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Informed Consent for Clinical Trials

Informed Consent Image

On this page you will find information on:

What is Informed Consent

Before enrolling in a clinical trial, the following information must be given to each potential research subject

When Appropriate, one or more of the following elements of information must also be provided in the informed consent document

A potential research subject must have an opportunity to

Informed consent may not include language that

To many, the term informed consent is mistakenly viewed as the same as getting a research participant's signature on the consent form. FDA believes that obtaining a research participant's verbal or written informed consent is only part of the process. Informed consent involves providing a potential participant with: 

adequate information to allow for an informed decision about participation in the clinical investigation.

facilitating the potential participant's understanding of the information.

an appropriate amount of time to ask questions and to discuss with family and friends the research protocol and whether you should participate.

obtaining the potential participant's voluntary agreement to participate.

continuing to provide information as the clinical investigation progresses or as the subject or situation requires.

To be effective, the process must provide sufficient opportunity for the participant to consider whether to participate. ( 21 CFR 50.20 .) FDA considers this to include allowing sufficient time for participants to consider the information and providing time and opportunity for the participant to ask questions and have those questions answered. The investigator (or other study staff who are conducting the informed consent interview) and the participant should exchange information and discuss the contents of the informed consent document. This process must occur under circumstances that minimize the possibility of coercion or undue influence. (21 CFR 50.20.)

What is Informed Consent? 

As new medical products are being developed, no one knows for sure how well they will work, or what risks they will find.   Clinical trials are used to answer questions such as: 

Are new medical products safe enough to outweigh the risks related to the underlying condition?,

How should the product be used? (for example, the best dose, frequency, or any special precautions necessary to avoid problems),

How effective is the medical product  at relieving symptoms, treating or curing a condition.

The main purpose of clinical trials is to “study” new medical products in people.  It is important for people who are considering participation in a clinical trial to understand their role, as a “subject of research” and not as a patient. 

While research subjects may get personal treatment benefit from participating in a clinical trial, they must understand that they:

may not benefit from the clinical trial,

may be exposed to unknown risks,

are entering into a study that may be very different from the standard medical practices that they currently know 

To make an informed decision about whether to participate or not in a clinical trial, people need to be informed about:

what will be done to them,

how the protocol (plan of research) works,

what risks or discomforts they may experience,

participation being a voluntary decision on their part.

This information is provided to potential participants through the informed consent process.  Informed consent means that the purpose of the research is explained to them, including what their role would be and how the trial will work. 

A central part of the informed consent process is the informed consent document. The Food and Drug Administration (FDA) does not dictate the specific language required for the informed consent document,  but does require certain basic elements of consent be included.

Before enrolling in a clinical trial, the following information must be given to each potential research subject:

A statement explaining that the study involves research.

An explanation of the purposes of the research.

The expected length of time for participation.

A description of all the procedures that will be completed during enrollment on the clinical trial.

Information about all experimental procedures the will be completed during the clinical trial.

A description of any predictable risks.

Any possible discomforts (e.g., injections, frequency of blood test etc.) that could occur as a result of the research.

Any possible benefits that may be expected from the research.

Information about any alternative procedures or treatment (if any) that might benefit the research subject.

A statement describing:

the confidentiality of information collected during the clinical trial,

how records that identify the subject will be kept

the possibility that the FDA may inspect the records.

For research involving more than minimal risk information including

an explanation as to whether any compensation or medical treatments are available if injury occurs,

what they consist of, or

where more information may be found.

questions about the research,

research subjects' rights,

injury related to the clinical trial.

Research subject participation is voluntary,

Research subjects have the right to refuse treatment and will not losing any benefits for which they are entitled,

Research subjects may choose to stop participation in the clinical trial at any time without  losing benefits for which they are entitled.

Contact information will be provided for answers to :

A statement that:

When Appropriate, one or more of the following elements of information must also be provided in the informed consent document:

A statement that the research treatment or procedure may involve unexpected risks (to the subject, unborn baby, if the subject is or may become pregnant).

Any reasons why the research subject participation may be ended by the clinical trial investigator (e.g., failing to follow the requirements of the trial or changes in lab values that fall outside of the clinical trial limits).

Added costs to the research subject that may result from participating in the trial.

The consequence of leaving a trial before it is completed (e.g. if the research and procedures  require a slow and organized end of participation).

A statement that important findings discovered during the clinical trial will be provided to the research subject.

The approximate number of research subjects that will be enrolled in the study.

A potential research subject must have an opportunity to:

read the consent document,

ask questions about anything they do not understand. 

Usually, if one is considering participating in a clinical trial, he or she may take the consent document home to discuss with family, friend or advocate.

An investigator should only get consent from a potential research subject if:

enough time was given to the research subject to consider whether or not to participate

the investigator has not persuaded or influenced the potential research subject.

The information must be in language that is understandable to the research subject.

Informed consent may not include language that:

the research subject is made to ignore or appear to ignore any of the research subject's legal rights,

releases or appears to release the investigator, the sponsor, the institution, or its agents from their liability for negligence.

Participating in clinical trials is voluntary.  You have the right not to participate, or to end your participation in the clinical trial at any time. Read the informed consent document carefully.  Ask questions about any information you don’t understand or find confusing.

Draft Guidance: Informed Consent Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors

  • Open access
  • Published: 14 January 2021

The reality of informed consent: empirical studies on patient comprehension—systematic review

  • Tomasz Pietrzykowski 1 &
  • Katarzyna Smilowska   ORCID: orcid.org/0000-0001-9167-1624 2  

Trials volume  22 , Article number:  57 ( 2021 ) Cite this article

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Informed consent is a basic concept of contemporary, autonomy-based medical practice and facilitates a shared decision-making model for relations between physicians and patients. Thus, the extent to which patients can comprehend the consent they grant is essential to the ethical viability of medicine as it is pursued today. However, research on patients’ comprehension of an informed consent’s basic components shows that their level of understanding is limited.

Systemic searches of the PubMed and Web of Science databases were performed to identify the literature on informed consent, specifically patients’ comprehension of specific informed consent components.

In total, 14 relevant articles were retrieved. In most studies, few clinical trial participants correctly responded to items that examined their awareness of what they consented to. Participants demonstrated the highest level of understanding (over 50%) regarding voluntary participation, blinding (excluding knowledge about investigators’ blinding), and freedom to withdraw at any time. Only a small minority of patients demonstrated comprehension of placebo concepts, randomisation, safety issues, risks, and side effects.

Conclusions

We found that participants’ comprehension of fundamental informed consent components was low, which is worrisome because this lack of understanding undermines an ethical pillar of contemporary clinical trial practice and questions the viability of patients’ full and genuine involvement in a shared medical decision-making process.

Peer Review reports

Introduction

Written informed consent (IC) is considered a basic principle of medical practice. It provides information and shares knowledge between the physician and patient and creates a shared-decision-based healthcare plan [ 1 ]. In this regard, the IC should implement a principle of autonomy, by which a patient’s right to deliberately decide for herself whether to accept or refuse the offered treatment must be respected [ 2 , 3 ]. However, patients’ adequate understanding of the provided information is a major limitation.

Within its ethical and legal foundations, the informed consent process is pivotal to supporting ethically sound medical intervention. However, obtaining adequately informed consent from patients is complex because it requires human interactions involving discussion of several elements, such as the patient’s condition and therapeutic options, including risks and benefits, inconveniences, and uncertainties. In this regard, IC must include both a form that patients are required to read and sign, and oral communication to ensure adequate understanding to facilitate voluntary willingness to participate in a clinical trial [ 4 ].

Major barriers to adequate IC understanding include the patients’ subjective impression that they are well informed and physicians’ over-confidence in the intelligibility and quality of the information they provide to patients. Nonetheless, the concept of respecting patients’ autonomy in medical research is based on the assumption that the informed consent process actually leads to patients’ full comprehension of what they are consenting to. Unless this assumption is demonstrably true, the ethical viability of the current medical experimentation practice is seriously flawed.

Given that most available studies focused on informed consent obtained for the purpose of clinical trials, we limited our scope to this kind of research practice. However, there is no reason to assume that the level of understanding of informed consent granted by patients in a routine medical practice is significantly higher than that in clinical trials. On the contrary, we find it plausible that patients recruited to clinical trials are relatively better informed and physicians may explain the nature of a research intervention and participation conditions more thoroughly. Therefore, it is improbable that patients’ actual comprehension of consent in standard medical practice is higher than in the relatively better examined conditions of clinical trials, and there are reasons to expect that it is lower. With this reservation, our conclusions may be extended beyond clinical trial conditions to the more general practice of obtaining informed consent in medical practice.

Therefore, we systematically reviewed the available literature on patients’ actual (rather than declared) understanding of what they consented to, with particular interest in questionnaires developed to objectify patients’ understanding of the consent content, rather than their subjective impression on how well informed they were during the consenting process, and whether they were satisfied with the way in which their consent was obtained.

We performed a systematic review using the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) criteria [ 5 ]. The electronic search to identify and capture informed consent literature was conducted between October 2019 and January 2020. We queried PubMed and Web of Science databases using the following search terms: “informed consent [mh] AND (comprehension [mh] OR perception [mh] OR knowledge [mh] OR decision making [mh] OR understanding OR communication [mh]) AND (randomised controlled trials as topic [mh] OR clinical trial as topic [mh])”. No year restrictions were applied. To make the search as comprehensive as possible, we used the Boolean operators “AND” and “OR” to link the search terms.

Inclusion criteria were (a) studies assessing comprehension of IC, (b) English-language articles in peer-reviewed academic/scientific journals, (c) full-text articles available electronically, and (d) articles with available questionnaires used to examine the level of patients’ understanding.

Exclusion criteria were (a) studies comparing or evaluating methods of informed consent not related to IC comprehension (defined in inclusion criteria), (b) studies that used intervention to improve patients’ understanding, (c) studies that included patients with cognitive decline, (d) qualitative research, (e) articles based on patients’ impression of understanding, (f) studies based on interviews, (g) studies that did not provide the questionnaire used, (h) conference abstracts, and (i) animal studies.

We included only articles that examined knowledge about the information included in the IC. In this regard, we excluded articles based on interviews and questionnaires that examined only patients’ impressions of understanding (e.g. “Did you receive adequate information about the study?”).

Article selection was performed independently by the first (TP) and second (KS) authors. Database searches were completed in a blinded manner using identical search terms. After identifying eligible articles, any doubts were resolved during a meeting to review the queried article(s) against the inclusion and exclusion criteria. The final selection of eligible articles included in the critical appraisals was made based on the agreement between TP and KS.

Selection process

The study selection process is shown in Fig.  1 . In total, 4263 articles were retrieved from the databases, of which 14 were included in the review based on the inclusion/exclusion criteria (Table  1 ). The number of participants varied across studies, ranging from 29 [ 16 ] to 1835 [ 9 ]. In most studies ( n = 12), participants were adults [ 7 , 8 , 9 , 10 , 11 , 12 , 13 , 14 , 15 , 17 , 18 , 19 ]; three studies examined parents or guardians [ 6 , 10 , 16 ]; and one study included both adult patients and parents or guardians [ 10 ]. Medical specialties included infectious disease in 42% ( n = 6), including vaccine studies in 21% ( n = 3), oncology in 28% ( n = 4); rheumatology in 21% ( n = 3); neurology in 7% ( n = 2), and others in 7%. Two studies included clinical trials in more than one specialty [ 8 , 15 ]. Most studies examined IC-related questions that covered compensation, withdrawal criteria and consequences, study versus treatment, study administration, and randomisation.

figure 1

Selection process for eligible articles

Understanding of informed consent

Questionnaires that examined participants’ understanding of IC components included true/false items [ 9 , 10 , 18 ], multiple choice items, and the Quality of Informed Consent survey [ 7 , 11 ]. Questionnaires differed in the number of items and content. All questionnaires examined participants’ recall of IC content, except one, where participants used the IC text to find the answers to the survey questions [ 19 ]. Additionally, the elapsed time between participants’ experience of the informed consent process and their IC research participation ranged from before the actual IC [ 18 ] process to 5 years after the IC [ 15 ]; four studies did not report this measure [ 8 , 12 , 16 , 19 ].

Three studies examined participants’ understanding of the research purpose. Schumacher et al. reported that all participants understood that they were participating in a research study and recognised its purpose [ 7 ]. In the remaining two studies, most participants comprehended the study aims (70–90%) [ 9 , 19 ].

Voluntary participation was examined in seven studies [ 6 , 7 , 8 , 9 , 11 , 13 , 14 ]. Bergenmar et al. reported the highest level of comprehension, with 96% of participants comprehending the voluntary nature of their participation [ 11 ]. In contrast, Chu et al. reported the lowest level of comprehension, with 53.6% [ 8 ]. Additionally, Krosin et al. noted a significant difference between urban and rural participants, with 85% and 21%, respectively, showing comprehension of the voluntary nature of participation [ 13 ]. Chu et al. reported that 53.6% patients understood that physicians should not persuade them to participate in a study [ 8 ]. Criscione et al. reported that 10% of participants indicated that their personal doctor would mind if they dropped out of the study [ 14 ].

Freedom to withdraw was reported in eight studies [ 6 , 7 , 8 , 10 , 12 , 14 , 17 , 19 ], which was a relatively well-comprehended IC component, with the lowest level of 63% reported by Criscione et al. [ 14 ]. Ponzio et al. reported that all participants correctly understood their right to withdraw at any time [ 19 ]. Additionally, one study reported on awareness of withdrawal consequences, with 44% demonstrating comprehension of this point; and withdrawal criteria, with only 10% showing comprehension [ 13 ].

Comprehension of randomisation was investigated in seven studies, with Harrison’s study reporting the highest level of understanding (96%), and Bertoli et al. reporting the lowest (10%) [ 8 , 11 , 12 , 14 , 15 , 16 ]. Similarly, the understating of placebo and active treatment ranged from 13% [ 15 ] to 97% [ 9 ]. Differences by specialty regarding comprehension of the placebo concept were noted by Pope et al., with the lowest comprehension reported in the ophthalmology group (13%) and the highest in the rheumatology group (49%) [ 15 ].

Risks and benefits were explored in nine [ 6 , 7 , 9 , 10 , 11 , 13 , 14 , 18 , 19 ] and three studies [ 6 , 7 , 19 ], respectively. Krosin et al. reported that only 7% of patients comprehended risks associated with involvement in clinical trials [ 13 ]. In contrast, in one group, all patients (who could use the IC text to find questionnaire answers) were aware of potential side effects and risks of the treatment [ 19 ]. Ponzio et al. reported the highest between-group differences in the comprehension of study benefits, which ranged from 35.5 to 96.6%, depending on whether participants were successful in finding the answer in the IC text [ 19 ].

It is worth noting that Schumacher et al. reported that patients were not aware that the proposed treatment was experimental and not standard therapy [ 7 ]. Additionally, only 20% of participants understood that the benefits of treatment were uncertain and that participation was associated with additional risks. Similarly, over 30% of patients were not aware that alternative treatments were available.

Furthermore, Chu et al. found that only 43.4% of patients understood that they would not be reimbursed for all adverse events related to the study. Of note, the authors did not specify the conditions regarding reimbursement. The number of correct responses was higher in the healthy control group than in the patient group (excluding the last question related to reimbursement) [ 8 ].

Finally, Bertoli et al. reported that 86 participants (83.5%) recalled that they had fully read the informed consent form, while 11.7% had partially read it and 9% did not remember to what extent they had read it. Interestingly, most patients (51.4%) rated their knowledge about the study as high, but objective evaluation of participants’ knowledge showed that only 14.3% demonstrated a high level of knowledge, and 58.1% and 27.6% showed intermediate and low knowledge, respectively [ 12 ]. Pope et al. reported that 18% of participants admitted that they had not fully read the study information letter and 10% admitted that they were afraid to ask questions [ 15 ].

Assessment of risk of bias

Studies included in this review were either randomised nor blinded for the outcomes related to IC. Therefore, the assessment of risk of bias was not possible [ 20 ].

We concluded that there are significant discrepancies in research participants’ understanding of voluntary participation, blinding, and freedom to withdraw. Only rarely did all participants respond correctly to questionnaire items, indicating that they actually comprehended what they consented to. We found that participants presented the highest level of understanding (over 50%) about voluntary participation, blinding (excluding knowledge about investigators’ blinding), and freedom to withdraw at any time. Further, our results suggest that only a small minority of patients had a clear and accurate understanding of all aspects of their consent. In particular, patients presented significant difficulties in grasping the concept of placebo randomisation, safety, risks, and side effects [ 7 , 8 , 9 , 10 , 11 , 12 , 13 , 14 , 15 , 16 , 18 , 19 ]. Additionally, some patients had very limited comprehension of the research benefits [ 6 , 19 ].

Our findings are consistent with the results of previous meta-analyses on the quality of the informed consent process in clinical trials [ 21 ]. However, in general, patients included in our review demonstrated lower levels of comprehension. Tam et al. [ 21 ] reported that two-thirds of participants (the highest reported level) understood the freedom to withdraw from a study at any time, followed by the nature of the study, the voluntary nature of participation, and the potential benefits. In contrast, our results showed that 69.6% of participants understood the purpose of the study and only 54.9% could name at least one risk. Finally, approximately half of the participants understood placebo and randomisation concepts. However, in contrast to our review, Tam et al. included data from interviews in their analysis. Surprisingly, in 58.5% of interviews, participants could not establish whether the interviewers were investigators in the original clinical trial and, as such, could influence the results [ 21 ]. In a previous systematic review of clinical trial IC or surgery IC, Falagas et al. concluded that only 50% of participants properly understood all IC components [ 22 ].

These findings demonstrate that crucial information, including risks and benefits, voluntariness, and the relation of trials to standard therapy, are not actually comprehended by a substantial number of participants. This seriously undermines the present practice of providing a sound ethical basis for experimenting with human subjects. Moreover, it seems that patients’ understanding of specific IC components has not changed over the past 20 years [ 21 ]. The guidelines for good clinical practice in trials, introduced by the World Health Organization 20 years ago, have not affected patients’ comprehension [ 21 , 23 ].

It is natural to expect a correlation between general health literacy and comprehension of information relevant to informed consent. The extent to which deficits in understanding consent depend on insufficient general health literacy remains to be examined. However, this may not be crucial to the existing practice viability in obtaining informed consent as a safeguard for respecting patients’ autonomy in clinical trials. It is inevitable that patients recruited for clinical trials will have varying education and health literacy levels. There is no reason to assume that patients included in clinical trials have lower than average health literacy. Therefore, the outcomes suggest that, in the daily practice of clinical trials, patients with diverse education and health literacy levels agree to participate in medical testing based on defective, or at least incomplete, comprehension of the relevant information. This suggests that the present routines regarding patients’ autonomy (and thus—dignity) in clinical trials are ethically questionable, if not explicitly flawed.

None of the studies included in our review directly examined relations between patients’ health literacy and their level of comprehension regarding the consent they granted. However, Chaisson et al. reported that patients’ education was considered as a factor potentially influencing their understanding of the consent. They administered questionnaires in English or Setswana and concluded that participants who had a higher education level or chose to complete the questionnaires in English rather than Setswana demonstrated better overall comprehension. Similarly, Schumacher et al. and Krosin et al. found significant correlations between comprehension scores and formal education levels [ 7 , 13 ]. Ellis et al. distributed a survey to adult participants in the USA and Mali, plus the parents or guardians of a child in an additional group of Mali participants. Within Malian adults, only 9% signed the IC, while the remaining 91% provided a fingerprint. In the Malian parents or guardians group, 84% provided a fingerprint rather than a signature. The literacy rate for parents or guardians varied between sites, ranging from 3 to 17%. Of note, the questionnaire was initially intended to teach participants rather than to collect data [ 10 ]. The researchers found that patients’ literacy was not a significant factor in their ability to understand the consent they were asked to grant.

The studies included in this review have some limitations that should be considered while interpreting the results. First, they demonstrated a high level of heterogeneity in sample size and type of underlying medical condition. We speculate that this may also have influenced patients’ understanding of informed consent. For example, Pope et al. reported significant differences in the level of understanding within patients recruited to rheumatology, ophthalmology, and cardiology studies [ 15 ]. Similarly, Chu et al. reported that 61% of healthy controls were recruited from phase I trials, in which they were under the close monitoring and care of the researchers, while 80.8% of patients were recruited from phase III or IV trials that were conducted in outpatient clinics [ 8 ]. Second, especially in oncology, the presumed potential benefit of a novel treatment may exceed the presumed risk of the study, biasing patients towards consenting to participate in the trial despite a limited understanding of its experimental nature. Third, although education level was usually mentioned, health literacy was not examined in most studies. Additionally, other factors related to underlying disease may influence patients’ comprehension, including fatigue, depression, cognitive status, and emotional factors associated with study inclusion and doctor’s office visits. The resulting scope of interference with patients’ ability to grasp the full meaning of the consent remains unexamined. However, such factors should be considered when assessing the current practice of obtaining informed consent. Finally, the scales used to examine patients’ understanding differed across studies and ranged from multiple choice to Likert-like scale items, which limited our ability to adequately compare patients’ understanding across studies.

In many cases, patients may be unaware that they lack understanding and therefore do not ask for clarification. In some cases, the information on expected therapeutic benefits may overshadow other aspects of the project, making patients less receptive to technical or more discouraging sides of the trial. Interestingly, our findings suggest that mothers asked to consent to including their children in a clinical trial were more determined to comprehend all relevant information than adult patients deciding on their own involvement in a trial. However, this is based on the results from a single study in this review [ 6 ].

The relatively consistent series of empirical findings opens further questions that have not been satisfactorily addressed in the literature to date. We hypothesise that patients seriously overrate their own level of comprehension. The extent to which they mistakenly feel that they have understood all relevant information while, in fact, they miss many important aspects of the consent present an interesting question that we are preparing to investigate. Similarly, physicians may seriously overrate their patients’ level of comprehension based on (1) their own efforts to effectuate patients’ understanding, (2) their confidence in patients’ declaration of understanding and satisfaction, and (3) their own health literacy influencing their belief that the information offered to patients is easier to understand than is actually the case.

Thus, further research should target empirical testing of the hypothesised discrepancies between (1) the actual level of understanding by patients regarding what they consented to, (2) their subjective confidence that they understood what they consented to, and (3) physicians’ confidence that their patients actually understood what they consented to.

Noting the scarcity of analogous research on the actual understanding of consent by patients in regular therapeutic practice, we recommend that future studies examine such comprehension in ordinary medical settings rather than only through the context of clinical trials. Since physicians typically take more care and effort to explain all relevant aspects of a clinical trial, we assume that, in a standard therapeutic setting, lack of comprehension regarding consent may be even larger. Therefore, a lack of relevant research in therapeutic clinical settings constitutes a remarkable gap in a crucial aspect of ethically viable medical practice.

We found that the level of comprehension regarding informed consent components, such as voluntary participation, blinding, and freedom to withdraw, was low, being understood by only half of the patients. This seriously undermines the ethical foundations of current practices for obtaining consent in clinical trials, potentially also challenging the standard approach to safeguarding patients’ autonomy in ordinary medical settings.

Availability of data and materials

The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.

Abbreviations

  • Informed consent

Injection drug users

Medical Literature analysis and retrieval system online (a database)

Medical subject headings

Excerpta Medica database

Agozzino E, Borrelli S, Cancellieri M, Carfora FM, Di Lorenzo T, Attena F. Does written informed consent adequately inform surgical patients? A cross sectional study. BMC Med Ethics. 2019;20(1):1.

Article   Google Scholar  

Neff MJ. Informed consent: what is it? Who can give it? How do we improve it? Respir Care. 2008;53(10):1337–41.

PubMed   Google Scholar  

Durand MA, Moulton B, Cockle E, Mann M, Elwyn G. Can shared decision-making reduce medical malpractice litigation? A systematic review. BMC Health Serv Res. 2015;15:167.

Manti S, Licari A. How to obtain informed consent for research. Breathe (Sheffield, England). 2018;14(2):145–52.

Liberati A, Altman DG, Tetzlaff J, Mulrow C, Gotzsche PC, Ioannidis JP, et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate healthcare interventions: explanation and elaboration. Bmj. 2009;339:b2700.

Minnies D, Hawkridge T, Hanekom W, Ehrlich R, London L, Hussey G. Evaluation of the quality of informed consent in a vaccine field trial in a developing country setting. BMC Med Ethics. 2008;9:15.

Schumacher A, Sikov WM, Quesenberry MI, Safran H, Khurshid H, Mitchell KM, et al. Informed consent in oncology clinical trials: a Brown University Oncology Research Group prospective cross-sectional pilot study. PLoS One. 2017;12(2):e0172957.

Chu SH, Jeong SH, Kim EJ, Park MS, Park K, Nam M, et al. The views of patients and healthy volunteers on participation in clinical trials: an exploratory survey study. Contemp Clin Trials. 2012;33(4):611–9.

Chaisson LH, Kass NE, Chengeta B, Mathebula U, Samandari T. Repeated assessments of informed consent comprehension among HIV-infected participants of a three-year clinical trial in Botswana. PLoS One. 2011;6(10):e22696.

Article   CAS   Google Scholar  

Ellis RD, Sagara I, Durbin A, Dicko A, Shaffer D, Miller L, et al. Comparing the understanding of subjects receiving a candidate malaria vaccine in the United States and Mali. Am J Trop Med Hyg. 2010;83(4):868–72.

Bergenmar M, Molin C, Wilking N, Brandberg Y. Knowledge and understanding among cancer patients consenting to participate in clinical trials. Eur J Cancer. 2008;44(17):2627–33.

Bertoli AM, Strusberg I, Fierro GA, Ramos M, Strusberg AM. Lack of correlation between satisfaction and knowledge in clinical trials participants: a pilot study. Contemp Clin Trials. 2007;28(6):730–6.

Krosin MT, Klitzman R, Levin B, Cheng J, Ranney ML. Problems in comprehension of informed consent in rural and peri-urban Mali, West Africa. Clin Trials. 2006;3(3):306–13.

Criscione LG, Sugarman J, Sanders L, Pisetsky DS, St Clair EW. Informed consent in a clinical trial of a novel treatment for rheumatoid arthritis. Arthritis Rheum. 2003;49(3):361–7.

Pope JE, Tingey DP, Arnold JM, Hong P, Ouimet JM, Krizova A. Are subjects satisfied with the informed consent process? A survey of research participants. J Rheumatol. 2003;30(4):815–24.

McNally T, Grigg J. Parents’ understanding of a randomised double-blind controlled trial. Paediatr Nurs. 2001;13(4):11–4.

Itoh K, Sasaki Y, Fujii H, Ohtsu T, Wakita H, Igarashi T, et al. Patients in phase I trials of anti-cancer agents in Japan: motivation, comprehension and expectations. Br J Cancer. 1997;76(1):107–13.

Harrison K, Vlahov D, Jones K, Charron K, Clements ML. Medical eligibility, comprehension of the consent process, and retention of injection drug users recruited for an HIV vaccine trial. J Acquir Immune Defic Syndr Hum Retrovirol. 1995;10(3):386–90.

Ponzio M, Uccelli MM, Lionetti S, Barattini DF, Brichetto G, Zaratin P, et al. User testing as a method for evaluating subjects' understanding of informed consent in clinical trials in multiple sclerosis. Mult Scler Relat Disord. 2018;25:108–11.

Page MJ, McKenzie JE, Higgins JPT. Tools for assessing risk of reporting biases in studies and syntheses of studies: a systematic review. BMJ Open. 2018;8(3):e019703.

Tam NT, Huy NT, Thoa le TB, Long NP, Trang NT, Hirayama K, et al. Participants’ understanding of informed consent in clinical trials over three decades: systematic review and meta-analysis. Bull World Health Organ. 2015;93(3):186–98h.

Falagas ME, Korbila IP, Giannopoulou KP, Kondilis BK, Peppas G. Informed consent: how much and what do patients understand? Am J Surg. 2009;198(3):420–35.

Idanpaan-Heikkila JE. WHO guidelines for good clinical practice (GCP) for trials on pharmaceutical products: responsibilities of the investigator. Ann Med. 1994;26(2):89–94.

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Research Centre for Public Policy and Regulatory Governance, Faculty of Law and Administration, University of Silesia in Katowice, Katowice, Poland

Tomasz Pietrzykowski

Department of Neurology; Centre of Expertise for Parkinson & Movement Disorders, Radboud University Medical Center, Donders Institute for Brain, Cognition and Behaviour, PO Box 9101, 6500 HB, Nijmegen, the Netherlands

Katarzyna Smilowska

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T.S. conceived this study, decided on the framework for analysis, carried out the literature searching and analysis, and drafted the manuscript. K.S. decided on the framework for analysis, carried out the literature searching and analysis, and drafted the manuscript. All authors have read and approved the final version.

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Correspondence to Katarzyna Smilowska .

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Pietrzykowski, T., Smilowska, K. The reality of informed consent: empirical studies on patient comprehension—systematic review. Trials 22 , 57 (2021). https://doi.org/10.1186/s13063-020-04969-w

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importance of informed consent in research studies

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Educational Research Basics by Del Siegle

Research ethics and informed consent.

As researchers, we are bound by rules of ethics. For example, we usually cannot collect data from minors without parental or guardian permission. All research participants must give their permission to be part of a study and they must be given pertinent information to make an “informed” consent to participate. This means you have provided your research participants with everything they need to know about the study to make an “informed” decision about participating in your research. Researchers must obtain a participant’s (and parents’ if the participant is a minor) permission before interacting with the participant or if the participant is the focus of the study. Generally, this permission is given in writing; however, there are cases where the research participant’s completion of a task (such as a survey) constitutes giving informed consent. Research participants have the right to refuse to participate without penalty if they wish. Each university that receives federal funds (and most do) must have an Institutional Review Board (IRB) that reviews all research conducted at the university. Therefore, anyone doing research associated with the university must submit and receive IRB approval before beginning research. Even if the research is exempt from a full review by the IRB, an Exemption Form must be filed and approved by the Department chair and submitted and reviewed by the IRB.

Researchers are bound by a code of ethics that includes the following protections for subjects

  • Protected from physical or psychological harm (including loss of dignity, loss of autonomy, and loss of self-esteem)
  • Protection of privacy and confidentiality
  • Protection against unjustifiable deception
  • The research participant must give voluntary informed consent to participate in research. Guardians must give consent for minors to participate. In addition to guardian consent, minors over age 7 (the age may vary) must also give their consent to participate.

NOTE: Voluntary informed consent means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over reaching, or other ulterior form of constraints or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable them to make an understanding and enlightened decision. This latter element requires that before the acceptance of an affirmation decision by the participant there should be made known to them the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonably to be expected; and the effects upon their health or person which may possibly come from their participation in the study.

The consent form that study participants sign should cover the following main points:

  • It should tell the participants what they are being asked to do, by whom, and for what purpose. Participants must know the identity of the researcher, his or her affiliations if any, and whom to contact for information if they have problems with the research process. This not only includes contact information for the researcher, but also contact information for the university IRB.
  • It should inform the participants of any risks they might be taking by participating in the research.
  • It should inform the participants what rights they have in the process, particularly the right of review of material and the right to withdraw from the process.
  • It should indicate whether or not participants’ names will be used in the study, whether any other names will be used, or whether pseudonyms will be substituted.
  • It should indicate how the results of the study will be disseminated and whether participants can expect to benefit in any way, monetarily or otherwise, from participating in the study.
  • It should indicate that participants are free to participate or not participate in the research without prejudice to them.
  • In the case of children, it must be signed by the child’s legal guardian. Children cannot be expected to give total informed consent.
  • The consent form should be written in the second person (e.g., “You have the right to …”) and in easy to understand language.

THE UNIVERSITY OF CONNECTICUT gives assurance that it will comply with the Department of Health and Human Services (DHHS) regulations for the protection of human research subjects and has set up an Institutional Review Board to review all research associated with the University. Researchers (including student researchers) are required to file a IRB prior to conducting research. Certain types of studies qualify for exempt or expedited review. Research involving minors SELDOM qualifies for exempt status . Even if a study qualifies for exempt status, the researcher must still file a IRB with the Department Head and submit it to the IRB.

Note: Exempt and expedited studies that are not DoJ-funded or subject to FDA regulations must complete a short study status report every year. Full board review and expedited studies that are DoJ-funded or subject to FDA regulations must complete the continuing review process. Therefore, if a research project extends beyond one year, the project must be reviewed each year by the institutional review board as long as data are being collected. If a researcher changes any aspect of a study (including adding or changing questions on a survey) an amendment must be filed and approved by the IRB before using the survey. If a researcher plans to enroll more participants than he or she indicated in the initial IRB, an amendment must be filed and approved by the IRB before enrolling the additional participants. If a researcher wishes to change any of the research procedures that were approved in the approved IRB, and amendment must be filed and approved by the IRB before those changes are made. If a researcher has completed data collection and is only analyzing data and writing the research results, then IRB renewals are no longer required. Informed consent must also be given for interviews. Informed consent can be given verbally, provided there is a witness.

The following criteria are often considered by Institutional Review Boards for the Protection of Human Subjects:

  • Are risks greater than “minimal risk”*?
  • Are risks minimized?
  • Are risks reasonable in relation to the benefits?
  • Is subject selection equitable (e.g., subject population included or excluded; risk of coercion in recruitment, etc.)
  • Is the process for obtaining consent appropriate?
  • Is informed consent appropriately documented?
  • Is there adequate provision for monitoring the data collection to insure safety of the subjects?
  • Are the provisions for protecting privacy adequate?
  • Are the provisions for maintaining confidentiality adequate?
  • Have additional safeguards for subjects vulnerable to coercion or undue influence been included?
  • Is “annual” continuing review sufficient?
  • Do the research staff/investigators have appropriate expertise to perform their responsibilities in the study?

*”minimal risk” means that the probability and magnitude of harm or discomfort anticipated in the research are no greater in and of themselves from those ordinarily encountered in daily life or during the performance of routine physical or psychological examination or tests.

Heightened Awareness of Problems with Unethical Research

In 1966 Dr. Henry Beecher, an anesthesiologist, wrote an article for the June 16, 1966 New England Journal of Medicine called “Ethics and Clinical Research”. In it he described 22 examples of research studies with controversial ethics that had been conducted by reputable researchers and published in major journals. He noted that “unethical or questionable ethical procedures are not uncommon.” Beecher’s article played an important role in heightening the awareness of researchers, the public, and the press to the problem of unethical human subjects research.

Establishment of the National Research Act The publicizing of the Public Health Service Syphilis Study at Tuskeegee (1932-1971) led to the establishment of the National Research Act of 1974 which created a national commission that ultimately issued the Belmont Report (1979). The Belmont Report outlined three basic ethical principles. The TUSKEGEE SYPHILIS STUDY involved 399 African-American men with latent syphilis who were not told by researchers there was a cure for the disease.  This was done so the researchers could study the long-term effects of the disease. The Tuskegee syphilis study, coupled with abuses reported in the NUREMBERG TRIALS indicated that researchers and the research they conduct needed to be monitored.

Three Basic Ethical Principles Outlined in the Belmont Report

Respect for Persons (Treat individuals as autonomous human beings, capable of making their own decisions and choices, and do not use people as a means to an end) Three Requirements Based on Respect for Persons

– obtain and document informed consent – respect the privacy interests of research participants – consider additional protection when conducting research on individuals with limited autonomy

Beneficence (Minimize the risks of harm and maximize the potential benefits) Five Requirements Based on Beneficence

– use procedures that present the least risk to participants consistent with answering the scientific question – gather data from procedures or activities that are already being performed for non-research reasons – risks to subjects should be reasonable in relation to both the potential benefits to the participants and the importance of the knowledge expected to result – maintain promises of confidentiality – monitor the data to ensure the safety of participants

Justice (Treat people fairly and design research so that its burdens and benefits are shared equitably) Two Requirements Based on Justice

– select participants equitably – avoid exploitation of vulnerable populations or populations of convenience

Rationale for an Institutional Review Board (IRB) The ethical principles and federal regulation generated by the Belmont Report provide a framework for IRBs to evaluate research involving human subjects. An objective review of research is necessary because

  • highly motivated people tend to focus on their goals and may unintentionally overlook other implications or aspects of their work and
  • no one can be totally objective about his or her work.

The IRB review system is designed to provide an independent, objective review of research involving human subjects so that the privilege of conducting human subjects research may be maintained.

Only activities that meet the definition of research with human subjects need review by an Institutional Review Board (IRB).

Research is a

  • systematic investigation (this might range from applying scientific methodology involving independent and dependent variables to an ethnographic study of a community)
  • including research development, testing, and evaluation (this also includes pilot studies, feasibility studies, and other preliminary studies)
  • designed to develop or contribute to generalizable knowledge (An essential consideration is whether it is the intention of the investigator to contribute to generalizable knowledge).

Some activities that involve interactions with humans and data gathering may not fit the definition of research with human subjects, since they are designed to accomplish something else, such as in-house quality improvement. For example, a survey of college students about their university’s counseling services may be designed to improve the service delivery for students on campus. Publication of the results is sometimes used as a measure of whether research is generalizable, but this is too narrow a measure for two reasons. First, not every study will produce results worthy of publication. Second, there are other ways that results can be made available to others. They may be presented at a conference. They may be shared with colleagues through the Internet, appear in a dissertation, provided to Board members in a project report, or archived for future research).

A human subject is a “living individual about whom an investigator (whether professional or student) conducting research obtains:

  • Data through intervention or interaction (does not need to be face-to-face, could be via email or a participant observation) with the individual or
  • Identifiable private information” (a) information about behaviors that occur in a context where the individual can reasonably expect that no observations or recording is taking place or b) information that is provided for a specific purpose and for which the individual can reasonably expect will not be made public).

Once the IRB approves a protocol, it must be reviewed at least annually (every 12 months) until data collection is complete, although IRBs may specify a shorter review period. The extent of the yearly review will vary depending on the research. Amendments and changes to approved protocols must be approved prior to their implementation. An exception could occur if a revision to approved procedures was in response to an unanticipated risk and had to be implemented immediately for the health or well-being of the subjects. Such revisions must be reported promptly to the IRB, not when the research is completed.

The federal regulations governing research with human subjects, which have been adopted by numerous federal departments and agencies, are often referred to as the Common Rule, which is modified from time to time. They were first written by the Department of Health and Human Services (DHHS). The DHHS regulations are often referred to as 45 CFR 46. Pregnant women, fetuses, neonates, children, and prisoners are considered vulnerable populations and are provided additional protection in the DHHS regulations . The DHHS regulations do not have specific additional protections for the elderly, for mentally disabled persons, or for persons whose decision-making capabilities are impaired. Investigators may consider and the IRB may require additional safeguards for these populations. The Common Rule does not include requirements for formatting protocols for IRB review. Formatting requirements are institution specific. Most institutions decide to apply the Common Rule to all research with human subjects, regardless of the funding source.

Research is eligible for expedited review when it poses no more than minimal risk (minimal risk means that “the probability and magnitude of harm or discomfort anticipated in the research are not greater…than those ordinarily encountered in daily life…”) to the participants and when all the activities fall within the categories identified as eligible.

Research is only eligible for exemption if all the activity associated with the research fall into one of six categories of activities described in federal regulations. Three of these are frequently used by social and behavioral scientists:

  • Research conducted in established or commonly accepted educational settings, involving normal educational practices
  • Research involving survey procedures, interview procedures, or observations of public behavior providing that any disclosure of identifiable information outside the research setting would not place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation (Note: By institution choice, interviews with children and participant observation with children may not be exempt).
  • Research involving the collection or study of existing data (collected prior to the research for purposes other than the research) if the data is publicly available or recorded by the investigator in such a manner that the subjects cannot be identified.

The regulations do allow some research with children to be exempt (although institutional policy may not). The duration of the study and the experience of the investigator are not criteria for determining eligibility for exemption.

IRBs must either have sufficient expertise among their members or seek expertise through consultation if the members are not familiar with a methodology or population under consideration. They must have the expertise and professional competence to evaluate research activities commonly conducted by their institution. The primary purpose of the IRB is to protect the rights and welfare of research subjects. An IRB must exercise all of its authorities in order to do so, including monitoring research when appropriate. Although IRBs serve their institutions, they do not represent the interests of their institutions. According to federal regulations, institutional officials may not override an IRB disapproval of a protocol.

While physical risks are minimal in social and behavioral science research, risks associated with participation in social and behavioral science research are often more elusive and less predictable. Every interaction in a research context is a communication of some sort, and communications can go awry. For example, notification by mail to set up a follow-up appointment for a participant in a research study may result in an inadvertent breach of confidentiality.

Risks in social and behavioral sciences generally fall into three categories (in rare circumstances the risk may be physical such as a study of victims of domestic violence who may become the victims of retaliatory violence):

  • Invasion of Privacy – This can occur if personal information is accessed or collected without the subjects’ knowledge or consent. The subjects’ participation may be revealed without their knowledge (e.g., e-mail communications with a subject about recovering from sexual assault might be read by family members).
  • Breach of Confidentiality — The primary source of risk in the social and behavioral sciences is that information obtained by researchers could harm subjects if disclosed outside the research setting. This could include unintended disclosure of subject’s HIV status resulting in loss of health insurance coverage; revelation of sexual preferences that results in discrimination; disclosure of employee attitudes about their employer resulting in job lose; revealing information about illegal activities or status (drug use or immigrant status) resulting in legal consequences.
  • Study Procedures — In some cases, simply participating in the research can cause social or psychological harm. Subjects who experienced abuse as children may experience emotional or psychological distress by participating in a study.

When assessing risk associated with participation in a research study, there are two distinct elements of risk that need to be considered.

  • The Probability of Harm — The likelihood that a specific harm might occur
  • The Magnitude of Such Harm

Risks in research participation are specific to time, situation, and culture. Thus, what may be a socially sensitive issue or topic at one time or place may not be so at another time or place. Risks in social and behavioral science research are mostly culturally determined. For example, asking women if they have had abortions would carry very different risk in cultures where abortion is a routine medical practice, a country where it is illegal, and a country where it is legal but fraught with religious and political controversy. Risks will differ according to the subject population. A survey about sexually transmitted disease would carry different risks for middle class suburban men, Catholic clergy, and gang members (who in one study claimed to have STD’s when they did not). The risk of emotional distress cannot be managed by anonymizing data, but rather by developing a plan to respond to the distress should it occur.

Risks and Benefits — Researchers tend to underestimate risks involved in activities with which they are familiar and to overestimate the benefits of things that are important to them. Thus, an independent assessment of risk is critical. One function of Institutional Review Boards is to provide this independent assessment. When potential outcomes are severe, people tend to overestimate their probability, regardless of the true probability. And when potential outcomes are less severe, such as embarrassment, people tend to underestimate their probability. Federal regulations, based on the ethical principle of beneficence, require that risks associated with research be reasonable in relation to the anticipated benefits. A great deal of research in the social and behavioral sciences offers little potential for direct benefits to the subjects themselves. The benefits of the research often lie in the importance of the knowledge to be gained. Most research in the social and behavioral sciences poses little or no risk to the subject.

A Certificate of Confidentiality protects sensitive information provided by research subjects from civil, criminal, or administrative subpoena. This protects identifiable research information from forced disclosure. The Certificates are issued by the National Institute of Health (NIH) and may be secured for any research (even non-NIH research), regardless of the source of funding or even for un-funded research. Certificates of Confidentiality may be granted for studies collecting information that, if disclosed, could have adverse consequences for subjects or damage their financial standing, employability, insurability, or reputation. Substance abuse or other illegal behaviors; sexual attitudes, preferences, or practices; genetic information; and psychological well-being are kinds of information that can be protected.

If the only identifier collected in the course of a study would be the signature on the consent document and the principal source of harm would be a breach of confidentiality, a waiver of documentation of informed consent should be sought. A waiver of documentation of informed consent is helpful when the consent form is the only document that links the subject to the study.

Note: Some of the material provided here was adapted from material available in CITI (Course in The Protection of Human Research Subjects).

Last updated on January 16, 2023

Informed consent

Information and guidance for researchers, what is informed consent.

Informed consent is one of the founding principles of research ethics. Its intent is that human participants can enter research freely (voluntarily) with full information about what it means for them to take part, and that they give consent before they enter the research.

Consent should be obtained before the participant enters the research (prospectively), and there must be no undue influence on participants to consent. The minimum requirements for consent to be informed are that the participant understands what the research is and what they are consenting to.  

There are two distinct stages to a standard consent process for competent adults:

  • Stage 1 (giving information) : the person reflects on the information given; they are under no pressure to respond to the researcher immediately.  
  • Stage 2 (obtaining consent): the researcher reiterates the terms of the research, often as separate bullet points or clauses; the person agrees to each term (giving explicit consent) before agreeing to take part in the project as a whole. Consent has been obtained.

Researchers should ensure that they comply with the General Data Protection Regulation (GDPR) during and after the consent process, especially if they will be collecting 'special category' (ie sensitive) data or personal data in the course of their research (also refer to the advice on consent in research involving children ).  See also the guidance on data protection and research and the data protection checklist for use when preparing an application for ethical review.

Where your research includes filming or photography, you should refer to specific guidance in the Photography and GDPR toolkit .

Written or oral consent – which process suits your project?

Which process to use depends on the research project (its context, design and participants), though an oral process is usually only appropriate where a written process is not feasible. Any consent process must be understandable to the participants concerned. Please see the sections below to find out about different processes which may be used depending on the context, as well as informed consent templates for each process.

Written informed consent process

A written process is used where:

  • Reading and signing forms is not problematic.
  • The research is complex or has multiple stages.
  • First access to the research participants is by providing written information.

Though opinions differ about the legal force of signed consent forms, they provide extra proof that the terms of consent have been understood. This can be especially important when seeking consent for copyright over data, or for future uses of data. Also, future funders or regulators may want written proof of the terms of original consent.

For literate participants who are not put off by written information, a written process is often a straightforward way of communicating the 'research contract'.

Between the provision of information and obtaining consent, the participant should be given a reasonable amount of time to consider whether to consent and to ask questions, though the time given depends on the project design, the context of the research and the participants.

The written consent templates below can be adapted to suit your study.

Oral informed consent process

An oral consent process is where researcher and participant have a conversation to give information and obtain consent.  There is no paper form to sign. It is normally used:

  • where literacy is a problem
  • where there are cultural or political concerns with signing contract-like documents
  • where either the researcher and/or the participant could be put at risk by existence of a paper record
  • where time for consent is limited, eg a chance interaction between researcher and participant (although you should not use an oral process merely to correct poor planning of research)
  • for research conducted via remote video conferencing software

It may also be more appropriate when interviewing elite participants as part of the research.

For all other research, how you arrange the oral process depends on how you will encounter your participants (for example email, phone, an on-the-street-meeting by chance). Between the information-giving and consent stage the participant should be given a reasonable amount of time to consider whether to consent, though this depends on the project design, the type of participants and the context of the research.

When obtaining oral consent, please ensure you are recording the consent process either using a recording device (for example audio recorder if you are conducting an interview that needs to be recorded) or, if participants do not agree to audio recording or if using or keeping audio records is unsafe, by using a researcher record of oral consent template or completing a written consent form on their behalf.

The oral consent templates below can be adapted to suit your study, but careful consideration is required to ensure that these are appropriate for the research and the participants.

Informed consent templates

Written informed consent process (including online surveys), template agreements, cases where 'implied consent' may be acceptable (for example online surveys).

Researchers should always aim to inform people fully and obtain appropriate consent. However, in some cases the research may be straightforward enough that a separate, deliberate process for obtaining consent is not needed. In these cases participants, by their actions, imply consent. This is seen most often in research:

BPG 06 Internet-mediated research

PDF icon

Template information sheet for online research

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  • where no participant personal details are obtained
  • where the topic of research is very low risk and no special category data will be collected
  • where participation is confined to one small task, eg completing a survey or simple pencil or computer task

Please note: consent cannot be inferred from inaction (eg failure to move away from a camera).  

When consent works against the aims of research

If your research employs deception, you will not be able to inform participants fully about your project’s true aims. In this case please check if you can fully apply the CUREC approved procedure on research involving the deception of participants . If the deception raises ethical concerns such that the application is not covered by this procedure please complete a CUREC 2 application form.

Some research settings evolve very rapidly (for example in conflict studies). Similarly, some research participants may only be revealed in time-poor or emergency settings (eg heart attack patients). This infringes on the standard information-giving stage of research. The vulnerability of participants in those settings may justify an expedited or fully waived consent process. Again it is important to describe the research setting clearly. You may need to complete a CUREC 2 application to the relevant committee in these cases: please check with your DREC or your IDREC .

Last updated Thursday 2 December 2021

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Home » Informed Consent in Research – Types, Templates and Examples

Informed Consent in Research – Types, Templates and Examples

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Informed Consent in Research

Informed Consent in Research

Informed consent is a process of communication between a researcher and a potential participant in which the researcher provides adequate information about the study, its risks and benefits, and the participant voluntarily agrees to participate. It is a cornerstone of ethical research involving human subjects and is intended to protect the rights and welfare of participants.

Types of Informed Consent in Research

There are different types of informed consent in research , which may vary depending on the nature of the study, the type of participants, and the context. Some of the common types of informed consent in research include:

Written Consent

This is the most common type of informed consent, where participants are provided with a written document that explains the study and its requirements. The document typically includes information about the purpose of the study, procedures involved, risks and benefits, confidentiality, and participant rights. Participants are asked to sign the document as an indication of their willingness to participate.

Oral Consent

In some cases, oral consent may be used when a written document is not practical or feasible. Oral consent involves explaining the study and its requirements to participants verbally and obtaining their consent. This method may be used for studies with illiterate or visually impaired participants or when conducting research remotely.

Implied Consent

Implied consent is used in studies where participants’ actions are taken as an indication of their willingness to participate. For example, a participant may be considered to have given implied consent if they show up for a scheduled appointment for the study.

Opt-out Consent

This method is used when participants are given the opportunity to decline participation in a study. Participants are provided with information about the study and are given the option to opt-out if they do not wish to participate. This method is commonly used in population-based studies or surveys.

Assent is used in studies involving minors or participants who are unable to provide informed consent due to cognitive impairment or disability. Assent involves obtaining the agreement of the participant to participate in the study, along with the consent of a legally authorized representative.

Informed Consent Format in Research

Here’s a basic format for informed consent that can be customized for specific research studies:

  • Introduction : Begin by introducing yourself and the purpose of the study. Clearly state that participation is voluntary and that participants can withdraw at any time without penalty.
  • Study Overview : Provide a brief overview of the study, including its purpose, methods, and expected outcomes.
  • Procedures : Describe the procedures involved in the study in clear, concise language. Include information about the types of data that will be collected, how they will be collected, and how long the study will take.
  • Risks and Benefits : Outline the potential risks and benefits of participating in the study. Be honest and upfront about any discomfort, inconvenience, or potential harm that may be involved, as well as any potential benefits.
  • Confidentiality and Privacy : Explain how participant data will be collected, stored, and used, and what measures will be taken to ensure confidentiality and privacy.
  • Voluntary Participation: Emphasize that participation is voluntary and that participants can withdraw at any time without penalty. Explain how to withdraw from the study and who to contact if participants have questions or concerns.
  • Compensation and Incentives: If applicable, explain any compensation or incentives that will be offered to participants for their participation.
  • Contact Information: Provide contact information for the researcher or a representative from the research team who can answer questions and address concerns.
  • Signature : Ask participants to sign and date the consent form to indicate their voluntary agreement to participate in the study.

Informed Consent Templates in Research

Here is an example of an informed consent template that can be used in research studies:

Introduction

You are being invited to participate in a research study. Before you decide whether or not to participate, it is important for you to understand why the research is being done, what your participation will involve, and what risks and benefits may be associated with your participation.

Purpose of the Study

The purpose of this study is [insert purpose of study].

If you agree to participate, you will be asked to [insert procedures involved in the study].

Risks and Benefits

There are several potential risks and benefits associated with participation in this study. Some of the risks include [insert potential risks of participation]. Some of the benefits include [insert potential benefits of participation].

Confidentiality

Your participation in this study will be kept confidential to the extent allowed by law. All data collected during the study will be stored in a secure location and only accessed by authorized personnel. Your name and other identifying information will not be included in any reports or publications resulting from this study.

Voluntary Participation

Your participation in this study is completely voluntary. You have the right to withdraw from the study at any time without penalty. If you choose not to participate or if you withdraw from the study, there will be no negative consequences.

Contact Information

If you have any questions or concerns about the study, you can contact the investigator(s) at [insert contact information]. If you have questions about your rights as a research participant, you may contact [insert name of institutional review board and contact information].

Statement of Consent

By signing below, you acknowledge that you have read and understood the information provided in this consent form and that you freely and voluntarily consent to participate in this study.

Participant Signature: _____________________________________ Date: _____________

Investigator Signature: ____________________________________ Date: _____________

Examples of Informed Consent in Research

Here’s an example of informed consent in research:

Title : The Effects of Yoga on Stress and anxiety levels in college students

Introduction :

We are conducting a research study to investigate the effects of yoga on stress and anxiety levels in college students. We are inviting you to participate in this study.

If you agree to participate, you will be asked to attend four yoga classes per week for six weeks. Before and after the six-week period, you will be asked to complete surveys about your stress and anxiety levels. Additionally, we will measure your heart rate variability at the beginning and end of the six-week period.

Risks and Benefits:

There are no known risks associated with participating in this study. However, the benefits of practicing yoga may include decreased stress and anxiety levels, increased flexibility and strength, and improved overall well-being.

Confidentiality:

All information collected during this study will be kept strictly confidential. Your name will not be used in any reports or publications resulting from this study.

Voluntary Participation:

Participation in this study is completely voluntary. You are free to withdraw from the study at any time without penalty.

Contact Information:

If you have any questions or concerns about this study, you may contact the principal investigator at (phone number/email address).

By signing this form, I acknowledge that I have read and understood the above information and agree to participate in this study.

Participant Signature: ___________________________

Date: ___________________________

Researcher Signature: ___________________________

Importance of Informed Consent in Research

Here are some reasons why informed consent is important in research:

  • Protection of participants’ rights : Informed consent ensures that participants understand the nature and purpose of the research, the risks and benefits of participating, and their rights as participants. It empowers them to make an informed decision about whether to participate or not.
  • Ethical responsibility : Researchers have an ethical responsibility to respect the autonomy of participants and to protect them from harm. Informed consent is a crucial way to uphold these principles.
  • Legality : Informed consent is a legal requirement in most countries. It is necessary to protect researchers from legal liability and to ensure that research is conducted in accordance with ethical standards.
  • Trust : Informed consent helps build trust between researchers and participants. When participants understand the research process and their role in it, they are more likely to trust the researchers and the study.
  • Quality of research : Informed consent ensures that participants are fully informed about the research and its purpose, which can lead to more accurate and reliable data. This, in turn, can improve the quality of research outcomes.

Purpose of Informed Consent in Research

Informed consent is a critical component of research ethics, and it serves several important purposes, including:

  • Respect for autonomy: Informed consent respects an individual’s right to make decisions about their own health and well-being. It recognizes that individuals have the right to choose whether or not to participate in research, based on their own values, beliefs, and preferences.
  • Protection of participants : Informed consent helps protect research participants from potential harm or risks that may arise from their involvement in a study. By providing participants with information about the study, its risks and benefits, and their rights, they are able to make an informed decision about whether to participate.
  • Transparency: Informed consent promotes transparency in the research process. It ensures that participants are fully informed about the research, including its purpose, methods, and potential outcomes, which helps to build trust between researchers and participants.
  • Legal and ethical requirements: Informed consent is a legal and ethical requirement in most research studies. It ensures that researchers obtain voluntary and informed agreement from participants to participate in the study, which helps to protect the rights and welfare of research participants.

Advantages of Informed Consent in Research

The advantages of informed consent in research are numerous, and some of the most significant benefits include:

  • Protecting participants’ autonomy: Informed consent allows participants to exercise their right to self-determination and make decisions about whether to participate in a study or not. It also ensures that participants are fully informed about the risks, benefits, and implications of participating in the study.
  • Promoting transparency and trust: Informed consent helps build trust between researchers and participants by providing clear and accurate information about the study’s purpose, procedures, and potential outcomes. This transparency promotes open communication and a positive research experience for all parties involved.
  • Reducing the risk of harm: Informed consent ensures that participants are fully aware of any potential risks or side effects associated with the study. This knowledge enables them to make informed decisions about their participation and reduces the likelihood of harm or negative consequences.
  • Ensuring ethical standards are met : Informed consent is a fundamental ethical requirement for conducting research involving human participants. By obtaining informed consent, researchers demonstrate their commitment to upholding ethical principles and standards in their research practices.
  • Facilitating future research : Informed consent enables researchers to collect high-quality data that can be used for future research purposes. It also allows participants to make an informed decision about whether they are willing to participate in future studies.

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  • Open access
  • Published: 09 April 2021

The informed consent process in health research with under-served populations: a realist review protocol

  • Eleanor Hoverd   ORCID: orcid.org/0000-0002-8482-655X 1 ,
  • Sophie Staniszewska 2 &
  • Jeremy Dale 3  

Systematic Reviews volume  10 , Article number:  103 ( 2021 ) Cite this article

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The informed consent process aims to provide potential participants with information about health research that enables them to make an informed decision as to whether they choose to participate, or not. However, it remains unclear as to whether the process is effective for those who are under-served in health research. It is a pivotal issue within health research that the diversity of people who participate is broadened. The National Institute for Health Research (NIHR) pledges to support equality, diversity and inclusion, actively creating opportunities for all citizens whom are eligible, to take part in health research.

In order to understand how the informed consent process for under-served populations in health research works, under what circumstances and in what respects, a realist review approach will be undertaken. Searches will be carried out using electronic databases (EMBASE, MEDLINE, Web of Science and PsycINFO), along with selected websites and grey literature. Development of initial rough programme theory(ies) will lead to a more refined programme theory that will provide an explanation of context, mechanism and outcomes. Stakeholder involvement by NIHR (Public) Research Champions, health professionals and clinical academics will provide expert opinion about concepts and programme theory.

Findings of this realist review will highlight how the informed consent process in health research affects the experience and decision-making process of potential participants from under-served populations. They will be written up in accordance with RAMESES guidelines and disseminated to patients and the public, health researchers, health professionals and policymakers through peer-reviewed publication, presentations and discussions. The review will contribute to our understanding of the mechanisms that cause both positive and negative outcomes in the informed consent process for those whom are often under-represented in health research to inform policy, study design and delivery.

Peer Review reports

Health research in the twenty-first century must be inclusive in order to generate evidence that is applicable to diverse populations [ 1 ]. However, it is recognised that many groups are under-served in health research. There is an increasingly urgent need to address this. One factor contributing to this is the informed consent process. Through a lack of flexibility and sensitivity in the way in which it is designed and delivered [ 2 , 3 , 4 ], participants from under-served populations may be inadvertently excluded [ 5 , 6 , 7 ].

Defining under-served as a concept is vital to developing understanding of how informed consent enables or inhibits diversity in research. The INCLUDE (Innovations in Clinical Trials Designs in Under-represented groups) project has been looking to improve representation of under-served groups in clinical trials in the UK [ 8 ]. Following involvement from a range of stakeholder groups as part of the project, it is recommended that the term under-served is preferred when describing the many groups of people whom are often not represented in health research, such as ethnic minority groups [ 8 ]. It is unclear from the wider literature as to what a suitable definition of under-served groups is, as this varies according to setting and perspective, but they are often those groups whom are met with difficulties in accessing and utilising resources [ 9 ]. It is a term frequently used by the World Health Organization (WHO) often describing areas as rural, remote or poor and populations as excluded or vulnerable, although a definition is not evident [ 10 , 11 ]. This will be explored further during the realist review as part of mapping out the territory, identifying the types of populations that are under-served in health research, as part of the scoping the literature [ 12 ]. In addition, a suitable working definition will be proposed by the stakeholder groups for the purpose of this review.

Previous studies on the informed consent process have reported that potential participants’ lack of understanding of study information is a significant issue [ 13 , 14 , 15 ]. The informed consent process, when carried out effectively, respects the decision made by a potential participant as to whether they wish to take part, or not, in health research [ 16 ]. However, evidence suggests that information provided to potential participants is often complicated and lengthy causing concern around issues of comprehension and effectiveness, putting into question the validity of the whole process [ 3 , 16 , 17 , 18 , 19 ]. This raises questions about the effectiveness and appropriateness of the informed consent process—the way in which it is designed and delivered for populations that may not be suited to receiving a uniform process and about the circumstances under which it works, if it works [ 4 , 5 ].

Previous systematic reviews have focussed on understanding and improving the informed consent process, although little has changed in the way in which it is carried out [ 13 , 18 , 20 ]. There is some evidence to suggest that the use of multi-media interventions to improve understanding, along with extended discussions during the informed consent process, may be effective, although these interventions have not been adopted in practice [ 18 , 21 ]. In the past, there have been a number of concerns from researchers and Institutional Review Boards (IRBs) including how to conduct appraisal of computer-based informed consent, costs associated with the development of new technology to support the informed consent process, lack of support from government agencies and issues around protecting confidentiality, thus resulting in reluctance to change from traditional consent methods [ 15 , 22 ].

Since these systematic reviews were carried out, global healthcare has rapidly begun to adopt digital technology to deliver interventions, provide information and communicate to patients [ 23 ]. The World Health Organization (WHO) has recently produced a Global Digital Health Strategy 2020–2024, aiming to make health systems around the world stronger, for the benefit of all populations [ 24 ]. The need for further research to understand how the informed consent process is experienced and understood by those whom are under-served is vital in order to contribute to the development of a more flexible, innovative informed consent process. This may also provide further benefit in understanding the requirements of these populations in order to develop a digital process that has the capability of being utilised more broadly within health care [ 18 ].

Failing to include diverse representation of populations in health research risks producing findings that are not applicable, nor meaningful to the wider population, can lead to methodological weakness [ 25 ]. It can also limit discovery and produce unforeseen consequences, preventing the broader population from benefitting [ 26 ]. The recent effect of COVID-19 on ethnic minority populations demonstrates the urgent need for ensuring health research is inclusive [ 22 ], providing an opportunity to identify how research processes are supporting this requirement. There is a need for further evidence to help policymakers and health researchers improve the process to make health research more inclusive, keep up with the diverse needs of our population, improve our understanding of what works and for which groups, and adapt it to work in various settings and under different conditions, whilst maintaining its validity.

Realist review methodology

The informed consent process is complex [ 13 , 17 , 18 , 27 ]. A realist review will advance knowledge by offering a deeper understanding as to how, why and in what contexts an informed consent process works best for enabling under-served populations to make an informed decision as to whether to participate in health research [ 28 ]. Whilst there is considerable literature on the informed consent process in health research, there remains a gap in addressing the complexities of the process that affect the opportunity for under-served individuals to make a decision about taking part.

This realist review will gather feedback and advice from content experts on the evolving programme theory and will not entail primary data collection. NIHR (Public) Research Champions and health professionals will be asked to offer their views as ‘content’ experts concerning the believability and comprehensiveness of a programme theory and offer suggestions of locating further data [ 29 ]. Stakeholders will provide expert opinion, adding value to the review [ 28 ]. This iterative process will add to the evidence in a way that goes beyond a traditional systematic review [ 30 ]. The experiences of these groups will help to clarify how the informed consent process is expected to work, whilst including and referring to the evidence in order to explain the mechanisms.

Realist reviews seek to develop theories using an explanatory approach which is particularly important for understanding informed consent as a complex social intervention that heavily depends on the context of delivery and how it is delivered [ 31 ]. The CMO configurations (C—context, M—mechanism, O—outcome) embedded within the programme theory will help to provide causal explanations that explain the relationships between contexts (C), which ‘activate’ mechanisms, resulting in one or more outcomes (O) [ 32 ]. This will lead to the development of a programme theory that will be tested and refined, providing an explanation as to how the informed consent process operates [ 12 ].

An important aspect of the realist review is its ability to provide a transferable framework that facilitates consideration of how a process such as informed consent is controlled and understood by government authorities; in the UK, these include the Medicines and Healthcare products Regulatory Agency (MHRA) and Health Research Authority (HRA), IRBs, researchers, health professionals and participants in health research [ 31 ]. The explanatory powers of the programme theory of informed consent are transferable to different settings where the same mechanisms are likely to be in operation. This review will also provide evidence around what the current informed process experience looks like for under-served populations and, in addition, will explore which mechanisms, contexts and conditions affect their decision-making during the informed consent process.

This realist review protocol has been written according to the PRISMA-P guidelines [ 33 ].

Review aim, questions and objectives

Over-arching research question:.

What contextual factors influence the decision to take part in health research in under-served populations?

The aim is to develop and refine a programme theory that explains the factors that influence the decision to take part in health research in under-served populations.

To undertake a realist review of the literature to identify the contexts and mechanisms that affect the informed consent process and the decision to participate in health research in under-served populations

To draw on the review’s programme theory to develop guidance that addresses barriers to participating in health research in under-served populations

Stakeholder groups

This review will involve stakeholders (described below) who will be invited to comment on the process of informed consent in health research as NIHR (Public) Research Champions, health professionals and clinical academics. NIHR (Public) Research Champions are volunteers who are interested in raising awareness about health research, particularly to those who often do not participate [ 34 ]. This mix of stakeholders is considered to hold positions that are relevant to the topic of the review and to have a vested interest on behalf of under-served populations [ 35 ]. Ethical approval is not required as stakeholders will be contributing collaboratively to content and dissemination, not providing data [ 36 , 37 , 38 ]. These stakeholders will provide advice on what may be in a programme theory, helping with refinement and sharing views on the credibility of a programme theory, along with suggestions as to where to find more data [ 29 ]. They will be considered “content” experts as entitled by Wong and will be invited to be involved and asked to provide input at certain steps in the review as displayed in Table 1 [ 29 ]. It will be beneficial to share the findings with health researchers and policymakers such as the National Institute for Health Research (NIHR) and Health Research Authority (HRA), but it is not possible for the scope of this review to involve them in discussions as this would require more time and resources to do so.

Due to the current social distancing requirements associated with the COVID-19 pandemic, discussions with stakeholders will be held using the Microsoft Teams online platform unless stakeholders indicate a preference for other technology that would support accessibility [ 39 ]. Stakeholders will be sent an invitation to join the meeting via EH, to limit accessibility to those invited. There will be two, separate stakeholder group meetings, one for health professionals/clinical academics and one for NIHR (Public) Research Champions, that will enable uninhibited discussions [ 35 ]. A maximum of 10 participants per meeting will be set to provide the opportunity for all to speak. Stakeholders will be contacted via email before the scheduled meetings to offer a brief training session on Microsoft Teams (if required) and a summary of what to expect to ensure meetings run smoothly.

Patient and public involvement

The initial ideas for this review were discussed with NIHR (Public) Research Champions at a local, West Midlands primary care Patient Public Involvement (PPI) meeting held by EH. It was agreed that the topic is important and relevant to patients and the public. NIHR (Public) Research Champions will form a key stakeholder group and will be central to providing expertise at the second and third iterations of the review. At the end of the review, they will comment on the findings and contribute to the dissemination plan through helping to write a lay summary and designing a leaflet for dissemination to their peers.

Patient and public involvement through NIHR (Public) Research Champions will provide insights and opinion on the informed consent process including what it should look like in health research, along with sharing valuable input throughout the realist review steps [ 38 ]. PPI will be facilitated through inviting an existing Equality, Diversity and Inclusion working group from the Clinical Research Network West Midlands that consists of NIHR (Public) Research Champions who are interested in tackling health inequalities within health research specifically. In addition to the NIHR (Public) Research Champions, snowballing of interest from other PPI volunteers who express interest in providing expertise will be invited at their request, to comment at planned meetings also.

Multi-disciplinary involvement

In addition to the PPI stakeholder group, a multi-disciplinary group of health care professionals, clinical academics and the PPI Lead of the CRN West Midlands Equality, Diversity and Inclusion working group from the West Midlands will be invited for consultation, drawing on their expertise and insider knowledge related to the informed consent process in health research and under-served populations. The group collectively will have a variety of experiences including carrying out the informed consent process with local populations from all across the West Midlands, including rural and urban areas and in various settings, such as care homes, secondary care settings and general practice; experience of recruiting participants from under-served populations; and a vested “stake” in reducing health inequalities in health research and also insight into the difficulties of recruiting potential participants from under-served populations in health research. This experience and knowledge will be beneficial when prioritising, refining programme theory and building CMO (Context, Mechanism, Outcome) configurations [ 29 ]. Some professionals may have experience of not being able to carry out the informed consent process with particular patients, or in certain locations, and these experiences are also considered vital in helping to provide explanations of what works and what does not, for whom and in what context.

As recommended by Pawson et al. (2005), a series of steps in accordance with standard Cochrane headings can provide a helpful approach to carrying out a realist review. Therefore, this review will be conducted in this logical way [ 31 ].

Step 1 Development of an initial programme theory

In order to develop an initial programme theory that will ‘map out’ what the informed consent process involves and how it is predicted to work, a scoping search will be conducted [ 40 ]. It is recognised that it is natural for a scoping search to be an iterative process and often challenging, due to the complexity of the intervention under study [ 41 ]. This may require refining of the research question(s) for a length of time during the review [ 42 ]. EH will carry out the scoping search based on terms focussed on the intervention (informed consent). This will enable identification of existing theories about how under-served populations experience and understand information provided during the informed consent process in health research and in what context, and under what conditions it is effective, or ineffective. A combination of electronic databases, along with websites such as the Health Research Authority (HRA), will be searched, see Table 2 . It is also acknowledged that through discussions with stakeholders, further sources may be identified and used to inform the programme theory. The support of an information specialist to support searching will also be requested, as recommended by Pawson [ 32 ].

A list of important intervention theories for exploration will be compiled that will be of relevance to the research questions. Following the creation of a list of all relevant programme theories, they will be shortlisted according to which are deemed to be the most important for further exploration [ 31 ].

Step 2 Evidence searching

Purposive sampling will be used to search the literature. Using this sampling method will enable an iterative process that will allow repeated searching and refinement of search terms as understanding develops throughout the review [ 31 ]. Pawson et al. suggest approaching the search in four parts as follows:

Carry out a background search of the literature

Develop, refine, verify or disprove a theory based on available evidence

Implement the search strategy to identify relevant evidence

Perform a final search that will help to identify further studies that may contribute to sharpening the programme theories discovered [ 31 ].

Free text and MeSH (medical subject headings) will be used to ensure thoroughness. Each database will require an individual search which will be fine-tuned accordingly, to ensure relevant papers are identified. The reference lists of papers included will be examined for locating further papers that may add to the richness of data. To ensure validity and diligence of the search process, experts within the field of interest will be contacted to verify results. Following each stage of the search, it will be essential to check whether any new literature adds anything different to the knowledge around the intervention (informed consent process). This will help to determine when saturation has been reached [ 31 ].

Searching will be conducted and reported in accordance with RAMESES standards [ 38 ]. An example of an initial search strategy for MEDLINE, containing the search terms, is available in Additional file 1 (Search 1).

Step 3 Document selection and data extraction

Preliminary screening of the literature using article titles and abstracts will identify all papers that are potentially relevant. Secondary screening of full texts by the main reviewer (EH) will be carried out according to pre-determined inclusion/exclusion criteria (see Table 3 ). A second reviewer will screen a 10% sample of the results, for agreement, with a record of exclusions made throughout the screening process. Any disagreements will be settled by the stakeholder group. Records will be managed using Endnote Online to manage references.

According to Wong, realist reviews must take a logical approach in considering the trustworthiness of data [ 29 ]. It is important to note that because this review is developing theory and data will come from many sources, Wong suggests assessing the trustworthiness of data by [ 29 ]:

Presuming that empirical data has been acquired methodically.

Deciding if there is lack of clarity around data collection methods, in which case trustworthiness should be regarded with uncertainty.

Making the effort to locate multiple, pertinent sources of data in relation to facets of programme theory. Relevance is key [ 29 ].

In addition to this, utilising a data extraction form will help to provide a reliable approach to data extraction [ 42 ]. The data extraction form will be developed once a programme theory has been established as the content of the form will be informed by the initial programme theory. The data extraction form will be piloted on two articles before implementation, but an open-minded approach will be taken as it is understood that it may be necessary to have several forms to avoid a one-size-fits all approach to extraction [ 28 ].

Data extraction forms will be used in conjunction with Pawson et al.’s recommended approach to gathering information through notetaking and annotation [ 31 , 43 , 44 , 45 , 46 ]. Utilising these methods will provide a comprehensive and auditable trail for data extraction and critical appraisal.

Step 4 Data analysis and synthesis

Synthesis of the evidence will aim to develop, test and refine the programme theory through analysis of the data [ 47 ]. Data will be mapped to create a data matrix according to CMO configurations which will help with interpretations and in producing theory [ 38 ]. Data synthesis will be guided by the approach used by Rivas et al. to support interpretation and development of the programme theory. Following a similar approach will improve methodological quality through [ 43 ]:

Comparing evidence to gain better understanding

Amalgamating data that provide evidence of corresponding mechanisms and outcomes

Further reflecting on evidence that demonstrates opposing outcomes, but similar contexts

Considering the circumstances of evidence that finds different contexts and outcomes

Using judgement to determine methodological strengths and weaknesses [ 30 , 48 ]

Step 5 Refinement and validation of the programme theory

Refining and validating the programme theory that is based on the synthesised data will be carried out with stakeholders who will provide ‘expertise’ to ensure their knowledge and experiences support it [ 28 ]. EH will conduct a remote meeting via Microsoft Teams to share analysis and results of the review allowing stakeholders to be involved in interpreting and refining the programme theory. The involvement of stakeholders will improve how the findings will assist with creating recommendations. Any matters raised by stakeholders that have not been discovered in the findings will be further explored to confirm, refute or refine the programme theory. The timescale for completion of the review will limit the number of times the programme theory can be refined. The final programme theory will be presented in a narrative form with a description of the realist synthesis, in accordance with RAMESES guidelines and standards [ 38 ].

Step 6 Development of recommendations

The review is intended to provide government agencies, IRBs, researchers and health professionals with an explanation of what is effective, what is ineffective and what is unknown about the informed consent process for improving experience and understanding to aid decision-making in under-served populations. EH will lead a discussion remotely whereby stakeholders will be presented with the final programme theory and be given time to determine and agree upon a set of recommendations. Input from the identified key stakeholders will ensure relevance of the recommendations. They may also contribute to further recommendations for developing training on how best to deliver the informed consent process and highlight potential avenues for exploring the design of health research studies.

Ethics and dissemination

Ethical approval is not necessary for this study although all stakeholders will be fully informed of the study intentions. However, there are several ethical considerations to make around patient and public involvement as recommended by Pandya-Wood et al. [ 19 ]. Some of these ethical considerations will also be applied to the professional stakeholder group as to ensure a professional approach is taken. These include role of the public contributor, avoidance of tokenism, the opportunity to withdraw, fairness of opportunity, taking a sensitive approach, and respecting confidentiality and valuing public contributions [ 19 ] (see Table 4 ).

The expertise from NIHR (Public) Research Champions, or public contributors, during stakeholder meetings will help to refine the focus of the searching, help to inform the initial programme theory, provide advice throughout the review, discuss and provide feedback on CMO configurations, and help to create recommendations [ 29 ].

Dissemination

Findings from the review will be disseminated to patients and the public (in the form of a lay summary), researchers, health professionals and policymakers in relation to the informed consent process with under-served populations. The findings will offer deeper understanding about the relationships between the informed consent process and the contexts and mechanisms which influence decision-making by under-served populations. Findings will be shared as set out in Table 5 . The aim of disseminating findings with policymakers is to influence their thinking [ 28 ].

The UK is currently lacking policy that drives inclusion in health research. This realist review will derive from the available literature, along with the expertise of stakeholders, a refined programme theory to explain the context, mechanism and outcomes for the informed consent process in health research with under-served populations.

To our knowledge, this is the first realist review aimed at developing an original programme theory on the informed consent process in health research for under-served populations. As with any research, there are strengths and limitations. These include:

Using realist methods to explore the contexts and mechanisms of the complexities behind the informed consent process in health research, for under-served populations

The involvement of National Institute for Health Research (NIHR) public Research Champions, healthcare professionals and clinical academics in refining the programme theory will ensure the study is relevant

Availability of evidence relating to under-served populations participating in health research may limit theory building

Owing to the current COVID-19 pandemic , stakeholder involvement in the programme theory development may be restricted, and will be limited to remote communication

The results of the review will be useful for policymakers, health researchers and government agencies—sharing explanations about the informed consent process—for creating a health research environment that is more inclusive.

It is worth noting that the current COVID-19 pandemic may potentially cause disruption to this review. This is most likely to affect stakeholder involvement. A flexible approach to stakeholder meetings aims to minimise this as much as possible. Any impact, or variations to the original protocol because of the pandemic, will be discussed in the review results paper.

Availability of data and materials

Not applicable.

Abbreviations

Centre for engagement and dissemination

Context, mechanism, outcome

Clinical research network

Health research authority

Innovations in clinical trials designs in under-represented groups

Institutional review boards

Medicines and healthcare products regulatory agency

National institute for health research

Patient and public involvement and engagement

World health Organization

Corbett J, D'Angelo C, Gangitano L, et al. Future of Health: findings from a survey of stakeholders on the future of health and healthcare in England. Dep Health. 2017;1–72. https://www.rand.org/pubs/research_reports/RR2147.html . Accessed 11 Feb 2020.

Davis T, Holcombe R, Berkel H, et al. Informed consent for clinical trials: a comparative study of standard versus simplified forms. J Natl Cancer Inst. 1998;90(9):668–74. https://doi.org/10.1093/jnci/90.9.668 .

Article   CAS   PubMed   Google Scholar  

Dunn L, Jeste D. Enhancing informed consent for research and treatment. Neuropsychopharmacology. 2001;24(6):595–607. https://doi.org/10.1016/S0893-133X(00)00218-9 .

Kadam R. Informed consent process: a step further towards making it meaningful! Perspect Clin Res. 2017;8(3):107–12. https://doi.org/10.4103/picr.PICR_147_16 .

Article   PubMed   PubMed Central   Google Scholar  

Hughson J, Woodward-Kron R, Parker A, et al. A review of approaches to improve participation of culturally and linguistically diverse populations in clinical trials. Trials. 2016. https://doi.org/10.1186/s13063-016-1384-3 .

McDougall G, Simpson G, Friend M. Strategies for research recruitment and retention of older adults of racial and ethnic minorities. J Geront Nurs. 2015. https://doi.org/10.3928/00989134-20150325-01 .

Redwood S, Gill P. Under-representation of minority ethnic groups in research- call for action. Br J Gen Pract. 2013;63(612):342–3. https://doi.org/10.3399/bjgp13X668456 .

Witham, M.D., Anderson, E., Carroll, C. et al. Developing a roadmap to improve trial delivery for under-served groups: results from a UK multi-stakeholder process. Trials. 2020; doi.org/ https://doi.org/10.1186/s13063-020-04613-7

Wang V. Encyclopedia of Strategic Leadership and Management Hershey. Pennsylvania: IGI Global; 2017. https://igi-global.com . Accessed 19 May 2020. https://doi.org/10.4018/978-1-5225-1049-9 .

Book   Google Scholar  

World Health Organisation. Increasing access to health workers in underserved areas: a conceptual framework for measuring results: Bulletin of the World Health Organisation. Geneva: WHO Press; 2010. www.who.int/bulletin/volumes/88/5/09-070920/en/ . Accessed June 2020.

World Health Organisation. Resolution on community health workers to be considered at the upcoming World Health Assembly. News and Events. Geneva: WHO Press; 2019 https://www.who.int/hrh/news/2019/community-health-workers-resolution-at-wha/en/ . Accessed June 2020.

Papoutsi C, Mattick K, Pearson M, Brennan N, Briscoe S, Wong G. Social and professional influences on antimicrobial prescribing for doctors-in-training: a realist review. J Antimicrobial Chemo. 2017;72(9):2418–30. https://doi.org/10.1093/jac/dkx194 .

Article   CAS   Google Scholar  

Flory J, Emmanuel E. Interventions to improve research participants' understanding in informed consent for research: a systematic review. JAMA. 2004;292(13):1593–601. https://doi.org/10.1001/jama.292.13.1593 .

Montalvo W, Larson E. Participant comprehension of research for which they volunteer: a systematic review. J Nurs Schol. 2014. https://doi.org/10.1111/jnu.12097 .

Pandiya A. Readability and comprehensability of informed consent forms for clinical trials. Perspect Clin Res. 2010;1(3):98–100.

PubMed   PubMed Central   Google Scholar  

HRA. Applying a proportionate approach to the process of seeking consent. 2017. http://www.file:///C:/Users/mhsman/Downloads/Proportionate_approach_to_seeking_consent_HRA_Guidance.pdf . Accessed: 20 Apr 2020.

Joffe S, Cook E, Cleary P, et al. Quality of informed consent in cancer clinical trials: a cross-sectional survey. Lancet. 2001;358(9295):1772–7. https://doi.org/10.1016/S0140-6736(01)06805-2 .

Nishimura A, Carey J, Erwin P. Improving understanding in the research informed consent process: a systematic review of 54 interventions tested in randomised control trials. BMC Med Ethics. 2013;14(1). https://doi.org/10.1186/1472-6939-14-28 .

Pandya-Wood R, Barron D, Elliot J. A framework for public involvement at the design stage of NHS health and social care research: time to develop ethically conscious standards. Res Involvement Engagement. 2017;3(1):6. https://doi.org/10.1186/s40900-017-0058-y .

Article   Google Scholar  

Thanh Tam N, Tien Huy N, Bich Thoa L, et al. Participants' understanding of informed consent in clinical trials over three decades: systematic review and meta-analysis. Bull World Health Organisation. 2015;93:186–98.

Jimison H, Sher P, Appleyard R, et al. The use of multimedia in the informed consent process. J Amer Med Info Assoc. 1998;5(3):245–56. https://doi.org/10.1136/jamia.1998.0050245 .

Kirby T. Evidence mounts on the disproportionate effect of COVID-19 on ethnic minorities. Lancet Respir Med. 2020;8(6):547–8. https://doi.org/10.1016/S2213-2600(20)30228-9 .

Article   CAS   PubMed   PubMed Central   Google Scholar  

Department of Health and Social Care. Policy paper. The future of healthcare: our vision for digital, data and technology in health and care 2018. www.gov.uk/government/publications/the-future-of-healthcare-our-vision-for-digital-data-and-technology-in-health-and-care/the-future-of-healthcare-our-vision-for-digtial-data-and-technology-in-health-and-care . Accessed 19 May 2020.

World Health Organisation. Draft Global Strategy on Digital Health 2020. http://www.who.int/docs/default-source/documents/gs4dhdaa2a9f352b0445bafbc79ca799dce4d.pdf?sfvrsn=f112ede5_38 . Accessed 16 May 2020.

Manrai A, Birgit H, Funke P, et al. Genetic misdiagnoses and the potential for health disparities. N Eng; J Med. 2016;375(7):655–65. https://doi.org/10.1056/NEJMsa1507092 .

Popejoy A, Fullerton S. Genomics is failing on diversity. Nature. 2016;538(7624):161–4. https://doi.org/10.1038/538161a .

O'Neill O. Some limits of informed consent. J Med Ethics. 2003;29(1):4–7. https://doi.org/10.1136/jme.29.1.4 .

Pawson R, Greenhalgh T, Harvey G, et al. Realist synthesis: an introduction 2004. http://www.ccsr.ac.uk/methods/ . Accessed 10 Feb 2020.

Wong G. Data Gathering in realist reviews. Looking for needles in haystacks. In: Emmel, N, Greenhalgh, J, Manzano et al. Doing Realist Research London Sage. 2018. p.132.

Pearson M. Realist synthesis: what is it and why might I want to use it? 2011. http://www.medicine.exeter.ac.uk/media/universityofexeter/medicalschool/research/pentag/20111-12-06_Pearson_Realist_review_What_How_Why.pdf . Accessed 15 Feb 2020.

Pawson R, Greenhalgh T, Harvey G, Walshe K. Realist review - a new method of systematic review designed for complex policy interventions. J Health Serv Res Policy. 2005;10(1_suppl):21–34. https://doi.org/10.1258/1355819054308530 .

Pawson R. Evidence-based policy: a realist perspective. Can J Prog Eval. 2006;23(2):268–70.

Google Scholar  

Moher D, et al. Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) 2015 statement. Syst Rev. 2015; 4 (1):1. https://doi.org/10.1186/2046-4053-4-1 .

National Institute for Health Research. Research Champions 2020. http://www.nihr.ac.uk/patients-carers-and-the-public/i-want-to-help-with-research/research-champions.htm . Accessed 20 Apr 2020.

Leigh-Hunt D. Identifying and managing internal and external stakeholder interests. Understanding organisations: identifying and managing internal and external stakeholder interests. Health Knowledge Education, CPD and Revalidation from Phast 2016. http://www.healthknowledge.org.uk/public-health-textbook/organisation-management/5b-understanding-ofs/managing-internal-external-stakeholders . Accessed 19 May 2020.

Carrieri D, Pearson M, Mattick K, Papoutsi C, Briscoe S, Wong G, et al. Interventions to minimise doctors' mental ill-health and its impacts on the workforce and patient care: the Care Under Pressure realist review. Health Serv Deliv Res. 2020;8(19):1–132. https://doi.org/10.3310/hsdr08190 .

INVOLVE Patient and public involvement in research and research ethics committee review 2009. http://www.invo.org.uk/wp-content/uploads/2011/12/INVOLVENRESfinalStatement310309.pdf . Accessed 12 Jun 2020.

Wong G, Greenhalgh T, Westhorp G, Pawson R. Development of methodological guidance, publication standards and training materials for realist and meta-narrative reviews: the RAMESES (Realist and Meta-narrative Evidence Syntheses - Evolving Standards) project. Health Serv Deliv Res. 2014a;2(30):1–252. https://doi.org/10.3310/hsdr02300 .

NCCfP. Online engagement: a guide to creating and running virtual meetings and events 2020. http://www.publicengagement.ac.uk/sites/default/files/publication/creating_and_running_virtual_events_-_april_2020_v1.pdf . Accessed 13 Apr 2020.

Wong G, Westhorp G, Pawson R, Greenhalgh T Realist synthesis. Realist Training Materials. 2013. Available from: http://www.ramesesproject.org/media/Realist_reviews_training_materials.pdf . Accessed 01 Feb 2021.

Hurwitz B, Greenhalgh T, Skultans V. Narrative research in health and illness. Oxford: Blackwell Publishing Ltd; 2004. https://doi.org/10.1002/9780470755167 .

Emmel N, Greenhalgh J, Manzano A, et al. Doing realist research. London: Sage; 2018. https://doi.org/10.4135/9781526451729 .

Rivas C, Vigours C, Cameron J, et al. A realist review of which advocacy interventions work for which abused women under what circumstances. Cochrane Database Syst Rev. 2019. https://doi.org/10.1002/14651858.CD013135 .

Rycroft-Malone J, McCormack B, Hutchinson A. Realist synthesis: illustrating the method for implementation research. Impl Sci. 2012;7(1). https://doi.org/10.1186/1748-5908-7-33 .

Weetman K, Wong H, Scott E, et al. Improving best practice for patients receiving hospital discharge letters: a realist review protocol. BMJ Open. 2017;7(11):e018353. https://doi.org/10.1136/bmjopen-2017-018353 .

Mogre V, Scherpbier A, Dorman T. A realist review of educational interventions to improve the delivery of nutrition care by doctors and future doctors. Syst Rev. 2014. https://doi.org/10.1186/2046-4053-3-148 .

Ahikari B, Vincent R, Wong G. A realist review of community engagement with health research. Wellcome Open Res. 2019;4(87):1–35. https://doi.org/10.12688/wellcomeopenres.15298.2 .

Gough D. Weight of evidence: a framework for the appraisal of the quality and relevance of evidence. Res Pap Educ. 2007;22(2):213–28. https://doi.org/10.1080/02671520701296189 .

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Acknowledgements

SS is part funded by the NIHR Applied Research Collaboration (ARC) West Midlands, the NIHR Health Protection Research Unit (HPRU) Gastrointestinal Infections, and the NIHR HPRU Genomics and Enabling data.

Eleanor Hoverd is funded by a National Institute for Health Research (NIHR), HEE/NIHR ICA Programme Predoctoral Clinical Academic Fellowships grant number NIHR 300317. Funding for the open access charges for the publication of this protocol was provided by the NIHR Clinical Research Network West Midlands.

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Hoverd, E., Staniszewska, S. & Dale, J. The informed consent process in health research with under-served populations: a realist review protocol. Syst Rev 10 , 103 (2021). https://doi.org/10.1186/s13643-021-01652-2

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The Role of the Nurse in Informed Consent to Treatments: An Observational-Descriptive Study in the Padua Hospital

Veronica strini.

1 Clinical Research Unit, University-Hospital of Padua, via Giustiniani 2, 35128 Padua, Italy

Roberta Schiavolin

2 Continuity of Care Service, University-Hospital of Padua, via Giustiniani 2, 35128 Padua, Italy; [email protected]

Angela Prendin

3 Independent Research, University-Hospital of Padua, via Giustiniani 2, 35128 Padua, Italy; ti.oohay@nidnerpa

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The authors confirm that the data supporting the findings of this study are available within the article. Raw data or tables omitted in this article that support the findings of this study are available from the corresponding author, upon reasonable request.

Background: The process to obtain valid informed consent in healthcare reflects many aspects. Healthcare professionals that take care of the patient must provide him all the necessary information and verify his understanding, considering individual characteristics. Nurses are one of the main participants in this process. Objective: This study assesses nurses’ perceptions of their role in the informed consent process. Material and Methods: An observational study involving 300 nurses operating in 13 wards of the Padua Hospital, through the submitting of a questionnaire in the period November–December 2018. Results: The final sample is made up of 206 nurses—27 males (13.11%) and 179 females (86.89%). Work experience, on average 15 years, is significant in determining the answers to questions about opinions and experiences. Age is significant in determining how often nurses provide information to the patient’s family members about the actions to be taken after discharge. The ward was decisive in the responses related to information provided to patients on the nursing care level and the actions to be taken after discharge, and the definition of the nurse’s duties. Conclusions: The data collected show the need for interventions to reduce the causes of difficult that the nurse has in informing patients.

1. Background

Informed consent in healthcare is the process throughout patient decides freely and independently whether to start or continue the planned health treatment, after receiving specific information and made understandable to him by the doctor or health team based on their respective skills [ 1 ]. Information and informed consent play an essential role from a legal, as well as ethical point of view [ 2 ], as patients have the right to know their state of health, the diagnosis, and treatments available, the risks and probable benefits, and consequently choose any alternative [ 3 ]. Informed consent should be a process of mutually shared responsibility by the patient and the physician, ensuring adequate and relevant information that is well comprehended by the individual patient, and is used correctly for their decision-making [ 4 ]. It is very important to illustrate to the patient the possible risks in relation to complications and benefits, the presence of reasonable alternatives to the procedure, and the right of the patient to withdraw his consent at any time [ 5 ]. The accuracy of healthcare professionals in informing the patient should provide the necessary elements to make the most convenient and appropriate decision for his well-being [ 6 ]. Disclosure of information and informed consent are relatively new concepts in the patient–physician relationship. They are based primarily on the principle of autonomy, and they have many favorable practical advantages. However, the practical implementation of these requirements is fraught with difficulties, some of which can cause harm to the patient or be obstacles in fulfilling the moral obligation of beneficence [ 4 ]. There are numerous limitations in this process included: Patient understanding, potentially alterations by factors, such as age, training, cognitive level, loss of control and level of anxiety, patient autonomy, how patients use information disclosed by healthcare professionals, and the time required to fully inform patients [ 7 ]. A central reference for the ethics of the health professions is represented by therapeutic self-determination, defined as the individual’s right to decide on their own health, as a guarantee of their identity and dignity [ 8 ]. Information, in the past, has been considered as an exclusively medical aspect, but today must be considered as clinical, because it is common to many professions, integrated and focused on clinical-care pathways, rather than on individual services [ 9 ]. The practice of informed consent is multifaceted and presents complex legal and ethical challenges. Without a clear understanding of the underlying concepts and legal requirements that guide the process, informed consent may fall short of its goals. Nurses can be integral to the process while still practicing within their defined scope of practice. Nurses may serve to ensure patient comprehension, facilitate documentation of consent, address patient anxiety, and identify the appropriate surrogate decision-maker when needed [ 10 ]. Patient understanding and safety is the responsibility of all healthcare professionals [ 11 ].

The ideal completion of the informed consent process may be achieved if surgeons and knowledgeable nurses collaborate for the patient’s good. With a broadened knowledge base on the realities and requirements of the informed consent process, nurses and surgeons may each contribute within their legal scope of practice to reduce the risk of litigation by fully meeting the legal obligations imposed by informed consent statutes [ 10 ].

For the nursing profession, the core-interest is the person and to respond effectively and competently to their nursing care needs, through a true involvement of individuals and families in the care processes that concern them [ 12 ]. Practices related to informed consent and the roles of nurses in the process are strongly influenced by the model of relationships between the different actors: Patients, their families, and healthcare professionals [ 13 ]. Nurses, who have intense interaction with patients, family members, and doctors, can ensure that patients’ right to making an informed decision is respected. In daily practice, it is unclear whether nurses perform these roles in line with their professional service, or more doing the task of assisting doctors in providing patient care [ 13 ].

Although the literature argues that nurses should be advocates for this role, there is limited evidence that nurses are adequately prepared for this role, and that their role is adequately valued. To identify what nurses in preparation, need to be able to skillfully and confidently participate in the informed consent process in a highly hierarchical context, we explored the perception that nurses have regarding their involvement in different contexts of the same hospital, allowing comparative evaluations. In detail, nursing in Italy has reached important milestones in terms of training, decision-making autonomy, and responsibility, and in 2001 the university degree for nursing became the only path to access the profession. In recent years, a new generation of young university-trained nurses have been admitted into the world of work.

A primary reference for Italian nurses is the Code of Ethics for Nurses, and only a previous study has explored their practical adherence to the above standards [ 14 ] and the perception of the nursing role in this particular aspect.

To evaluate the perception of nurses regarding their role in informed consent to treatments.

2. Materials and Methods

This is a prospective descriptive observational study.

2.1. Sampling and Inclusion/Exclusion Criteria

The sample is made up of nursing staff operating in 13 wards of an Italian hospital: Cardiology, neurology, neurosurgery, hematology, general surgery, thoracic surgery, general medicine, Medical Clinic 1, Medical Clinic 5, geriatrics, urology, plastic surgery, and the specialized medical area ward. The final study sample is composed of 206 nurses.

2.2. Inclusion Criteria

  • - Active presence of nursing staff within the various teams during data collection;
  • - Voluntary participation in the study.

2.3. Exclusion Criteria

  • - Nursing staff of wards not included in the study: Intensive Care, Pediatrics, Operating Room, due to the lack of relevance with the proposed questionnaire.
  • - Lack of nursing staff within the team in the period dedicated to data collection;
  • - Not joining the study.

The questionnaire ( Appendix A ) was taken from the study by Ingravallo et al. [ 14 ]. The acquisition and permission for the use of the questionnaire were obtained through a direct request to the author. The questionnaire consists of an initial part of the personal data with information regarding gender, age, type of professional training, length of professional experience, activities in the ward or in an outpatient service. The questionnaire is divided into two units: Nurses’ opinions and experiences. The questionnaires were administered by the researchers with dedicated and delayed weekly accesses from 15 November 2018 to 21 December 2018. Final access dedicated to the collection of the completed questionnaires was then carried out in each ward.

3. Statistical Analysis

Data collection, recording, and analysis were carried out using Microsoft Office Excel and R software. For the latter, “coin” and “exactRankTests” tool utilities were used.

Responses on a scale of intensity were dichotomized into two categories: “negative” (for nothing, little) and “positive” (enough, a lot). Frequency responses were dichotomized into the two categories “not frequently” (never, rarely, sometimes) and ”frequently” (almost always, always). Continuous variables (i.e., age and length of professional experience) were dichotomized by the median values.

Descriptive statistics were presented as n (%) or mean (standard deviation (SD)), median, and range for categorical or continuous variables. A p -value < 0.05 was considered statistically significant.

The final sample of respondents, from all wards ( Table 1 ), was made up of 206 nurses (68.67%)—consisting of 27 males (23.11%) and 179 females (86.89%). The average age of the participants in years was 39.83 ± 9.78. The professional training of the sample ( Table 2 ) was divided into three groups—64 nurses (31.07%) had obtained the Regional School Diploma, 135 nurses (65.53%) had a Bachelor’s Degree, and 7 nurses (3.4%) had a Master’s Degree. Two subgroups were added to these—17 participants (8.25%) had completed a Post Bachelor’s Degree, while only one participant (0.49%) had completed a Post Master’s Degree. The average working period corresponding to 15.71 ± 10.53, and the average working time in the ward is 10.48 ± 9.09.

Distribution of respondents by hospital ward.

Description of participant education.

4.1. Opinion Analysis

Between the five statements posed, statistical significance was found only in statement 7a, which appears to be statistically associated with the demographic and educational characteristics of the interviewees. In detail, it is observed that male subjects respond significantly more positively than female subjects. Furthermore, those who have been working for less time as nurses believe that the studies have been adequate to learn how to communicate information to the patient, compared to those who have been working longer. In particular, it is emphasized that there are no statistically significant differences between wards and the answers given to the opinion questions.

4.2. Experience Analysis

There were significant differences between the answers given in the various wards ( Table 3 ). In question 8a, which investigates how often the nurse has provided patients information about the nursing care plan, it was found that: The general surgery ward responded significantly with values lower than the scale compared to the hematology and neurosurgery wards. Compared to the neurosurgery ward, the neurology and urology wards also gave answers tending towards the minimum values of the scale.

Different answers of the wards in relation to question 8a.

The responses to question 8d ( Table 4 ), which investigates how often nurses provide patients information about the disease they were suffering from, are relevant. In the Medical Clinic 5 ward, nurses responded with significantly more negative scale values than in the cardiology and hematology ward. In the hematology ward, they responded significantly with higher values of the scale than in the neurology, thoracic surgery, general surgery, Medical Clinic 1, and Medical Clinic 5 wards.

Most significant response differences in relation to question 8d.

Question 8g ( Table 5 ) investigates how often the nurse provided information to the patient about what to do at discharge: The nurses of the plastic surgery ward responded with significantly higher values than the wards of Medical Clinic 5, general surgery, and neurology.

Significant differences in response to question 8g.

As regards the age of respondents, it was significant that in question 8c how often nurses provide information about an invasive nursing maneuver before carrying it out, with increasing age nurses respond with statistically more negative values than the scale.

There are significant differences between wards. Question 9b asks how much it facilitated the work of the nurse to provide information to the patient about the nursing care plan. The nurses in the general surgery ward responded more negatively than the scale compared to their colleagues in hematology and neurosurgery.

4.3. Analysis of the Difficulty in Communicating Information to Patients

The analyses did not show statistically significant associations between the difficulties expressed by the nurse in providing information to the patient requested in question 10 and the demographic and educational characteristics of the interviewees. In question 11, related to the causes of difficulties in providing information to patients, it was found that: Subjects respond differently based on education, gender, and ward. The following considerations emerged from the analyses:

  • - Those who do not have a Master’s Degree more easily select option 11, which focuses on the lack of personal training regarding how to communicate with patients.
  • - Those with a Master’s Degree are more likely to select answer 11f, which indicates the lack of sufficient information about the patient’s diagnostic-therapeutic project.
  • - Men more than women, those with more work experience, and those with a Master’s Degree are more likely to select option 11a, which indicates the patient’s poor ability to understand information.

This option was specially selected for the geriatrics ward ( Table 6 ).

Response rate to question 11, with option 11e in the various wards.

4.4. Written Consent

Question 13b asked how often the nurse asked the patient to sign the written consent for the execution of surgery or instrumental investigation. It appears that in the hematology ward, the answer was higher than in neurosurgery, thoracic surgery, general surgery, and Medical Clinic 5.

4.5. Information to Family Members

Question 14c asked, “How often did you provide the patient’s family with information about: What to do after discharge?”. Regarding work experience, it should be noted that as the years of work increase, the question is answered with significantly more positive values. Particularly in the hematology ward, the nurses responded with significantly higher values on the scale than their colleagues in the general surgery, cardiology, general medicine, and Medical Clinic Wards 5. In the Medical Clinic Ward 5, the responses had significantly lower values compared to the wards of urology, plastic surgery, and geriatrics. In the plastic surgery ward, they responded with significantly higher values than their colleagues in the cardiology and general medicine. Finally, there appears to be no significant associations for question 15—“How often did you provide family members with information that you did not provide to the patient?”.

4.6. Role of the Nurse within the Team

There were associations fund regarding the education level of the nurse and ward they worked on. In particular, the response in the neurology ward was significantly lower than in the neurosurgery ward. Nurses who had obtained a Master’s Degree gave answers’ rate lower compared to the values of those who have a Bachelor’s Degree.

4.7. Analysis of Marginal Responses

Questions 8a asked, “How often did you provide patients with information about the nursing care plan?”, 14b asked, “How often did you provide the patient’s family with information about: The nursing care plan?” and 14c, mentioned above, no significant deviation from the central value of the scale was observed. In the case of question 7a—“The course of study adequately prepared me to communicate information to the patient.”—no statistically significant differences were found.

5. Discussion

This study investigated the perception that nurses have regarding their training, provided by their curriculum, in communicating information to patients. As a first result, it emerged that male subjects (13.11% of nurses) responded significantly more positive values ( p -value = 0.002) than female subjects (86.89%). As a second result, it emerged that nurses with less work experience believed they have adequate preparation to inform patients: Their responses found significantly more positive values ( p -value = 0.000). It can be deduced that nurses with less work experience consider the training they have received adequate to communicate information to the patient compared to those who have worked longer. The data did not show statistically significant associations with the level of education and the young age of the nurses. On the contrary, in the study carried out by Ingravallo et al., in addition to the reduced work experience ( p -value = 0.042), associations with young age ( p -value = 0.016) and university education ( p -value = 0.002) were found [ 15 ]. Nurses with these characteristics are more confident that their training is adequate to provide information to patients. In general, the answers to this question do not differ from significantly positive or negative values ( p -value> 0.05), suggesting the need for updating within universities and hospital wards, involving more nurses who have been operating for a longer time [ 10 , 11 ]. The years of work within the various ward (10.48 ± 9.09), the achievement of Post Bachelor’s Degree (8.25%) and Post Master’s Degree (0.49%) were not significant in determining the answers to questions of opinion and experiences. As reported in 2010, both graduate and non-graduate nurses may have difficulty in their own ethical responsiveness to address areas of interest in all healthcare contexts [ 12 ]. In his investigation in four different surveyed regions of the United States, Ulrich found that informed consent remains one of the most frequently cited ethical issues occurring in daily clinical practice [ 16 ]. As reported by Axson in 2017, this remains the same today: Thirty percent of our participants disagree with the statement that their undergraduate education has prepared them to actively engage in informed consent processes. Despite this lack of preparation in university education, three-quarters of nurses in the study reported that when they are unsure of one component of the informed consent process, they know which resources they are available on their unit to assist them [ 11 ]. In Ingravallo’s study of 2017 [ 14 ], regarding the item on whether nurses had any difficulty in providing information to patients, both Korean and Italian nurses reported only slight difficulties, correlated to lack of time or opportunity during work hours, patients’ inability to understand the information and inadequate information regarding the patient’s treatment plan. The same author says that there is inadequate focus on communication skills in both the medical and nursing educational curriculums.

The present study has shown, with statistically significant values ( p -value < 0.05), that nurses in their practice inform and require the patient’s consent before carrying out invasive nursing maneuvers. This data agrees with what is expressed by Ingravallo et al. in which 94% of nurses claim to inform patients about these procedures [ 15 ]. However, according to the nurses, providing this information did not facilitate them in carrying out their work: When they were asked to indicate whether informing the patient about the invasive nursing procedures implemented facilitated the nursing practice, they responded with values significantly lower than the scale items ( p -value < 0.05). Furthermore, a statistically significant association ( p -value < 0.05) emerges between the increase in the age of nurses and the frequency with which they inform patients before performing invasive nursing maneuvers: With increasing age, the nurses provide information, with respect to the invasive nursing maneuvers they implement, with less frequency to patients. This may be because with increasing age and professional experience, nurses are less motivated to inform patients about the services they are about to perform. This is because they often perform their duties in a routine way, maintain their knowledge is rooted, and show little interest in updating [ 17 ]. It can be deduced that they do not provide information on this, since they believe that patients cannot understand them. In fact, from the analyses carried out, this aspect is indicated as one of the main problems in providing information to patients (option selected by 39 nurses); this data emerged predominantly ( p -value < 0.05), especially for those nurses who have more work experience. In general, it emerges that nurses claim to frequently inform patients about what to do after discharge, answering the question with significantly higher values than the items on the scale ( p -value < 0.05). This finding agrees with the literature in the study by Ingravallo et al.—69% of nurses provide this information to patients [ 15 ]. In particular, patients were more informed about the actions they must carry out after discharge within in the wards of hematology (almost always: 38.10%, always: 33.33%) and plastic surgery (almost always: 55%, always: 25%). On the contrary, in Medical Clinic 5 (never: 9.09%, rarely: 22.73%), neurology (never: 18.75%, rarely: 18.75%) and in general surgery (never: 5, 88%, rarely: 41.18%) patients are not adequately informed.

In the Aveyard focus group study [ 18 ], many nurses expressed the view that consent was implied prior to nursing care procedures if the patient has not objected. It was recognized that much of the routine nursing care would fall under this concept of implicit consent if a minimal explanation is provided to the patient. However, according to Cole [ 19 ], the use of implied consent still relies on the nurse to render some of the decisions for the patient rather than for the patient who has the autonomy to make their own decisions.

The previous theme is often connected with the practice of providing information by nurses to patients’ relatives. Colleagues in hematology respond with significantly more positive values than colleagues in general surgery, cardiology, general medicine, and Medical Clinic 5. Furthermore, the frequency with which nurses inform family members about this is strongly correlated ( p -value < 0.05) to their work experience: As they increase their working years, they claim to provide this information more frequently than their colleagues with less work experience. It can be assumed that more experienced nurses are more aware of the key role that family members play in taking care of the patient once discharged, so they take the time to inform them adequately.

Ingravallo affirmed, in 2017, that partial or no disclosure of diagnosis and prognosis and family-centered decision-making remain common, especially among older patients and patients with cancer [ 14 ]. This is mainly attributed, in Italy, to a culture that prioritizes family and community ties over individual ‘self-governance’.

Regarding the definition of the nurse’s tasks in informing the patient within the team, in this study the nurses responded with significantly lower values than the items on the scale ( p -value < 0.05). This data disagrees with what emerged in the study by Ingravallo et al., in which 59% of nurses affirmed the presence of an adequate definition of tasks within the teams they considered [ 15 ]. This difference in response can also be found in the causes of difficulties in providing information to patients (especially in the geriatrics ward: 70%). Nurses with Master’s Degrees most likely attribute it to the lack of sufficient information about the diagnostic project of the patient and the patient’s poor ability to understand information, the latter being selected more by male participants.

In addition to personal characteristics, cultural background, and educational background, the relationship between nurse and patient is influenced by many other factors that are beyond the nurse’s control [ 20 ]. For example, the care environment [ 21 ] and organizational factors, such as a high workload: These may be poorly perceived by patients, but are highly perceived by nurses, creating discrepancies between patient and nurse expectations in behaviors care [ 22 ].

In the present study, nurses were given the opportunity to express personal considerations on the matter. The most-reported difficulties are related to: The lack of an appropriate place to inform patients and caregivers that guarantees privacy; the lack of time to dedicate oneself to informing the patient correctly (reported by 64 nurses); inform the nursing staff of the diagnostic and therapeutic process of the patients (reported by 54 nurses). It is important that there is little communication between nurse and doctor for organizational reasons: Many times, the nurse is forced to provide information of medical relevance to the patient and family members. The present study emphasizes that family members ask nurses for information that is not within their competence with statistically significant values ( p -value < 0.05). Studies show that patients believe nurses are well informed about their medical conditions, medications, and treatments [ 10 , 22 ]. Nurses, in fact, consider themselves more accessible in providing information to patients than doctors [ 23 ]: This is due to the limited time that doctors must talk to patients and family members [ 24 , 25 ]. Moreover, Italian nurses are currently still facing fundamental changes in their roles and responsibilities, and this may result in uncertainty about their role and their level of autonomy within a team [ 15 ]. Furthermore, in this study appears the need to better define the role of nurses in information delivery to patients in Italy.

6. Conclusions

In daily practice, nurses take a fundamental role during the informed consent process. As patient advocates and direct care providers, nurses have a unique opportunity to meaningfully advocate for mutual decision-making—a process that promotes patient autonomy, comprehension, and self-determination. Empowered by a comprehensive understanding of the informed consent process, nurses can serve in that advocacy role without running the risk of practicing outside their professional scope by assuming the responsibility for consenting the patient. The ideal completion of the informed consent process may be achieved if surgeons and knowledgeable nurses collaborate for the patient’s good. With a broadened knowledge base on the realities and requirements of the informed consent process, nurses and surgeons may each contribute within their legal scope of practice to reduce the risk of litigation by fully meeting the legal obligations imposed by informed consent statutes [ 10 ].

The present study could be extended to several realities to have a larger sample, compare the results obtained and make them generalizable to Italian nursing practice. Furthermore, it would be useful to carry out studies, parallel to this, which also involve doctors and patients from different wards, to compare the results and have a global concept of informed consent in the hospital environment. This provides useful data to raise awareness among Healthcare Professionals and Institutions regarding the difficulties still present.

The following limitations were found in this study:

  • - The presence of low sample size by ward and educational qualification;
  • - The results of the study cannot be generalized to all Italian hospital wards, nor to care settings outside the hospital.

8. Ethical Aspects

Before starting the data collection, authorization was requested from the wards involved in the study. The purposes of the study and the methods of data collection were explained to the participants. The privacy and anonymity of the participants were guaranteed, respecting the voluntary nature of participation in the study.

Acknowledgments

We thank Giosuè Bacchin for his precious assistance for document translation.

Appendix A. Patient Information and Consent Questionnaire

Appendix a.1. patient information and consent.

Questionnaire on the views and experiences of nurses in the hospital

1. Age _______

2. Sex M ☐ F ☐

3. Professional training

☐ Regional School Diploma ☐ Bachelor’s Degree ☐ Master’s Degree

☐ Post Bachelor’s Degree   ☐ Post Master’s Degree ☐ PhD

☐ Other (specify) ___________________________

4. How long have you been working as a nurse? __________ years (if less than 1 year specify the months)

5. How long have you been working in this ward? ___________ years (if less than 1 year specify the months)

6. His work activity takes place mainly in: Ward ☐ Outpatient/DH ☐

Appendix A.1.1. Part 1: Opinions

7. How much do you agree with each of the following statements?

Appendix A.1.2. Part 2: Experiences

We ask you to answer the next questions considering what your relationship has been in the last month with patients who were conscious and at least partially able of receiving information and expressing their consent

8. How often did you provide information to patients about:

9. How much did it facilitate your work to provide information regarding:

10. Was it difficult to provide information to patients?

11. If you answered a lot or enough, can you indicate what were the main causes of difficulty? (can give more than one answer)

a Little personal training on how to communicate with patients

b Lack of opportunities (hospitalization too short, patient managed only for a short time)

c There is little time available during the shift

d Too much complexity of the information to be provided

e Poor patient’s ability to understand information

f Not having sufficient information about the patient’s diagnostic-therapeutic project

g Other _________________________________________________________________

12. How often did patients or their family members ask you for information that was not a nursing concern?

13. How often:

14. How often did you provide the patient’s family with information about:

15. How often did you provide family members, separately, with information that you did not provide to the patient?

16. Was the nurse’s duties in providing information to the patient well defined in the medical-nursing team?

17. Is there something else that you want to point out on the issues of information and consent or something you want to specify about the answers you gave to the questionnaire?

_____________________________________________________________________________

Author Contributions

Conceptualization: V.S., R.S. and A.P.; Methodology, V.S., R.S. and A.P.; Software, V.S., R.S. and A.P.; Validation, V.S., R.S. and A.P.; Formal Analysis, V.S., R.S. and A.P.; Investigation, V.S., R.S. and A.P.; Resources, V.S., R.S. and A.P.; Data Curation, V.S., R.S. and A.P.; Writing—Original Draft Preparation, V.S., R.S. and A.P.; Writing—Review and Editing, V.S., R.S. and A.P.; Visualization, V.S., R.S. and A.P.; Supervision, V.S., R.S. and A.P.; Project Administration, V.S., R.S. and A.P.; Funding Acquisition, V.S., R.S. and A.P. All authors contributed to the same and review of the work. All authors have read and agreed to the published version of the manuscript.

This research received no external funding.

Institutional Review Board Statement

Ethical review and approval were waived for this study, due to the fact that the participants were not patients, but healthcare professionals, and that anonymity and privacy were guaranteed at every step of the study.

Informed Consent Statement

Informed consent was obtained from all subjects involved in the study.

Data Availability Statement

Conflicts of interest.

The authors declare no conflict of interest.

Publisher’s Note: MDPI stays neutral with regard to jurisdictional claims in published maps and institutional affiliations.

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