed a sample size requirement for a methodological study of diagnostic strategies in randomized trials, based on a confidence interval approach [ 40 ].

Q: What should I call my study?

A: Other terms which have been used to describe/label methodological studies include “ methodological review ”, “methodological survey” , “meta-epidemiological study” , “systematic review” , “systematic survey”, “meta-research”, “research-on-research” and many others. We recommend that the study nomenclature be clear, unambiguous, informative and allow for appropriate indexing. Methodological study nomenclature that should be avoided includes “ systematic review” – as this will likely be confused with a systematic review of a clinical question. “ Systematic survey” may also lead to confusion about whether the survey was systematic (i.e. using a preplanned methodology) or a survey using “ systematic” sampling (i.e. a sampling approach using specific intervals to determine who is selected) [ 32 ]. Any of the above meanings of the words “ systematic” may be true for methodological studies and could be potentially misleading. “ Meta-epidemiological study” is ideal for indexing, but not very informative as it describes an entire field. The term “ review ” may point towards an appraisal or “review” of the design, conduct, analysis or reporting (or methodological components) of the targeted research reports, yet it has also been used to describe narrative reviews [ 41 , 42 ]. The term “ survey ” is also in line with the approaches used in many methodological studies [ 9 ], and would be indicative of the sampling procedures of this study design. However, in the absence of guidelines on nomenclature, the term “ methodological study ” is broad enough to capture most of the scenarios of such studies.

Q: Should I account for clustering in my methodological study?

A: Data from methodological studies are often clustered. For example, articles coming from a specific source may have different reporting standards (e.g. the Cochrane Library). Articles within the same journal may be similar due to editorial practices and policies, reporting requirements and endorsement of guidelines. There is emerging evidence that these are real concerns that should be accounted for in analyses [ 43 ]. Some cluster variables are described in the section: “ What variables are relevant to methodological studies?”

A variety of modelling approaches can be used to account for correlated data, including the use of marginal, fixed or mixed effects regression models with appropriate computation of standard errors [ 44 ]. For example, Kosa et al. used generalized estimation equations to account for correlation of articles within journals [ 15 ]. Not accounting for clustering could lead to incorrect p -values, unduly narrow confidence intervals, and biased estimates [ 45 ].

Q: Should I extract data in duplicate?

A: Yes. Duplicate data extraction takes more time but results in less errors [ 19 ]. Data extraction errors in turn affect the effect estimate [ 46 ], and therefore should be mitigated. Duplicate data extraction should be considered in the absence of other approaches to minimize extraction errors. However, much like systematic reviews, this area will likely see rapid new advances with machine learning and natural language processing technologies to support researchers with screening and data extraction [ 47 , 48 ]. However, experience plays an important role in the quality of extracted data and inexperienced extractors should be paired with experienced extractors [ 46 , 49 ].

Q: Should I assess the risk of bias of research reports included in my methodological study?

A : Risk of bias is most useful in determining the certainty that can be placed in the effect measure from a study. In methodological studies, risk of bias may not serve the purpose of determining the trustworthiness of results, as effect measures are often not the primary goal of methodological studies. Determining risk of bias in methodological studies is likely a practice borrowed from systematic review methodology, but whose intrinsic value is not obvious in methodological studies. When it is part of the research question, investigators often focus on one aspect of risk of bias. For example, Speich investigated how blinding was reported in surgical trials [ 50 ], and Abraha et al., investigated the application of intention-to-treat analyses in systematic reviews and trials [ 51 ].

Q: What variables are relevant to methodological studies?

A: There is empirical evidence that certain variables may inform the findings in a methodological study. We outline some of these and provide a brief overview below:

• Country: Countries and regions differ in their research cultures, and the resources available to conduct research. Therefore, it is reasonable to believe that there may be differences in methodological features across countries. Methodological studies have reported loco-regional differences in reporting quality [ 52 , 53 ]. This may also be related to challenges non-English speakers face in publishing papers in English.
• Authors’ expertise: The inclusion of authors with expertise in research methodology, biostatistics, and scientific writing is likely to influence the end-product. Oltean et al. found that among randomized trials in orthopaedic surgery, the use of analyses that accounted for clustering was more likely when specialists (e.g. statistician, epidemiologist or clinical trials methodologist) were included on the study team [ 54 ]. Fleming et al. found that including methodologists in the review team was associated with appropriate use of reporting guidelines [ 55 ].
• Source of funding and conflicts of interest: Some studies have found that funded studies report better [ 56 , 57 ], while others do not [ 53 , 58 ]. The presence of funding would indicate the availability of resources deployed to ensure optimal design, conduct, analysis and reporting. However, the source of funding may introduce conflicts of interest and warrant assessment. For example, Kaiser et al. investigated the effect of industry funding on obesity or nutrition randomized trials and found that reporting quality was similar [ 59 ]. Thomas et al. looked at reporting quality of long-term weight loss trials and found that industry funded studies were better [ 60 ]. Kan et al. examined the association between industry funding and “positive trials” (trials reporting a significant intervention effect) and found that industry funding was highly predictive of a positive trial [ 61 ]. This finding is similar to that of a recent Cochrane Methodology Review by Hansen et al. [ 62 ]
• Journal characteristics: Certain journals’ characteristics may influence the study design, analysis or reporting. Characteristics such as journal endorsement of guidelines [ 63 , 64 ], and Journal Impact Factor (JIF) have been shown to be associated with reporting [ 63 , 65 – 67 ].
• Study size (sample size/number of sites): Some studies have shown that reporting is better in larger studies [ 53 , 56 , 58 ].
• Year of publication: It is reasonable to assume that design, conduct, analysis and reporting of research will change over time. Many studies have demonstrated improvements in reporting over time or after the publication of reporting guidelines [ 68 , 69 ].
• Type of intervention: In a methodological study of reporting quality of weight loss intervention studies, Thabane et al. found that trials of pharmacologic interventions were reported better than trials of non-pharmacologic interventions [ 70 ].
• Interactions between variables: Complex interactions between the previously listed variables are possible. High income countries with more resources may be more likely to conduct larger studies and incorporate a variety of experts. Authors in certain countries may prefer certain journals, and journal endorsement of guidelines and editorial policies may change over time.

Q: Should I focus only on high impact journals?

A: Investigators may choose to investigate only high impact journals because they are more likely to influence practice and policy, or because they assume that methodological standards would be higher. However, the JIF may severely limit the scope of articles included and may skew the sample towards articles with positive findings. The generalizability and applicability of findings from a handful of journals must be examined carefully, especially since the JIF varies over time. Even among journals that are all “high impact”, variations exist in methodological standards.

Q: Can I conduct a methodological study of qualitative research?

A: Yes. Even though a lot of methodological research has been conducted in the quantitative research field, methodological studies of qualitative studies are feasible. Certain databases that catalogue qualitative research including the Cumulative Index to Nursing & Allied Health Literature (CINAHL) have defined subject headings that are specific to methodological research (e.g. “research methodology”). Alternatively, one could also conduct a qualitative methodological review; that is, use qualitative approaches to synthesize methodological issues in qualitative studies.

Q: What reporting guidelines should I use for my methodological study?

A: There is no guideline that covers the entire scope of methodological studies. One adaptation of the PRISMA guidelines has been published, which works well for studies that aim to use the entire target population of research reports [ 71 ]. However, it is not widely used (40 citations in 2 years as of 09 December 2019), and methodological studies that are designed as cross-sectional or before-after studies require a more fit-for purpose guideline. A more encompassing reporting guideline for a broad range of methodological studies is currently under development [ 72 ]. However, in the absence of formal guidance, the requirements for scientific reporting should be respected, and authors of methodological studies should focus on transparency and reproducibility.

Q: What are the potential threats to validity and how can I avoid them?

A: Methodological studies may be compromised by a lack of internal or external validity. The main threats to internal validity in methodological studies are selection and confounding bias. Investigators must ensure that the methods used to select articles does not make them differ systematically from the set of articles to which they would like to make inferences. For example, attempting to make extrapolations to all journals after analyzing high-impact journals would be misleading.

Many factors (confounders) may distort the association between the exposure and outcome if the included research reports differ with respect to these factors [ 73 ]. For example, when examining the association between source of funding and completeness of reporting, it may be necessary to account for journals that endorse the guidelines. Confounding bias can be addressed by restriction, matching and statistical adjustment [ 73 ]. Restriction appears to be the method of choice for many investigators who choose to include only high impact journals or articles in a specific field. For example, Knol et al. examined the reporting of p -values in baseline tables of high impact journals [ 26 ]. Matching is also sometimes used. In the methodological study of non-randomized interventional studies of elective ventral hernia repair, Parker et al. matched prospective studies with retrospective studies and compared reporting standards [ 74 ]. Some other methodological studies use statistical adjustments. For example, Zhang et al. used regression techniques to determine the factors associated with missing participant data in trials [ 16 ].

With regard to external validity, researchers interested in conducting methodological studies must consider how generalizable or applicable their findings are. This should tie in closely with the research question and should be explicit. For example. Findings from methodological studies on trials published in high impact cardiology journals cannot be assumed to be applicable to trials in other fields. However, investigators must ensure that their sample truly represents the target sample either by a) conducting a comprehensive and exhaustive search, or b) using an appropriate and justified, randomly selected sample of research reports.

Even applicability to high impact journals may vary based on the investigators’ definition, and over time. For example, for high impact journals in the field of general medicine, Bouwmeester et al. included the Annals of Internal Medicine (AIM), BMJ, the Journal of the American Medical Association (JAMA), Lancet, the New England Journal of Medicine (NEJM), and PLoS Medicine ( n  = 6) [ 75 ]. In contrast, the high impact journals selected in the methodological study by Schiller et al. were BMJ, JAMA, Lancet, and NEJM ( n  = 4) [ 76 ]. Another methodological study by Kosa et al. included AIM, BMJ, JAMA, Lancet and NEJM ( n  = 5). In the methodological study by Thabut et al., journals with a JIF greater than 5 were considered to be high impact. Riado Minguez et al. used first quartile journals in the Journal Citation Reports (JCR) for a specific year to determine “high impact” [ 77 ]. Ultimately, the definition of high impact will be based on the number of journals the investigators are willing to include, the year of impact and the JIF cut-off [ 78 ]. We acknowledge that the term “generalizability” may apply differently for methodological studies, especially when in many instances it is possible to include the entire target population in the sample studied.

Finally, methodological studies are not exempt from information bias which may stem from discrepancies in the included research reports [ 79 ], errors in data extraction, or inappropriate interpretation of the information extracted. Likewise, publication bias may also be a concern in methodological studies, but such concepts have not yet been explored.

A proposed framework

In order to inform discussions about methodological studies, the development of guidance for what should be reported, we have outlined some key features of methodological studies that can be used to classify them. For each of the categories outlined below, we provide an example. In our experience, the choice of approach to completing a methodological study can be informed by asking the following four questions:

• What is the aim?

A methodological study may be focused on exploring sources of bias in primary or secondary studies (meta-bias), or how bias is analyzed. We have taken care to distinguish bias (i.e. systematic deviations from the truth irrespective of the source) from reporting quality or completeness (i.e. not adhering to a specific reporting guideline or norm). An example of where this distinction would be important is in the case of a randomized trial with no blinding. This study (depending on the nature of the intervention) would be at risk of performance bias. However, if the authors report that their study was not blinded, they would have reported adequately. In fact, some methodological studies attempt to capture both “quality of conduct” and “quality of reporting”, such as Richie et al., who reported on the risk of bias in randomized trials of pharmacy practice interventions [ 80 ]. Babic et al. investigated how risk of bias was used to inform sensitivity analyses in Cochrane reviews [ 81 ]. Further, biases related to choice of outcomes can also be explored. For example, Tan et al investigated differences in treatment effect size based on the outcome reported [ 82 ].

Methodological studies may report quality of reporting against a reporting checklist (i.e. adherence to guidelines) or against expected norms. For example, Croituro et al. report on the quality of reporting in systematic reviews published in dermatology journals based on their adherence to the PRISMA statement [ 83 ], and Khan et al. described the quality of reporting of harms in randomized controlled trials published in high impact cardiovascular journals based on the CONSORT extension for harms [ 84 ]. Other methodological studies investigate reporting of certain features of interest that may not be part of formally published checklists or guidelines. For example, Mbuagbaw et al. described how often the implications for research are elaborated using the Evidence, Participants, Intervention, Comparison, Outcome, Timeframe (EPICOT) format [ 30 ].

Sometimes investigators may be interested in how consistent reports of the same research are, as it is expected that there should be consistency between: conference abstracts and published manuscripts; manuscript abstracts and manuscript main text; and trial registration and published manuscript. For example, Rosmarakis et al. investigated consistency between conference abstracts and full text manuscripts [ 85 ].

In addition to identifying issues with reporting in primary and secondary studies, authors of methodological studies may be interested in determining the factors that are associated with certain reporting practices. Many methodological studies incorporate this, albeit as a secondary outcome. For example, Farrokhyar et al. investigated the factors associated with reporting quality in randomized trials of coronary artery bypass grafting surgery [ 53 ].

Methodological studies may also be used to describe methods or compare methods, and the factors associated with methods. Muller et al. described the methods used for systematic reviews and meta-analyses of observational studies [ 86 ].

Some methodological studies synthesize results from other methodological studies. For example, Li et al. conducted a scoping review of methodological reviews that investigated consistency between full text and abstracts in primary biomedical research [ 87 ].

Some methodological studies may investigate the use of names and terms in health research. For example, Martinic et al. investigated the definitions of systematic reviews used in overviews of systematic reviews (OSRs), meta-epidemiological studies and epidemiology textbooks [ 88 ].

In addition to the previously mentioned experimental methodological studies, there may exist other types of methodological studies not captured here.

• 2. What is the design?

Most methodological studies are purely descriptive and report their findings as counts (percent) and means (standard deviation) or medians (interquartile range). For example, Mbuagbaw et al. described the reporting of research recommendations in Cochrane HIV systematic reviews [ 30 ]. Gohari et al. described the quality of reporting of randomized trials in diabetes in Iran [ 12 ].

Some methodological studies are analytical wherein “analytical studies identify and quantify associations, test hypotheses, identify causes and determine whether an association exists between variables, such as between an exposure and a disease.” [ 89 ] In the case of methodological studies all these investigations are possible. For example, Kosa et al. investigated the association between agreement in primary outcome from trial registry to published manuscript and study covariates. They found that larger and more recent studies were more likely to have agreement [ 15 ]. Tricco et al. compared the conclusion statements from Cochrane and non-Cochrane systematic reviews with a meta-analysis of the primary outcome and found that non-Cochrane reviews were more likely to report positive findings. These results are a test of the null hypothesis that the proportions of Cochrane and non-Cochrane reviews that report positive results are equal [ 90 ].

• 3. What is the sampling strategy?

Methodological reviews with narrow research questions may be able to include the entire target population. For example, in the methodological study of Cochrane HIV systematic reviews, Mbuagbaw et al. included all of the available studies ( n  = 103) [ 30 ].

Many methodological studies use random samples of the target population [ 33 , 91 , 92 ]. Alternatively, purposeful sampling may be used, limiting the sample to a subset of research-related reports published within a certain time period, or in journals with a certain ranking or on a topic. Systematic sampling can also be used when random sampling may be challenging to implement.

• 4. What is the unit of analysis?

Many methodological studies use a research report (e.g. full manuscript of study, abstract portion of the study) as the unit of analysis, and inferences can be made at the study-level. However, both published and unpublished research-related reports can be studied. These may include articles, conference abstracts, registry entries etc.

Some methodological studies report on items which may occur more than once per article. For example, Paquette et al. report on subgroup analyses in Cochrane reviews of atrial fibrillation in which 17 systematic reviews planned 56 subgroup analyses [ 93 ].

This framework is outlined in Fig.  2 .

A proposed framework for methodological studies

Conclusions

Methodological studies have examined different aspects of reporting such as quality, completeness, consistency and adherence to reporting guidelines. As such, many of the methodological study examples cited in this tutorial are related to reporting. However, as an evolving field, the scope of research questions that can be addressed by methodological studies is expected to increase.

In this paper we have outlined the scope and purpose of methodological studies, along with examples of instances in which various approaches have been used. In the absence of formal guidance on the design, conduct, analysis and reporting of methodological studies, we have provided some advice to help make methodological studies consistent. This advice is grounded in good contemporary scientific practice. Generally, the research question should tie in with the sampling approach and planned analysis. We have also highlighted the variables that may inform findings from methodological studies. Lastly, we have provided suggestions for ways in which authors can categorize their methodological studies to inform their design and analysis.

Acknowledgements

Abbreviations, authors’ contributions.

LM conceived the idea and drafted the outline and paper. DOL and LT commented on the idea and draft outline. LM, LP and DOL performed literature searches and data extraction. All authors (LM, DOL, LT, LP, DBA) reviewed several draft versions of the manuscript and approved the final manuscript.

This work did not receive any dedicated funding.

Availability of data and materials

Ethics approval and consent to participate.

Not applicable.

Consent for publication

Competing interests.

DOL, DBA, LM, LP and LT are involved in the development of a reporting guideline for methodological studies.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

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Stanford Medicine-led study identifies novel target for epilepsy treatment

Researchers find that a little-understood part of the brain appears to be involved in starting seizures and keeping them going.

April 17, 2024 - By Kimberlee D'Ardenne

Stanford Medicine researchers and their colleagues found that removing or inhibiting the fasciola cinereum may help epilepsy patients who aren't helped by surgery. Tom - stock.adobe.com

Removing part of the brain’s temporal lobe is the only treatment available to the millions of people with a form of epilepsy that medications often don’t alleviate. But even that approach fails a third of the time.

A new study from Stanford Medicine researchers and their colleagues offers an explanation and suggests a more effective approach to treatment. They found that a previously overlooked region of the hippocampus, the fasciola cinereum, appears to be involved in instigating and propagating seizures. Removing or inhibiting the fasciola cinereum may help those patients who don’t find relief after surgery.

“The hippocampus is the best studied part of the brain by far, but there is shockingly little known about the fasciola cinereum,” said Ivan Soltesz , PhD, the James R. Doty Professor in Neurosurgery and Neurosciences and a senior author on the study. “This relatively small region was consistently involved in seizure activity in mice and in people undergoing pre-surgical electrical recordings. Our findings suggest that all patients with drug-resistant temporal lobe epilepsy should have depth electrodes placed in the fasciola cinereum as part of the surgery planning process.”

The work was published April 17 in Nature Medicine . Soltesz and Vivek Buch , MD, the Christina and Hamid Moghadam Faculty Scholar as well as the surgical director of the Stanford Comprehensive Epilepsy Center , are co-senior authors.

A tale of a tail

Worldwide, 65 million people live with epilepsy. Tens of millions have mesial temporal lobe epilepsy, with seizures originating, in part, from the amygdala, an almond-shaped structure involved in processing emotions, and the hippocampus, a region necessary for forming memories. When people with mesial temporal lobe epilepsy of just one hemisphere do not respond to anti-seizure drug therapies, the standard of care is surgery. In these procedures, the amygdala and most of the hippocampus in one hemisphere are either surgically removed or ablated, a technique that involves using a laser to heat up and destroy tissue. Because of the symmetry of the temporal lobe — both hemispheres of the brain have an amygdala and hippocampus — people who have these surgeries usually have minimal side effects, according to the researchers.

Ivan Soltesz

Before performing the surgery, physicians need to identify the brain tissue responsible for seizure activity. They do this by placing electrodes in areas of the brain suspected of starting or propagating seizures and taking recordings from the electrodes. This process, called stereoelectroencephalography, or sEEG, lets them map where in the brain seizure activity happens.

Though the amygdala and its next-door neighbor the hippocampus are common locations for sEEG recordings, the electrodes are typically placed in only the anterior and middle regions of the hippocampus. The human hippocampus, located deep in each hemisphere of the brain near the level of the ear, looks like a sea horse lying on its side, with its head pointing toward the front of the brain. sEEG electrodes are commonly placed in the anterior and medial regions, corresponding to the head, body and the beginnings of the tail of the sea horse.

The idea to record from the fasciola cinereum — the far tip of the sea horse’s tail — in patients with epilepsy undergoing sEEG for surgical planning first formed about three years ago, when Ryan Jamiolkowski , MD, PhD, co-lead author of the study and a resident in neurosurgery, joined the Soltesz lab.

At the time, Quynh-Anh Nguyen, PhD, co-lead author on the study and former postdoctoral scholar in the Soltesz lab who is now at Vanderbilt University, was screening for the hippocampal neurons that were active during seizures in mice. Unexpectedly, Nguyen discovered that neurons in a posterior region of the hippocampus, the fasciola cinereum, were involved in seizures.

Jamiolkowski and the research team used optogenetic techniques to test whether the fasciola cinereum could be a target for epilepsy interventions. The neurons in the fasciola cinereum were made to contain special proteins capable of shutting down neuronal activity when exposed to blue light. When electrical recordings from the hippocampus showed seizure activity, the researchers shined blue light onto the fasciola cinereum, shortening the duration of seizures in mice.

Recording from the human hippocampus tail

To understand the fasciola cinereum’s role in seizure activity in humans, Jamiolkowski and Buch recorded from the small region in six patients. All were undergoing sEEG to identify the source of their seizures in preparation for future surgeries to cure their epilepsy. The fasciola cinereum contributed recorded seizures in all six patients, including some episodes in which the head and body regions of the hippocampus were quiet.

Ryan Jamiolkowski

One of the patients with mesial temporal lobe epilepsy of the left hemisphere had already undergone laser ablation of the amygdala and anterior and middle regions of the hippocampus. The patient continued having seizures, and follow-up sEEG showed that the only part of the hippocampus that remained, the fasciola cinereum, was involved in all recorded seizures. The patient underwent a second surgical ablation that removed almost all of the fasciola cinereum, and the frequency of the seizures decreased by 83%, from one to two each month to once every three months.

The researchers said that patients whose seizures involve the fasciola cinereum may need to undergo two surgeries because of the shape of the hippocampus.

“The hippocampus curves like a banana, and the optical fiber used for laser ablation is a straight line. Reaching anterior and posterior regions requires different trajectories that are not currently feasible to combine into one procedure. The results of our study do not challenge the importance of ablating the amygdala and anterior hippocampus but suggest considering a second ablation targeting the posterior hippocampal tail for the patients whose seizures recur,” Jamiolkowski said.

Three of the patients had bilateral involvement of the mesial temporal lobe, which means the amygdala and hippocampus in both the right and left hemisphere showed seizure activity. Because new memories cannot be formed without at least one intact hippocampus, these patients instead received responsive neurostimulation from a device that detects and interrupts seizure activity. However, most responsive neurostimulation units can be configured to target only the anterior regions of the hippocampus on both sides of the brain. The findings from this study suggest that a more personalized approach that also allows the device to monitor and interrupt seizure activity in the posterior hippocampal tail region might be more beneficial to patients.

“Because one-third of patients — a high percentage — do not get seizure freedom from surgery, we should be putting sEEG electrodes in the fasciola cinereum in all temporal lobe epilepsy patients; seizure activity in this region could be a reason why these surgeries sometimes fail,” Jamiolkowski added. “Knowing which patients have seizures involving the fasciola cinereum would let us target it with either ablation or neurostimulation and help us treat patients better than a one-size-fits all approach.”

A researcher from Cambridge University contributed to the study.

Funding for this study was provided by the Stanford Maternal and Child Health Research Institute, the Tashia and John Morgridge Endowed Fellowship, the Lennox-Gastaut Syndrome Foundation Cure 365, the Stanford Neuroscience Scholars Program, and the National Institutes of Health (grants R25NS065741, K99NS121399, K99NS126725, NS121106 and P30AG066515).

• Kimberlee D'Ardenne Kimberlee D'Ardenne is a freelance writer.

About Stanford Medicine

Stanford Medicine is an integrated academic health system comprising the Stanford School of Medicine and adult and pediatric health care delivery systems. Together, they harness the full potential of biomedicine through collaborative research, education and clinical care for patients. For more information, please visit med.stanford.edu .

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Violent crime is a key midterm voting issue, but what does the data say?

Political candidates around the United States have released thousands of ads focusing on violent crime this year, and most registered voters see the issue as very important in the Nov. 8 midterm elections. But official statistics from the federal government paint a complicated picture when it comes to recent changes in the U.S. violent crime rate.

With Election Day approaching, here’s a closer look at voter attitudes about violent crime, as well as an analysis of the nation’s violent crime rate itself. All findings are drawn from Center surveys and the federal government’s two primary measures of crime : a large annual survey from the Bureau of Justice Statistics (BJS) and an annual study of local police data from the Federal Bureau of Investigation (FBI).

This Pew Research Center analysis examines the importance of violent crime as a voting issue in this year’s congressional elections and provides the latest available government data on the nation’s violent crime rate in recent years.

The public opinion data in this analysis is based on a Center survey of 5,098 U.S. adults, including 3,993 registered voters, conducted Oct. 10-16, 2022. Everyone who took part is a member of the Center’s American Trends Panel (ATP), an online survey panel that is recruited through national, random sampling of residential addresses. This way, nearly all U.S. adults have a chance of selection. The survey is weighted to be representative of the U.S. adult population by gender, race, ethnicity, partisan affiliation, education and other categories. Read more about the ATP’s methodology . Here are the questions used in the survey , along with responses, and its methodology .

The government crime statistics cited here come from the National Crime Victimization Survey , published by the Bureau of Justice Statistics, and the National Incident-Based Reporting System , published by the Federal Bureau of Investigation. For both studies, 2021 is the most recent year with available data.

Around six-in-ten registered voters (61%) say violent crime is very important when making their decision about who to vote for in this year’s congressional elections. Violent crime ranks alongside energy policy and health care in perceived importance as a midterm issue, but far below the economy , according to the Center’s October survey.

Republican voters are much more likely than Democratic voters to see violent crime as a key voting issue this year. Roughly three-quarters of Republican and GOP-leaning registered voters (73%) say violent crime is very important to their vote, compared with around half of Democratic or Democratic-leaning registered voters (49%).

Conservative Republican voters are especially focused on the issue: About eight-in-ten (77%) see violent crime as very important to their vote, compared with 63% of moderate or liberal Republican voters, 65% of moderate or conservative Democratic voters and only about a third of liberal Democratic voters (34%).

Older voters are far more likely than younger ones to see violent crime as a key election issue. Three-quarters of registered voters ages 65 and older say violent crime is a very important voting issue for them this year, compared with fewer than half of voters under 30 (44%).

There are other demographic differences, too. When it comes to education, for example, voters without a college degree are substantially more likely than voters who have graduated from college to say violent crime is very important to their midterm vote.

Black voters are particularly likely to say violent crime is a very important midterm issue. Black Americans have consistently been more likely than other racial and ethnic groups to express concern about violent crime, and that remains the case this year.

Some 81% of Black registered voters say violent crime is very important to their midterm vote, compared with 65% of Hispanic and 56% of White voters. (There were not enough Asian American voters in the Center’s survey to analyze independently.)

Differences by race are especially pronounced among Democratic registered voters. While 82% of Black Democratic voters say violent crime is very important to their vote this year, only a third of White Democratic voters say the same.

Annual government surveys from the Bureau of Justice Statistics show no recent increase in the U.S. violent crime rate. In 2021, the most recent year with available data , there were 16.5 violent crimes for every 1,000 Americans ages 12 and older. That was statistically unchanged from the year before, below pre-pandemic levels and far below the rates recorded in the 1990s, according to the National Crime Victimization Survey .

For each of the four violent crime types tracked in the survey – simple assault, aggravated assault, robbery and rape/sexual assault – there was no statistically significant increase either in 2020 or 2021.

The National Crime Victimization Survey is fielded each year among approximately 240,000 Americans ages 12 and older and asks them to describe any recent experiences they have had with crime. The survey counts threatened, attempted and completed crimes, whether or not they were reported to police. Notably, it does not track the most serious form of violent crime, murder, because it is based on interviews with surviving crime victims.

The FBI also estimates that there was no increase in the violent crime rate in 2021. The other major government study of crime in the U.S., the National Incident-Based Reporting System from the Federal Bureau of Investigation, uses a different methodology from the BJS survey and only tracks crimes that are reported to police.

The most recent version of the FBI study shows no rise in the national violent crime rate between 2020 and 2021. That said, there is considerable uncertainty around the FBI’s figures for 2021 because of a transition to a new data collection system . The FBI reported an increase in the violent crime rate between 2019 and 2020, when the previous data collection system was still in place.

The FBI estimates the violent crime rate by tracking four offenses that only partly overlap with those tracked by the National Crime Victimization Survey: murder and non-negligent manslaughter, rape, aggravated assault and robbery. It relies on data voluntarily submitted by thousands of local police departments, but many law enforcement agencies do not participate.

In the latest FBI study, around four-in-ten police departments – including large ones such as the New York Police Department – did not submit data, so the FBI estimated data for those areas. The high nonparticipation rate is at least partly due to the new reporting system, which asks local police departments to submit far more information about each crime than in the past. The new reporting system also makes it difficult to compare recent data with data from past years.

While the total U.S. violent crime rate does not appear to have increased recently, the most serious form of violent crime – murder – has risen significantly during the pandemic. Both the FBI and the Centers for Disease Control and Prevention (CDC) reported a roughly 30% increase in the U.S. murder rate between 2019 and 2020, marking one of the largest year-over-year increases ever recorded. The FBI’s latest data , as well as provisional data from the CDC , suggest that murders continued to rise in 2021.

Despite the increase in the nation’s murder rate in 2020, the rate remained well below past highs, and murder remains the least common type of violent crime overall.

There are many reasons why voters might be concerned about violent crime, even if official statistics do not show an increase in the nation’s total violent crime rate. One important consideration is that official statistics for 2022 are not yet available. Voters might be reacting to an increase in violent crime that has yet to surface in annual government reports. Some estimates from nongovernmental organizations do point to an increase in certain kinds of violent crime in 2022: For example, the Major Cities Chiefs Association, an organization of police executives representing large cities, estimates that robberies and aggravated assaults increased in the first six months of this year compared with the same period the year before.

Voters also might be thinking of specific kinds of violent crime – such as murder, which has risen substantially – rather than the total violent crime rate, which is an aggregate measure that includes several different crime types, such as assault and robbery.

Some voters could be reacting to conditions in their own communities rather than at the national level. Violent crime is a heavily localized phenomenon , and the national violent crime rate may not reflect conditions in Americans’ own neighborhoods.

Media coverage could affect voters’ perceptions about violent crime , too, as could public statements from political candidates and elected officials. Republican candidates, in particular, have emphasized crime on the campaign trail this year.

More broadly, the public often tends to believe that crime is up, even when the data shows it is down. In 22 of 26 Gallup surveys conducted since 1993, at least six-in-ten U.S. adults said there was more crime nationally than there was the year before, despite the general downward trend in the national violent crime rate during most of that period.

• Criminal Justice
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8 facts about Black Lives Matter

#blacklivesmatter turns 10, support for the black lives matter movement has dropped considerably from its peak in 2020, fewer than 1% of federal criminal defendants were acquitted in 2022, before release of video showing tyre nichols’ beating, public views of police conduct had improved modestly, most popular.

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Study at Tufts is taking a close look at test subjects and what they eat to unlock the mysteries of food

Jon Hamdorf is a free spirit who lives for adventure. His latest was a little different .

It started in mid-January when he checked into a 12th-floor room in a drab brick building in Boston’s Chinatown. At age 70, Hamdorf has no permanent address and spends his days traveling or living on his boat in Maine. But for this jaunt, this intrepid soul was confined to a rigid schedule, required to eat specific meals that were handed to him, and forbidden to go outside without a chaperone — all in the service of science.

“This, to me, is like going to Nepal or going to Israel. It’s like another adventure,” said Hamdorf, a retired CPA.

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The thrill, he said, lay in the purpose. For three two-week stints, Hamdorf had agreed to become a study subject in a project seeking to answer questions that have troubled nearly every person who brings fork to mouth: What will happen in my body after I eat this food? Will it make me fat, raise my cholesterol, mess up my gut microbiome — or perhaps extend my life?

The Nutrition for Precision Health Study, a $170 million national research project seeking to enroll 10,000 people nationwide, aims to develop a way to pinpoint the optimal diet for every person. The study is being carried out by six clinical centers across the country, including the New England Clinical Center, run by Tufts University and Massachusetts General Hospital.

Current nutrition advice is based on averages, on what seems to work best for most people. But in many studies, people eating the exact same mix of nutrients have differing responses in measures like blood glucose or blood pressure, explains Holly Nicastro, the national study’s program director.

The study will try to find out exactly why, so that someday — it is hoped — people will be able to consume a diet tailored to their unique biology.

The study is also seeking to overcome the challenges that have long dogged nutrition research. Typically, nutrition data relies on asking people what they remember eating. But memories are notoriously inaccurate, and often biased by, say, embarrassment over having eaten that entire sleeve of Oreos. Nutrition for Precision Health is testing other methods of documenting what people consume, including with an app, a questionnaire, or a tiny camera mounted on eyeglasses that is activated by chewing.

“We have the technology to actually get away from the reliance on memory,” said Sarah L. Booth, director of the Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University. “This is one of the exciting aspects of this study. We may be completely revolutionizing how we study nutrition.”

Participants first complete a “module” in which they follow their normal diet for 10 days and report what they ate. If they want to continue, they choose either to pick up prepackaged meals to eat at home or to enroll in the “live-in diet” module, the tightly controlled sojourn that Hamdorf selected. By keeping people inside and under watch, researchers can track — with precision and certainty — what people eat, and what effects those foods have throughout the body.

Hamdorf was among an inaugural group of four participants in the live-in diet phase in Boston. All had previously signed up for the All of Us Research Program of the National Institutes of Health, which aims to enroll 1 million or more participants to contribute their health data, including genetics, to build a database that can inform thousands of studies. Only existing All of Us members are invited to take part in the nutrition study.

On the first day, the participants gave blood and saliva samples, had their bones scanned, their metabolic rates measured, and their fat-to-muscle ratio documented. They were also equipped with blood-glucose monitors attached at the waist to continuously track fluctuations in blood sugar, and wrist bands that tracked activity and sleep.

The next day, the daily routines kicked in: 6:30 a.m. weight and vital signs taken; 8 a.m. breakfast; 12 p.m. lunch; 3 p.m. snack; 6 p.m. dinner; 11 p.m. lights out.

The strict schedule proved more liberating than confining, Hamdorf said. “It feels very good to be structured like this,” he said. “You just show up for the meals, and you don’t have to go shopping or anything.”

Between meals and tests, participants were free to use the exercise equipment on the 13th floor, stretch on the mats in the yoga room, gather in the game room, or relax in their spacious private rooms with picture windows. They loved interacting with many of the 150 people working in offices, laboratories, and the kitchen at the Human Nutrition Research Center on Aging.

Occasionally, they took a stroll outside, but only when a staff member could accompany them, lest anyone get an urge for an ice cream cone; the researchers must be able to attest that the participants ate only what they were served inside.

And what were they served?

Precisely at noon near the end of their first two-week stint, the four participants trooped to the 11th-floor dining room, accompanied by Paul J. Fuss, clinical research manager, who stayed to keep an eye on them as they ate.

The kitchen staff brought them plates wrapped in plastic and labeled with their names. Each meal is tailored to the individual’s calorie needs; participants are not supposed to gain or lose weight.

Each also has a tiny rubber spatula to scoop up every crumb. “We’re pretty much asking you to lick the plate without licking the plate,” said Kayla Airaghi, a dietitian. If they can’t finish, the staff will weigh the leftovers, tracking consumption down to a 10th of a gram.

On this day, Lori Mattheiss, 60, of Andover got a hamburger, peaches, and potato chips; her husband, Tim Carter, 63, was served two hamburger sliders. Jane Cashell, 75, of Clinton, ate broccoli, chicken nuggets, and mac and cheese. Hamdorf got Spanish rice, chicken with taco seasoning, and cheddar cheese.

“It’s not the food we normally eat,” Mattheiss said. “I’m eating things I haven’t eaten since I was a kid.” On other days she’s had a Yodel, Kool-Aid, canned fruit cocktail, Fritos.

In this two-week session, participants consumed what they called the traditional American diet. The researchers, however, resist labeling it; officially it’s described only by its contents, high in refined grains and sugar-sweetened drinks and low in fruits, vegetables, whole grains, and fish.

In the second and third two-week visits — which were spaced apart with at least two weeks in between — the participants ate high-fat and high-protein fare, and, finally, a diet replete with fruits, vegetables, beans, nuts, whole grains, and fish (the four liked this one best).

The three diets were chosen not because they’re recommended but because they are the most common diet patterns in the United States, said Sai Krupa Das, a senior scientist at the center and principal investigator for the New England branch of the study. “They are reflective of what we consume as a nation,” she said.

And the goal is not to determine which diet is best, but rather to measure individuals’ varying response to the different components.

The researchers acknowledge that it will be difficult to attract a diverse population to this phase of the project. How many people can put their lives on hold for two weeks at a time? Carter and Mattheiss, who trade stocks online, worked during their stays, and other remote workers might be able to do the same. But bus drivers? Restaurant owners? Parents of young children? Even the $6,200 stipend for completing all three two-week sessions may not be enough to compensate for lost work.

Despite the challenges, the NIH’s Nicastro said, “We do have ambitious diversity goals,” which they expect to achieve at least with “Module 1,” in which participants eat what they normally do and record it. But even for the more demanding modules — the prepackaged meals or the live-in diet — research sites are working with churches, barbershops, community centers, and other places to sign people up for All of Us, and then recruit them into the nutrition study, Nicastro said.

Rafael Pérez-Escamilla, a professor at the Yale School of Public Health, who is not involved in the study, believes the Nutrition for Precision Health will probably answer some fascinating scientific questions — but, he said, it won’t do much to improve people’s health or reach those suffering the worst effects of a poor diet.

“We live in a country where about 70 percent of adults are either overweight or obese, and 70 percent or more of their calories are coming from ultraprocessed or junk foods, including sugar-sweetened beverages,” he said. “The problem is heavily concentrated among the poor.”

Pérez-Escamilla would much prefer to see a similar investment in efforts to increase access to healthy foods, such as “produce prescription programs” that supply debit cards to purchase fresh fruits and vegetables.

Christopher Gardner, a Stanford professor who has studied the health benefits of dietary components but is not involved with the Nutrition for Precision Health study, called it an “incredibly ambitious” project. He predicted that the researchers would identify the key good and bad bacteria in the gut, and which foods promote them.

Gardner serves on the scientific advisory board for a private company, Zoe, that is offering personalized nutrition advice based on biological information. People take at-home tests and get instructions on what to eat based on the results.

This is exactly what the NIH study eventually hopes to offer, but Das, the principal investigator in Boston, said the results will have stronger scientific backing. “The market’s always ahead of the science,” she said, when asked about Zoe.

At the end of their two-week stay, the participants face two full days of testing, every aspect of their biology measured. On the last day, they drink two cups of vanilla Ensure and then sit in a chair from 8 a.m. to 1 p.m., giving blood samples at set intervals to measure how nutrients are metabolized.

The “live-in diet” sessions are expected to wrap up in mid-2026. Then, with a trove of data from each individual, multiplied across thousands of participants, the project will deploy artificial intelligence to come up with proposed algorithms for determining who should eat what. But that’s not the end: A series of studies will have to be conducted to validate those algorithms.

Nicastro is eager to learn what factors are driving individual responses. “It could be genetics, it could be microbiome, it could be something about the environment, and or probably a lot of these things mixed together,” she said. The ultimate goal is to enable doctors or dietitians to test for certain factors and then produce a personalized eating plan.

Meanwhile, the first four participants, settled back at home with their lime-green souvenir water bottles, are already finding themselves making changes in their diet. Cashell loved the third diet so much she’s trying to re-create the recipes in her kitchen. Hamdorf noticed that during the experiment he never felt hungry, yet looked forward to each meal — and realized he needed to eat more, and drink more water. Matthiess and Carter are trying to eat less in the evening and include more fruits and nuts.

All were gratified to have been part of the study.

“You don’t have many opportunities to contribute to important scientific research,” Carter said. “And I feel lucky that I am able to do that.”

Felice J. Freyer can be reached at [email protected] . Follow her @felicejfreyer .