the participant section of a research plan specifies

Search form

Research and innovation menu, research and innovation, research plan content.

• When drafting the  Research Plan , follow the format and use the section headings (i.e. A – I) provided below, refer to the bulleted items for section content.
• For each section, this guidance includes a description of why the information is important for IRB review ( in italics ).

A.  Introduction and Background

In reviewing the protocol, the IRB must consider the rationale for the study and the importance of the knowledge that may reasonably be expected to result.

Briefly  summarize the nature, scientific or scholarly rationale and significance of the proposed study and any relevant background information on the topic. Explain the relevance of the study to previous and/or continuing work in the field. Discuss why novel inquiry is necessary. If there is a gap in knowledge, explain how it is anticipated that this research will address the gap. If this research is intended to replicate previous research, provide rationale.

B.  Specific Aims/Study Objectives

The IRB must evaluate the objectives of the research in order to determine whether the risks to participants are reasonable in relation to the importance of the knowledge that may be gained.

• Clearly  outline the specific research question(s). Include the study objective(s) and/or hypothesis.

C.  Methods, Materials, and Analysis

The study design, methods and procedures must be adequately described in order for the IRB to understand all activities in which human subjects will participate. The IRB must also be able to differentiate those procedures that are performed for research purposes from those that are performed for routine care or evaluation.

NOTE: The focus of this section is on methods and procedures. Risks must be discussed later in Section G.

Describe the study design and research methods used to meet the study aims and objectives stated above (e.g., on-line survey, open ended interview, randomized controlled trial, participant observation, field based research, lab/task based, etc.).

If there will be multiple groups of participants completing different sets of activities/tasks, clearly delineate the activities to occur for each group.

Describe in chronological order all research activities/procedures involving participants. This should walk the reader step-by-step through the research activities and include a description of the research procedures and instruments.

Include the title and descriptions of any measures, questionnaires, tasks, tests, and/or procedures. Titles need to be used consistently throughout the description(s).

The description must include whether these are standardized in the field or designed for this specific study.

Depending on the complexity or number of procedures, consider inserting a table or attaching an inventory list of measures or questionnaires as an appendix.

If the research involves any procedures typically used in a biomedical/clinical setting and/or administration of medications (e.g., blood draw, ultrasound, MRI, x-rays/radiographs, etc.) include the following:

The justification for the use of the procedures.

The dosage.

The qualifications of study personnel to conduct the procedures.

If research will be conducted at the  Lewis Center for Neuroimaging (LCNI),  the investigator will need to work with the LCNI director to ensure research procedures are in line with their standard operating procedures. The Research Plan will need to reference the established LCNI SOP in the Research Plan.

If using deception, discuss the related activities, what that deception entails, and when and how the debriefing process will occur.

Include an estimate of the time each participant will spend completing the activities (in minutes or hours), the number of sessions the participant will engage in, and the total length of participation (in days, weeks, months, or years) from the beginning to the end of the study.

If follow-up with participants is planned, discuss the procedures and under what circumstances follow-up will occur.

Describe the methods of data collection and recording that will be utilized in the study (e.g., hand-written notes, survey platform, computer programs, videotapes, audiotapes, photographs, etc.).

Describe the specific locations where the activities will be conducted (i.e., in what labs, clinics, field sites, or online platforms will the procedures occur?). The investigator must determine if additional local, State and/or international policies and regulations are applicable to the research and include this information in the Research Plan.

Explain how the data will be analyzed/studied (i.e., quantitatively or qualitatively and what statistical tests are planned), how the interpretation will address the research questions, and how the research will be disseminated.

Describe how the data will be reported (e.g., aggregated, anonymously, pseudonyms for participants, etc.).

D.  Research Population, Recruitment Methods, & Compensation

In order to approve research, the IRB must determine that the selection of participants is equitable and reasonably related to the purpose and aims of the research. The IRB must also consider whether adequate safeguards are in place to minimize any risks that are unique to vulnerable populations (e.g., pregnant women, fetuses, children, prisoners, cognitively impaired persons, etc.). To make this determination, the IRB must review all methods and materials used to contact and recruit potential participants, including letters, flyers, emails, etc.

1.  Participant Population

Describe the participant population:

Provide the rationale for including the participant population. When including any vulnerable populations in the study (e.g., children, prisoners, pregnant women, fetuses, etc.) explain why inclusion of this population is necessary to accomplish the research aims.

List the inclusion criteria such as age range, race or ethnicity, gender, language and literacy, etc.

List the exclusion criteria and rationale.

Address whether or not participants are fluent in English and/or if any of the study activities (i.e. recruitment, consent, assessments, etc.) will be carried out in a language other than English.

Describe how the research team member(s) are fluent in the language of the participants or if a translator will be used.

Describe how materials will be presented in the language understandable to participants (e.g. will translated materials be used?). If there is no written language, state this and explain translation.

Discuss the number of participants needed for the project including the following:

Provide the targeted number of individuals to be included in the research. If more than one group, provide numbers needed for each group and total number for the entire project. Ranges are acceptable (e.g. 20-25 individuals, survey distributed to 200 people and expected 65% response rate).

Provide rationale for targeted numbers.

2.  Recruitment Methods

Describe the process and/or method by which participants will be recruited for the research, including the following:

When and how will each step of recruitment occur (i.e., initial contact, introductions, follow-ups, etc.)?

Describe how the participant population is accessed. Discuss relevant permissions (e.g., access to listservs, online databases, etc.).

State any recruitment materials that will be used, such as advertisements, flyers, or verbal scripts. If there are no written recruitment materials, explain.

Explain which research roles (e.g., PI, Research Assistant, etc.) will recruit participants and how they will be trained.

Describe any screening tests and/or procedures that will be used to ensure that potential participants are eligible to participate.

If any part of the recruitment procedures involves a language other than English describe any differences in the recruitment procedures for non-English speaking participants.

For research involving treatment (e.g. behavioral intervention, drug or device studies, etc.):

Describe how research treatment will be distinguished from regular treatment.

Indicate whether the individuals who will recruit participants have provided or will provide treatment or care to the prospective participants. If treatment providers also have a role in the research, describe measures to avoid or diminish undue influence.

3.  Compensation/Reimbursement

If there is the possibility that there will be costs to the participant or to a third party (e.g., an insurer), identify the specific expenses (e.g., drug tests, procedures, hospitalization, travel, etc.) and provide a justification for those costs.

If participants are to receive compensation for their time, please describe the following or simply state no compensation will be offered:

The amount and nature of the compensation (e.g., cash, gift card, course credit, etc.).

Explain how and when compensation will be provided, including payment schedules, whether or not compensation will be reduced if the participant does not complete all activities in the study, and how any proration will occur.

Explain how the method and amount of compensation is appropriate for the participant population and study activities (e.g., based on time commitment, number of study visits, travel expenses, age of participant population, etc.).

E. Informed Consent Process

Informed consent is a process, not just a form and obtaining informed consent is a central protection for human participants. The IRB must ensure the informed consent process clearly discloses and facilitates the understanding of all information needed to make an informed decision to participate while promoting the voluntariness of participation.

Below are the key components of the informed consent process. In some cases it may be appropriate to seek a  waiver or alteration of informed consent or a waiver of documentation of informed consent  from the IRB.

1.  Informed Consent Process

Describe the informed consent process, including:

How the required  elements of informed consent  will be conveyed to participants (i.e., informed consent document, verbal script, online statement, letter, etc.).

Where and when the informed consent process will take place (i.e., in-person in private room, phone, etc.).

Any cultural considerations (e.g., tribal or group permission requirements, age of majority, technological limitations, etc.).

Steps that will be taken to ensure voluntary participation and to minimize the possibility of coercion or undue influence.

Which research roles (e.g., PI, Research Assistant, etc.) will conduct the consent process and how that person will be trained (e.g. previous experience or related training, one-on-one training with PI, etc.).

If multiple participant groups or consent procedures are to be included, these need to be clearly delineated.

In certain circumstances, the IRB may approve a consent process which does not include, or which alters, some or all of the elements of informed consent or waive the requirements to obtain informed consent. See the RCS  Waiver or Alteration of Informed Consent Guidance  for the criteria that must be met and information that must be included in this section to request consideration of a waiver or alteration of informed consent by the IRB.

2.  Facilitate Understanding

Describe how the investigator will ensure that the participants understand all aspects of their involvement in the research (i.e., will participants be asked questions about the procedures, or encouraged to ask questions?).

Describe any special provisions for individuals who might have trouble comprehending the consent information.

If any participants do not speak English, describe:

Whether or not the researcher is fluent in the language.

Whether or not and how a translator will be used.

Whether or not translated consent materials will be used.

Whether or not there are any differences in the consent process for different populations based on the language they speak.

Describe the process by which the investigator will ensure ongoing consent.

3.  Documentation

Describe how the researcher plans to document that each participant has provided informed consent and/or assent.

In certain circumstances, the IRB may waive the requirement to obtain a signed consent form based on specific criteria. See the RCS  Waiver or Alteration of Informed Consent Guidance  for the criteria that must be met and information that must be included in this section to request consideration of a waiver of documentation from the IRB.

4.  Additional Considerations

     If the research involves:

Minors (those under the age of majority) or individuals of diminished capacity:

Describe the capacity of the participant and their ability to assent.

Describe how assent to participate will be obtained and documented.

If a  waiver of assent or waiver of assent documentation  is being requested, provide justification.

Explain how the permission of the parent(s), guardian(s), or legally authorized representatives will be obtained and documented.

If a waiver of permission or waiver of permission documentation is being requested, provide justification.

Explain how participants will be deceived and why it is necessary for the study.

Deception is an alteration of informed consent; provide justification for how the use of deception meets the criteria for alteration of informed consent. See the RCS  Waiver or Alteration of Informed Consent Guidance  for the criteria that must be met and information that must be included in this section to request consideration of a waiver or alteration of informed consent by the IRB.

Describe the debriefing process and provide a script.

Protected Health Information:

If the research involves the use of  protected health information  from a covered entity (including those listed on the  UO Hybrid Entity Status and Documentation of HIPAA Covered Components declaration ), describe how authorization from participants to access and use their information will be obtained (i.e., signed HIPAA form).

If requesting a waiver of authorization, see the  HIPAA waiver  guidance for the criteria that must be met. Justification for how the criteria are satisfied must be included in this section.

Clinical Trials:

For a study that meets the definition of a clinical trial, one IRB approved informed consent form used to enroll subjects must be posted on a publicly available Federal Web site that has a repository for such informed consent forms. More information about the posting requirement and definitions can be found on our website here .

Describe in this section of the Research Plan where the consent form will be posted and acknowledge the required timeframe for posting (e.g., clinicaltrials.gov or the regulations.gov document portal ).  NOTE: the investigator will be responsible for demonstrating at the time of continuing review, progress reporting, and/or closure of the study that this requirement has been satisfied.

F.  Participant Privacy, Data Disposition, and Data Confidentiality

In order to approve research, the IRB must determine that there are adequate provisions in place to protect the privacy of subjects and maintain the confidentiality of research records and data collected.

1.  Privacy

Describe the steps that will be taken to promote the protection of participants’ privacy. Consider the following:

The methods used to identify and contact potential participants.

The settings in which an individual will be interacting with an investigator.

The appropriateness of all personnel present for research activities.

The methods used to obtain information about participants.

The sensitivity of the requested information:

In relation to the potential privacy risks of the information.

In relation to options for participants to disclose identity.

Privacy guidelines developed by relevant professional associations and scholarly disciplines (e.g., oral history, anthropology, psychology).

Steps to ensure access to the minimum amount of information necessary to complete the study.

Information that is obtained about individuals other than the “target participants,” and whether such individuals meet the regulatory definition of “human participant” (e.g., a participant provides information about a family member for a survey).

Describe what personal or identifiable information will be obtained to facilitate the research and as part of data collection. If participant data will be collected without identifiers, please state this.

2.  Data Disposition

Describe what data will be collected, including identifiable information and audio/video/digital recordings or photos. In addition, consider the following:

Any other information collected to facilitate the research (i.e., contact information for recruitment).

Any exiting data and its disposition (i.e. obtaining data from another source coded, or identifiable etc.).

3.  Confidentiality

Describe the steps that will be taken to secure data and/or specimens for the research:

Describe if participants’ private information will be coded (i.e., identifying information has been replaced with a number, pseudonym, etc.), include:

How the key to decipher the code (i.e., list linking participants’ names with pseudonyms or participant number) will be stored?

Who will have access to the code key?

If, how, and why the code key will be retained.

If participant identities will be disclosed as a result of this research (e.g., attributing a direct quote, etc.), provide:

Justification for appropriateness of direct identification.

Parameters for disclosure (e.g., will participants be allowed to review prior to dissemination).

How permissions from participant will be solicited including any restrictions.

 Describe storage and transfer including:

How the data will be collected and stored, including format (e.g., audio/video recordings or photographs, hard or electronic copy,  identifiable  or  de-identified ).

Security during transmission and sharing between researchers and participants.

Who will have access to data (e.g., training of staff, authorization of access).

How long the records will be kept after the study is completed.

The security of the area where data will be stored (e.g., locked office, password protected computer, encryption, firewalls, virus detection, etc.).

Describe any intent for future use of data beyond this research including:

If other researchers will be permitted access/use the data.

How data will be maintained and stored.

How participant permissions for the future use will be obtained and tracked.

If seeking a Certificate of Confidentiality through NIH, this needs to be stated.

G. Potential Research Risks and Discomforts to Participants

In order to approve the research, the IRB must consider the risks posed to participants by the research and any efforts to mitigate those risks. The IRB needs to determine that the risks have been both minimized and are reasonable in relation to the anticipated benefits to participants as well as to the importance of the knowledge that may be gained. The IRB will also consider whether the informed consent process provides potential participants with an accurate and fair description of the risks or discomforts.

Describe any reasonably foreseeable risks of harm or discomforts for individuals and/or groups that may result from participation in the research. While risks associated with participation may not be expected, most protocols carry some risk. Consider the following:

Information risks (e.g., loss of privacy and/or breach of confidentiality).

Psychological or emotional risks (e.g., fear, stress, confusion, guilt, loss of self-esteem, depression, triggering of past emotional experiences).

Social risks (e.g., social stigma, chance of being ostracized or shunned), economic risks (e.g., change in employment or insurability).

Physical risks or harms (e.g., fatigue, pain or discomfort, potential for injury, illness or disease, or death, side effects and contraindications of drugs or substances used in the research).

Legal risks (e.g., risk of prosecution, mandatory reporting).

Genetic privacy risk (e.g., stigmatization, self-stigmatization, limits to insurance coverage or employability, misattributed paternity, etc.).

For  each  identified risk, explain all of the following:

Likelihood of the risk occurring.

Magnitude of the effects the risk would have should they occur.

How the risk will be minimized.

How the risk will be disclosed in the informed consent process.

If the protocol involves treatment or intervention, describe the “standard of care” and describe how the risks of the research treatments or interventions compare.

When appropriate, describe any provisions for data and safety monitoring for the progress of the research and the safety of the participants.

 If there is a separate Data and Safety Monitoring Plan (DSMP), state this and attach.

If there is an established Data and Safety Monitoring Board/Committee (DSMB/C) to monitor the progress of the research and the safety of participants, clearly indicate this. The frequency and operations of the DSMB/C should be covered in the DSMP.

H.  Potential Benefits of the Research

In order to approve this research, the IRB must determine that the anticipated benefits to research participants and the knowledge researchers expect to gain are reasonable in relation to the potential risks.

Describe any anticipated benefits that may result from the research. Consider the following:

Direct benefits that may result from participation (e.g., psychological or emotional benefits, learning benefits, physical benefits, diagnostic or therapeutic benefits, etc.). If there are no direct benefits to participants, clearly state this.

Benefits to the general participant population.

General benefits of the research for society, science and humanity; potential generalizable knowledge.

NOTE: Compensation for participation is not a benefit and should not be included in this section.

I.  Investigator Qualifications, Roles, & Training

In order to approve this research, the IRB needs to determine that research personnel are adequately trained and knowledgeable regarding the study procedures and the protection of human research participants.

1.  Investigator Qualifications

Provide a brief description for all key research personnel (i.e., Principal Investigator, Faculty Advisor, Co-Investigators or any other research personnel with responsibility for study oversight and research design). Include all of the following:

Academic background.

Research experience.

Experience with the proposed participant population.

Experience with the proposed procedures and methodology.

For students, include any applicable coursework (e.g., research methodology courses).

2.  Roles and Research Duties

Describe the roles and the associated research activities/duties. For example, Research Assistants will consent participants and administer surveys.

Do not list individual names. Limit roles to Principal Investigator, Co-Investigator, Faculty Advisor, Research Assistant, and Project Coordinator.

3.  Training and Oversight

Describe how the study personnel will be adequately trained to conduct research activities in accordance with the approved protocol and in compliance with federal regulations and university policy.

Describe any specific training or expertise required for procedures proposed in this research. Explain all of the following:

Training standards or requirements that must be met.

Who will be providing the training?

How will the training be tracked/documented?

4.  Translator

If a translator will be used for any aspects of the research, provide the translator’s name and qualifications for translation (e.g. native speaker, student of the language, etc.).

How to write a research plan: Step-by-step guide

Last updated

30 January 2024

Reviewed by

Short on time? Get an AI generated summary of this article instead

Today’s businesses and institutions rely on data and analytics to inform their product and service decisions. These metrics influence how organizations stay competitive and inspire innovation. However, gathering data and insights requires carefully constructed research, and every research project needs a roadmap. This is where a research plan comes into play.

Read this step-by-step guide for writing a detailed research plan that can apply to any project, whether it’s scientific, educational, or business-related.

• What is a research plan?

A research plan is a documented overview of a project in its entirety, from end to end. It details the research efforts, participants, and methods needed, along with any anticipated results. It also outlines the project’s goals and mission, creating layers of steps to achieve those goals within a specified timeline.

Without a research plan, you and your team are flying blind, potentially wasting time and resources to pursue research without structured guidance.

The principal investigator, or PI, is responsible for facilitating the research oversight. They will create the research plan and inform team members and stakeholders of every detail relating to the project. The PI will also use the research plan to inform decision-making throughout the project.

• Why do you need a research plan?

Create a research plan before starting any official research to maximize every effort in pursuing and collecting the research data. Crucially, the plan will model the activities needed at each phase of the research project .

Like any roadmap, a research plan serves as a valuable tool providing direction for those involved in the project—both internally and externally. It will keep you and your immediate team organized and task-focused while also providing necessary definitions and timelines so you can execute your project initiatives with full understanding and transparency.

External stakeholders appreciate a working research plan because it’s a great communication tool, documenting progress and changing dynamics as they arise. Any participants of your planned research sessions will be informed about the purpose of your study, while the exercises will be based on the key messaging outlined in the official plan.

Here are some of the benefits of creating a research plan document for every project:

Project organization and structure

Well-informed participants

All stakeholders and teams align in support of the project

Clearly defined project definitions and purposes

Distractions are eliminated, prioritizing task focus

Timely management of individual task schedules and roles

Costly reworks are avoided

• What should a research plan include?

The different aspects of your research plan will depend on the nature of the project. However, most official research plan documents will include the core elements below. Each aims to define the problem statement , devising an official plan for seeking a solution.

Specific project goals and individual objectives

Ideal strategies or methods for reaching those goals

Required resources

Descriptions of the target audience, sample sizes , demographics, and scopes

Key performance indicators (KPIs)

Project background

Research and testing support

Preliminary studies and progress reporting mechanisms

Cost estimates and change order processes

Depending on the research project’s size and scope, your research plan could be brief—perhaps only a few pages of documented plans. Alternatively, it could be a fully comprehensive report. Either way, it’s an essential first step in dictating your project’s facilitation in the most efficient and effective way.

• How to write a research plan for your project

When you start writing your research plan, aim to be detailed about each step, requirement, and idea. The more time you spend curating your research plan, the more precise your research execution efforts will be.

Account for every potential scenario, and be sure to address each and every aspect of the research.

Consider following this flow to develop a great research plan for your project:

Define your project’s purpose

Start by defining your project’s purpose. Identify what your project aims to accomplish and what you are researching. Remember to use clear language.

Thinking about the project’s purpose will help you set realistic goals and inform how you divide tasks and assign responsibilities. These individual tasks will be your stepping stones to reach your overarching goal.

Additionally, you’ll want to identify the specific problem, the usability metrics needed, and the intended solutions.

Know the following three things about your project’s purpose before you outline anything else:

What you’re doing

Why you’re doing it

What you expect from it

Identify individual objectives

With your overarching project objectives in place, you can identify any individual goals or steps needed to reach those objectives. Break them down into phases or steps. You can work backward from the project goal and identify every process required to facilitate it.

Be mindful to identify each unique task so that you can assign responsibilities to various team members. At this point in your research plan development, you’ll also want to assign priority to those smaller, more manageable steps and phases that require more immediate or dedicated attention.

Select research methods

Once you have outlined your goals, objectives, steps, and tasks, it’s time to drill down on selecting research methods . You’ll want to leverage specific research strategies and processes. When you know what methods will help you reach your goals, you and your teams will have direction to perform and execute your assigned tasks.

Research methods might include any of the following:

User interviews : this is a qualitative research method where researchers engage with participants in one-on-one or group conversations. The aim is to gather insights into their experiences, preferences, and opinions to uncover patterns, trends, and data.

Field studies : this approach allows for a contextual understanding of behaviors, interactions, and processes in real-world settings. It involves the researcher immersing themselves in the field, conducting observations, interviews, or experiments to gather in-depth insights.

Card sorting : participants categorize information by sorting content cards into groups based on their perceived similarities. You might use this process to gain insights into participants’ mental models and preferences when navigating or organizing information on websites, apps, or other systems.

Focus groups : use organized discussions among select groups of participants to provide relevant views and experiences about a particular topic.

Diary studies : ask participants to record their experiences, thoughts, and activities in a diary over a specified period. This method provides a deeper understanding of user experiences, uncovers patterns, and identifies areas for improvement.

Five-second testing: participants are shown a design, such as a web page or interface, for just five seconds. They then answer questions about their initial impressions and recall, allowing you to evaluate the design’s effectiveness.

Surveys : get feedback from participant groups with structured surveys. You can use online forms, telephone interviews, or paper questionnaires to reveal trends, patterns, and correlations.

Tree testing : tree testing involves researching web assets through the lens of findability and navigability. Participants are given a textual representation of the site’s hierarchy (the “tree”) and asked to locate specific information or complete tasks by selecting paths.

Usability testing : ask participants to interact with a product, website, or application to evaluate its ease of use. This method enables you to uncover areas for improvement in digital key feature functionality by observing participants using the product.

Live website testing: research and collect analytics that outlines the design, usability, and performance efficiencies of a website in real time.

There are no limits to the number of research methods you could use within your project. Just make sure your research methods help you determine the following:

What do you plan to do with the research findings?

What decisions will this research inform? How can your stakeholders leverage the research data and results?

Recruit participants and allocate tasks

Next, identify the participants needed to complete the research and the resources required to complete the tasks. Different people will be proficient at different tasks, and having a task allocation plan will allow everything to run smoothly.

Prepare a thorough project summary

Every well-designed research plan will feature a project summary. This official summary will guide your research alongside its communications or messaging. You’ll use the summary while recruiting participants and during stakeholder meetings. It can also be useful when conducting field studies.

Ensure this summary includes all the elements of your research project . Separate the steps into an easily explainable piece of text that includes the following:

An introduction: the message you’ll deliver to participants about the interview, pre-planned questioning, and testing tasks.

Interview questions: prepare questions you intend to ask participants as part of your research study, guiding the sessions from start to finish.

An exit message: draft messaging your teams will use to conclude testing or survey sessions. These should include the next steps and express gratitude for the participant’s time.

Create a realistic timeline

While your project might already have a deadline or a results timeline in place, you’ll need to consider the time needed to execute it effectively.

Realistically outline the time needed to properly execute each supporting phase of research and implementation. And, as you evaluate the necessary schedules, be sure to include additional time for achieving each milestone in case any changes or unexpected delays arise.

For this part of your research plan, you might find it helpful to create visuals to ensure your research team and stakeholders fully understand the information.

Determine how to present your results

A research plan must also describe how you intend to present your results. Depending on the nature of your project and its goals, you might dedicate one team member (the PI) or assume responsibility for communicating the findings yourself.

In this part of the research plan, you’ll articulate how you’ll share the results. Detail any materials you’ll use, such as:

Presentations and slides

A project report booklet

A project findings pamphlet

Documents with key takeaways and statistics

Graphic visuals to support your findings

• Format your research plan

As you create your research plan, you can enjoy a little creative freedom. A plan can assume many forms, so format it how you see fit. Determine the best layout based on your specific project, intended communications, and the preferences of your teams and stakeholders.

Find format inspiration among the following layouts:

Written outlines

Narrative storytelling

Visual mapping

Graphic timelines

Remember, the research plan format you choose will be subject to change and adaptation as your research and findings unfold. However, your final format should ideally outline questions, problems, opportunities, and expectations.

• Research plan example

Imagine you’ve been tasked with finding out how to get more customers to order takeout from an online food delivery platform. The goal is to improve satisfaction and retain existing customers. You set out to discover why more people aren’t ordering and what it is they do want to order or experience. 

You identify the need for a research project that helps you understand what drives customer loyalty . But before you jump in and start calling past customers, you need to develop a research plan—the roadmap that provides focus, clarity, and realistic details to the project.

Here’s an example outline of a research plan you might put together:

Project title

Project members involved in the research plan

Purpose of the project (provide a summary of the research plan’s intent)

Objective 1 (provide a short description for each objective)

Objective 2

Objective 3

Proposed timeline

Audience (detail the group you want to research, such as customers or non-customers)

Budget (how much you think it might cost to do the research)

Risk factors/contingencies (any potential risk factors that may impact the project’s success)

Remember, your research plan doesn’t have to reinvent the wheel—it just needs to fit your project’s unique needs and aims.

Customizing a research plan template

Some companies offer research plan templates to help get you started. However, it may make more sense to develop your own customized plan template. Be sure to include the core elements of a great research plan with your template layout, including the following:

Introductions to participants and stakeholders

Background problems and needs statement

Significance, ethics, and purpose

Research methods, questions, and designs

Preliminary beliefs and expectations

Implications and intended outcomes

Realistic timelines for each phase

Conclusion and presentations

How many pages should a research plan be?

Generally, a research plan can vary in length between 500 to 1,500 words. This is roughly three pages of content. More substantial projects will be 2,000 to 3,500 words, taking up four to seven pages of planning documents.

What is the difference between a research plan and a research proposal?

A research plan is a roadmap to success for research teams. A research proposal, on the other hand, is a dissertation aimed at convincing or earning the support of others. Both are relevant in creating a guide to follow to complete a project goal.

What are the seven steps to developing a research plan?

While each research project is different, it’s best to follow these seven general steps to create your research plan:

Defining the problem

Identifying goals

Choosing research methods

Recruiting participants

Preparing the brief or summary

Establishing task timelines

Defining how you will present the findings

Should you be using a customer insights hub?

Do you want to discover previous research faster?

Do you share your research findings with others?

Do you analyze research data?

Start for free today, add your research, and get to key insights faster

Editor’s picks

Last updated: 18 April 2023

Last updated: 27 February 2023

Last updated: 6 February 2023

Last updated: 6 October 2023

Last updated: 5 February 2023

Last updated: 16 April 2023

Last updated: 7 March 2023

Last updated: 9 March 2023

Last updated: 12 December 2023

Last updated: 11 March 2024

Last updated: 6 March 2024

Last updated: 5 March 2024

Last updated: 13 May 2024

Latest articles

Related topics, .css-je19u9{-webkit-align-items:flex-end;-webkit-box-align:flex-end;-ms-flex-align:flex-end;align-items:flex-end;display:-webkit-box;display:-webkit-flex;display:-ms-flexbox;display:flex;-webkit-flex-direction:row;-ms-flex-direction:row;flex-direction:row;-webkit-box-flex-wrap:wrap;-webkit-flex-wrap:wrap;-ms-flex-wrap:wrap;flex-wrap:wrap;-webkit-box-pack:center;-ms-flex-pack:center;-webkit-justify-content:center;justify-content:center;row-gap:0;text-align:center;max-width:671px;}@media (max-width: 1079px){.css-je19u9{max-width:400px;}.css-je19u9>span{white-space:pre;}}@media (max-width: 799px){.css-je19u9{max-width:400px;}.css-je19u9>span{white-space:pre;}} decide what to .css-1kiodld{max-height:56px;display:-webkit-box;display:-webkit-flex;display:-ms-flexbox;display:flex;-webkit-align-items:center;-webkit-box-align:center;-ms-flex-align:center;align-items:center;}@media (max-width: 1079px){.css-1kiodld{display:none;}} build next, decide what to build next.

Users report unexpectedly high data usage, especially during streaming sessions.

Users find it hard to navigate from the home page to relevant playlists in the app.

It would be great to have a sleep timer feature, especially for bedtime listening.

I need better filters to find the songs or artists I’m looking for.

Log in or sign up

Get started for free

Want to create or adapt books like this? Learn more about how Pressbooks supports open publishing practices.

44 Drafting the Methods Section

Drafting the methods section.

While the substance of the methods section will differ by genre and method chosen, basic components can be derived across genres. Methods sections in the social sciences tend to have five sub-components. They must:

• summarize the method used while arguing the value and limitations of the method for your data/context;
• discuss the data of your study (participants, artifacts, academic literature)
• present the instruments and measures used;
• outline the procedure of the data (i.e. how it was collected and ensured of its integrity), and
• Analysis : discuss how you analyzed your data.

Splitting these sections into components, however, should not give you the impression that the methods section is merely a list. The methods section is also an argument (Johnson, 2018), meaning that it aims to convince your reader of the value of your method through a narrative that briefly applies your method to the context of your research. In addition, the method must find a way to align with the research question stated in the introduction. Your methodology should build upon the introduction, justifying that the approach you utilized to investigate the problem is suitable (see Table 7.3.1 for common justifications for some established methods). We will refer back to this key point as we overview each step of the methods section.

A simple summary of your method is a good way to begin the method’s section. The length and depth of this summary depends entirely on the method chosen and the audience it is presented to. If the method is commonly known and used within your field, an overly intricate summary of the method is not necessary; a couple sentences overview will work fine. If the method is not commonly used or entirely new, however, more argument will be required for your audience to understand your choice of method. For instance, grounded theory is a commonly used paradigm in many qualitative social science journals. It is therefore unnecessary to sketch the method’s history in detail. Rather, a simple definition, such as grounded theory being an inductive approach which only designates codes after data collection (and how you enacted in your project) will suffice. On the other hand, newer methods such as linked data (methods based on web technologies such as HTTP, RDF, SPARQL, and URIs to enable semantic connections between various databases) would require a more extensive discussion. In addition, while it is good to offer your own summary of the method, the definition used by another researcher (particularly methodological researchers) is a simple way to align your research with a legitimate approach in your field.

The key point to keep in mind for summarizing your method is to outline its theory insofar as it explains your procedure, that is, discuss the method’s intentions with respect to how you applied it. We will touch on this again in the procedure section.

As you provide an overview of your method, you must also justify it. Justification of your method must appeal to the method’s ethical, practical and factual utility for the project. Ethical justifications are those that argue that the method is best for reducing the harm of research on your participants (and the communities they inhabit). It must also make the point that your method aligns with the principles of your institution’s ethical values.

Factual issues have to do with the value of the data your method is able to gather. It must consider whether the method is appropriate to your research question and topic. If, for instance, the research question is about “Malaysian immigrants’ conception of justice in comparison to American immigrants,” then you may argue that ‘in-depth interviews’ are the only approach deep enough to unravel a person’s “conception of justice.” Arguments for the factual benefits of a method frequently highlight its novelty for studying a particular method. For instance, there could be a lack of discourse analyses of Uber’s advertising materials (the previous research being content analyses). One could then argue that a discourse analysis approach not only has merits in its own right, but it also may be able to discover data which other approaches miss. Finally, you should outline the strengths of the methods in relation to all aspects of your research process (e.g., alignment with your theory, personal values, practicality etc.).

Practical justifications highlight why the method is suitable given logistics, administrative and everyday concerns. For example, if you are interested in studying how Malaysian migrants’ prepare for their transit to America, an ethnographic approach might be tempting. But practically (financially and time-wise), you might not be able to visit Malaysia to observe their preparations. Hence, you might decide that surveys or interviews (while less desirable) are more practical in that instance.

Again, we emphasize the importance of highlighting the limitations of your method. Every method has weaknesses, it is vital that show an awareness of them. It is important, however, not to have the weaknesses outweigh your method’s benefits. Your reader should be able to understand why you choose the methods, so you need to explain how, in spite of the limitation, your method is the most suitable choice. Hence, you need to justify why you decided to choose the methods over others. To help in the weighing of the costs and benefits of different methodological approaches, we have provided below a list of the potential limitations of some of the more common methods used in the social sciences.

Once you have provided an overview of your method and its value for your context, the next step is to discuss the data or population that the method will be used upon. Summarizing the data or population of your method often requires answering (Johnson, 2017): (a) how many participants/cases compose your data? (b) what are some of the common or key attributes of your data? And c) how did you select your data/participants?

The first question means answering the size (e.g., n = 88) of your corpus. Commentary on the size of your sample should also consider the total population that you are attempting to comment on. For instance, if you are writing about “student experiences with online open book examinations,” then it is important to consider how many students participated in the research compared to the students that took the examination (i.e., identify the characteristics of the sample versus the target populations). Answering the common attributes of this case study would mean considering the descriptives (usually sample size, mean, distribution etc.) or characteristics (e.g. gender, age, class, ethnicity) of participants/unit of observation. Building from our previous example, we should ask pertinent questions about the participants that took this exam: what was the average score of the exam? What grade level is this course? Which discipline was this course in, and which discipline do most students in this specific class come from? Finally, we need to also discuss how we recruited these students. Outline your recruitment process by discussing how you advertised the study, whether a stipend or incentive was offered, and how students finally agreed to join in the study (mainly regarding whether consent forms were required). For online texts or any other data that is not a participant/population, the same questions can be answered. The amount of the texts, components of the texts (their genre and author mainly), and the data collection process is all relevant to your method.

Box 7.1 – Writing About Recruitment

• Have I discussed how I advertised the study?
• Have I stated if a stipend was used?
• Have I stated if a consent form was used?
• How were participants identified?
• Where were they recruited?

While the above questions must be asked for all methods, the key concerns will differ depending on whether your research is primary, secondary, content analysis or theoretical research. Primary research is research that collects and derives its own raw data by sampling participants/cases, such as selecting and interviewing participants. Secondary research uses data from other primary research projects, such as a systematic literature review of other research. Theoretical research uses other papers and articles, sometimes even other data (like secondary research), but with the purpose of advancing a new argument in the field. Its method does not have to be as explicit as the other two methods of research. The following table summarizes the distinct tasks of the three approaches when discussing methodology. As theoretical research often uses articles and other social artifacts to make its argument, its methodological concerns are similar to content analysis. For that reason, we have grouped them together in the following table.

It is important to note that merely listing these components of your data/participants does not satisfy the requirements of a good methods section. Remember that you are still making an argument. While discussing the attributes relevant to your study, you are still arguing why you selected these participants/cases for your study, why you are listing that demographic/characteristic(s) as important to your study, and why you chose this sampling method over the other options . Allow yourself to be guided by the argument and the relevant things to include in your sections will follow. The following box provides a checklist of questions to help you to evaluate whether your methods section has successfully addressed all the key questions regarding your ‘data’.

Box 7.2 – Checkist for Summarizing the Data of Your Study

• Have I stated how many participants/data was in my study?
• Including in comparison to the relevant groups that they occupy?
• Have I discussed all the key attributes of my data?
• Have I discussed the relevant demographics of the populations and groups I am researching?
• If it is textual data, what is important to know about the author and genre of this text?
• Have I discussed the sampling method of my study?
• Have I argued the value and limitations of my sampling method?

Instruments and Measures

Research instruments are the tools that you use to collect, analyze and measure data in your research. These include literature reviews, survey questionnaires, interviews, focus groups, ethnography etc. In your methods section, you must describe how these serve to collect data, for example, was the survey composed of only open-ended questions, how many questions were included in the survey etc. Likewise, if you are using interviews, you need to discuss what kind of interviews were conducted (semi-structured, unstructured, structured)? How were the questions organized (e.g. by theme, no order etc.). Again, if you are doing a meta-analysis (literature review), you need to detail how it was done, what search engines, databases and search criteria were used etc. To reiterate, description of your instruments requires a an outline of how you used the particular measure to collect data.

As you will remember from your methods classes, when we talk about measurement in social research, we are referring to the process of operationalization (i.e., what concrete observations are being checked to empirically indicate a concept?). To do this, you must first identify the key variables or issues in your research question and explain how your research instrument captures it. For example, say your research question is “Do international students engage in economic transnationalism while studying on campus?” You will want to indicate how you will determine (a) who is an international student? and (b) what is economic transnationalism? It might seem silly that you need to operationalize “international student” but practically, you must have a system to determine who is an international student. It would be hard to walk around campus and determine who is an international student without having some criteria e.g. a student without Canadian citizenship. But again, how would you determine which student has Canadian citizenship and which ones do not? Operationalization requires that you specify precisely how you determine who is an international student (maybe you simply let participants self-declare their status on the survey or at the beginning of the interview). Likewise, “economic transnationalism” is a concept that needs to be measured (operationalized). You need to specify how in your research you will determine that economic transnationalism was taking place. Maybe you determined that if participants engaged in at least one economic activity (such as remitting money to origin countries, conducting business in origin countries, investing in origin countries etc), then economic transnationalism has taken place. The key to measurement is making it clear (and justifying) to your readers how your key concepts and variables are determined in the study. This requires that you consider how other researchers have measured these variables. If your measures are different from how other researchers measure the same concepts/variables, you need to justify why. On the other hand, the use of existing measures assures measurement consistency and contributes to the reliability of your study.

Measurement in quantitative studies can get complex by recoding, and the creation of composites such as indexes and scales. You must discuss how you recode variables and how the new variables allow you to better measure concepts. Likewise, you need to justify how the scales and indexes that you are using improve your measurements. If you are using established indexes and scales, it is important that you justify why they are applicable in your research. Again, if you are creating new measures, you need to identify why existing ones were inadequate for your research goals. As mentioned before, the methodology is not merely checking boxes, it requires justification of your choices, and engagement with an argument and or the literature (see the following example).

Box 7.3 – Examples – How a Team of Researchers Measured Friendship

Source: Walsworth, S., Somerville, K., & Robinson, O. (2021). The importance of weak friendships for international student satisfaction: Empirical evidence from Canada. International Journal of Intercultural Relations , 80 , 134-146.

The procedure is a step-by-step description of what you did to collect and analyze your data (see Figure 7.6.1 and Box 7.6.3). It should be the largest part of your methods section (Johnson, 2017), and it will incorporate explanation of how you collected your data, interpreted your data, and organized your data in your final-write up. As pointed out in the introduction, it is in this part of the methods section that the imitation function of methods – helping others to find our findings – is completed (Johnson, 2017). After providing a walkthrough of each step of your research process, it then discusses how you analyzed that data. The procedure clearly divides and orders the steps of your research chronologically, seeking to present a summative narrative of your research from recruitment/sampling of data to analysis. Documenting your procedure allows another researcher to attempt the exact same process as you with the expectation that they should be able to find (roughly) the same results. It is through this cross-reference system that the method can likewise become generalizable. If other researchers can replicate your procedure across contexts with effective results, then the method proves itself intuitive and effective to be useful for further research. It is an important kind of tedium!

Box 7.4 – Procedure Checklist

Recruitment

• Did I discuss how I recruited my participants and/or collect my data? Did I mention and outline the type of sampling method I used?
• Did I discuss how I ensured ethical fairness in gathering my data?
• Did I discuss how many participants I reached out to, and if any problems occurred in gathering my data?
• Did I discuss how I solved problems in recruiting my participants?

Data Collection

• Have I discussed the method for collecting data in my study (interviews, surveys, census data)?
• Have I discussed procedures for cleaning, recoding, and otherwise ensuring the integrity of my data?

The final aim of your methods section will be to discuss how you processed and analyzed the data collected. This will differ significantly depending on the method chosen, but there are a few standard things to do depending on whether your paper is qualitative or quantitative. The following table highlights:

The next table provides a demonstration of the analysis portion of Alexander Wilson’s (2021) methodology in his undergraduate honours thesis.

The above table shows that honours student, Alexander Wilson (2021) began by discussing the instrument used to organize the analysis (NVivo) and then moves onto the steps taken to conduct a discourse analysis (which is overviewed earlier in the paper). It discusses how the media data was analyzed, through an open reading to a codification of the issues according to their being “hopes or externalities” of Uber’s service. The codification is situated within the overall method of discourse analysis, which seeks to interpret the meaning of speech/text with respect to the larger discussion that it is contributing to. For Alexander, this larger discussion leads to a change in legislation, so it is his goal to interpret the significance of Uber’s promises and externalities in the media discourse with respect to the final legislative conclusions.

Box 7.5 – Reviewing and Revising the Methods Section

• Have I summarized the method?
• Will this summary make sense to someone doing similar research?
• Have I adequately highlighted the elements of this method which are especially relevant for my research?
• Have I adequately highlighted elements of this method which are relevant for my argument regarding its value for my research?
• Have I argued the value of my approach?
• Have I argued that this methodological approach will be effective for gathering data in an ethical manner?
• What other approaches can I compare my method with? What are the tradeoffs?
• Have I summarized the data of my study?
• Have I clarified the type of my data (participants, text, articles etc.)?
• Have I stated common attributes of that data?
• Have I disclosed important ethical concerns regarding interaction with that data or population?
• Have I outlined the instruments and materials used in my study?
• Have I discussed the design and procedure of my study?
• Have I outlined how I analyzed the data?
• Did I adequately discuss the key steps of my analysis?
• Did I state how many iterations of my analysis were conducted (how many readings, how many calculations)?

Johnson, M. (2017). “Writing a Methods Section” In Allen, M. (2017).  The SAGE Encyclopedia of Communication Research Methods  (Vols. 1-4). Thousand Oaks, CA: SAGE Publications, Inc doi: 10.4135/9781483381411

Walsworth, S., Somerville, K., & Robinson, O. (2021). The importance of weak friendships for international student satisfaction: Empirical evidence from Canada.  International Journal of Intercultural Relations ,  80 , 134-146.

Gudykunst, W. B., Yang, S., & Nishida, T. (1985). A Cross-Cultural Test of Uncertainty Reduction Theory: Comparisons of acquaintances, friends, and dating relationships in japan, korea, and the united states.  Human Communication Research,  11 (3), 407-454.  https://doi.org/10.1111/j.1468-2958.1985.tb00054.x

Maeda, E., & Ritchie, L. D. (2003). The concept of shinyuu in japan: A replication of and comparison to cole and Bradac’s study on U.S. friendship.  Journal of Social and Personal Relationships,  20 (5), 579-598.  https://doi.org/10.1177/02654075030205001

Hall, J. A. (2019). How many hours does it take to make a friend?  Journal of Social and Personal Relationships,  36 (4), 1278-1296.  https://doi.org/10.1177/0265407518761225

The tools used to obtain data (e.g., questionnaires, interviews etc.).

The activities that a researcher takes to collect data.

the descriptives (usually sample size, mean, distribution etc.) or characteristics (e.g. gender, age, class, ethnicity) of participants/unit of observation

how you advertised the study, whether a stipend or incentive was offered, and how students finally agreed to join in the study

Research that collects and derives its own raw data by sampling participants or cases, such as selecting and interviewing respondents.

Uses data from other primary research projects, such as a systematic literature review of other research.

Uses other papers and articles, sometimes even other data (like secondary research), but with the purpose of advancing a new argument in the field.

things created by humans e.g., books, graffiti, advertisements, photographs, blogs etc.

The process of defining how one is going to measure a phenomenon that is not directly measurable.

Practicing and Presenting Social Research Copyright © 2022 by Oral Robinson and Alexander Wilson is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License , except where otherwise noted.

Share This Book

Have a language expert improve your writing

Run a free plagiarism check in 10 minutes, generate accurate citations for free.

• Knowledge Base

Methodology

• What Is a Research Design | Types, Guide & Examples

What Is a Research Design | Types, Guide & Examples

Published on June 7, 2021 by Shona McCombes . Revised on November 20, 2023 by Pritha Bhandari.

A research design is a strategy for answering your   research question  using empirical data. Creating a research design means making decisions about:

• Your overall research objectives and approach
• Whether you’ll rely on primary research or secondary research
• Your sampling methods or criteria for selecting subjects
• Your data collection methods
• The procedures you’ll follow to collect data
• Your data analysis methods

A well-planned research design helps ensure that your methods match your research objectives and that you use the right kind of analysis for your data.

Table of contents

Step 1: consider your aims and approach, step 2: choose a type of research design, step 3: identify your population and sampling method, step 4: choose your data collection methods, step 5: plan your data collection procedures, step 6: decide on your data analysis strategies, other interesting articles, frequently asked questions about research design.

• Introduction

Before you can start designing your research, you should already have a clear idea of the research question you want to investigate.

There are many different ways you could go about answering this question. Your research design choices should be driven by your aims and priorities—start by thinking carefully about what you want to achieve.

The first choice you need to make is whether you’ll take a qualitative or quantitative approach.

Qualitative research designs tend to be more flexible and inductive , allowing you to adjust your approach based on what you find throughout the research process.

Quantitative research designs tend to be more fixed and deductive , with variables and hypotheses clearly defined in advance of data collection.

It’s also possible to use a mixed-methods design that integrates aspects of both approaches. By combining qualitative and quantitative insights, you can gain a more complete picture of the problem you’re studying and strengthen the credibility of your conclusions.

Practical and ethical considerations when designing research

As well as scientific considerations, you need to think practically when designing your research. If your research involves people or animals, you also need to consider research ethics .

• How much time do you have to collect data and write up the research?
• Will you be able to gain access to the data you need (e.g., by travelling to a specific location or contacting specific people)?
• Do you have the necessary research skills (e.g., statistical analysis or interview techniques)?
• Will you need ethical approval ?

At each stage of the research design process, make sure that your choices are practically feasible.

Here's why students love Scribbr's proofreading services

Discover proofreading & editing

Within both qualitative and quantitative approaches, there are several types of research design to choose from. Each type provides a framework for the overall shape of your research.

Types of quantitative research designs

Quantitative designs can be split into four main types.

• Experimental and   quasi-experimental designs allow you to test cause-and-effect relationships
• Descriptive and correlational designs allow you to measure variables and describe relationships between them.

With descriptive and correlational designs, you can get a clear picture of characteristics, trends and relationships as they exist in the real world. However, you can’t draw conclusions about cause and effect (because correlation doesn’t imply causation ).

Experiments are the strongest way to test cause-and-effect relationships without the risk of other variables influencing the results. However, their controlled conditions may not always reflect how things work in the real world. They’re often also more difficult and expensive to implement.

Types of qualitative research designs

Qualitative designs are less strictly defined. This approach is about gaining a rich, detailed understanding of a specific context or phenomenon, and you can often be more creative and flexible in designing your research.

The table below shows some common types of qualitative design. They often have similar approaches in terms of data collection, but focus on different aspects when analyzing the data.

Your research design should clearly define who or what your research will focus on, and how you’ll go about choosing your participants or subjects.

In research, a population is the entire group that you want to draw conclusions about, while a sample is the smaller group of individuals you’ll actually collect data from.

Defining the population

A population can be made up of anything you want to study—plants, animals, organizations, texts, countries, etc. In the social sciences, it most often refers to a group of people.

For example, will you focus on people from a specific demographic, region or background? Are you interested in people with a certain job or medical condition, or users of a particular product?

The more precisely you define your population, the easier it will be to gather a representative sample.

• Sampling methods

Even with a narrowly defined population, it’s rarely possible to collect data from every individual. Instead, you’ll collect data from a sample.

To select a sample, there are two main approaches: probability sampling and non-probability sampling . The sampling method you use affects how confidently you can generalize your results to the population as a whole.

Probability sampling is the most statistically valid option, but it’s often difficult to achieve unless you’re dealing with a very small and accessible population.

For practical reasons, many studies use non-probability sampling, but it’s important to be aware of the limitations and carefully consider potential biases. You should always make an effort to gather a sample that’s as representative as possible of the population.

Case selection in qualitative research

In some types of qualitative designs, sampling may not be relevant.

For example, in an ethnography or a case study , your aim is to deeply understand a specific context, not to generalize to a population. Instead of sampling, you may simply aim to collect as much data as possible about the context you are studying.

In these types of design, you still have to carefully consider your choice of case or community. You should have a clear rationale for why this particular case is suitable for answering your research question .

For example, you might choose a case study that reveals an unusual or neglected aspect of your research problem, or you might choose several very similar or very different cases in order to compare them.

Data collection methods are ways of directly measuring variables and gathering information. They allow you to gain first-hand knowledge and original insights into your research problem.

You can choose just one data collection method, or use several methods in the same study.

Survey methods

Surveys allow you to collect data about opinions, behaviors, experiences, and characteristics by asking people directly. There are two main survey methods to choose from: questionnaires and interviews .

Observation methods

Observational studies allow you to collect data unobtrusively, observing characteristics, behaviors or social interactions without relying on self-reporting.

Observations may be conducted in real time, taking notes as you observe, or you might make audiovisual recordings for later analysis. They can be qualitative or quantitative.

Other methods of data collection

There are many other ways you might collect data depending on your field and topic.

If you’re not sure which methods will work best for your research design, try reading some papers in your field to see what kinds of data collection methods they used.

Secondary data

If you don’t have the time or resources to collect data from the population you’re interested in, you can also choose to use secondary data that other researchers already collected—for example, datasets from government surveys or previous studies on your topic.

With this raw data, you can do your own analysis to answer new research questions that weren’t addressed by the original study.

Using secondary data can expand the scope of your research, as you may be able to access much larger and more varied samples than you could collect yourself.

However, it also means you don’t have any control over which variables to measure or how to measure them, so the conclusions you can draw may be limited.

As well as deciding on your methods, you need to plan exactly how you’ll use these methods to collect data that’s consistent, accurate, and unbiased.

Planning systematic procedures is especially important in quantitative research, where you need to precisely define your variables and ensure your measurements are high in reliability and validity.

Operationalization

Some variables, like height or age, are easily measured. But often you’ll be dealing with more abstract concepts, like satisfaction, anxiety, or competence. Operationalization means turning these fuzzy ideas into measurable indicators.

If you’re using observations , which events or actions will you count?

If you’re using surveys , which questions will you ask and what range of responses will be offered?

You may also choose to use or adapt existing materials designed to measure the concept you’re interested in—for example, questionnaires or inventories whose reliability and validity has already been established.

Reliability and validity

Reliability means your results can be consistently reproduced, while validity means that you’re actually measuring the concept you’re interested in.

For valid and reliable results, your measurement materials should be thoroughly researched and carefully designed. Plan your procedures to make sure you carry out the same steps in the same way for each participant.

If you’re developing a new questionnaire or other instrument to measure a specific concept, running a pilot study allows you to check its validity and reliability in advance.

Sampling procedures

As well as choosing an appropriate sampling method , you need a concrete plan for how you’ll actually contact and recruit your selected sample.

That means making decisions about things like:

• How many participants do you need for an adequate sample size?
• What inclusion and exclusion criteria will you use to identify eligible participants?
• How will you contact your sample—by mail, online, by phone, or in person?

If you’re using a probability sampling method , it’s important that everyone who is randomly selected actually participates in the study. How will you ensure a high response rate?

If you’re using a non-probability method , how will you avoid research bias and ensure a representative sample?

Data management

It’s also important to create a data management plan for organizing and storing your data.

Will you need to transcribe interviews or perform data entry for observations? You should anonymize and safeguard any sensitive data, and make sure it’s backed up regularly.

Keeping your data well-organized will save time when it comes to analyzing it. It can also help other researchers validate and add to your findings (high replicability ).

On its own, raw data can’t answer your research question. The last step of designing your research is planning how you’ll analyze the data.

Quantitative data analysis

In quantitative research, you’ll most likely use some form of statistical analysis . With statistics, you can summarize your sample data, make estimates, and test hypotheses.

Using descriptive statistics , you can summarize your sample data in terms of:

• The distribution of the data (e.g., the frequency of each score on a test)
• The central tendency of the data (e.g., the mean to describe the average score)
• The variability of the data (e.g., the standard deviation to describe how spread out the scores are)

The specific calculations you can do depend on the level of measurement of your variables.

Using inferential statistics , you can:

• Make estimates about the population based on your sample data.
• Test hypotheses about a relationship between variables.

Regression and correlation tests look for associations between two or more variables, while comparison tests (such as t tests and ANOVAs ) look for differences in the outcomes of different groups.

Your choice of statistical test depends on various aspects of your research design, including the types of variables you’re dealing with and the distribution of your data.

Qualitative data analysis

In qualitative research, your data will usually be very dense with information and ideas. Instead of summing it up in numbers, you’ll need to comb through the data in detail, interpret its meanings, identify patterns, and extract the parts that are most relevant to your research question.

Two of the most common approaches to doing this are thematic analysis and discourse analysis .

There are many other ways of analyzing qualitative data depending on the aims of your research. To get a sense of potential approaches, try reading some qualitative research papers in your field.

If you want to know more about the research process , methodology , research bias , or statistics , make sure to check out some of our other articles with explanations and examples.

• Simple random sampling
• Stratified sampling
• Cluster sampling
• Likert scales
• Reproducibility

 Statistics

• Null hypothesis
• Statistical power
• Probability distribution
• Effect size
• Poisson distribution

Research bias

• Optimism bias
• Cognitive bias
• Implicit bias
• Hawthorne effect
• Anchoring bias
• Explicit bias

A research design is a strategy for answering your   research question . It defines your overall approach and determines how you will collect and analyze data.

A well-planned research design helps ensure that your methods match your research aims, that you collect high-quality data, and that you use the right kind of analysis to answer your questions, utilizing credible sources . This allows you to draw valid , trustworthy conclusions.

Quantitative research designs can be divided into two main categories:

• Correlational and descriptive designs are used to investigate characteristics, averages, trends, and associations between variables.
• Experimental and quasi-experimental designs are used to test causal relationships .

Qualitative research designs tend to be more flexible. Common types of qualitative design include case study , ethnography , and grounded theory designs.

The priorities of a research design can vary depending on the field, but you usually have to specify:

• Your research questions and/or hypotheses
• Your overall approach (e.g., qualitative or quantitative )
• The type of design you’re using (e.g., a survey , experiment , or case study )
• Your data collection methods (e.g., questionnaires , observations)
• Your data collection procedures (e.g., operationalization , timing and data management)
• Your data analysis methods (e.g., statistical tests  or thematic analysis )

A sample is a subset of individuals from a larger population . Sampling means selecting the group that you will actually collect data from in your research. For example, if you are researching the opinions of students in your university, you could survey a sample of 100 students.

In statistics, sampling allows you to test a hypothesis about the characteristics of a population.

Operationalization means turning abstract conceptual ideas into measurable observations.

For example, the concept of social anxiety isn’t directly observable, but it can be operationally defined in terms of self-rating scores, behavioral avoidance of crowded places, or physical anxiety symptoms in social situations.

Before collecting data , it’s important to consider how you will operationalize the variables that you want to measure.

A research project is an academic, scientific, or professional undertaking to answer a research question . Research projects can take many forms, such as qualitative or quantitative , descriptive , longitudinal , experimental , or correlational . What kind of research approach you choose will depend on your topic.

Cite this Scribbr article

If you want to cite this source, you can copy and paste the citation or click the “Cite this Scribbr article” button to automatically add the citation to our free Citation Generator.

McCombes, S. (2023, November 20). What Is a Research Design | Types, Guide & Examples. Scribbr. Retrieved June 29, 2024, from https://www.scribbr.com/methodology/research-design/

Is this article helpful?

Shona McCombes

Other students also liked, guide to experimental design | overview, steps, & examples, how to write a research proposal | examples & templates, ethical considerations in research | types & examples, what is your plagiarism score.

Institutional Review Board

Health Sciences and Minimal Risk Research IRBs

Conducting Human Participant Research

May 27, 2022

This section of the Investigator Manual covers a range of information related to conducting human participant research, including recruitment, communicating with participants, privacy issues, and different types of research.

Recruitment Guidelines

Participant remuneration & compensation, consent processes and documentation, hipaa processes & documentation, research with special populations, translation & interpreter requirements, privacy & confidentiality, identifiability, data safety monitoring plans (dsmp), communicating with participants, special procedures, regulatory information, va research, different types of research.

• General Recruitment Guidelines
• Initial Contact Guidelines
• Email Recruitment Guidelines
• Clinical Recruitment Guidelines
• MyChart Recruitment Guidelines
• Social Media Recruitment Guidelines
• Eligibility Screening

Link to this section

The IRB is responsible for ensuring that any payment or remuneration offered to participants in human subject research is fair and not an undue inducement to participate. Remuneration for participation in research should be reasonable and the amount paid should be comparable to other research projects involving similar time, effort, and inconvenience. Payment amounts should not be large enough to constitute an undue inducement to participate in a risky or uncomfortable procedure. Additional guidelines for specific situations:

• Short research studies involving one visit: Participants may be provided payment contingent upon completion of the study. Participants who are disqualified through no fault of their own must be paid for the time and effort they expended prior to their termination from the study.
• Research studies involving multiple visits or lengthy or repeated participation: Partial payment should be provided to participants who withdraw, are discharged early from the study by the investigator, or otherwise fail to complete the study as agreed. The amount of partial payment should relate to the amount of time, effort, or discomfort involved. Payment schedules may be designed on a per-day, per-visit, or per-procedure rate, or some combination thereof. The terms for partial payment must be described in the application and in the consent form.
• Completion bonuses: Such remuneration may be acceptable to encourage the completion of all study procedures/visits. The amount of such incentives depends on the risk and duration of the study interventions.
• Lottery incentives: Research teams that wish to employ recruitment incentives in which research participants are entered into a drawing to win a prize should consult with the UW Office of Legal Affairs.

For additional information on payment requirements, see HRP 316-WORKSHEET-Payment . For information on the campus policy for payments, see Payments to Research Participants .

• Informed Consent Document
• Assent Process and Documentation
• Remote & Electronic Consent Processes
• Waivers of Signed Consent
• Waivers & Alterations of Informed Consent
• Enrolling Participants with Limited English Proficiency
• Reconsenting Participants
• Other Consent Considerations
• HIPAA Authorization Document
• Remote Authorization
• Preparatory to Research Activities
• Partial and Full Waivers of Authorization
• Altered Authorization
• Data Use Agreements
• Accounting for Disclosures
• Authorization & Participants with Limited English Proficiency
• Participants with Impaired Decision-Making
• Pregnant Persons and/or Neonates
• Participants with Status Relationship
• Participants Receiving Protective Services or Mental Health Treatment
• Recruiting Veterans for non-VA Research
• Other Special Populations

If the subject/representative has limited English proficiency, you must obtain the services of an interpreter fluent in both English and the language understood by the subject/representative. The interpreter may be a member of the research team, a family member, or friend of the subject/representative. If the research involves medical care and/or is more than minimal risk, use of family or friends to interpret is discouraged.

Research with UW Health patients requires the use of professional interpreters, however the individual and/or their representatives may insist upon the use of a friend or family member to provide them with interpreting services. In this case, you should retain a healthcare interpreter to participate in the exchange to ensure that it represents accurate communication of information between investigators and patients.

For assistance in obtaining translation and interpreter services, contact UWHC Interpreter Services .

• Protecting Participant Privacy & Confidentiality
• Certificates of Confidentiality

Identifiability of data under the under the Common Rule (45 CFR 46) and the Health Insurance Portability and Accountability Act (HIPAA) differs.

Identifabilty under the Common Rule

An identifier includes any information that could be used to link research data with an individual subject.

• The Common Rule defines “individually identifiable” to mean that the identity of the subject is, or may be, readily ascertained by the investigator or associated with the information.
• A data set may be identifiable under the Common Rule if it contains: initials, address, zip code, phone number, gender, age, birth date, occupation, employer, racial or ethnic group, type of biopsy performed, date sample taken, diagnosis, primary care physician, referring physician, and genealogy.
• Age, ethnicity/race, gender may be identifiers under the Common Rule if fewer than 5 individuals possess a particular cluster of traits.
• Data may be identifiable if any combination of variables could potentially identify a subject.
• Some of the identifiers listed above become less problematic if the sample size is large enough so that the potential identifiers could describe several individuals and thus cannot be linked to only one person. Conversely, if the sample size is small, the potential to identify an individual may increase, even in the absence of direct identifiers.

Identifiability under HIPAA

The HIPAA Privacy Rule regulation specifies 18 identifiers (listed in policy UW-114 ), most of which are demographic. Inclusion of even one of the identifiers makes a data set identifiable. However, there are levels of identifiability. The following are considered limited identifiers under HIPAA: geographic area smaller than a state, elements of dates (date of birth, date of death, dates of clinical service), and age over age 89. The remaining identifiers in the list are considered to be direct identifiers. If the data set contains any limited identifiers, but none of the direct identifiers, it is considered a limited data set under HIPAA.

Definitions

What it means for data to be coded, de-identified or anonymous is important when it comes to understanding the identifiability of data.

• Coded data This refers to data which have been stripped of all direct subject identifiers, but in this case each record has its own study ID or code, which is linked to identifiable information such as name or medical record number. The linking file must be separate from the coded data set. This linking file may be held by someone on the study team (e.g. the PI) or it could be held by someone outside of the study team (e.g. a researcher at another institution). A coded data set may include limited identifiers under HIPAA. Of note, the code itself may not contain identifiers such as subject initials or medical record number.
• De-identified data This refers to data which have been stripped of all subject identifiers, including all 18 HIPAA identifiers. This means that there can be no data points that are considered limited identifiers under HIPAA, i.e. geographic area smaller than a state, elements of dates (date of birth, date of death, dates of clinical service), and age over age 89. If the data set contains any limited identifiers, it is considered a limited data set under HIPAA. If the data includes an indirect link to subject identifiers (e.g. via coded ID numbers), then the data is considered by the IRB to be coded, not de-identified. Please note that data can be considered de-identified under the Common Rule but NOT the HIPAA Privacy Rule (e.g., limited data sets), and vice versa (e.g., no HIPAA identifiers are included but the combination of data points could make subjects identifiable).
• Anonymous data Essentially the same thing as de-identified data, this refers to data which have been stripped of all subject identifiers and which have no indirect links to subject identifiers. There should be no limited identifiers in an anonymous data set.

Any study that presents more than minimal risk to subjects must describe a data and safety monitoring plan. Studies utilizing IRB protocol templates will be prompted to provide this information.

In the case of minimal risk research, the IRB may require a DSMP if the committee deems that monitoring of the study is needed to ensure the protection of the rights and welfare of subjects or data integrity, which could affect the welfare of future subjects.

See HRP-335 for IRB considerations in reviewing Data and Safety Monitoring Plans.

• General Communication Guidelines
• Use of Personal Cell Phones for Research
• Use of Video or Audio Recording
• Controlled Substances
• HIPAA Privacy & Security Rules
• Federal Educational Privacy Act (FERPA)
• FDA Regulations and IRB Review
• General Information about VA Research
• VA Requirements
• Use of Preparatory to Research
• Recruiting Veterans
• Special Populations in VA Research
• Certificates of Confidentiality in VA Research
• Collaborative VA Research
• Photography, Video and/or Audio Recording for VA Research
• VA International Research
• Posting VA Clinical Trial Consent Forms
• Research in K-12 Settings
• Tribal Research
• Analysis Center Projects
• Research Registries and Repositories
• Decedent Research
• Technology & New Media Research
• Biomedical Interventions Conducted in Non-Clinical Settings
• Fetal Tissue Research
• Biospecimens & Data: IRB Review Requirements
• Biospecimen & Data Research: Informed Consent Requirements
• Biospecimen & Data Research: Storage
• Sharing Data, Specimens, or Images
• Study Personnel Training and Preparatory Activities

Have a language expert improve your writing

Run a free plagiarism check in 10 minutes, automatically generate references for free.

• Knowledge Base
• Methodology

Research Design | Step-by-Step Guide with Examples

Published on 5 May 2022 by Shona McCombes . Revised on 20 March 2023.

A research design is a strategy for answering your research question  using empirical data. Creating a research design means making decisions about:

• Your overall aims and approach
• The type of research design you’ll use
• Your sampling methods or criteria for selecting subjects
• Your data collection methods
• The procedures you’ll follow to collect data
• Your data analysis methods

A well-planned research design helps ensure that your methods match your research aims and that you use the right kind of analysis for your data.

Table of contents

Step 1: consider your aims and approach, step 2: choose a type of research design, step 3: identify your population and sampling method, step 4: choose your data collection methods, step 5: plan your data collection procedures, step 6: decide on your data analysis strategies, frequently asked questions.

• Introduction

Before you can start designing your research, you should already have a clear idea of the research question you want to investigate.

There are many different ways you could go about answering this question. Your research design choices should be driven by your aims and priorities – start by thinking carefully about what you want to achieve.

The first choice you need to make is whether you’ll take a qualitative or quantitative approach.

Qualitative research designs tend to be more flexible and inductive , allowing you to adjust your approach based on what you find throughout the research process.

Quantitative research designs tend to be more fixed and deductive , with variables and hypotheses clearly defined in advance of data collection.

It’s also possible to use a mixed methods design that integrates aspects of both approaches. By combining qualitative and quantitative insights, you can gain a more complete picture of the problem you’re studying and strengthen the credibility of your conclusions.

Practical and ethical considerations when designing research

As well as scientific considerations, you need to think practically when designing your research. If your research involves people or animals, you also need to consider research ethics .

• How much time do you have to collect data and write up the research?
• Will you be able to gain access to the data you need (e.g., by travelling to a specific location or contacting specific people)?
• Do you have the necessary research skills (e.g., statistical analysis or interview techniques)?
• Will you need ethical approval ?

At each stage of the research design process, make sure that your choices are practically feasible.

Prevent plagiarism, run a free check.

Within both qualitative and quantitative approaches, there are several types of research design to choose from. Each type provides a framework for the overall shape of your research.

Types of quantitative research designs

Quantitative designs can be split into four main types. Experimental and   quasi-experimental designs allow you to test cause-and-effect relationships, while descriptive and correlational designs allow you to measure variables and describe relationships between them.

With descriptive and correlational designs, you can get a clear picture of characteristics, trends, and relationships as they exist in the real world. However, you can’t draw conclusions about cause and effect (because correlation doesn’t imply causation ).

Experiments are the strongest way to test cause-and-effect relationships without the risk of other variables influencing the results. However, their controlled conditions may not always reflect how things work in the real world. They’re often also more difficult and expensive to implement.

Types of qualitative research designs

Qualitative designs are less strictly defined. This approach is about gaining a rich, detailed understanding of a specific context or phenomenon, and you can often be more creative and flexible in designing your research.

The table below shows some common types of qualitative design. They often have similar approaches in terms of data collection, but focus on different aspects when analysing the data.

Your research design should clearly define who or what your research will focus on, and how you’ll go about choosing your participants or subjects.

In research, a population is the entire group that you want to draw conclusions about, while a sample is the smaller group of individuals you’ll actually collect data from.

Defining the population

A population can be made up of anything you want to study – plants, animals, organisations, texts, countries, etc. In the social sciences, it most often refers to a group of people.

For example, will you focus on people from a specific demographic, region, or background? Are you interested in people with a certain job or medical condition, or users of a particular product?

The more precisely you define your population, the easier it will be to gather a representative sample.

Sampling methods

Even with a narrowly defined population, it’s rarely possible to collect data from every individual. Instead, you’ll collect data from a sample.

To select a sample, there are two main approaches: probability sampling and non-probability sampling . The sampling method you use affects how confidently you can generalise your results to the population as a whole.

Probability sampling is the most statistically valid option, but it’s often difficult to achieve unless you’re dealing with a very small and accessible population.

For practical reasons, many studies use non-probability sampling, but it’s important to be aware of the limitations and carefully consider potential biases. You should always make an effort to gather a sample that’s as representative as possible of the population.

Case selection in qualitative research

In some types of qualitative designs, sampling may not be relevant.

For example, in an ethnography or a case study, your aim is to deeply understand a specific context, not to generalise to a population. Instead of sampling, you may simply aim to collect as much data as possible about the context you are studying.

In these types of design, you still have to carefully consider your choice of case or community. You should have a clear rationale for why this particular case is suitable for answering your research question.

For example, you might choose a case study that reveals an unusual or neglected aspect of your research problem, or you might choose several very similar or very different cases in order to compare them.

Data collection methods are ways of directly measuring variables and gathering information. They allow you to gain first-hand knowledge and original insights into your research problem.

You can choose just one data collection method, or use several methods in the same study.

Survey methods

Surveys allow you to collect data about opinions, behaviours, experiences, and characteristics by asking people directly. There are two main survey methods to choose from: questionnaires and interviews.

Observation methods

Observations allow you to collect data unobtrusively, observing characteristics, behaviours, or social interactions without relying on self-reporting.

Observations may be conducted in real time, taking notes as you observe, or you might make audiovisual recordings for later analysis. They can be qualitative or quantitative.

Other methods of data collection

There are many other ways you might collect data depending on your field and topic.

If you’re not sure which methods will work best for your research design, try reading some papers in your field to see what data collection methods they used.

Secondary data

If you don’t have the time or resources to collect data from the population you’re interested in, you can also choose to use secondary data that other researchers already collected – for example, datasets from government surveys or previous studies on your topic.

With this raw data, you can do your own analysis to answer new research questions that weren’t addressed by the original study.

Using secondary data can expand the scope of your research, as you may be able to access much larger and more varied samples than you could collect yourself.

However, it also means you don’t have any control over which variables to measure or how to measure them, so the conclusions you can draw may be limited.

As well as deciding on your methods, you need to plan exactly how you’ll use these methods to collect data that’s consistent, accurate, and unbiased.

Planning systematic procedures is especially important in quantitative research, where you need to precisely define your variables and ensure your measurements are reliable and valid.

Operationalisation

Some variables, like height or age, are easily measured. But often you’ll be dealing with more abstract concepts, like satisfaction, anxiety, or competence. Operationalisation means turning these fuzzy ideas into measurable indicators.

If you’re using observations , which events or actions will you count?

If you’re using surveys , which questions will you ask and what range of responses will be offered?

You may also choose to use or adapt existing materials designed to measure the concept you’re interested in – for example, questionnaires or inventories whose reliability and validity has already been established.

Reliability and validity

Reliability means your results can be consistently reproduced , while validity means that you’re actually measuring the concept you’re interested in.

For valid and reliable results, your measurement materials should be thoroughly researched and carefully designed. Plan your procedures to make sure you carry out the same steps in the same way for each participant.

If you’re developing a new questionnaire or other instrument to measure a specific concept, running a pilot study allows you to check its validity and reliability in advance.

Sampling procedures

As well as choosing an appropriate sampling method, you need a concrete plan for how you’ll actually contact and recruit your selected sample.

That means making decisions about things like:

• How many participants do you need for an adequate sample size?
• What inclusion and exclusion criteria will you use to identify eligible participants?
• How will you contact your sample – by mail, online, by phone, or in person?

If you’re using a probability sampling method, it’s important that everyone who is randomly selected actually participates in the study. How will you ensure a high response rate?

If you’re using a non-probability method, how will you avoid bias and ensure a representative sample?

Data management

It’s also important to create a data management plan for organising and storing your data.

Will you need to transcribe interviews or perform data entry for observations? You should anonymise and safeguard any sensitive data, and make sure it’s backed up regularly.

Keeping your data well organised will save time when it comes to analysing them. It can also help other researchers validate and add to your findings.

On their own, raw data can’t answer your research question. The last step of designing your research is planning how you’ll analyse the data.

Quantitative data analysis

In quantitative research, you’ll most likely use some form of statistical analysis . With statistics, you can summarise your sample data, make estimates, and test hypotheses.

Using descriptive statistics , you can summarise your sample data in terms of:

• The distribution of the data (e.g., the frequency of each score on a test)
• The central tendency of the data (e.g., the mean to describe the average score)
• The variability of the data (e.g., the standard deviation to describe how spread out the scores are)

The specific calculations you can do depend on the level of measurement of your variables.

Using inferential statistics , you can:

• Make estimates about the population based on your sample data.
• Test hypotheses about a relationship between variables.

Regression and correlation tests look for associations between two or more variables, while comparison tests (such as t tests and ANOVAs ) look for differences in the outcomes of different groups.

Your choice of statistical test depends on various aspects of your research design, including the types of variables you’re dealing with and the distribution of your data.

Qualitative data analysis

In qualitative research, your data will usually be very dense with information and ideas. Instead of summing it up in numbers, you’ll need to comb through the data in detail, interpret its meanings, identify patterns, and extract the parts that are most relevant to your research question.

Two of the most common approaches to doing this are thematic analysis and discourse analysis .

There are many other ways of analysing qualitative data depending on the aims of your research. To get a sense of potential approaches, try reading some qualitative research papers in your field.

A sample is a subset of individuals from a larger population. Sampling means selecting the group that you will actually collect data from in your research.

For example, if you are researching the opinions of students in your university, you could survey a sample of 100 students.

Statistical sampling allows you to test a hypothesis about the characteristics of a population. There are various sampling methods you can use to ensure that your sample is representative of the population as a whole.

Operationalisation means turning abstract conceptual ideas into measurable observations.

For example, the concept of social anxiety isn’t directly observable, but it can be operationally defined in terms of self-rating scores, behavioural avoidance of crowded places, or physical anxiety symptoms in social situations.

Before collecting data , it’s important to consider how you will operationalise the variables that you want to measure.

The research methods you use depend on the type of data you need to answer your research question .

• If you want to measure something or test a hypothesis , use quantitative methods . If you want to explore ideas, thoughts, and meanings, use qualitative methods .
• If you want to analyse a large amount of readily available data, use secondary data. If you want data specific to your purposes with control over how they are generated, collect primary data.
• If you want to establish cause-and-effect relationships between variables , use experimental methods. If you want to understand the characteristics of a research subject, use descriptive methods.

Cite this Scribbr article

If you want to cite this source, you can copy and paste the citation or click the ‘Cite this Scribbr article’ button to automatically add the citation to our free Reference Generator.

McCombes, S. (2023, March 20). Research Design | Step-by-Step Guide with Examples. Scribbr. Retrieved 24 June 2024, from https://www.scribbr.co.uk/research-methods/research-design/

Is this article helpful?

Shona McCombes

Nursing Tutorials

Research mcqs-part-ii.

51. Which of the following can best be described as a categorical variable? a. Age b. Annual Income c. Grade Point Average d. Religion

52. In research, something that does not “vary” is called a ___________. a. Variable b. Method c. Constant d. control group

53. The strongest evidence for causality comes from which of the following research methods? a. Experimental b. Causal-comparative c. Correlational d. Ethnography

54. good qualitative problem statement: a. Defines the independent and dependent variables b. Conveys a sense of emerging design c. Specifies a research hypothesis to be tested d. Specifies the relationship between variables that the researcher expects to find

55. Sometimes a comprehensive review of the literature prior to data collection is not recommended by grounded theorists. a. True b. False

56. The research participants are described in detail in which section of the research plan? a. Introduction b. Method c. Data analysis d. Discussion

57. The statement of purpose in a research study should: a. Identify the design of the study b. Identify the intent or objective of the study c. Specify the type of people to be used in the study d. Describe the study

58. A qualitative research question: a. Asks a question about some process, or phenomenon to be explored b. Is generally an open-ended question c. both a and b are correct d. None of the above

59. According to the text, which of the following orders is the recommended in the flowchart of the development of a research idea? a. Research topic, research problem, research purpose, research question, hypothesis b. Research topic, research purpose, research problem, research question, hypothesis c. Research topic, research problem, research purpose, research question, hypothesis d. Research topic, hypothesis, research problem, research question, research purpose

60. One step that is not included in planning a research study is: a. Identifying a researchable problem b. A review of current research c. Statement of the research question d. Conducting a meta-analysis of the research e. Developing a research plan

61. Sources of researchable problems can include: a. Researchers’ own experiences as educators b. Practical issues that require solutions c. Theory and past research d. All of the above

62. Which of the following is a function of theory? a. Integrating and summarizing current knowledge b. Making predictions c. Explaining phenomena d. All of the above are important functions of theory

63. A review of the literature prior to formulating research questions allows the researcher to do which of the following? a. To become familiar with prior research on the phenomenon of interest b. To identify potential methodological problems in the research area c. To develop a list of pertinent problems relative to the phenomenon of interest d. All of the above

64. Computer database searches can be done: a. With a computer with CD-ROM drive b. At the library c. Online d. All of the above

65. What is the primary approach that is used by the IRB to assess the ethical acceptability of a research study? a. Utilitarianism b. Deontology c. Ethical skepticism d. Comparativeism

66. The feasibility of a research study should be considered in light of: a. Cost and time required to conduct the study b. Skills required of the researcher c. Potential ethical concerns d. All of the above

67. A formal statement of the research question or “purpose of research study” generally; a. Is made prior to the literature review b. Is made after the literature review c. Will help guide the research process d. b and c

68. Research hypotheses are ______. a. Formulated prior to a review of the literature b. Statements of predicted relationships between variables c. Stated such that they can be confirmed or refuted d. b and c

69. Hypotheses in qualitative research studies usually _____. a. Are very specific and stated prior to beginning the study b. Are often generated as the data are collected, interpreted, and analyzed c. Are never used d. Are always stated after the research study has been completed

70. A research plan _____. a. Should be detailed b. Should be given to others for review and comments c. Sets out the rationale for a research study d. All of the above

71. The Method section of the research plan typically specifies EXCEPT; a. The research participants b. The results of prior studies that address the phenomena of interest c. The apparatus, instruments, and materials for the research study d. The planned research procedures

72. The Introduction section of the research plan a. Gives an overview of prior relevant studies b. Contains a statement of the purpose of the study c. Concludes with a statement of the research questions &, for quantitative research, it includes the research hypothesis d. All of the above

73. Which of the following is necessary in obtaining informed consent? a. A description of the statistical analyses that will be carried out b. A description of the purpose of the research c. A description of the reliability and validity of test instruments d. A list of publications that the researcher has had in the last ten years

74. Which of the following need(s) to be obtained when doing research with children? a. Informed consent from the parent or guardian b. Assent from the child if he or she is capable c. Informed consent from the child d. Both a and b

75. Ideally, the research participant’s identity is not known to the researcher. This is called: a. Anonymity b. Confidentiality c. Deception d. Desensitizing

76. Which of the following is true about the use of deception in research? a. It should never be used b. It can be used anytime c. If there is deception in a study, the participants may need to be debriefed d. The use of deception must be outweighed by other benefits of the study e. Both c and d are true

77. Which of the following is not an ethical guideline for conducting research with humans? a. Getting informed consent of the participant b. Telling participants they must continue until the study has been completed c. Keeping participants’ identity anonymous d. Telling participants they are free to withdraw at any time

78. ________ means that the participant’s identity, although known to the researcher, is not revealed to anyone outside of the researcher and his or her staff. a. Anonymity b. Confidentiality

79. Which of the following is not true? a. Misrepresenting and creating fraudulent data is dishonest b. Misrepresenting data is very easy to detect c. Misrepresenting data can be difficult to detect d. Breaking confidentiality is not a problem

80. What is it called when the participants are not revealed to any one but researcher and staff? a. Confidentiality b. Anonymity c. Ethics d. Discretion

81. Research participants must give what before they can participate in a study? a. Guidelines b. A commitment c. Informed consent d. Private information

82. Identify the term that refers to a post study interview in which all aspects of the study are revealed, reasons for the use of deception are given, and the participants’ questions are answered? a. Desensitizing b. Debriefing c. Dehoaxing d. Deploying

83. A set of principles to guide and assist researchers in deciding which goals are most important and in reconciling conflicting values when conducting research is called ____. a. Research ethics b. Deontological approach c. Utilitarianism d. None of the above

84. IRB is an acronym for which of the following? a. Internal Review Board b. Institutional Rating Board c. Institutional Review Board d. Internal Request Board

85. The act of publishing the same data and results in more than one journal or publication refers to which of the following professional issues: a. Partial publication b. Duplicate publication c. Deception d. Full publication

86. Which term refers to publishing several articles from the data collected in one large study? a. Duplicate publication b. Partial publication c. Triplicate publication d. None of these

87. Which of the following is a right of each participant in research? a. Deception b. Utilitarianism c. Freedom to withdraw d. Participants have no rights

88. The use of statistics to make assumptions concerning some unknown aspect of a population from a sample of that population is known as follow; a. Inferential Statistics b. Parameter c. Descriptive Statistics d. Sampling

89. Which of the following is not an assumption underlying testing and measurement? a. Various approaches to measuring aspects of the same thing can be useful b. Error is rarely present in the measurement process c. Present-day behavior predicts future behavior d. Testing and assessment benefit society

90. Systematic error is associated with: a. Reliability b. Validity

91. Which of the following generally cannot be done in qualitative studies conducted in the field? a. Getting informed consent b. Keeping participants from physical harm c. Maintaining consent forms d. Having full anonymity rather than just confidentiality

92. Which of the following is a type of criterion–related validity evidence? a. Concurrent evidence b. Predictive evidence c. Internal consistency d. Both a and b are correct answers

93. The actual population of study participants selected from a larger population is known as: a. Target population b. Accessible population c. Population d. Cluster

94. Sampling criteria may be used by Nurse to develop the desired sample. Characteristics those must be present for a subject to be included in the sample is called: a. Inclusion criteria b. Exclusion criteria c. Representativeness d. Consent

95. Selection of sample in this study is an important step in doing research. A good sample is: a. One that includes both male and female nurses b. One that shows a balance in the number of nurses from hospital and school c. One that is representative of the population from which it was selected d. One that can be manipulated and controlled

96. A study in which we see the nurse’s level of education is classified in which level of measurement? a. Nominal-scale b. Ordinal scale c. Interval scale d. Ratio-scale

97. Which one of the following supports “reasoning moves from general to specific situation or conclusion”? a. Scientific reasoning b. Deductive reasoning c. Inductive reasoning d. None of the above

98. Which one of the following is a type of nonparametric test? a. t-test b. Chi-squire c. z-test d. f-test

99. Which one of the following is consists of rules for assigning numbers to objects to represent quantities of attributes? a. Reliability b. Measurement c. Measurement error d. Validity

100. Following are the elements of research critique EXCEPT ONE; a. Methodological dimensions b. Practical dimensions c. Ethical dimensions d. Interpretive dimensions

Leave a Reply Cancel reply

Your email address will not be published. Required fields are marked *

Save my name, email, and website in this browser for the next time I comment.

G. 400 - PHS 398 Research Plan Form

1. Introduction to Application (for Resubmission and Revision applications)

2. specific aims, 3. research strategy, 4. progress report publication list, 5. vertebrate animals, 6. select agent research, 7. multiple pd/pi leadership plan, 8. consortium/contractual arrangements, 9. letters of support, 10. resource sharing plan(s), 11. authentication of key biological and/or chemical resources, 12. appendix.

Your application should represent a sound approach to the investigation of an important biomedical research, behavioral research, technological, engineering, or scientific question, and be worthy of support under the stated criteria of the FOA. It should be self-contained and written with the care and thoroughness accorded to papers for publication.

Review the application carefully to ensure you have included information essential for evaluation. The scientific and technical merit of the proposed research is the primary concern for all research supported by the National Institutes of Health (NIH) and other PHS agencies.

Read all the instructions in the FOA before completing this form to ensure that your application meets all IC-specific criteria.

Who should use the PHS 398 Research Plan Form:

Use the PHS 398 Research Plan Form only if you are submitting a research, multi-project, or SBIR/STTR application.

Additional Instructions for SBIR/STTR:

You are strongly encouraged to contact agency program staff for pre-application guidance and/or for more specific information on the research topics described in the solicitation.

The applicant small business must not propose market research, patent applications, or litigation. The research proposed in this application may, however, be carried out through construction and evaluation of a laboratory prototype, where necessary.

CRP uses SBIR funding, but is not a Phase I/II/IIB or Fast-Track application. However, CRP applications should follow all Phase II-specific instructions.

Applicants must follow all policies and requirements related to formatting, page limits, and proprietary information. See the following pages for more information:

• Format Attachments
• Page Limits
• NIH Grants Policy Statement, Section 2.3.11.2: Confidentiality of Information
• NIH Grants Policy Statement, Section 2.3.11.2.2: The Freedom of Information Act

Introduction

Who must complete the "introduction to application" attachment:.

An "Introduction to Application" attachment is required only if the type of application is resubmission or revision or if the FOA specifies that one is needed. An introduction is not allowed for new or renewal applications.

Descriptions of different types of applications are listed here: NIH Types of Applications .

Follow the page limits for the introduction in the NIH Table of Page Limits unless otherwise specified in the FOA.

Attach this information as a PDF file. See NIH's Format Attachments page.

Resubmission applications: See specific instructions on the content of the introduction on the NIH's Resubmission Applications page.

Competing Revisions: See specific instructions on the content of the introduction on the NIH's Competing Revisions page.

Additional Instructions for Multi-project:

Overall Component: The "Introduction" attachment is required for all resubmission and revision applications.

Other Components: The "Introduction" attachment is optional for resubmissions and revisions applications. Although the "Introduction" attachment is optional, you may get a system warning if there is no attachment.

Research Plan Section

Who must complete the "specific aims" attachment:.

The "Specific Aims" attachment is required unless otherwise specified in the FOA.

Follow the page limits for the Specific Aims in the NIH Table of Page Limits unless otherwise specified in the FOA.

State concisely the goals of the proposed research and summarize the expected outcome(s), including the impact that the results of the proposed research will have on the research field(s) involved.

List succinctly the specific objectives of the research proposed (e.g., to test a stated hypothesis, create a novel design, solve a specific problem, challenge an existing paradigm or clinical practice, address a critical barrier to progress in the field, or develop new technology).

Overall Component: The "Specific Aims" attachment is required.

Other Components: The "Specific Aims" attachment is required.

Phase I Applications : State the specific objectives of the Phase I research and development effort, including the technical questions you will try to answer to determine the Phase I feasibility of the proposed approach and the impact that the results of the proposed research will exert on the research field(s) involved. State concisely and realistically what the proposed research is intended to accomplish in terms of its potential for technological innovation and commercial application. Define the proposed product, process or service to ultimately be developed. Include milestones for each of the aims as these will be used in the evaluation process.

Phase II, Phase IIB, and CRP Applications: State the specific objectives of the Phase II research and development effort including the impact that the results of the proposed research will exert on the research field(s). State concisely and realistically what the proposed research is intended to accomplish in terms of its potential for technological innovation and commercial application. Define the proposed product, process, or service to ultimately be developed. Include milestones for each of the aims as these will be used in the evaluation process.

Fast-Track Applications: Create a heading titled "Phase I Specific Aims" and follow the instructions above for "Phase I Applications." Note that your Phase I milestones must be clear, appropriate, and measurable. Failure to adequately address these criteria may negatively affect the application's impact score. Next, create a heading titled "Phase II Specific Aims" and follow the instructions above for "Phase II Applications." Note that the page limit applies to both phases in combination, not to each phase individually.

Who must complete the "Research Strategy" attachment:

The "Research Strategy" attachment is required.

Follow the page limits for the Research Strategy in the NIH Table of Page Limits , unless otherwise specified in the FOA. Although multiple sections of information are required in the Research Strategy as detailed below, the page limit applies to the entirety of the single "Research Strategy" attachment.

For applications submitted for due dates on or before January 24, 2019:

Organize the Research Strategy in the specified order and use the instructions provided below unless otherwise specified in the FOA. Start each section with the appropriate heading - Significance, Innovation, Approach.

Cite published experimental details in the Research Strategy attachment and provide the full reference in G. 220 - R&R Other Project Information Form, Bibliography and Reference Cited .

• Although some overall information may be duplicative between the Research Strategy and PHS Human Subjects and Clinical Trials Information form, it is usually inappropriate to copy/paste large blocks of text. Use the Research Strategy attachment to discuss the overall strategy, methodology, and analyses of your proposed research. Use the PHS Human Subjects and Clinical Trials Information form to provide detailed information for human subjects studies and clinical trials.
• The PHS Human Subjects and Clinical Trials Information form will capture detailed study information, including eligibility criteria; inclusion of women, minorities, and children; protection and monitoring plans; and statistical design and power.
• You are encouraged to refer to information in the PHS Human Subjects and Clinical Trials Information form as appropriate in your discussion of the Research Strategy (e.g., see Question 2.4 Inclusion of Women, Minorities, and Children ).

Note for Applicants with Multiple Specific Aims: You may address the Significance, Innovation, and Approach either for each Specific Aim individually or for all of the Specific Aims collectively.

1. Significance

• Explain the importance of the problem or critical barrier to progress that the proposed project addresses.
• Describe the scientific premise for the proposed project, including consideration of the strengths and weaknesses of published research or preliminary data crucial to the support of your application.
• Explain how the proposed project will improve scientific knowledge, technical capability, and/or clinical practice in one or more broad fields.

Additional Instructions for Research:

Describe how the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field will be changed if the proposed aims are achieved.

Overall and Other Components: Describe how the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field will be changed if the proposed aims are achieved.

Explain the project's potential to lead to a marketable product, process, or service.

Phase II, CRP, Fast-Track, and Phase IIB Competing Renewals: Explain how the commercialization plan demonstrates a high probability of commercialization.

2. Innovation

• Explain how the application challenges and seeks to shift current research or clinical practice paradigms.
• Describe any novel theoretical concepts, approaches or methodologies, instrumentation or interventions to be developed or used, and any advantage over existing methodologies, instrumentation, or interventions.
• Explain any refinements, improvements, or new applications of theoretical concepts, approaches or methodologies, instrumentation, or interventions.

3. Approach

• Describe the overall strategy, methodology, and analyses to be used to accomplish the specific aims of the project. Describe the experimental design and methods proposed and how they will achieve robust and unbiased results. Unless addressed separately in the Resource Sharing Plan , include how the data will be collected, analyzed, and interpreted, as well as any resource sharing plans as appropriate. Resources and tools for rigorous experimental design can be found at the Enhancing Reproducibility through Rigor and Transparency website.
• For trials that randomize groups or deliver interventions to groups, describe how your methods for analysis and sample size are appropriate for your plans for participant assignment and intervention delivery. These methods can include a group- or cluster-randomized trial or an individually randomized group-treatment trial. Additional information is available at the Research Methods Resources webpage.
• Discuss potential problems, alternative strategies, and benchmarks for success anticipated to achieve the aims.
• If the project is in the early stages of development, describe any strategy to establish feasibility, and address the management of any high risk aspects of the proposed work.
• Explain how relevant biological variables, such as sex, are factored into research designs and analyses for studies in vertebrate animals and humans. For example, strong justification from the scientific literature, preliminary data, or other relevant considerations, must be provided for applications proposing to study only one sex. Refer to the NIH Guide Notice on Sex as a Biological Variable in NIH-funded Research for additional information.
• Point out any procedures, situations, or materials that may be hazardous to personnel and the precautions to be exercised. A full discussion on the use of select agents should appear in the Select Agent Research attachment below.
• If research on Human Embryonic Stem Cells (hESCs) is proposed but an approved cell line from the NIH hESC Registry cannot be chosen, provide a strong justification for why an appropriate cell line cannot be chosen from the registry at this time.

Provide a tentative sequence or timetable for the project.

As applicable, also include the following information as part of the Research Strategy, keeping within the three sections (Significance, Innovation, and Approach) listed above.

Preliminary Studies for New Applications:

For new applications, include information on preliminary studies. Discuss the PD/PI's preliminary studies, data, and or experience pertinent to this application. Except for Exploratory/Developmental Grants (R21/R33), Small Research Grants (R03), and Academic Research Enhancement Award (AREA) Grants (R15), preliminary data can be an essential part of a research grant application and can help to establish the likelihood of success of the proposed project. Early stage investigators should include preliminary data.

Phase I Applications: Preliminary data are not required for Phase I Applications; however, such results may assist reviewers in assessing the likelihood of success of the proposed project and may be included in the Research Strategy attachment.

Fast-Track Applications: Preliminary data are expected for Fast-Track Applications.

SBIR Direct Phase II (if this is an allowable application type): Summarize the specific aims of the preliminary work that forms the basis for this Phase II application, quantitative milestones (i.e., a quantitative definition of success) for each aim, and the importance of the findings. Additionally, emphasize the progress made toward each aim's achievement. Describe the technology developed, its intended use, and who will use it. Provide data or evidence of the capability, completeness of design, and efficacy, along with the rationale for selection of the criteria used to validate the technology, prototype, or method. Describe the current status of the product (e.g., under development, commercialized, in use, discontinued). If applicable, describe the status of FDA approval for your product, process, or service (e.g., continuing pre-IND studies, filed on IND, in Phase I (or II or III) clinical trials, applied for approval, review ongoing, approved, not approved). List the generic and/or commercial names of products. A list of publications, patents, and other printed materials should be included in Item 5 (Progress Report Publication List) - do not include that information here.

Progress Report for Renewal and Revision Applications:

Note that the Progress Report falls within the Research Strategy and is therefore included in the page limits for the Research Strategy.

For renewal/revision applications, provide a Progress Report. Provide the beginning and ending dates for the period covered since the last competitive review. In the Progress Report, you should:

• Summarize the specific aims of the previous project period and the importance of the findings, and emphasize the progress made toward their achievement.
• Explain any significant changes to the specific aims and any new directions, including changes resulting from significant budget reductions.
• Discuss previous participant enrollment (e.g., recruitment, retention, inclusion of women, minorities, children, etc.) for any studies meeting the NIH definition for clinical research . Use the Progress Report section to discuss, but not duplicate information collected elsewhere in the application.

Do not include a list of publications, patents, or other printed materials in the Progress Report. That information will be included in the "Progress Report Publication List" attachment.

Phase II, Phase IIB, and CRP Competing Renewal and Revision Applications: In the Progress Report, in addition to what's listed above, describe the technology developed from this SBIR/STTR, its intended use, and who will use it. Describe the current status of the product (e.g., under development, commercialized, in use, discontinued). If applicable, describe the status of FDA approval for your product, process, or service (e.g., continuing pre-IND studies, filed on IND, in Phase I (or II or III) clinical trials, applied for approval, review ongoing, approved, not approved).

• Describe the strengths and weaknesses in the rigor of the prior research (both published and unpublished) that serves as the key support for the proposed project.
• Describe the overall strategy, methodology, and analyses to be used to accomplish the specific aims of the project. Describe plans to address weaknesses in the rigor of the prior research that serves as the key support for the proposed project. Describe the experimental design and methods proposed and how they will achieve robust and unbiased results. Unless addressed separately in the Resource Sharing Plan , include how the data will be collected, analyzed, and interpreted, as well as any resource sharing plans as appropriate. Resources and tools for rigorous experimental design can be found at the Enhancing Reproducibility through Rigor and Transparency website.

Who must complete the "Progress Report Publication List" attachment:

A "Progress Report Publication List" attachment is required only if the type of application is renewal.

Descriptions of different types of applications are listed here: NIH's Types of Applications .

List the titles and complete references to all appropriate publications, manuscripts accepted for publication, patents, and other printed materials that have resulted from the project since it was last reviewed competitively.

You are allowed to cite interim research products. Note: interim research products have specific citation requirements. See related Frequently Asked Questions on citing interim research products and claiming them as products of your NIH award.

Provide the NIH Manuscript Submission reference number (e.g., NIHMS97531) or the PubMed Central (PMC) reference number (e.g., PMCID234567) for each of the following:

• Articles that fall under the Public Access Policy ,
• Articles that were authored or co-authored by the applicant and arose from NIH support,
• Articles that were authored or co-authored by the applicant and arose from AHRQ funding provided after February 19, 2016 (see the Guide Notice on Policy for Public Access to AHRQ-Funded Scientific Publications ).

If the PMCID is not yet available because the Journal submits articles directly to PMC on behalf of their authors, indicate "PMC Journal - In Process." NIH maintains a list of such journals .

Citations that are not covered by the Public Access Policy, but are publicly available in a free, online format may include URLs or PubMed ID (PMID) numbers along with the full reference.

Overall and Other Components: If you include a "Progress Report Publication List" attachment, you can include it in either the Overall Component or within each Other Component, but do not attach the same information in multiple locations.

Phase II, Phase IIB, and CRP Applications: List the titles and complete references to all appropriate publications, manuscripts accepted for publication, patents, copyrights, trademarks, invention reports and other printed materials, if any, that resulted from the Phase I or describe patent status, trade secrets or other demonstration of IP protection, and other printed materials that have resulted from the Phase I effort.

Other Research Plan Section

Who must complete the "vertebrate animals" attachment:.

Include a "Vertebrate Animals" attachment if you answered "Yes" to the question "Are Vertebrate Animals Used?" on the G. 220 - R&R Other Project Information Form.

Do not use this attachment to circumvent the page limits of the Research Strategy.

If live vertebrate animals are involved in the project, address each of the following criteria:

• Description of Procedures: Provide a concise description of the proposed procedures to be used that involve live vertebrate animals in the work outlined in the "Research Strategy" attachment. The description must include sufficient detail to allow evaluation of the procedures. Identify the species, strains, ages, sex, and total numbers of animals by species, to be used in the proposed work. If dogs or cats are proposed, provide the source of the animals.
• Justifications: Provide justification that the species are appropriate for the proposed research. Explain why the research goals cannot be accomplished using an alternative model (e.g. computational, human, invertebrate, in vitro).
• Minimization of Pain and Distress: Describe the interventions including analgesia, anesthesia, sedation, palliative care and humane endpoints that will be used to minimize discomfort, distress, pain, and injury.

Each of the criteria must be addressed. Failure to adequately address the criteria may negatively affect the application's impact score. In addition to the 3 criteria above, you should also:

• Identify all project performance (or collaborating) sites and describe the proposed research activities with vertebrate animals that will be conducted at those sites.
• Explain when and how animals are expected to be used if plans for the use of animals have not been finalized.

See the following pages for more information:

• NIH's Office of Laboratory Animal Welfare website
• NIH's Vertebrate Animals Section Worksheet
• See the NIH Grants Policy Statement, Section 4.1.1: Animal Welfare Requirements (an applicable Animal Welfare Assurance will be required if the grantee institution does not have one)

Overall Component: The "Vertebrate Animals" attachment is optional unless specifically requested in the FOA.

Other Components: Complete the "Vertebrate Animals" section if you answered "Yes" to the question "Are Vertebrate Animals Used?" on the G. 220 - R&R Other Project Information Form .

Who must complete the "Select Agent Research" attachment:

Include a "Select Agent Research" attachment if your proposed activities involve the use of select agents at any time during the proposed project period, either at the applicant organization or at any performance site.

For more information:

Select agents are hazardous biological agents and toxins that have been identified by HHS or the U.S. Department of Agriculture (USDA) as having the potential to pose a severe threat to public health and safety, to animal and plant health, or to animal and plant products. The Centers for Disease control and Prevention (CDC) and the Animal APHIS Select Agent Programs jointly maintain a list of these agents. See the Federal Select Agent Program website.

See also the NIH Grants Policy Statement, Section 4.1.24.1.1: Select Agents .

Excluded select agents: If the activities proposed in the application involve only the use of a strain(s) of select agents which has been excluded from the list of select agents and toxins as per 42 CFR 73.3 , the select agent requirements do not apply. Use this "Select Agent Research" attachment to identify the strain(s) of the select agent that will be used and note that it has been excluded from this list. The CDC maintains a list of exclusions, which is available on the Select Agents and Toxins Exclusions website.

Applying for a select agent to be excluded: If the strain(s) is not currently excluded from the list of select agents and toxins but you have applied or intend to apply to HHS for an exclusion from the list, use this section to indicate the status of your request or your intent to apply for an exclusion and provide a brief justification for the exclusion.

All applicants proposing to use select agents: Address the following three points for each site at which select agent research will take place. Although no specific page limitation applies to this section, be succinct.

• Identify the select agent(s) to be used in the proposed research.
• Provide the registration status of all entities* where select agent(s) will be used.
• If the performance site(s) is a foreign institution, provide the name(s) of the country or countries where select agent research will be performed.
• *An "entity" is defined in 42 CFR 73.1 as "any government agency (Federal, State, or local), academic institution, corporation, company, partnership, society, association, firm, sole proprietorship, or other legal entity."
• Provide a description of all facilities where the select agent(s) will be used.
• Describe the procedures that will be used to monitor possession, use, and transfer of select agent(s).
• Describe plans for appropriate biosafety, biocontainment, and security of the select agent(s).
• Describe the biocontainment resources available at all performance sites.

Who must complete the "Multiple PD/PI Leadership Plan" attachment:

Any applicant who designates multiple PD/PIs (on the G. 240 - R&R Senior/Key Person Profile (Expanded) Form ) must include a Multiple PD/PI Leadership Plan. For applications designating multiple PD/PIs, all such individuals must be assigned the PD/PI role on the G. 240 - R&R Senior/Key Profile (Expanded) Form , even those at organizations other than the applicant organization.

Do not submit a Multiple PD/PI Leadership Plan if you are not submitting a multiple PD/PI application.

Overall Component: The "Multiple PD/PI Leadership Plan" attachment is required if more than one PD/PI is specified on the Overall Component's G. 240 - R&R Senior/Key Profile (Expanded) Form.

A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, including communication plans, processes for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PD/PIs and other collaborators.

If budget allocation is planned, the distribution of resources to specific components of the project or the individual PD/PIs should be delineated in the Multiple PD/PI Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Grant Award.

For background information on the multiple PD/PI initiative, see NIH's Multiple Principal Investigators page.

Who must complete the "Consortium/Contractual Arrangements" attachment:

Include a "Consortium/Contractual Arrangements" attachment if you have consortiums/contracts in your budget.

Explain the programmatic, fiscal, and administrative arrangements to be made between the applicant organization and the consortium organization(s). If consortium/contractual activities represent a significant portion of the overall project, explain why the applicant organization, rather than the ultimate performer of the activities, should be the grantee.

Note: The signature of the authorized organization representative in G. 200 - SF 424 (R&R), Authorized Representative signifies that the applicant and all proposed consortium participants understand and agree to the following statement:

The appropriate programmatic and administrative personnel of each organization involved in this grant application are aware of the agency's consortium agreement policy and are prepared to establish the necessary inter-organizational agreement(s) consistent with that policy.

Refer to the NIH Grants Policy Statement, Section 15: Consortium Agreements for more information.

Overall and Other Components: Unless otherwise specified in the FOA, you have the option to:

• include a single consolidated "Consortium/Contractual Arrangements" attachment in the Overall Component, or
• include component-specific "Consortium/Contractual Arrangements" attachment(s) within the components that include subawards, or
• include a "Consortium/Contractual Arrangements" attachment in the Overall Component and include component-specific attachments within the components that include subawards. Each filename must be unique.

Phase I Applications: Normally, a minimum of two-thirds or 67% of the research or analytical effort must be carried out by the small business concern (SBC). The total amount of all consultant and contractual arrangements to third parties for portions of the scientific and technical effort generally may not exceed 33% of the total amount requested (direct, F&A/indirect, and fee). Occasionally, deviations from these requirements may occur. Deviations must be approved in writing by the funding agreement officer after consultation with the agency SBIR Program Manager/Coordinator.

Phase II and Phase IIB Applications: Normally, a minimum of one-half or 50% of the research or analytical effort must be carried out by the SBC. The total amount of consultant and contractual arrangements to third parties for portions of the scientific and technical effort generally may not exceed 50% of the total Phase II amount requested (direct, F&A/indirect, and fee). Occasionally, deviations from these requirements may occur. Deviations must be approved in writing by the funding agreement officer after consultation with the agency SBIR Program Manager/Coordinator.

Phase I and Phase II Applications: The basis for determining the percentage of work to be performed by each of the cooperative parties in Phase I or Phase II will be the total requested costs (direct, F&A/indirect, and fee) attributable to each party, unless otherwise described and justified in this attachment.

Fast-Track SBIR Applications: Create two separate sections entitled "Phase I Consortium/Contractual Arrangements" and "Phase II Consortium/Contractual Arrangements," and complete the sections following the instructions provided above for each phase.

Phase I, Phase II and Phase IIB STTR Applications: At least 40% of the work must be performed by the SBC and at least 30% of the work must be performed by the single partnering research institution. The basis for determining the percentage of work to be performed by each of the cooperative parties will be the total of the requested costs (direct, F&A/indirect, and fee) attributable to each party, unless otherwise described and justified in this attachment.

Certification showing the cooperative R&D arrangement between the SBC and the research institution will be requested prior to an award.

The single partnering research institution must certify at the time of application that at least 30% of the work of the STTR project will be performed by the research institution. This 30% requirement applies to the single collaborating organization identified as the "research institution."

The requisite signature, printed name, title, and date of signature of the duly authorized representative of the research institution affirming certifications made by the research institution must be included in a letter stating:

"The small business concern and the research institution certify jointly that: (1) the proposed STTR project will be conducted jointly by the small business concern and the research institution in which not less than 40 percent of the work will be performed by the small business concern and not less than 30 percent of the work will be performed by the research institution ("cooperative research and development"); (2) the proposed STTR project is a cooperative research or research and development effort to be conducted jointly by the small business concern and the research institution in which not less than 40 percent of the work will be performed by the small business concern and not less than 30 percent of the work will be performed by the research institution ("performance of research and analytical work"); and (3) regardless of the proportion of the proposed project to be performed by each party, the small business concern will be the primary party that will exercise management direction and control of the performance of the project.

If the research institution is a contractor-operated Federally Funded Research and Development Center (FFRDC), the duly authorized representative of the contractor-operated Federally funded research and development center certifies, additionally, that it: "(4) is free from organizational conflicts of interests relative to the STTR program; (5) did not use privileged information gained through work performed for an STTR agency or private access to STTR agency personnel in the development of this STTR grant application; and (6) used outside peer review, as appropriate, to evaluate the proposed project and its performance therein."

The applicant SBC should convert the letter from the partnering research institution into a PDF attachment, and include it as part of this attachment.

Fast-Track STTR Applications: Create two separate sections entitled "Phase I Consortium/Contractual Arrangements" and "Phase II Consortium/Contractual Arrangements," and complete the sections following the instructions provided above for each phase.

Combine all letters of support into a single PDF file and attach this information here. Do not place these letters in the Appendix.

Follow the attachment guidelines on NIH's Format Attachments page.

Attach a file with all letters of support, including any letters necessary to demonstrate the support of consortium participants and collaborators such as Senior/Key Personnel and Other Significant Contributors included in the grant application.

Letters should stipulate expectations for co-authorship, and whether cell lines, samples, or other resources promised in the letter are freely available to other investigators in the scientific community or will be provided to the particular investigators only.

For consultants, letters should include rate/charge for consulting services and level of effort/number of hours per budget period anticipated. In addition, letters ensuring access to core facilities and resources should stipulate whether access will be provided as a fee-for-service.

Letters are not required for personnel (such as research assistants) not contributing in a substantive, measurable way to the scientific development or execution of the project.

Do not include consultant biographical sketches in the "Letters of Support" attachment, as consultant biosketches should be in the "Biographical Sketch" section (see exception for SBIR/STTR Applications in the SBIR/STTR-specific instructions) .

Overall and Other Components: Unless specific instructions are provided in the FOA, applicants have the option of including the "Letters of Support" attachment in the Overall Component, Other Components, or both. To avoid duplication, each letter should appear only once in the application. Letters that apply to the entire application (or to multiple components) should be presented in the Overall Component as a single PDF, while letters that apply only to a particular individual component should be presented in that component as a single PDF.

Involvement of consultants and collaborators in the planning and research stages of the project is permitted. With the application, include letters from each individual and/or collaborator confirming their role(s) in the project. The letter(s) should be prepared on the consultant or collaborator's letterhead and addressed to the SBC. One page is recommended.

At a minimum, each consultant and collaborator letter should (1) verify their commitment to the project; (2) refer to the specific project by name, acknowledging the PD/PI as the lead on the project; and (3) specify what services/tasks the consultant or collaborator will contribute (e.g. expertise, number of hours/ percent of effort, summary of tasks to be completed). For consultants, the letter should also include the rate/charge for consulting services. Also include biographical sketches for each consultant.

Letters of interest from potential commercial partners or investors and letters of commitment of funds or other resources that will enhance the likelihood of commercialization should be placed following the letters of support for consultants and collaborators.

STTR only: The single "partnering" research institution must provide a letter to the applicant small business concern certifying that at least 30% of the work of the STTR project will be performed by the research institution.

Data Sharing Plan: Investigators seeking $500,000 or more in direct costs (exclusive of consortium F&A) in any budget period are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible (for example human subject concerns, the Small Business Innovation Development Act provisions, etc.). Specific FOAs may require that all applications include this information regardless of the dollar level. Applicants are encouraged to read the FOA carefully and discuss their data-sharing plan with their program contact at the time they negotiate an agreement with the Institute/Center (IC) staff to accept assignment of their application. For more information , see the NIH Data Sharing Policy or the NIH Grants Policy Statement, Section 2.3.7.10: NIH Genomic Data Sharing and Section 8.2.3.3: Genomic Data Sharing (GDS) Policy/ Policy for Genome-Wide Association Studies (GWAS) .

Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms or state why such sharing is restricted or not possible. For more information , see the NIH Grants Policy Statement, Section 8.2.3.2: Sharing Model Organisms .

Genomic Data Sharing (GDS): Applicants seeking funding for research that generates large-scale human or non-human genomic data are expected to provide a plan for sharing of these data. Examples of large-scale genomic data include genome-wide association studies (GWAS), single nucleotide polymorphisms (SNP) arrays, and genome sequence, transcriptomic, epigenomic, and gene expression data. Supplemental Information to the NIH GDS provides examples of genomic research projects that are subject to the Policy. For more information see the NIH GDS Policy , the NIH Grants Policy Statement, Section 8.2.3.3: Genomic Data Sharing (GDS) Policy/ Policy for Genome-Wide Association Studies (GWAS) , and the GDS website.

Note on GDS: For proposed studies generating human genomic data under the scope of the GDS Policy , an institutional certification may be submitted at the time of application submission, but it is not required at that time. The institutional certification, however, will be requested as Just-in-Time (JIT) information prior to award. The institutional certification, or in some cases, a provisional institutional certification, must be submitted and accepted before the award can be issued.

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value and further the advancement of the research. When resources have been developed with NIH funds, and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. See the NIH Grants Policy Statement, Section 8.2.3: Sharing Research Resources .

If applicable to the proposed science, briefly describe methods to ensure the identity and validity of key biological and/or chemical resources used in the proposed studies. A maximum of one page is suggested.

For more Information:

Key biological and/or chemical resources are characterized as follows.

• Key biological and/or chemical resources may or may not be generated with NIH funds and: 1) may differ from laboratory to laboratory or over time; 2) may have qualities and/or qualifications that could influence the research data; and 3) are integral to the proposed research. These include, but are not limited to, cell lines, specialty chemicals, antibodies, and other biologics.
• Standard laboratory reagents that are not expected to vary do not need to be included in the plan. Examples are buffers and other common biologicals or chemicals.
• See NIH's page on Rigor and Reproducibility for more information.

Refer to the FOA to determine whether there are any special appendix instructions for your application. See the updated NIH Guide Notice on the Appendix Policy .

Overall and Other Components: The "Appendix" attachment is optional.

Phase I SBIR/STTR Applications: Do not include appendices unless specifically solicited by NIH.

A maximum of 10 PDF attachments is allowed in the Appendix. If more than 10 allowable appendix attachments are needed, combine the remaining information into attachment #10.

Use filenames for attachments that are descriptive of the content.

A summary sheet listing all of the items included in the Appendix is encouraged but not required. When including a summary sheet, it should be included in the first appendix attachment.

The only allowable appendix materials are:

• Blank data collection forms, blank survey forms, and blank questionnaire forms - or screenshots thereof
• Simple lists of interview questions

Note: In your blank forms and lists, do not include items such as: data, data compilations, lists of variables or acronyms, data analyses, publications, manuals, instructions, descriptions or drawings/figures/diagrams of data collection methods or machines/devices.

• Blank informed consent/assent forms
• Other items only if they are specified in the FOA as allowable appendix materials

No other items are allowed in the Appendix. Simply relocating disallowed materials to other parts of the application will result in a noncompliant application.

Some FOAs may have different instructions for the Appendix. Always follow the instructions in your FOA if they conflict with these instructions.

Note: Applications will be withdrawn and not reviewed if they do not follow the appendix requirements in these instructions or in your FOA.

Information that expands upon or complements information provided in any section of the application - even if it is not required for the review - is not allowed in the Appendix unless it is listed in the allowed appendix materials above or in your FOA. For example, do not include material transfer agreements (MTA) in the appendix unless otherwise specified in the FOA.

• The NIH Guide Notice on Reminder: NIH Applications Must Be Complete and Compliant With NIH Policy and Application Instructions At Time of Submission .
• Failure of reviewers to address non-required appendix materials in their reviews is not an acceptable basis for an appeal of initial peer review. For more information, see the NIH Grants Policy Statement, Section 2.4.2: Appeals of Initial Scientific Review .
• Appendix Policy Frequently Asked Questions

An official website of the United States government

The .gov means it’s official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

The site is secure. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

• Publications
• Account settings

Preview improvements coming to the PMC website in October 2024. Learn More or Try it out now .

• Advanced Search
• Journal List
• J Grad Med Educ
• v.4(1); 2012 Mar

Qualitative Research Part II: Participants, Analysis, and Quality Assurance

This is the second of a two-part series on qualitative research. Part 1 in the December 2011 issue of Journal of Graduate Medical Education provided an introduction to the topic and compared characteristics of quantitative and qualitative research, identified common data collection approaches, and briefly described data analysis and quality assessment techniques. Part II describes in more detail specific techniques and methods used to select participants, analyze data, and ensure research quality and rigor.

If you are relatively new to qualitative research, some references you may find especially helpful are provided below. The two texts by Creswell 2008 and 2009 are clear and practical. 1 , 2 In 2008, the British Medical Journal offered a series of short essays on qualitative research; the references provided are easily read and digested. 3 – , 8 For those wishing to pursue qualitative research in more detail, a suggestion is to start with the appropriate chapters in Creswell 2008, 1 and then move to the other texts suggested. 9 – , 11

To summarize the previous editorial, while quantitative research focuses predominantly on the impact of an intervention and generally answers questions like “did it work?” and “what was the outcome?”, qualitative research focuses on understanding the intervention or phenomenon and exploring questions like “why was this effective or not?” and “how is this helpful for learning?” The intent of qualitative research is to contribute to understanding. Hence, the research procedures for selecting participants, analyzing data, and ensuring research rigor differ from those for quantitative research. The following sections address these approaches. table 1 provides a comparative summary of methodological approaches for quantitative and qualitative research.

A Comparison of Qualitative and Quantitative Methodological Approaches

Data collection methods most commonly used in qualitative research are individual or group interviews (including focus groups), observation, and document review. They can be used alone or in combination. While the following sections are written in the context of using interviews or focus groups to collect data, the principles described for sample selection, data analysis, and quality assurance are applicable across qualitative approaches.

Selecting Participants

Quantitative research requires standardization of procedures and random selection of participants to remove the potential influence of external variables and ensure generalizability of results. In contrast, subject selection in qualitative research is purposeful; participants are selected who can best inform the research questions and enhance understanding of the phenomenon under study. 1 , 8 Hence, one of the most important tasks in the study design phase is to identify appropriate participants. Decisions regarding selection are based on the research questions, theoretical perspectives, and evidence informing the study.

The subjects sampled must be able to inform important facets and perspectives related to the phenomenon being studied. For example, in a study looking at a professionalism intervention, representative participants could be considered by role (residents and faculty), perspective (those who approve/disapprove the intervention), experience level (junior and senior residents), and/or diversity (gender, ethnicity, other background).

The second consideration is sample size. Quantitative research requires statistical calculation of sample size a priori to ensure sufficient power to confirm that the outcome can indeed be attributed to the intervention. In qualitative research, however, the sample size is not generally predetermined. The number of participants depends upon the number required to inform fully all important elements of the phenomenon being studied. That is, the sample size is sufficient when additional interviews or focus groups do not result in identification of new concepts, an end point called data saturation . To determine when data saturation occurs, analysis ideally occurs concurrently with data collection in an iterative cycle. This allows the researcher to document the emergence of new themes and also to identify perspectives that may otherwise be overlooked. In the professionalism intervention example, as data are analyzed, the researchers may note that only positive experiences and views are being reported. At this time, a decision could be made to identify and recruit residents who perceived the experience as less positive.

Data Analysis

The purpose of qualitative analysis is to interpret the data and the resulting themes, to facilitate understanding of the phenomenon being studied. It is often confused with content analysis, which is conducted to identify and describe results. 12 In the professionalism intervention example, content analysis of responses might report that residents identified the positive elements of the innovation to be integration with real patient cases, opportunity to hear the views of others, and time to reflect on one's own professionalism. An interpretive analysis, on the other hand, would seek to understand these responses by asking questions such as, “Were there conditions that most frequently elicited these positive responses?” Further interpretive analysis might show that faculty engagement influenced the positive responses, with more positive features being described by residents who had faculty who openly reflected upon their own professionalism or who asked probing questions about the cases. This interpretation can lead to a deeper understanding of the results and to new ideas or theories about relationships and/or about how and why the innovation was or was not effective.

Interpretive analysis is generally seen as being conducted in 3 stages: deconstruction, interpretation, and reconstruction. 11 These stages occur after preparing the data for analysis, ie, after transcription of the interviews or focus groups and verification of the transcripts with the recording.

• Deconstruction refers to breaking down data into component parts in order to see what is included. It is similar to content analysis mentioned above. It requires reading and rereading interview or focus group transcripts and then breaking down data into categories or codes that describe the content.
• Interpretation follows deconstruction and refers to making sense of and understanding the coded data. It involves comparing data codes and categories within and across transcripts and across variables deemed important to the study (eg, year of residency, discipline, engagement of faculty). Techniques for interpreting data and findings include discussion and comparison of codes among research team members while purposefully looking for similarities and differences among themes, comparing findings with those of other studies, exploring theories which might explain relationships among themes, and exploring negative results (those that do not confirm the dominant themes) in more detail.
• Reconstruction refers to recreating or repackaging the prominent codes and themes in a manner that shows the relationships and insights derived in the interpretation phase and that explains them more broadly in light of existing knowledge and theoretical perspectives. Generally one or two central concepts will emerge as central or overarching, and others will appear as subthemes that further contribute to the central concepts. Reconstruction requires contextualizing the findings, ie, positioning and framing them within existing theory, evidence, and practice.

Ensuring Research Quality and Rigor

Within qualitative research, two main strategies promote the rigor and quality of the research: ensuring the quality or “authenticity” of the data and the quality or “trustworthiness” of the analysis. 8 , 12 These are similar in many ways to ensuring validity and reliability, respectively, in quantitative research.

 1. Authenticity of the data refers to the quality of the data and data collection procedures. Elements to consider include:

  • Sampling approach and participant selection to enable the research question to be addressed appropriately (see “Selecting Participants” above) and reduce the potential of having a biased sample.

  •  Data triangulation refers to using multiple data sources to produce a more comprehensive view of the phenomenon being studied, eg, interviewing both residents and faculty and using multiple residency sites and/or disciplines.

  • Using the appropriate method to answer the research questions, considering the nature of the topic being explored, eg, individual interviews rather than focus groups are generally more appropriate for topics of a sensitive nature.

  • Using interview and other guides that are not biased or leading, ie, that do not ask questions in a way that may lead the participant to answer in a particular manner.

  • The researcher's and research team's relationships to the study setting and participants need to be explicit, eg, describe the potential for coercion when a faculty member requests his or her own residents to participate in a study.

  • The researcher's and team members' own biases and beliefs relative to the phenomenon under study must be made explicit, and, when necessary, appropriate steps must be taken to reduce their impact on the quality of data collected, eg, by selecting a neutral “third party” interviewer.

 2. Trustworthiness of the analysis refers to the quality of data analysis. Elements to consider when assessing the quality of analysis include:

  • Analysis process: is this clearly described, eg, the roles of the team members, what was done, timing, and sequencing? Is it clear how the data codes or categories were developed? Does the process reflect best practices, eg, comparison of findings within and among transcripts, and use of memos to record decision points?

  • Procedure for resolving differences in findings and among team members: this needs to be clearly described.

  • Process for addressing the potential influence the researchers' views and beliefs may have upon the analysis.

  • Use of a qualitative software program: if used, how was this used?

In summary, this editorial has addressed 3 components of conducting qualitative research: selecting participants, performing data analysis, and assuring research rigor and quality. See table 2 for the key elements for each of these topics.

Conducting Qualitative Research: Summary of Key Elements

JGME editors look forward to reading medical education papers employing qualitative methods and perspectives. We trust these two editorials may be helpful to potential authors and readers, and we welcome your comments on this subject.

Joan Sargeant, PhD, is Professor in the Division of Medical Education, Dalhousie University, Halifax, Nova Scotia, Canada.

Investigator Manual: 5. Conducting Human Participant Research

In consideration of Respect for Persons, as detailed in the Belmont Report, investigators should ensure individuals have the necessary information to make a fully informed decision to participate in a study. Respect also means honoring an individual’s privacy and maintaining confidentiality when appropriate. When determining an appropriate consent process, certain considerations must be taken into account. For example, the age of participants, competency, understanding of the English language, etc.

Consent for participation in research is a process that involves an exchange of information and ongoing communication that takes places between an investigator and a potential research participant. An effective informed consent process involves the following elements:

• Conducting the process in a manner and location that ensures participant privacy.
• Providing adequate information about the study in a language understandable to the potential participant.
• Providing adequate opportunities for the potential participant to consider all options.
• Responding to the potential participant’s questions and/or concerns.
• Ensuring the potential participant comprehends the information provided.
• Obtaining the prospective participant’s voluntary agreement to participate.
• Documenting the consent appropriately
• Providing copies of the consent documents to the participants and continuing to provide information as the participant or research requires.

There are some basic elements of informed consent so a participant can make a fully informed decision to participate.

• A statement that the study involves research.
• An explanation of the purposes of the research.
• The expected duration of the subject’s participation.
• A description of the procedures and duration for each.
• A description of any reasonably foreseeable risks or discomforts to the subject.
• A description of any benefits to the participant or to others that may reasonably be expected from the research.
• A disclosure of alternative procedures or courses of treatment, if any, that might be advantageous to the subject.
• A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained.
• A statement of who, outside the research team, may have access to research data; e.g., University auditors; Institutional Review Board and OHRSP: OHRP, federal agencies, and other parties funding the research (if applicable).
• Details regarding remuneration made to participants, how payments will be prorated, and when they will be provided to participants.
• A statement that identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject or the legally authorized representative, if this might be a possibility; or
• A statement that the subject’s information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.
• For answers to pertinent questions about the research (researcher’s name and phone/address, and that of faculty advisor if the investigator is a student);
• Regarding research subjects’ rights (OHRSP); and
• In the event of a research-related injury to the subject.
• Participation is voluntary;
• Refusal to participate will involve no penalty or loss of benefits to which the individual is otherwise entitled; and
• The individual may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
• An indication that the subject may keep a copy of the consent form.

Timing: Informed consent from the subject and/or their legally authorized representative must be obtained before initiating any research activities or data collection. Consent requirements for screening vary based on different regulations a given research study may fall under.

Ongoing communication: While the initial verbal explanation and dialogue with the subject are critical so that subjects know what they are agreeing to before they consent, ideally the consent process should be an ongoing conversation throughout the study. Throughout the study, make yourself available to answer questions and encourage subjects to ask questions or voice concerns, tell subjects about changes in the study procedures or risks or alternatives, and allow subjects to withdraw from the study for any reason at any time.

Additional approaches: With prior IRB approval, other methods of communicating information about a study may be used to supplement the consent process, or in rarer cases, substitute for a consent document. These approaches include the use of audio-visual materials, brochures, drawings, and information posted on a specific website.

Qualifications of the person obtaining consent: Principal investigators are responsible for assuring that all investigators obtaining consent are qualified and appropriately trained to explain the research and assess participant comprehension as described below. Any person who may obtain consent in a study should be listed in the IRB application as key personnel, though the person need not be listed as an investigator in the consent document itself.

Decision-making capacity: Participants should be able to understand the nature and consequences of the study. If they cannot, a surrogate consent may be required.

Voluntariness: Participants should be free from coercion when deciding to participate. This requires that researchers carefully evaluate, plan, and implement the recruitment, consent documents, and consent process. If the participant indicates “No” through words or body language, further attempts at obtaining consent should not be pursued.

Assent is defined as “a child’s affirmative agreement to participate in research.” Passive resignation to submit to an intervention or procedure is not considered assent. Federal regulations do not specify any of the elements of informed assent and do not provide an age at which assent ought to be possible.

In determining whether children are capable of assenting, the IRB takes into account;

• The ages, maturity, and psychological state of the children involved;
• Whether all or some of the children are capable of assenting;
• If written documentation of assent is required; and,
• When parental permission is required, whether by one or both parents.

In general, all adults regardless of their diagnosis or condition, are presumed competent to consent to participate in research unless there is evidence to the contrary. When investigators propose to include individuals with questionable capacity, you must provide a plan for assessing the participants’ decision-making capacity. Assessment is done on an individual basis and should determine the potential participants’ ability to understand and express a reasoned choice based on:

• The voluntary nature of research participation and the information relevant to their participation (research procedures);
• Consequences of participation for the participant’s situation, especially about the participant’s health condition;
• Consequences of the alternatives to participation;
• Potential risks and benefits involved in the study; and
• Procedures to follow if the participant experiences discomfort or wishes to withdraw.

If the assessment shows evidence that the participant is competent to consent, you must obtain valid informed consent directly from the participant. If the assessment determines that the potential participant does not have sufficient capacity to consent, you must do the following:

• Document the participant is incapable of understanding the information presented regarding the research in the participant’s research record;
• Document how the legally authorized representative was determined in a manner consistent with state law;
• Document the information provided to the participant’s legally authorized representative regarding the cognitive and health status of the participant, the risks and benefits of the research, and the role of the legally authorized representative in the research record;
• Obtain the consent and signature of the participant’s legally authorized representative;
• If it is expected that participants will regain their ability to consent, a plan for re-consenting the participants after study activities need to be implemented.

Any method of obtaining informed consent other than face-to-face consent must allow for an adequate exchange of information and documentation. This method must also ensure that the signer of the consent form is the person who plans to enroll as a subject in the study or is the legally authorized representative of the subject. Research records should document what method was used to conduct the consent process and document that informed consent was obtained before beginning study procedures.

“Digital signatures” may be acceptable forms of documentation of written informed consent. Electronic, computer, or tablet-based consent documents may facilitate record keeping even when an individual is present and could sign a paper form. Digital signatures may be considered for face-to-face and remote consent, but the technologies and processes used must be described in the protocol or application.

For FDA-regulated research, the digital signature platform and process must be  21 CFR part 11 compliant . In addition, the research team must verify the participant’s identity.

An investigator may request the IRB waive the requirement to obtain a signed informed consent form for some or all subjects. For the IRB to waive this requirement, at least one of the following criteria must be met:

• The only record linking the subject and the research would be the informed consent form and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject (or legally authorized representative) will be asked whether the subject wants documentation linking the subject with the research, and the subject’s wishes will govern;
• The research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context; or
• If the subjects or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm, the research presents no more than minimal risk of harm to subjects provided there is an appropriate alternative mechanism for documenting that informed consent was obtained.

Persons with limited English proficiency are individuals who do not speak English as their primary language and/or who have a limited ability to read, speak, write, or understand English. Subjects who have limited English proficiency should be presented with informed consent information in a language understandable to them that includes all the required and additional elements for disclosure.

For consent document translations, the investigator may wish to delay translating until IRB approval is granted for the English version to avoid extra translation costs. The IRB must have all versions of the research materials (e.g., recruitment informed consent form(s), instruments) in both English and non-English on file. When submitting non-English consent documents and other research material, please complete and submit a Certificate of Translation form .

If the subject/representative has limited English proficiency, you must obtain the services of an interpreter fluent in both English and the language understood by the subject/representative. The interpreter may be a member of the research team, a family member, or a friend of the subject/representative. If the research involves medical care and/or is more than minimal risk, the use of family or friends to interpret is discouraged.

The IRB reviews study recruitment methods (including advertisements and payments) to evaluate whether they will affect the equitable selection of participants and to ensure that the proposed methods adequately protect the rights and welfare of participants. All recruitment material requires IRB approval before implementation.

The protocol application must include a description of the following:

• the source of subjects for all study groups (intervention/case and control);
• when, where, how, and by whom these potential subjects will be recruited;
• the methods employed to identify potential subjects;
• the materials used to recruit subjects, including the use of email and text messaging; and,
• the number of times a study team can attempt to contact participants is study-dependent and the IRB will assess accordingly.

All communication methods and the protections in place to minimize privacy and confidentiality risks associated with programed must be described to the IRB as part of the review process.

The IRB is responsible for ensuring that any payment or remuneration offered to participants in human subject research is fair and not an undue inducement to participate. Remuneration for participation in research should be reasonable and the amount paid should be comparable to other research projects involving similar time, effort, and inconvenience. Payment amounts should not be large enough to constitute an undue inducement to participate in a risky or uncomfortable procedure. Additional guidelines for specific situations:

Short research studies involving one visit:  Participants may be provided payment contingent upon completion of the study. Participants who are disqualified through no fault of their own must be paid for the time and effort they expended before their termination from the study.

Research studies involving multiple visits or lengthy or repeated participation:  Partial payment should be provided to participants who withdraw, are discharged early from the study by the investigator, or otherwise fail to complete the study as agreed. The amount of partial payment should relate to the amount of time, effort, or discomfort involved. Payment schedules may be designed on a per-day, per-visit, or per-procedure rate, or some combination thereof. The terms for partial payment must be described in the application and the consent form.

Completion bonuses:  Such remuneration may be acceptable to encourage the completion of all study procedures/visits. The amount of such incentives depends on the risk and duration of the study interventions.

The regulations identify prisoners and minors as vulnerable populations. Other groups of individuals may be vulnerable based on the nature of the research and data collection methods.

Prisoners: Department of Health & Human Services (DHHS), Subpart C of Part 46 provides additional protections for biomedical and behavioral research involving prisoners as subjects. These additional protections, or provisions, of the federal regulations, are intended to assure that 1) prisoners provide voluntary consent to participate in research; 2) prisoners’ confidentiality is rigorously protected; 3) prisoners are not used as subjects in studies for which non-incarcerated subjects are suitable. These provisions apply whether the research involves individuals who are prisoners at the time of enrollment in the research or who become prisoners after they become enrolled in the research.

DHHS also requires that the IRB have among its members:

• One or more individuals knowledgeable about and experienced in working with prisoners when research, involving prisoners, is to be reviewed;
• A majority of the Board, exclusive of the prisoner member(s), can have no association with the prison(s) involved apart from their membership on the IRB.

Children: If your research involves children under the age of 18, your protocol should include sufficient information in your protocol or application to justify the enrollment of children. Consider whether parental permission and assent should be obtained and incorporate this information in your application.

Participants with impaired decision-making: Your protocol or application should specify the method that will be used for assessing capacity to consent. For more information, refer to the Can I obtain consent from a decisional impaired individual? section of this document.

Other special populations: Examples of vulnerable populations include undocumented individuals; those who struggle with substance use and abuse; non-English speakers, students, employees of the researcher(s)/those with a status relationship with the researcher(s), and active-duty military members.

Additional protections may be required if recruiting vulnerable populations; for example: include having someone outside the study team observe the informed consent process, exclusion of the population if not required to achieve study objectives, and independent assessment to address consent capacity.

Snowball sampling (or chain sampling, chain-referral sampling, referral sampling) is a non-probability sampling technique where existing study subjects recruit or refer future subjects from among their acquaintances.

This recruitment approach may be approved by the IRB with justification for its use and how it relates to the study and subject population. The protocol should address how the risk of violating an individual’s privacy will be minimized and how snowball sampling may impact other study risks. Investigators are to provide this justification in the recruitment section of the protocol application form.

You are required to ensure human research includes adequate provisions to protect the privacy of participants and the confidentiality of data, as required by federal regulations.

• Privacy  refers to a person’s desire to control the access of others to themselves. For example, research participants may not want to be seen entering a place that might stigmatize them, such as a pregnancy counseling center that is identified as such by signs on the front of the building.
• Confidentiality  refers to the researcher’s agreement with the participant about how the research participant’s identifiable private information will be handled, managed, and disseminated.

For the IRB to assess privacy and confidentiality protections, the protocol should describe how participant privacy will be protected and how data kept confidential. The IRB will assess whether the participants’ privacy interests and confidentiality of data are protected in ways commensurate with the benefits to participants and the risks of everyday life.

Issued by NIH, the CoC protects the privacy of research participants by prohibiting forced disclosure of their individually identifiable, sensitive research information to anyone not associated with the research, except when the participant consents to such disclosures or in other limited specific situations.

All ongoing or new research with NIH funding and collects or uses identifiable, sensitive information is automatically issued a CoC as a term and condition of the NIH grant award. The Notice of Award and the NIH Grants Policy Statement will serve as documentation of the Certificate protection [a separate certificate document is no longer issued]. This automatic issuance of CoC protections also applies to research that receives re-distributed NIH funds. Studies that have been issued a CoC are required to inform the participants about the CoC protections and any exceptions to the CoC protections as part of the informed consent process.

Federally funded studies that meet the NIH definition of a clinical trial and any study (regardless of funding) that meets the FDA definition of an applicable clinical trial must be registered and study consent forms must include the required language.

NIH definition : A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.

FDA definition : Any experiment that involves a test article [1] and one or more human subjects and is subject to requirements for submission to the Food and Drug Administration. Clinical investigations must not be initiated unless that investigation has been reviewed and approved by an IRB.

Information on ClinicalTrials.gov is provided and updated by the sponsor or principal investigator of the clinical trial or designee Studies are registered on the website before commencing and updated throughout the study. On occasion, results of the study are submitted after the study ends. This Web site and database of clinical studies is commonly referred to as a “registry and results database.”

NU-RES can assist Pis with account setup and registration, but it is the PI’s responsibility to ensure their applicable study is registered on ClinicalTrials.gov.

Federal law requires the following exact statement to be included in the informed consent documents of applicable clinical trials:

“A description of this clinical trial will be available on http://www.ClinicalTrials.gov , as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.”

[1] FDA defines a test article as: any food additive, color additive, drug, biological product, electronic product, medical device for human use, or any other article subject to regulation under the act or under sections 351 and 354-360F of the Public Health Service Act:

The European Union has additional requirements regarding data privacy, referred to as the GDPR. Where Northeastern is working with personal data collected in, or transferred from, any European Economic Area country, GDPR will be relevant. This includes data collected, obtained, or used for research projects. Failure to follow GDPR if it applies puts the University at risk of noncompliance, monetary fines, and reputational harm so it is critical to understand and assess whether GDPR applies to your study.

GDPR requires a legal basis to collect and process (e.g., analyze) personal data. To use personal data for research, the legal basis that generally will apply is consent from the data subject. Consent must be  freely given, specific, informed,  and  unambiguous  as to the data subject’s wishes by a  statement  or by  clear affirmative action.

  Note that other privacy laws may exist that need to be considered.

When conducting research in international sites, protocols are to comply with not only the regulations and laws of the United States but the international site, as well. These may be the result of differences in language, culture, social history, and societal norms. Where the two sets of standards present a conflict, the research must meet the higher standard. While we do not impose our standards for written documentation on other cultures, we do not relax our standards for ethical conduct of research or for a meaningful consent and/or assent process, including ensuring additional protections for vulnerable participant populations (e.g., children, prisoners).

Researchers are to be cognizant of relevant national policies and take special consideration in cases such as the availability of national health insurance, different philosophical legal systems, and social policies that may make U.S. research forms and procedures inappropriate. In addition to obtaining approval from the Northeastern IRB, investigators are to obtain approval from international IRBs or local ethics committees. The Office for Human Research Protection retains a current list of International Compilation of Research Standards . This document provides contact information for bio-medical and social/behavioral science IRBs or equivalent ethics committees.

Documentation of permission or approval must be submitted with the IRB application materials. In the absence of these laws or guidance, the researcher is required to obtain approval from the local government or community leaders or provide information as to the absence of the local review. Examples of local reviews may include the following:

• Ethics committees
• Drug approval agencies
• Local ministries
• Local governance

What it means for data to be coded, de-identified, or anonymous is important when it comes to understanding the identifiability of data. The identifiability of data under the Common Rule (45 CFR 46) and the Health Insurance Portability and Accountability Act (HIPAA) differs.

Coded data refers to data that have been stripped of all direct subject identifiers, but in this case, each record has its study ID or code, which is linked to identifiable information such as name or medical record number. The linking file must be separate from the coded data set. This linking file may be held by someone on the study team (e.g. the PI) or it could be held by someone outside of the study team (e.g. a researcher at another institution). A coded data set may include limited identifiers under HIPAA. Of note, the code itself may not contain identifiers such as subject initials or medical record numbers.

  De-identified data refers to data that have been stripped of all subject identifiers, including all 18 HIPAA identifiers. This means that there can be no data points that are considered limited identifiers under HIPAA, i.e. geographic area smaller than a state, elements of dates (date of birth, date of death, dates of clinical service), and age over age 89. If the data set contains any limited identifiers, it is considered a limited data set under HIPAA. If the data includes an indirect link to subject identifiers (e.g. via coded ID numbers), then the data is considered by the IRB to be coded, not de-identified.

Anonymous data are essentially the same thing as de-identified data, this refers to data that have been stripped of all subject identifiers and which have no indirect links to subject identifiers. There should be no limited identifiers in an anonymous data set.

Identifiability under the Common Rule

• The Common Rule defines “individually identifiable” to mean that the identity of the subject is, or maybe, readily ascertained by the investigator or associated with the information.
• A data set may be identifiable under the Common Rule if it contains: initials, address, zip code, phone number, gender, age, birth date, occupation, employer, racial or ethnic group, dates of events, names of individuals related to the participant such as teacher or physician names, and genealogy.
• Age, ethnicity/race, and gender may be identifiers under the Common Rule if fewer than 5 individuals possess a particular cluster of traits.
• Data may be identifiable if any combination of variables could potentially identify a subject.
• Some of the identifiers listed above become less problematic if the sample size is large enough so that the potential identifiers could describe several individuals and thus cannot be linked to only one person. Conversely, if the sample size is small, the potential to identify an individual may increase, even in the absence of direct identifiers.

Identifiability under HIPAA

The HIPAA Privacy Rule regulation specifies 18 identifiers, most of which are demographic. The inclusion of even one of the following identifiers makes a data set identifiable. However, there are levels of identifiability. The following are considered limited identifiers under HIPAA: geographic area smaller than a state, elements of dates (date of birth, date of death, dates of clinical service), and age over age 89. The remaining identifiers in the bullet list are considered to be direct identifiers. If the data set contains any limited identifiers, but none of the direct identifiers, it is considered a limited data set under HIPAA.

Data Safety Monitoring Plan (DSMP) or Data Safety Monitoring Board (DSMB)

Any study that presents more than minimal risk to subjects must describe a data and safety monitoring plan. Studies utilizing  IRB protocol templates  will be prompted to provide this information. Most studies can utilize a DSMP, but some clinical trials or multi-site research may opt to utilize a DSMB instead. Please see NIH Guidance on Data and Safety Monitoring .

In the case of minimal risk research, the IRB may require a DSMP or DSMB if the committee deems that monitoring of the study is needed to ensure the protection of the rights and welfare of subjects or data integrity, which could affect the welfare of future subjects.

Deception: The IRB accepts the need for certain types of studies to employ strategies that include deception. However, the employment of such strategies must be justified. In general, deception is not acceptable if, in the judgment of the IRB, the participant may have declined to participate had they been fully informed of the true purpose of the research.

Radiation: If your study interventions involve the use/administration of radiation, additional state law requirements apply that are outside IRB purview. For information and assistance with these requirements, please refer to the NU Radiation Safety website .

If you are planning on conducting research in K-12 schools, additional requirements will apply to your research. These schools are autonomous institutions that retain the right to approve/reject any human research to be conducted on their site, in their facilities, or with their teachers, staff, or students. The IRB therefore requires documentation from an appropriate authority at each school or district granting permission to conduct human research.

Researchers are responsible for contacting each school or district to obtain this permission and meet the requirements each site may have for conducting human research (e.g., review by its research review committee). If review by a separate committee is required, you will need to plan additional time for this approval process as well as IRB review.

Other important items to keep in mind:

• Often K-12 school sites will require proof of IRB review before their approval.
• If teachers/school staff are members of the research team for non-exempt studies, they are to comply with training requirements.
• Some schools require research personnel to undergo background checks.
• Many school districts will not allow research activities to take place during normal class time.
• Many schools place limitations on the use of video or audio recordings in classrooms.
• Parental consent is required for minors to be included as research subjects.
• Minor assent is also required before including minors as research subjects.

Additional steps and protections are often needed when conducting research in collaboration with American Indian or Alaska Native (AI/AN) communities and populations. The Common Rule affirms that each tribe may have its definition of research and its own set of research protections and laws that may have more restrictions than the Common Rule. Research teams are responsible for ensuring any research on tribal land, using tribal resources, or focusing on individuals from a tribe is conducted in a manner that is respectful of tribal autonomy, sovereignty, and rights. While the IRB does not require approval/permission from the tribe to grant final approval, a researcher must receive appropriate review and approval from the tribe of their research.

The IRB uses the terms recruitment registry, data repository, and biospecimen repository for these various research tools/resources, although terminology can vary widely across institutions. Generally, the creation and maintenance of a research registry or repository requires IRB review and approval.

Recruitment Registry: a tool used to identify and track a group of individuals that have similar characteristics. The characteristics can vary widely (e.g., disease, genetic make-up, health behaviors, surgical procedures), but the registry intends to track and classify these groups of individuals. The IRB prefers the use of the word “registry” to be used to describe lists of people along with limited personal and, when applicable, medical information. The primary use of these lists is to provide investigators with pools of potential study volunteers, as in recruitment registries. Recruitment registries generally require IRB approval, both for the creation and maintenance of the registry itself, as well as for future projects that wish to use a registry as a recruitment method.

Data Repository: a tool used to compile a set of individual subject/patient data that will be used for analysis purposes. A data repository generally has data added to it in an ongoing manner that is stored long-term. Data in the repository are intended to be distributed to multiple users and subsequently used for ongoing analysis purposes. The IRB prefers the use of the term ‘data repository’ over terms such as ‘databases’ and ‘registries.’ If the primary intent of the repository is for use in future research projects, IRB review and approval are required and may be required for the subsequent use of the data from the repository.

Biospecimen/tissue repositories: Also known as a tissue bank, a mechanism for maintaining tissue, blood, and other biological specimens for unspecified future use. These repositories typically involve the collection and long-term storage of tissue and often corresponding data to be used primarily for future research projects. Tissue to be stored in the repository can be collected retrospectively, prospectively, or both. Tissue repositories can include tissue collected from other research protocols or clinical procedures. IRB review and approval are required for the banking of biospecimens and may be required for the subsequent use of the specimens from the repository.

The IRB review requirements for research involving decedents vary depending on whether the study involves ONLY decedents or decedents and living individuals.

The Common Rule (45 CFR 46.102I(1)) defines a human subject as “a living individual about whom an investigator (whether profession or student) conducting research (1) obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (2) obtains, uses, analyzes, or generates identifiable private information or identifiable biospecimens.”

The FDA does not explicitly state that regulations apply only to “living individuals.” The regulations, however, imply that the subject is alive. FDA regulations (21 CFR 56.102I) define a “human subject” as “an individual who is or becomes a participant in research, either as a recipient of a test article or as a control.” That section goes on to state that a subject may be “either a healthy individual or a patient.” And, at 21 CFR 812.3(p), “subject” means “a human who participates in an investigation, either as an individual on whom or on whose specimen an investigational device is used or as a control. A subject may be in normal health or may have a medical condition or disease.”

Based on the above, the IRB Office has determined that Common Rule and FDA Regulations do NOT apply to studies ONLY using information or biospecimens from deceased individuals. In these cases, researchers do not need to submit an IRB application for review of decedent ONLY research.

Online research sources such as Facebook, Twitter, blogs, chat rooms, discussion forums, and other social networking sites will be treated as publicly available data by the IRB in a very broad sense, and with several limitations.

Privacy Statements & Terms of Use: You are responsible for checking the privacy statement and terms of use of any site being used for research purposes. You must adhere to the written policies of any site used for research. The IRB expects that researchers will either: 1) obtain consent to use data from an individual’s social media page or 2) make an appropriate argument as part of the application process as to why the IRB should waive consent for the project.

Publicly available: The IRB does not consider sites that require the user to create an account, and then provide a login and password, to be publicly available data. Therefore, participants must be consented before an investigator can observe or interact with participants in these online environments. Members of sites that require a login expect privacy and do not expect that anything they post will be used for research purposes. In some circumstances, researchers can petition the IRB for a waiver of consent. In these situations, researchers will need to provide an appropriate argument/justification as to why a waiver of consent is appropriate.

Data mining: Facebook, Twitter, and others may provide data mining services where their developers will mine data from the site, for a fee, at the researcher’s request. Depending on the scope, the IRB may treat the data differently because data collection would be done by the media site and (likely) provided to the researcher without direct identifiers. The IRB deals with this type of research activity on a case-by-case basis.

View all MCQs in

Related MCQs

• Environment
• Science & Technology
• Business & Industry
• Health & Public Welfare
• Topics (CFR Indexing Terms)
• Public Inspection
• Presidential Documents
• Document Search
• Advanced Document Search
• Public Inspection Search
• Reader Aids Home
• Office of the Federal Register Announcements
• Using FederalRegister.Gov
• Understanding the Federal Register
• Recent Site Updates
• Federal Register & CFR Statistics
• Videos & Tutorials
• Developer Resources
• Government Policy and OFR Procedures
• Congressional Review
• My Clipboard
• My Comments
• My Subscriptions
• Sign In / Sign Up
• Site Feedback
• Search the Federal Register

The Federal Register

The daily journal of the united states government.

• Legal Status

This site displays a prototype of a “Web 2.0” version of the daily Federal Register. It is not an official legal edition of the Federal Register, and does not replace the official print version or the official electronic version on GPO’s govinfo.gov.

The documents posted on this site are XML renditions of published Federal Register documents. Each document posted on the site includes a link to the corresponding official PDF file on govinfo.gov. This prototype edition of the daily Federal Register on FederalRegister.gov will remain an unofficial informational resource until the Administrative Committee of the Federal Register (ACFR) issues a regulation granting it official legal status. For complete information about, and access to, our official publications and services, go to About the Federal Register on NARA's archives.gov.

The OFR/GPO partnership is committed to presenting accurate and reliable regulatory information on FederalRegister.gov with the objective of establishing the XML-based Federal Register as an ACFR-sanctioned publication in the future. While every effort has been made to ensure that the material on FederalRegister.gov is accurately displayed, consistent with the official SGML-based PDF version on govinfo.gov, those relying on it for legal research should verify their results against an official edition of the Federal Register. Until the ACFR grants it official status, the XML rendition of the daily Federal Register on FederalRegister.gov does not provide legal notice to the public or judicial notice to the courts.

Temporary Assistance for Needy Families Work Outcomes Measures

A Rule by the Children and Families Administration on 06/28/2024

This document has a comment period that ends in 179 days. (12/26/2024) Submit a formal comment

Thank you for taking the time to create a comment. Your input is important.

Once you have filled in the required fields below you can preview and/or submit your comment to the Health and Human Services Department for review. All comments are considered public and will be posted online once the Health and Human Services Department has reviewed them.

You can view alternative ways to comment or you may also comment via Regulations.gov at https://www.regulations.gov/commenton/ACF_FRDOC_0001-0138 .

• What is your comment about?

Note: You can attach your comment as a file and/or attach supporting documents to your comment. Attachment Requirements .

this will NOT be posted on regulations.gov

• Opt to receive email confirmation of submission and tracking number?
• Tell us about yourself! I am... *
• First Name *
• Last Name *
• State Alabama Alaska American Samoa Arizona Arkansas California Colorado Connecticut Delaware District of Columbia Florida Georgia Guam Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New Mexico New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania Puerto Rico Rhode Island South Carolina South Dakota Tennessee Texas Utah Vermont Virgin Islands Virginia Washington West Virginia Wisconsin Wyoming
• Country Afghanistan Åland Islands Albania Algeria American Samoa Andorra Angola Anguilla Antarctica Antigua and Barbuda Argentina Armenia Aruba Australia Austria Azerbaijan Bahamas Bahrain Bangladesh Barbados Belarus Belgium Belize Benin Bermuda Bhutan Bolivia, Plurinational State of Bonaire, Sint Eustatius and Saba Bosnia and Herzegovina Botswana Bouvet Island Brazil British Indian Ocean Territory Brunei Darussalam Bulgaria Burkina Faso Burundi Cambodia Cameroon Canada Cape Verde Cayman Islands Central African Republic Chad Chile China Christmas Island Cocos (Keeling) Islands Colombia Comoros Congo Congo, the Democratic Republic of the Cook Islands Costa Rica Côte d'Ivoire Croatia Cuba Curaçao Cyprus Czech Republic Denmark Djibouti Dominica Dominican Republic Ecuador Egypt El Salvador Equatorial Guinea Eritrea Estonia Ethiopia Falkland Islands (Malvinas) Faroe Islands Fiji Finland France French Guiana French Polynesia French Southern Territories Gabon Gambia Georgia Germany Ghana Gibraltar Greece Greenland Grenada Guadeloupe Guam Guatemala Guernsey Guinea Guinea-Bissau Guyana Haiti Heard Island and McDonald Islands Holy See (Vatican City State) Honduras Hong Kong Hungary Iceland India Indonesia Iran, Islamic Republic of Iraq Ireland Isle of Man Israel Italy Jamaica Japan Jersey Jordan Kazakhstan Kenya Kiribati Korea, Democratic People's Republic of Korea, Republic of Kuwait Kyrgyzstan Lao People's Democratic Republic Latvia Lebanon Lesotho Liberia Libya Liechtenstein Lithuania Luxembourg Macao Macedonia, the Former Yugoslav Republic of Madagascar Malawi Malaysia Maldives Mali Malta Marshall Islands Martinique Mauritania Mauritius Mayotte Mexico Micronesia, Federated States of Moldova, Republic of Monaco Mongolia Montenegro Montserrat Morocco Mozambique Myanmar Namibia Nauru Nepal Netherlands New Caledonia New Zealand Nicaragua Niger Nigeria Niue Norfolk Island Northern Mariana Islands Norway Oman Pakistan Palau Palestine, State of Panama Papua New Guinea Paraguay Peru Philippines Pitcairn Poland Portugal Puerto Rico Qatar Réunion Romania Russian Federation Rwanda Saint Barthélemy Saint Helena, Ascension and Tristan da Cunha Saint Kitts and Nevis Saint Lucia Saint Martin (French part) Saint Pierre and Miquelon Saint Vincent and the Grenadines Samoa San Marino Sao Tome and Principe Saudi Arabia Senegal Serbia Seychelles Sierra Leone Singapore Sint Maarten (Dutch part) Slovakia Slovenia Solomon Islands Somalia South Africa South Georgia and the South Sandwich Islands South Sudan Spain Sri Lanka Sudan Suriname Svalbard and Jan Mayen Swaziland Sweden Switzerland Syrian Arab Republic Taiwan, Province of China Tajikistan Tanzania, United Republic of Thailand Timor-Leste Togo Tokelau Tonga Trinidad and Tobago Tunisia Turkey Turkmenistan Turks and Caicos Islands Tuvalu Uganda Ukraine United Arab Emirates United Kingdom United States United States Minor Outlying Islands Uruguay Uzbekistan Vanuatu Venezuela, Bolivarian Republic of Viet Nam Virgin Islands, British Virgin Islands, U.S. Wallis and Futuna Western Sahara Yemen Zambia Zimbabwe
• Organization Type * Company Organization Federal State Local Tribal Regional Foreign U.S. House of Representatives U.S. Senate
• Organization Name *
• You are filing a document into an official docket. Any personal information included in your comment text and/or uploaded attachment(s) may be publicly viewable on the web.
• I read and understand the statement above.
• Preview Comment

Document Details

Information about this document as published in the Federal Register .

Document Statistics

Published document.

This document has been published in the Federal Register . Use the PDF linked in the document sidebar for the official electronic format.

Enhanced Content - Table of Contents

This table of contents is a navigational tool, processed from the headings within the legal text of Federal Register documents. This repetition of headings to form internal navigation links has no substantive legal effect.

FOR FURTHER INFORMATION CONTACT:

Supplementary information:, table of contents, i. background, ii. themes from consultation and research, a. workforce system alignment, iii. regulations, a. definition of exit, b. work outcomes data sources, c. federal matching for calculating work outcomes of tanf exiters, d. state-level matching for the supplemental work outcomes report, e. secondary school diploma or its recognized equivalent attainment rate, iv. justification for interim final rule, v. collection of information requirements, b. request for feedback, c. review and approval of the information collection, vi. regulatory review and analysis, list of subjects in 45 cfr part 265, part 265—data collection and reporting requirements, enhanced content - submit public comment.

• Submit a public comment on this document

Enhanced Content - Read Public Comments

1 comment has been received at regulations.gov, across 1 docket.

Agencies review all submissions and may choose to redact, or withhold, certain submissions (or portions thereof). Submitted comments may not be available to be read until the agency has approved them.

Enhanced Content - Sharing

• Email this document to a friend

Enhanced Content - Document Print View

• Print this document

Enhanced Content - Document Tools

These tools are designed to help you understand the official document better and aid in comparing the online edition to the print edition.

These markup elements allow the user to see how the document follows the Document Drafting Handbook that agencies use to create their documents. These can be useful for better understanding how a document is structured but are not part of the published document itself.

Enhanced Content - Developer Tools

This document is available in the following developer friendly formats:.

• JSON: Normalized attributes and metadata
• XML: Original full text XML
• MODS: Government Publishing Office metadata

More information and documentation can be found in our developer tools pages .

Official Content

• View printed version (PDF)

This PDF is the current document as it appeared on Public Inspection on 06/27/2024 at 8:45 am. It was viewed 0 times while on Public Inspection.

If you are using public inspection listings for legal research, you should verify the contents of the documents against a final, official edition of the Federal Register. Only official editions of the Federal Register provide legal notice of publication to the public and judicial notice to the courts under 44 U.S.C. 1503 & 1507 . Learn more here .

Office of Family Assistance (OFA), Administration for Children and Families (ACF), Department of Health and Human Services (HHS).

Interim final rule.

This interim final rule modifies ACF regulations in order to implement the statutory changes enacted by section 304 of the Fiscal Responsibility Act of 2023 (FRA) related to the reporting of work outcomes under the Temporary Assistance for Needy Families (TANF) program. ACF is promulgating this rule as an interim final rule to ensure states and territories have sufficient time to comply with data collection for fiscal year 2025.

This interim final rule (IFR) is effective on October 1, 2024. Comments on this IFR must be received on or before December 26, 2024.

ACF encourages the public to submit comments electronically to ensure they are received in a timely manner. You may submit comments, identified by Regulatory Information Number (RIN) 0970-AD04, by any of the following methods:

• Federal eRulemaking Portal: https://www.regulations.gov . Follow the instructions for submitting comments.

Instructions: All submissions received must include the agency name and RIN (0970-AD04) for this rulemaking. All comments received will be posted without change to https://www.regulations.gov,including any personal information provided.

We will not consider comments received beyond the 180-day comment period in modifying the interim final rule. You may find the following suggestions helpful for preparing your comments:

• Be specific;
• Address only issues raised by the rulemaking in the interim final rule and the information collections, not the changes to the statute itself;
• Explain reasons for any objections or recommended changes;
• Propose appropriate alternatives; and
• Reference the specific section of the interim final rule being addressed.

You can obtain copies of the proposed collection of information and submit comments by emailing [email protected] . Identify all requests by the title of the information collection.

Lauren Frohlich, TANF Data Division, Office of Family Assistance, ACF, at [email protected] or 202-401-9275. Deaf and hard of hearing individuals may call 202-401-9275 through their chosen relay service or 711 between 8 a.m. and 7 p.m. Eastern Time.

E. Secondary School Diploma or its Recognized Equivalent Attainment Rate

The Fiscal Responsibility Act (FRA) of 2023, Public Law 118-5 , requires each state, in consultation with the Secretary of the Department of Health and Human Services (HHS), to collect and report information relating to work outcomes measures for work-eligible individuals in the Temporary Assistance for Needy Families (TANF) Program. Section 304 of the legislation requires HHS to issue regulations implementing these new requirements. It states, “in order to ensure nationwide comparability of data, the Secretary, after consultation with the Secretary of Labor and with States, shall issue regulations governing the reporting of performance indicators under this subsection.”

We are updating the existing TANF data regulations ( 45 CFR part 265 , Data Collection and Reporting Requirements) to reflect the new reporting requirements. “Each state . . . shall collect and submit to the Secretary the information necessary for each indicator. . . .” Section 304. “State” is defined to mean “the 50 States of the United States, the District of Columbia, the Commonwealth of Puerto Rico, the United States Virgin Islands, Guam, and American Samoa.” 42 U.S.C. 619 (5). States and territories must begin reporting on those requirements in fiscal year (FY) 2025. For the remainder of the preamble, we will use the term “states” to refer to states and territories. These provisions do not apply to Tribal TANF programs.

Section 304 of the FRA specifies that to ensure nationwide comparability of data, all states must collect and submit “the information necessary” to determine four indicators of performance. These are:

• Employment Rate—2nd Quarter After Exit: The percentage of individuals who were work-eligible individuals as of the time of exit from the program, who are in unsubsidized employment during the second quarter after the exit;
• Employment Retention Rate—4th Quarter After Exit: The percentage of individuals who were work-eligible individuals as of the time of exit from the program who were in unsubsidized employment in the second quarter after the exit, who are also in unsubsidized Start Printed Page 53871 employment during the fourth quarter after the exit;
• Median Earnings—2nd Quarter After Exit: The median earnings of individuals who were work-eligible individuals as of the time of exit from the program, who are in unsubsidized employment during the second quarter after the exit; and
• Secondary School Diploma or its Recognized Equivalent Attainment Rate: The percentage of individuals who have not attained 24 years of age, are attending high school or enrolled in an equivalency program, and are work-eligible individuals or were work-eligible individuals as of the time of exit from the program, who obtain a high school degree or its recognized equivalent while receiving assistance under the state program funded under this part or within one year after the exit.

Further, the statute required HHS to consult with states and the Department of Labor (DOL) before issuing regulations. In response, HHS engaged in consultation including issuing a Request for Information (RFI) ( 88 FR 82902 , November 27, 2023) providing states and the general public with an opportunity to provide input, hosted listening sessions with state TANF leadership and data leads, held meetings with the DOL and the Department of Education (ED), and had discussions with practitioners and researchers as part of the Workforce IT Support Center Steering Committee and the National Association of Welfare Research Statistics annual conference. Through these discussions, we identified promising practices and recommendations for policy options.

Written responses to ACF's RFI included responses from state TANF agencies and social services departments, national associations that represent state and county human services agencies, and a small number of advocacy groups. The use of “state” in the summary of comments below refers to both states who responded directly and associations who collected comments and responded on behalf of member states.

TANF's new statutory work outcomes measures are similar to the performance measures established by the Workforce Innovation and Opportunity Act of 2014 (WIOA). DOL and ED shared lessons learned from implementing WIOA that inform our implementation of TANF's work outcomes measures, such as factors impacting the implementation timeline and data quality across sources. States also shared their experiences with WIOA and several respondents encouraged ACF—in partnership with DOL—to support opportunities for state workforce and human services agencies to engage in peer learning and information sharing around the new measures. They requested ACF, where possible, foster the alignment through shared definitions, data sources, and report timeframes. They noted that supporting alignment with WIOA outcome reporting strengthens collaboration between TANF and the broader workforce system, which will yield operational efficiencies across programs, identification of promising practices, a more client-centered culture, and improved service delivery.

We appreciate the time and attention that respondents gave to reviewing the RFI and preparing their comments. This IFR seeks to make the new reporting requirements as useful as possible for program improvement, considers the challenges of implementation, and provides flexibility for states when possible.

The Office of Family Assistance (OFA) is committed to improving the equitable administration of all OFA programs for the children and families we serve. In the RFI, we asked in what ways equity should be considered when implementing work outcome measures.

Respondents expressed gratitude for our consideration of equity in the implementation of the work outcomes measures. All noted the advantages of collecting and reporting data disaggregated by race, ethnicity, age, disability, and other demographic characteristics or geography.

We appreciate the importance of understanding outcome disparities in the TANF program, and we are committed to providing increased technical assistance to states on how to use their own data to understand outcomes disparities in the TANF program so that they can better ensure equity throughout the system.

Respondents also made suggestions for practices in the context of work outcomes that could support equity. We remain committed to supporting states as they identify and explore meaningful ways of addressing disparities and ensuring equity.

The following discussion provides information on the changes we are making in 45 CFR part 265 . We discuss how we will operationalize the statutory changes enacted in the FRA related to the reporting of work outcomes under the TANF program.

In § 265.2, “What definitions apply to this part?”, we added definitions of “exit” and “unsubsidized employment” for the purpose of calculating the Work Outcomes of TANF Exiters Report and the Secondary School Diploma or its Recognized Equivalent Attainment Rate. We also defined “secondary school diploma” and its “recognized equivalent.”

We added two new reporting requirements. States are required to submit the data required for the Work Outcomes of TANF Exiters Report quarterly and the Secondary School Diploma or its Recognized Equivalent Attainment Rate annually. The regulation also includes the option for states to voluntarily submit their own calculated work outcomes measures. The regulation details what to include in the supplemental report for states who choose to submit one. In addition to submitting the Work Outcomes of TANF Exiters Report, any state that does not have an Unemployment Insurance program and thus is currently unable to submit quarterly wage data to the ACF-designated wage match source will be required to submit the Supplemental Work Outcomes Report.

Other revisions:

• Section 265.1 What does this part cover?—replaced outdated reference to section 413 (rankings of State TANF programs) with section 411(f).
• Section 265.3 What reports must the State file on a quarterly basis?— added quarterly report Work Outcomes of TANF Exiters Report and details of (1) Employment Rate—2nd Quarter After Exit; (2) Employment Retention Rate—4th Quarter After Exit; and (3) Median Earnings—2nd Quarter After Exit.
• Section 265.4 When are quarterly reports due?—added Work Outcomes of TANF Exiters Report.
• Section 265.5 May States use sampling?—clarified that sampling is not allowed for either Work Outcomes of TANF Exiters Report or Secondary School Diploma or its Recognized Equivalent Attainment Rate and moves that clause to paragraph (d).
• Section 265.6 Must States file reports electronically?—added Work Outcomes of TANF Exiters Report, Secondary School Diploma or its Recognized Equivalent Attainment Rate, and Supplemental Work Outcomes Report.
• Section 265.7 How will we determine if the State is meeting the quarterly reporting requirements?— Start Printed Page 53872 added requirements for Work Outcomes of TANF Exiters Report.
• Section 265.9 What information must the State file annually?—added paragraphs (f), the Secondary School Diploma or its Recognized Equivalent Attainment Rate, and (g), Supplemental Work Outcomes Report.
• Section 265.10 When are annual reports due?—clarified due dates of all annual reports in § 265.9.

The work outcomes measures depend on a definition of what it means to “exit” the TANF program. The legislation defines “exit” as, “with respect to a State program funded under this part, ceases to receive assistance under the program funded by this part.”

We believe, and states concurred during consultation, that further clarification of what it means to “exit” the TANF program is necessary to ensure consistency across states' interpretations of the exiting population. Research studies and state respondents warned about the issue of “churn,” in which individuals and families cycle on and off the TANF caseload due to temporary jobs, shifting life circumstances, sanctions, or terminations of assistance for not meeting program administrative requirements. We note that TANF “leavers” studies from the early 2000s often defined a “leaver” as someone who has left cash assistance for at least two months, while WIOA defines a “common exit” as a participant not receiving DOL-administered services for at least 90 days. [ 1 ] DOL, states, researchers, and advocacy organizations all recommended that the TANF work outcomes measures align with WIOA's performance measures as much as possible, in order to support coordination between TANF and WIOA programs and their shared participants. That approach is supported by the statutory language requiring the Department to consult with DOL. For these reasons, and to account for the impact of churn, we are defining “exit” as a family having not received TANF assistance for at least 90 days. We are using “family” in the definition to account for the cases where, for example, due to sanction, the state removes the needs of the work-eligible individual from the assistance payment while continuing to provide assistance to the family. In other words, a work-eligible individual will be included as an exiter in these measures only when their family ceases to receive assistance, and will not meet the definition of an exiter when the needs of the work-eligible individual are removed from the assistance payment but the family continues to receive assistance. An individual in the family must have been “a work-eligible individual,” as defined in 45 CFR 261.2(n)(1) , in their last month of assistance.

Multiple respondents to the RFI stressed the importance of taking into account the reasons someone would exit TANF. Some individuals may have been taken off TANF because of a sanction for noncompliance with work activities, while others obtained jobs or moved out of state. States are currently required to report to ACF on the reasons for case closure in section two (2) of the TANF Data Report (ACF-199). However, states interpret and use the reporting categories of reasons for case closure inconsistently. For instance, on average, states reported that 34 percent of closed cases were closed due to “other/unknown” reasons, but across states that percentage ranged from 5 to 98 percent in FY 2022. [ 2 ] While OFA has decided not to use this IFR to modify the data reporting elements for case closure, we encourage states to improve the quality of their reporting for the existing data element in the TANF Data Report (ACF-199). OFA will include recommendations in guidance to states on how to improve the quality of this data element.

We note that some states may move individuals out of the TANF program and into separate state programs (funded by maintenance-of-effort funds) or solely state-funded programs (not reported as maintenance-of-effort). For some states, these may be distinctly different programs, while for other states the difference may just be the funding source. The statute clearly states “with respect to State program funded under this part” which refers only to the TANF program, and not separate state programs or solely state-funded programs. Therefore, when considering who exited TANF for this data collection, states should include those work-eligible individuals who were moved to separate state programs or solely-state funded programs and have not received TANF-funded assistance in at least 90 days.

States are proud of the work they are doing to improve TANF outcomes. Some states are already collecting and studying data for employment, retention, and income and are eager to share the results and best practices. These states explained both the benefits and drawbacks of the systems they use. Many included specific timelines, charts, and other visuals to depict the level of complexity involved. Others offered their templates and experience to ACF as we develop guidance and technical assistance products.

States that have already implemented similar measures rely on wage data for administration of state programs, using a combination of sources including state departments of labor, state unemployment insurance wage records, the State Wage Interchange System (SWIS), and the National Directory of New Hires (NDNH). [ 3 ]

Others expressed trepidation around the new measures. Most notably, they expressed concern around the resources and time required to implement data sharing agreements, system changes, and new processes. These commenters welcome a national approach that allows them to maintain their focus on program improvement.

Nearly all respondents noted the value in standard measures and the utility of having a centralized data match at the Federal level to meet the requirement of “nationwide comparability of data” in section 304 of the FRA. They also noted that the employment landscape can vary from region to region and state to state. They requested that ACF provide appropriate context when measures are published. Respondents noted macroeconomics (cost of living, unemployment rates, geography, state minimum wage, impacts of natural disasters etc.), program design and policy (county-administered versus state, benefit caps, political climate), and participant demographics (sex, gender, race, income, family status, disability, formerly incarcerated) as some of the factors that inform the outcome measures.

Taking into consideration the comments we received, ACF is Start Printed Page 53873 instituting a two-pronged approach: Federal matching for calculating Work Outcomes of TANF Exiters and a Supplemental Work Outcomes Report. Consultations with states and DOL, ED, and others informed our two-pronged approach and raised several important considerations. States expressed concerns about the implementation timeline if state-level data sharing agreements were needed, but other states were concerned about the lag in results with a Federal match that would make the outcomes less useful. ACF heard from various stakeholders that, while a Federal-level match with the NDNH has the benefit of reporting wages earned across state lines and from Federal employment, state-level matches could include other sources of wage data such as self-employment or gig work. Each data source and methodology has its own strengths and shortcomings, and these new measures provide an opportunity for learning about the best tools for assessing and improving outcomes for TANF exiters. More information about Federal matching for calculating Work Outcomes of TANF Exiters and the Supplemental Work Outcomes Report is below.

For the first three statutory measures ( i.e., work outcomes of TANF exiters), states will report information to ACF that is necessary to calculate the measures of work outcomes of TANF exiters at the Federal level. Specifically, states will be required to submit Social Security Numbers (SSNs) of all work-eligible individuals who exit TANF in a given quarter on a quarterly basis. ACF will then match those SSNs with quarterly wage records in the NDNH, which is a national database of wage and employment information on most American workers administered by ACF's Office of Child Support Services. [ 4 ] In FY 2022, over 752 million quarterly wage records were submitted to the NDNH. [ 5 ] ACF will use these matched results to compute the first three work outcomes measures on behalf of states. This approach will allow for standardized measures and will not require states to initiate new data-sharing agreements at the state level. We understand that Guam does not currently have an Unemployment Insurance program and therefore does not submit quarterly wage data to the NDNH. Guam will still need to submit the Work Outcomes of TANF Exiters report so that ACF is able to capture outcomes of individuals who find work outside of Guam after exiting the Guam TANF Program. In addition, any state, like Guam, that does not have an Unemployment Insurance program and thus is currently unable to submit quarterly wage records to the ACF-designated wage match source will be required to submit the Supplemental Work Outcomes Report. That report will be used to calculate the same performance measures as those in the Work Outcomes of TANF Exiters Report. We will work closely with Guam to assess the data and provide technical assistance to support calculating the performance measures.

The Work Outcomes of TANF Exiters measures have various operational timelines. The measures themselves specify employment and earnings at different intervals following exit. Further, as noted above, the definition of “exit” includes a 90 day wait period. ACF will provide subsequent guidance on and technical support regarding which “exiters” to include in each quarterly data submission. ACF will run matches each quarter so that states will not need to track or re-identify work-eligible individuals the second and fourth quarters after they exited TANF.

ACF will continue to explore how to share information gained from the Federal-level match to make the data available to and useful for state TANF programs, in addition to satisfying the reporting requirements of the FRA. This may involve providing preliminary match results to states on a quarterly basis before the data have settled and been finalized.

Several states requested the option to provide additional data that would enrich the outcomes generated from a centralized data match. The states that have systems and data-sharing agreements in place believe those systems to be timelier and more comprehensive. Notably, some states reported that they will continue to produce their own performance measure reports due not only to local statutory requirements but also to support program partnership and continuous improvement. ACF wants to empower states to analyze their own data for program improvement and policy decision-making. To support this effort, these regulations establish an additional Supplemental Work Outcomes Report to be submitted annually by interested states. This will allow states that already have performance reporting infrastructure in place to provide calculated outcomes measures results with alternative data sources. The report will include documentation of data sources and methodology to assess validity and support ongoing learning and identification of best practices. ACF will encourage this voluntary submission as a way for states and the Federal government to promote and learn more about alternative data sources as compared to matching to wage data at the Federal level. ACF will report on findings from the Supplemental Work Outcomes Report as part of ongoing learning and context for state performance measures. This report will be mandatory for any state, like Guam, that does not have an Unemployment Insurance program and is thus unable to submit quarterly wage data to the ACF-designated wage match source. The Supplemental Work Outcomes Report also provides an avenue for continued alignment with WIOA performance measures; states that have highly coordinated TANF and workforce agencies could demonstrate the benefits of state-level data matching (potentially through SWIS) and the addition of supplemental wage information, such as for those who are self-employed or participate in gig work and are not systematically captured in quarterly wage records. ACF is committed to providing technical assistance and support to states interested in developing their own infrastructure to calculate work outcomes, including helping develop relationships across state agencies, data system modifications, data sharing agreements, and data analysis capacity. ACF began this work with the TANF Data Collaborative  [ 6 ] and plans to continue to find innovative ways to support states as they focus on better outcomes for TANF recipients and exiters.

ACF has experience with TANF outcomes measures similar to the ones that the Work Outcomes for TANF Exiters Report will capture, through the Start Printed Page 53874 former High Performance Bonus measures, 42 U.S.C. 603(a)(4) , and more recently for performance measures that are reported as part of the Congressional Budget Justification. However, ACF has little experience collecting information related to the Secondary School Diploma or its Recognized Equivalent Attainment Rate (hereafter Secondary School Diploma Attainment Rate) for TANF participants and exiters. States reported to us that they also have little experience with this type of measure and anticipated that it would be more difficult to implement.

The Secondary School Diploma Attainment Rate measure presents its own unique challenges, and states have requested support for implementing this measure. Participant surveys may be the most direct way to obtain the data; however, states requested technical assistance to increase survey response rates. In addition, states want guidance for navigating the complex network of educational systems and setting up data-sharing agreements with the various entities involved.

We learned from our research, consultations, and the RFI that some states have existing longitudinal databases and cross-department agreements that would be well-suited for calculating these measures. Other states did not have this type of existing access and infrastructure. The ED, DOL, and respondents to the RFI emphasized that there are multiple ways a person may earn a secondary school diploma or recognized equivalent, including but not limited to adult school/education, community college, or public or private high school within K-12 systems. Local education agencies often have different geographical maps from TANF offices or workforce investment boards. For some states, secondary school equivalency testing may be independent of state government, while for others, such testing may be managed by state education agencies.

The wide range of structures and readiness for collecting information for this measure across states led us to the decision to leave the data source selection up to the states, following sub-regulatory guidance from ACF. ACF will provide thorough guidance and technical support for the calculation of the rate, including who belongs in the numerator and denominator. States must use universe-level data in their calculations, meaning that the rate should be based on the entire population that meets the criteria and not a sample of that population.

ACF recognizes that the typical secondary academic calendar is at odds with the Federal fiscal year and annual submission of the data for the Secondary School Diploma Attainment Rate. This is further complicated by the range of timelines of the various data sources and tracking individuals after exit. We note that the Secondary School Diploma Attainment Rate submission is on a longer lag because of the nature and complexity of the data and the 1-year post-exit wait period. ACF will provide guidance on and technical support regarding the reporting periods that should be covered in a given annual report. We acknowledge states are only able to submit information known to them at the time of reporting and commit to providing additional guidance to manage the level of effort associated with tracking this small subset of TANF participants.

ACF intends to support states in finding innovative ways to collect this information. ACF will ask for sources and methodology as part of the reporting to assess validity of the measure and to support ongoing learning and identification of best practices. Our Federal partners have learned a lot already from states' implementation of WIOA's credential attainment measure, which has some helpful parallels.

The Administrative Procedure Act (APA) generally requires agencies to follow certain procedures when promulgating rules. 5 U.S.C. 551 et seq. Under section 553(b)(B)) of the APA, however, a notice of proposed rulemaking is not required when an agency, for good cause, finds (and incorporates the finding and a brief statement of reasons in the rule issued) that notice and public comment is impracticable, unnecessary, or contrary to the public interest. We find that good cause exists because, under the specific circumstances here, it is impracticable to provide an opportunity for notice and comment prior to issuing this rule.

Providing notice and comment before issuing this rule was impracticable because of the limited time period following the statute's enactment in June 2023 for ACF to consult with states and DOL and then promulgate regulations with sufficient lead-time for states to make necessary system changes to comply with the statutory reporting obligations beginning on October 1, 2024. States will need to plan for, budget, and implement systems changes to comply with data collection and reporting requirements for fiscal year 2025. This may require states to reallocate their budgets, modify existing contracts, and/or enter into new ones, modify and/or enter into new data sharing agreements, and create and/or modify systems for data collection. We are issuing an IFR so that states have time to complete each of these necessary steps before the October 1, 2024, compliance date.

It also was not practicable to provide notice and comment because we needed time to consult with the DOL and with states, as required by section 304 of the FRA, prior to issuing regulations. In addition to being statutorily mandated, the consultation period was necessary to allow ACF to obtain state input on a number of technical questions before moving forward with the rule making process. This technical information from states was key to the agency's thinking and approach around this rulemaking. Consultations with DOL and ED began in July 2023, just one month after the statute was enacted, and have continued throughout the development of this regulation.

The consultation period, described in greater detail in section II above, included a RFI which was published on November 27, 2023. ACF had received 24 comments on the RFI by January 11, 2024. The RFI outlined several possible approaches and factors that needed to be considered and sought public comment. Those comments informed the approach set forth in this IFR.

In addition to issuing the RFI, ACF met with states and conducted listening sessions between September 2023 and January 2024. Almost all states, whether during listening sessions or in response to the RFI, requested that ACF expedite the issuance of regulations and develop guidance as soon as possible. Many respondents wrote that it will take several months or more to set up the necessary infrastructure required to respond to the requirements of the FRA. States specifically requested that the Department convey as soon as possible how it is interpreting Congress' definition of the statutory term “exit” so that states could provide the specifications necessary to their contractors or in-house developers so that they could begin the task of system changes. In anticipation of the implementation, some states have initiated system changes without the definition of “exit,” whereas others are waiting on guidance so that they do not risk costly updates that need to be modified. Further delay of the regulation could lead to states applying the statute ineffectively or inconsistently, which could ultimately reduce the data quality and comparability of the measures. Our goal has been to issue regulations as soon as possible so that states can make sound decisions on the allocation of resources Start Printed Page 53875 and operationalize plans in time for the fiscal year 2025 reporting deadlines.

We believe that issuing an IFR is in the interest of the entities that must meet the reporting requirements, and the effective date for this IFR is justified and reasonable. Although this IFR is being published with an effective date of October 1, 2024, we encourage interested parties to provide comments through December 26, 2024, so that we may have the benefit of public participation in advance of issuing a final rule. ACF will modify the IFR's provisions if warranted by public comments. As we implement the IFR, we welcome public comments on any relevant implementation issues, and we will take those comments into consideration in developing the final rule.

The Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., provides that a Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless it is approved by the Office of Management and Budget (OMB) under the PRA and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid Control Number. See 5 CFR 1320.5(a) and 1320.6 .

This interim final rule includes the following new information collections.

• Work Outcomes of TANF Exiters Report
• Secondary School Diploma or its Recognized Equivalent Rate
• Supplemental Work Outcomes Report

As required by PRA, we will submit the proposed information collection(s) to OMB for review and approval.

Work Outcomes of TANF Exiters Report: Quarterly, states will be required to submit Social Security numbers (SSNs) of all work-eligible individuals who exit TANF in a given quarter. Each state must file the report within 45 days following the end of the quarter (QE). The report must contain the SSNs of all individuals who are confirmed to have exited during the reporting period. An individual's exit date is confirmed when 90 days have elapsed since the participant last received assistance. States submit SSNs 45 days after the QE in which their exit date was confirmed. For example:

An individual exits on November 23, 2024 (FY 2025, Quarter [Q]1). For the state to confirm the exit date, 90-days must elapse since the participant last received assistance. The exit date is confirmed on February 21, 2025 (FY 2025, Q2). The individual's SSN is included as an exiter in the quarter ending (QE) March 31, 2025 report (FY 2025, Q2), covering reporting period October 1, 2024-December 31, 2024 (FY 2025, Q1).

ACF will then match the SSN with quarterly wage records in the NDNH to obtain records from two quarters after the individual's exit (FY 2025, Q3) through four quarters after the individual's exit (FY 2026, Q1). ACF will use the matched results to compute the measures on behalf of states: Employment Rate—2nd Quarter After Exit; Employment Retention Rate—4th Quarter After Exit; and Median Earnings—2nd Quarter After Exit.

Secondary School Diploma Attainment Rate: Annually, states will be asked to submit their calculated rate following the definitions and formula set by ACF. The report must include documentation of methodology and data sources.

Supplemental Work Outcomes Report: Annually, states have the option to submit the state's calculation of the first three work outcomes, following the definitions and formulas set by ACF. The report must include documentation of methodology and data sources. Any state like Guam that does not have an Unemployment Insurance program and thus is currently unable to submit quarterly wage records to the ACF-designated wage match source will be required to submit the Supplemental Work Outcomes Report.

In compliance with the requirements of Section 3506(c)(2)(A) of the PRA, the ACF is soliciting public comment on the specific aspects of the information collection described above. You can request copies of the proposed collections by emailing [email protected] . ACF requests comments on these new collections, including but not limited to the quality, utility, and clarity of the information to be collected and the estimated time to complete.

ACF is particularly interested in feedback on the estimated time to complete each of the new information collections. Currently, ACF is estimating the time to complete as follows:

In estimating time to complete, you should include the time associated with activities necessary to complete the requests. This should include the time associated with the following example activities (as applicable):

• Reviewing instructions
• Compiling information or materials to respond
• Acquiring, installing, and utilizing technology and systems
• Updating current technology and systems
• Completing and reviewing collected information
• Finalizing and sending information

Submit comments to [email protected] by August 27, 2024. Consideration will be given to comments and suggestions submitted within the timeframe specified.

The comments received in response to this notification will fulfill the requirement for a 60-day comment period in compliance with the requirements of section 3506(c)(2)(A) of the PRA. We will submit an information collection request for these new proposed collections to OMB for review and approval following consideration of public comment. These requirements will not become effective until approved by OMB.

We have examined the impacts of the final rule under Executive Order 12866 , Start Printed Page 53876 Executive Order 13563 , Executive Order 14094 , the Regulatory Flexibility Act ( 5 U.S.C. 601-612 ), the Congressional Review Act/Small Business Regulatory Enforcement Fairness Act ( 5 U.S.C. 801 , Pub. L. 104-121 ), and the Unfunded Mandates Reform Act of 1995 ( Pub. L. 104-4 ).

Executive Orders 12866, 13563, and 14094 direct us to assess all benefits, costs, and transfers of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). Rules are “significant” under Executive Order 12866 , section 3(f)(1) (as amended by Executive Order 14094 ), if they “have an annual effect on the economy of $200 million or more (adjusted every 3 years by the Administrator of [the Office of Information and Regulatory Affairs (OIRA)] for changes in gross domestic product); or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, territorial, or tribal governments or communities.” This interim final rule implements the data collection and reporting requirements of section 304 of the Fiscal Responsibility Act of 2023, which could entail a small incremental increase in time spent by state governments for these activities. Thus, this interim final rule is not a significant regulatory action under Executive Order 12866 , section 3(f)(1).

Because this rule is not likely to result in an annual effect on the economy of $100 million or more or meet other criteria specified in the Congressional Review Act/Small Business Regulatory Enforcement Fairness Act, this interim final rule does not fall within the scope of 5 U.S.C. 804(2) .

The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. The Secretary certifies that this interim final rule will not result in a significant impact on a substantial number of small entities. The primary impact is on state governments, which are not considered small entities under the RFA.

The Unfunded Mandates Reform Act of 1995 (UMRA) generally requires that each agency conduct a cost-benefit analysis, identify and consider a reasonable number of regulatory alternatives, and select the least costly, most cost-effective, or least burdensome alternative that achieves the objectives of the rule before promulgating any proposed or final rule that includes a Federal mandate that may result in expenditures of more than $100 million (adjusted for inflation) in at least one year by state, local, and tribal governments, or by the private sector. The current threshold after adjustment for inflation using the Implicit Price Deflator for the Gross Domestic Product is $183 million, reported in 2023 dollars. This interim final rule will not result in an unfunded mandate in any year that meets or exceeds this amount.

• Grant programs—social programs
• Public assistance programs
• Reporting and recordkeeping requirements

For the reasons discussed in the preamble, the OFA amends 45 CFR part 265 as follows:

1. The authority citation for part 265 is revised to read as follows:

Authority: 42 U.S.C. 603 , 605 , 607 , 609 , 611 , and 613 .

2. Amend § 265.1 by:

a. Revising paragraph (a);

b. Removing footnote 1 from paragraph (b) introductory text;

c. Revising paragraphs (b)(2) and (3); and

d. Adding paragraphs (b)(4) and (5).

The revisions and additions read as follows:

(a) This part explains how we will collect the information required by section 411(a) of the Act (data collection and reporting); the information required to implement section 407 of the Act (work participation requirements), as authorized by section 411(a)(1)(A)(xii); the information required to implement section 409 (penalties), section 403 (grants to States), section 405 (administrative provisions), section 411(b) (report to Congress), and section 411(f) (reporting performance indicators); and the data necessary to carry out our financial management and oversight responsibilities.

(2) The expenditure data in the quarterly TANF Financial Report (or, as applicable, the Territorial Financial Report);

(3) The definitions and other information on the State's TANF and MOE programs that must be filed annually;

(4) The definitions and other information necessary for the Work Outcomes of TANF Exiters Report; and

(5) The definitions and other information necessary for the Secondary School Diploma or its Recognized Equivalent Attainment Rate.

3. Amend § 265.2 by:

a. Revising paragraph (a); and

b. Adding paragraphs (c) through (e).

The revision and additions read as follows:

(a) Except as provided in paragraphs (b) through (e) of this section, the general TANF definitions at §§ 260.30 through 260.33 and the definitions of a work-eligible individual and the work activities in § 261.2 of this chapter apply to this part.

(c) For purposes of the Work Outcomes of TANF Exiters Report and the Secondary School Diploma or its Recognized Equivalent Attainment Rate, exit is the date that a family with a work-eligible individual ceases to receive assistance (as defined in § 260.31) from the TANF program. The last day of assistance cannot be determined until 90 days have elapsed since the participant last received assistance.

(d) For purposes of the Work Outcomes of TANF Exiters Report, unsubsidized employment means full- or part-time employment in the private or public sector after exiting the TANF program.

(e) For purposes of the Secondary School Diploma or its Recognized Equivalent Attainment Rate:

(1) A secondary school diploma is a “regular high school diploma” as that term is defined in 21 U.S.C. 7801(43) , the Elementary and Secondary Education Act of 1965 (ESEA), as amended by the Every Student Succeeds Act (ESSA).

(2) A recognized equivalent to a secondary school diploma is a certification recognized by a State that signifies that a student has completed the State's requirements for a high school education.

4. Amend § 265.3 by:

a. Revising paragraph (a)(1); and

b. Adding paragraph (g).

The revision and addition read as follows:

(1) Each State must collect on a monthly basis, and file on a quarterly basis, the data specified in the TANF Data Report, the TANF Financial Report (or, as applicable, the Territorial Financial Report), and the Work Outcomes of TANF Exiters Report.

(g) Work Outcomes of TANF Exiters Report. Each State must file the Social Security numbers of all work-eligible individuals, as defined in § 261.2(n), who have exited the program, as defined in § 265.2(b). This information will be used for calculating the following Work Outcomes performance indicators:

(1) Employment Rate—2nd Quarter After Exit: the percentage of individuals who were work-eligible individuals as of the time of exit from the program, who are employed during the second quarter after the exit;

(2) Employment Retention Rate—4th Quarter After Exit: the percentage of individuals who were work-eligible individuals as of the time of exit from the program who were employed in the second quarter after the exit, who are also employed during the fourth quarter after the exit; and

(3) Median Earnings—2nd Quarter After Exit: the median earnings of individuals who were work-eligible individuals as of the time of exit from the program, who are employed during the second quarter after the exit.

5. Amend § 265.4 by adding paragraph (d) to read as follows:

(d) Each State must file the Work Outcomes of TANF Exiters Report within 45 days following the end of the quarter.

6. Amend § 265.5 by:

a. Removing the last sentence of paragraph (a); and

b. Adding paragraph (d).

The addition reads as follows:

(d) States may not use sampling to report expenditure data, data included in the Work Outcomes of TANF Exiters Report, or data included in the Secondary School Diploma or its Recognized Equivalent Attainment Rate.

7. Revise § 265.6 to read as follows:

Each State must file all reports ( i.e., the TANF Data Report, the TANF Financial Report (or, as applicable, the Territorial Financial Report), the SSP-MOE Data Report, the Work Outcomes of TANF Exiters Report, and the Secondary School Diploma or its Recognized Equivalent Attainment Rate) electronically, based on format specifications that we will provide.

8. Amend § 265.7 by:

b. Redesignating paragraphs (e) and (f) as paragraphs (f) and (g); and

c. Adding new paragraph (e).

(a) Each State's quarterly reports (the TANF Data Report, the TANF Financial Report (or Territorial Financial Report), the SSP-MOE Data Report, and the Work Outcomes of TANF Exiters Report) must be complete and accurate and filed by the due date.

(e) For the Work Outcomes of TANF Exiters Report, “complete and accurate report” means that:

(1) The reported data accurately reflect information available to the State in case records, and automated data systems;

(2) The State reports data on all applicable elements ( i.e., no data are missing); and

(3) The State reports universe data on all work eligible individuals who exited TANF in a particular quarter.

9. Amend § 265.9 by:

a. Removing footnote 7 from paragraph (c)(9); and

b. Adding paragraphs (f) and (g).

The additions read as follows:

(f) Each State must submit the percentage of individuals who have not attained 24 years of age, are attending high school or enrolled in an equivalency program, and are work-eligible individuals or were work-eligible individuals as of the time of exit from the program, who obtain a high school degree or its recognized equivalent while receiving assistance under the State program funded under this part or within one year after the individuals exit from the program. The Secondary School Diploma or its Recognized Equivalent Attainment Rate report must include methodology and documentation of data sources.

(g) On a voluntary basis, a State may also submit calculated work outcomes measures that follow the definitions of the Work Outcomes of TANF Exiters (as defined in § 265.3(g)) based on alternative data sources. The report must include documentation of data sources. In addition to the Work Outcomes of TANF Exiters Report, this Supplemental Work Outcomes Report is mandatory for any State that is unable to submit quarterly wage data to the ACF-designated wage match source.

10. Revise § 265.10 to read as follows:

The annual reports required by § 265.9 are due 45 days after the end of the fiscal year.

Xavier Becerra,

Secretary, Department of Health and Human Services.

1.  See https://aspe.hhs.gov/​tanf-leavers-applicants-caseload-studies and https://www.dol.gov/​agencies/​eta/​performance/​definitions .

2.   Characteristics and Financial Circumstances of TANF Recipients, Fiscal Year 2022, Office of Family Assistance, Administration for Children and Families ( https://www.acf.hhs.gov/​ofa/​data/​characteristics-and-financial-circumstances-tanf-recipients-fiscal-year-2022 ).

3.  State Welfare (“TANF” or “IV-A”) Agencies are authorized to request NDNH information to carry out state responsibilities under programs funded under part A of title IV of the Social Security Act, specifically 42 U.S.C. 653(j)(3) . Section 304 of the FRA amended section 411 of the Social Security Act ( 42 U.S.C. 611 ) to specify that each state, in consultation with the Secretary of HHS, shall collect and submit the information necessary for the reporting of work outcomes for fiscal year 2025 and each fiscal year thereafter.

4.  For more detail on the NDNH: https://www.acf.hhs.gov/​sites/​default/​files/​documents/​ocse/​a_​guide_​to_​the_​national_​directory_​of_​new_​hires.pdf .

5.  FY 2022 Preliminary Data Report and Tables from Table P-97 ( https://www.acf.hhs.gov/​css/​policy-guidance/​fy-2022-preliminary-data-report-and-tables ).

6.  The TANF Data Collaborative was a 30-month pilot program that offered technical assistance and training to support cross-disciplinary teams of staff at eight state and county TANF programs in the routine use of TANF and other administrative data to inform policy and practice. Learn more about the program and participants here: https://www.acf.hhs.gov/​opre/​report/​tanf-data-collaborative-pilot-profiles-collection-data-analytics-projects-state-county .

[ FR Doc. 2024-13865 Filed 6-27-24; 8:45 am]

BILLING CODE 4184-36-P

• Executive Orders

Reader Aids

Information.

• About This Site
• Accessibility
• No Fear Act
• Continuity Information