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IRB Consent Form Templates

A collection of informed consent, assent, and debriefing templates that can be used for your human participant research study.

General Consent Form Templates

Social and Behavioral Research Projects (last updated 03/16/2023)

Biomedical Research Projects (last updated 07/18/2022)

Consent Form Templates for Specific Biomedical Procedures

MRI and fMRI

Blood Collection by Finger Stick

Blood Collection by Venipuncture

Oral Consent Template

Guidance for Protocols Involving Oral Consent

Debriefing Template

Guidance and Template for Debriefing Participants

Studies Involving Children (Assent/Permission Forms)

Parent-Guardian Permission for Studies Involving Children

Sample Parental Notification Form

Sample Child Assent Form

Performance Release for Minors

Performance Releases

Performance Release for Adults

Sample Consent Forms

Consent form templates.

These consent form templates have been posted for your reference.  When completing and IRB submission in IRBIS, please fill in the application and use the consent form builder specific to your project.  For more information, please find instructions here .

Summary of Changes to the Regulations for Informed Consent:  Revised Common Rule Changes to Informed Consent and Waiver Requirements

Summary of Changes to Consent Documents:

• Informed Consent Documents – Version 2.0 Summary of Changes
• Informed Consent Documents – Version 2.1 Summary of Changes
• Informed Consent Documents – 10/26/2020 Summary of Changes
• Informed Consent Documents – 4/10/2023 Summary of Changes

Concise Summary examples can be found here .

Guidance on the use of plain language in consent forms:

• Clinical Research Glossary
• Webinar: The Promise of Plain Language: Launching a Glossary to Support Participant Understanding of Clinical Research – Recording & Slides

There are a few additional forms that are not provided online and may be accessed below.  As needed, these should be completed and uploaded to your IRB application.

Foreign Language Consent Forms

COVID-19 Related Forms:

• Spanish-IRB-COVID Information Sheet
• Spanish COVID Consent Letter v2
• Spanish COVID Informational Sheet Translation Certificate

Informed Consent Short Form (for a single subject who may be illiterate, or otherwise unable to read the consent form — used when full consent form has to be read or translated for subject).

• Informed Consent Short Form Guidance
• Simplified Chinese

HIPAA Templates

• Sample HIPAA Authorization Template
• Sample HIPAA Authorization Template in Spanish ( Certification )

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• IRB Health Sciences and Behavioral Sciences (HSBS)

Informed Consent Guidelines & Templates

U-m hrpp informed consent information.

See the HRPP Operations Manual, Part 3, Section III, 6 e .

The human subjects in your project must participate willingly , having been adequately informed about the research.  

• If the human subjects are part of a vulnerable population (e.g., prisoners, cognitively impaired individuals, or children), special protections are required.
• If the human subjects are children , in most cases you must first obtain the permission of parents in addition to the consent of the children.

Contact the IRB Office for more information .

See the Waiver Guidelines  for information about, and policies regarding, waivers for informed consent or informed consent documentation. 

See the updated  Basic Informed Consent Elements document  for a list of 2018 Common Rule basic and additional elements. 

Informed Consent Process

Informed consent is the process of telling potential research participants about the key elements of a research study and what their participation will involve.  The informed consent process is one of the central components of the ethical conduct of research with human subjects.  The consent process typically includes providing a written consent document containing the required information (i.e., elements of informed consent) and the presentation of that information to prospective participants.  

In most cases, investigators are expected to obtain a signature from the participant on a written informed consent document (i.e., to document the consent to participate) unless the IRB has waived the consent requirement or documentation (signature) requirement .

• Projects which collect biospecimens for genetic analysis must obtain documented (signed) informed consent.
• It is an ethical best practice to include an informed consent process for most exempt research .   IRB-HSBS reviews, as applicable, the IRB application for exempt research, but not the informed consent document itself.  A suggested consent template for exempt research can be found below under the References and Resources section.  A companion protocol template for exempt research may be found in the feature box, Related Information (top right).

Informed consent documents

An  informed consent document  is typically used to provide subjects with the information they need to make a decision to volunteer for a research study.  Federal regulations ( 45 CFR 46.116 ) provide the framework for the type of information (i.e., the "elements") that must be included as part of the consent process.  New with the revised 2018 Common Rule is the requirement that the consent document begin with a "concise and focused" presentation of key information  that will help potential participants understand why they might or might not want to be a part of a research study.  

Key Information Elements

The image below displays the  five elements identified in the preamble to the revised Final Rule  as suggested key information.  

Note: Element number 5 (alternative procedures) applies primarily to clinical research.

General Information & Tips for Preparing a Consent Document

Reading level.

Informed consent documents should be written in plain language at a level appropriate to the subject population, generally at an 8th grade reading level .  A best practice is to have a colleague or friend read  the  informed consent document for comprehension before submission with the IRB application.  Always:

For guidance on using plain language, examples, and more, visit: http://www.plainlanguage.gov/

• Tailor the document to the subject population.
• Avoid technical jargon or overly complex terms.
• Use  straightforward  language that is understandable.

Writing tips

The informed consent document should succinctly describe the research as it has been presented in the IRB application.

• Use the second (you) or third person (he/she) to present the study details.  Avoid use of the first person (I).  
• Include a statement of agreement at the conclusion of the informed consent document. 
• The consent doucment must be consistent with what is described in the IRB application.

Document Formating for Uploading into eResearch

• Remove "track changes" or inserted comments from the consent documentation prior to uploading the document into the IRB application (Section 10-1) for review.
• Use a consistent, clearly identified file naming convention for multiple consent/assent documents.

Informed Consent Templates

IRB-HSBS strongly recommends that investigators use one of the informed consent templates developed to include the required consent elements (per  45 CFR 46.116 ), as well as other required regulatory and institutional language.  The templates listed below include the new consent elements outlined in the 2018 Common Rule.

References and Resources

Informed consent guidance.

PDF.  Lists the basic and additional elements required for inclusion or to be included, as appropriate to the research, in the informed consent documentation, along with the citiation number [e.g., _0116(b)(1)] within the revised Common Rule.  New elements associated with the 2018 Common Rule are indicated in bold text.

Informed Consent Templates (2018 Common Rule)

Strongly recommended for studies that involve the collection of biospecimens and/or genetic or genomic analysis, particularly  federally sponsored clinical trials that are required to post a consent document on a public website.  Last updated:  04/10/2024.

(Word) Blank template with 2018 revised Common Rule key information and other required informed consent elements represented as section headers; includes instructions and recommended language.  It is strongly advised that you modify this template to draft a project-specific informed consent document for your study for IRB review and approval.  Last updated: 04/10/2024

Other Templates

Informed Consent documents are not reviewed by the IRB for Exempt projects.  However, researchers are ethically bound to conduct a consent process with subjects.  This template is suggested for use with Exempt projects. Last updated 4/17/24

(Word) General outline to create and post a flyer seeking participation in a human subjects study.  Includes instructions.

(Word) Two sample letters for site approval cooperation between U-M and other institutions, organizations, etc.  Letters of cooperation must be on U-M letterhead and signed by an appropriate official.  These letters are uploaded into the Performance Site section of the eResearch IRB application.

For use by U-M Dearborn faculty, staff, and students conducting non-exempt human subjects research using subject pools. Last updated 4/10/24

For use by U-M Dearborn faculty, staff, and students conducting exempt human subjects research using subject pools

Researchers who will conduct data collection that is subject to the General Data Protection Regulation (GDPR) must use this template in tandem with a general consent for participation template/document.

• Brief protocol for exempt research including data management and security questionnaire

Child Assent and Parental Permission

• Child assent ages 3-6
• Child assent 7-11
• Parent permission
• Child assent 12-14

IRB-Health Sciences and Behavioral Sciences (IRB-HSBS)

Phone: (734) 936-0933 Fax: (734) 936-1852 [email protected]

• Human Subjects Protections

UCL Research Ethics

• Advice on writing an information sheet and consent form

Writing a Participant Information Sheet and Consent Form

Recruitment documents help people make informed choices about whether to participate in a research study. Find out how to write a Participant Information Sheet, example forms and further guidance.

Writing a Participant Information Sheet

Participant Information Sheets must be designed to assist participants to make informed choices. Potential recruits must be given sufficient information to allow them to decide whether or not they want to take part. The process of obtaining consent and the accompanying documentation must be approved by a research ethics committee and, where only verbal consent to research is contemplated include consideration of an appropriate process for witnessing the consent.

Researchers must take the steps necessary to ensure that all participants in the research understand the process in which they are to be engaged, including why their participation is necessary, how it will be used, and how and to whom it will be reported so that the prospective participant can make an informed decision about whether they really do want to take part.

It is highly recommended that the information provided is presented on headed paper and is accurate, clear and simple so that someone with a reading age of 8 would understand the contents (use short words, sentences and paragraphs). The information should be specific to the proposed research and appropriate for the social and cultural context in which is it being given. It is important to avoid technical terms, jargon and abbreviations, bias, coercion or any inappropriate inducements.

What should the Participant Information Sheet include:

• A friendly invitation to participate.
• A brief and simple explanation of the purposes of the research and a statement explaining how the participant was chosen and how many other participants will be involved in the study.
• A statement that participation is voluntary; refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled; and the participant may discontinue participation at any time without penalty or loss of benefits.
• A thorough explanation of the expected duration of participation in the research and the procedures to be followed.
• A description of any reasonably foreseeable risks or discomforts and any benefits to the participant. For research involving more than minimal risk, an explanation as to whether any compensation or any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained.
• A statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained.
• It is considered good practice for researchers to debrief participants at the conclusion of the research and to provide them with copies of any reports or other publications arising from their participation.
• If appropriate, a statement indicating that the data might be used for additional or subsequent research.
• An explanation of who to contact for answers to pertinent questions about the research and the rights of the participant and who to contact in the event of a research-related injury to the participant.
• If applicable, a statement declaring that each researcher who may have access to children (aged under 18) or vulnerable adults has undergone a satisfactory criminal records check.
• Remember to thank your participant for considering taking part in the study and include a statement indicating that the research study has been approved by the UCL Research Ethics Committee.

Language and layout

It is highly recommended that the information provided is presented on headed paper and is accurate, clear, and simple. The information should be specific to the proposed research and appropriate for the social and cultural context in which is it being given. It is important to avoid technical terms, jargon, and abbreviations, bias, coercion, or any inappropriate inducements.

The following points should be considered when writing an information sheet:

• Use clear, non-technical language. We recommend that you refer to the  Plain English Campaign
• Use appropriate language for the target audience. For example, consider the different ways needed to communicate with primary school children as opposed to their teachers, or people with expertise in the area of study as opposed to people with no such knowledge
• Divide the text into paragraphs for ease of reading
• Consider using sub-headings for clarity, such as questions and answers
• Make sure the font and font size are legible.

Ask someone else to review your information sheet before it is circulated.

• Template Participant Information Sheet  (Word)
• Template Consent Form  (Word)
• Guidance on obtaining consent from research participants online (for online and in-person study designs)

Authors: Dr Pippa Lally, Behavioural Science and Health, and Jack Hindley, Information Services Division, UCL

• Recording & Obtaining Consent

UCL Research Ethics Committee Guidance Note 2: Extract from Nuffield Council on Bioethics website

Page last updated: April 2023

Sample consent and permission forms

General consent form to participate in research (DOC)

Two stage project consent form (DOC)

Parent permission form for research with child (DOC)

Child assent form (DOC)

Multiple consent form including audio-recording and quotations (DOC)

Photo and video consent form (DOC)

Video-recording consent form (DOC)

Re-contact agreement form (DOC)

Post-debriefing consent form (DOC)

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• v.14(2); 2018 Jun

How to obtain informed consent for research

1 University of Messina, “G. Martino” Hospital, Messina, Italy

Amelia Licari

2 University of Pavia, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy

Current biomedical research on human subjects requires clinical trial, which is defined as “any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions [ i.e. drugs, cells or other biological products, surgical procedures, devices] to evaluate the effects on health outcomes” [1]. In our modern ethical conception, all research conducted on humans must be pre-emptively accepted by the subjects themselves through the procedure known as informed consent, which is a process by which “a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject’s decision to participate”, as stated in the International Council for Harmonisation Good Clinical Practice guidelines [2]. Informed consent is documented by means of a written, signed and dated informed consent form. This form is required in the following cases: 1) when the research involves patients, children, incompetent/incapacitated persons, healthy volunteers, immigrants or others ( e.g. prisoners); 2) when the research uses/collects human genetic material, biological samples or personal data [3].

Short abstract

The process of obtaining informed consent for clinical trials is tightly regulated; complications arise in circumstances when consent may be waived, or when needed from vulnerable populations http://ow.ly/rEMe30j5MVq

Current biomedical research on human subjects requires clinical trial, which is defined as “any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions [ i.e. drugs, cells or other biological products, surgical procedures, devices] to evaluate the effects on health outcomes” [ 1 ]. In our modern ethical conception, all research conducted on humans must be pre-emptively accepted by the subjects themselves through the procedure known as informed consent, which is a process by which “a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject’s decision to participate”, as stated in the International Council for Harmonisation Good Clinical Practice guidelines [ 2 ]. Informed consent is documented by means of a written, signed and dated informed consent form. This form is required in the following cases: 1) when the research involves patients, children, incompetent/incapacitated persons, healthy volunteers, immigrants or others ( e.g. prisoners); 2) when the research uses/collects human genetic material, biological samples or personal data [ 3 ].

The informed consent form must be written in language easily understood by the subjects, it must minimise the possibility of coercion or undue influence, and the subject must be given sufficient time to consider participation. However, informed consent is not merely a form that is signed, but is a process in which the subject has an understanding of the research and its risks, and it is tightly described in ethical codes and regulations for human subject research [ 2 ].

Educational aims

• To provide a comprehensive overview of issues in obtaining informed consent in clinical research.
• To describe the process of obtaining informed consent in clinical trials.
• To highlight the circumstances under which informed consent can be waived.
• To review the setting of obtaining informed consent from “vulnerable populations”.

The informed consent process

The voluntary expression of the consent by a competent subject and the adequate information disclosure about the research are critical and essential elements of the informed consent process [ 4 ]. Competent subjects able to comprehend the research-related information should personally decide and provide the consent on research participation. Conditions posing practical challenges in obtaining informed consent from the real subject may include situations of medical emergency or obtaining consent from “vulnerable” subjects and/or children [ 5 ].

Research-related information must be presented to enable people to voluntarily decide whether or not to participate as a research subject. For an ethically valid consent, information provided to a research subject should include, but not be limited to: information about the health condition for which the research is proposed; details of the nature and purpose of the research; the expected duration of the subject’s participation; a detailed description of study treatment or intervention and of any experimental procedures (including, in the case of randomised clinical trials (RCTs), also blinding and randomisation); a statement that participation in research is voluntary; probable risks and benefits associated with research participation; details of the nature of the illness and possible outcome if the condition is left untreated; availability, risks and benefits of alternative treatments; information about procedures adopted for ensuring data protection/confidentiality/privacy, including duration of storage of personal data; details about the handling of any incidental findings of the research; description of any planned genetic tests; details of insurance coverage in case of injury; reference contacts for any further answers to pertinent questions about the research and the subject’s rights and in case of any research-related injury to the subject; and any other information that seems necessary for an informed decision to be taken by the subject. Of particular importance, a statement offering the subject the opportunity to withdraw at any time from the research without consequences must be provided during the information disclosure [ 2 ]. Specific information should be provided in case of research projects involving children, incapacitated adults not able to give informed consent, illiterate populations, etc. (as will be described later in this article).

The information about the research should be given by a physician or by other individuals ( i.e.  researchers) with appropriate scientific training and qualifications [ 6 ]. Furthermore, the location where the informed consent is being discussed, and the subject’s physical, emotional and psychological capability, must be taken into consideration when taking consent from a human subject.

Informed consent: when is it not necessary?

After institutional review board (IRB) or independent ethics committee approval is achieved, obtaining informed consent from each human subject prior to his/her participation in clinical trial is mandatory [ 5 ]. However, when specific circumstances occur, the informed consent can be waived, and “research without consent” is possible, which allows enrolment of patients without their consent, under strict regulation [ 7 ]. In order that research without consent is considered justifiable, the following three conditions have to be met: 1) it is impracticable to obtain consent, 2) the research does not infringe the principle of self-determination, and 3) the research provides significant clinical relevance [ 8 ].

The first condition, of “impracticability”, occurs when obtaining informed consent is burdened by high impact in terms of time and economic resources or could compromise the study’s validity [ 8 ]. The second condition means that, although physicians are requested to ensure that the patient has understood the aim of the research and the risks and/or benefits associated with study participation, the researchers are also advised to respect the patient’s decision-making capacity, not interfering with his/her decisions and acting always in the patient’s best interest [ 9 ]. The third condition leads to justification of waiving consent when the clinical relevance and public health importance are potentially high [ 8 ].

The formal literature identifies different types of RCTs and classifies them into three macro-areas: 1) RCTs based on infeasibility of informed consent; 2) RCTs that omit informed consent only for control groups; and 3) RCTs that omit informed consent entirely.

RCTs based on infeasibility of informed consent

Emergency clinical studies, involving critically ill subjects, represent an exception to the requirement of informed consent. The investigated life-saving therapy and the medical intervention may be required immediately, not permitting the researchers to wait and respect all procedures of obtaining informed consent. Within this context, the researchers will be able to proceed with patient recruitment, also without the subject’s consent to treatment, when, prior to the study, the IRB has ascertained the presence of mandatory conditions ( table 1 ) [ 10 ].

Table 1

Conditions to be met in emergency clinical study

Cluster randomised studies include cluster-cluster and individual-cluster research [ 11 ]. In cluster-cluster designs ( e.g. studies on infectious disease prevention), the intervention involves the entire target community, so that single subjects cannot refuse it [ 12 ]. Conversely, in individual-cluster designs ( e.g. studies on primary care), although the intervention involves all the selected community, the right to refuse treatment is allowed. Under this circumstance, the omission of informed consent is justified only when the treatment refusal undermines the validity of the research study and/or procedures [ 13 ].

RCTs that omit informed consent only for control groups

In Zelen’s single-consent model ( e.g. RCTs in infectious or oncological diseases), randomisation occurs prior to any consent, and informed consent is sought only from individuals assigned to experimental treatment [ 14 ]. In the control group, the physicians do not make substantial changes in routine patient care, so informed consent is not required for patient enrolment [ 8 ].

In order to improve study recruitment, Zelen developed the double-consent design. Specifically, informed consent is requested for subjects to be involved in the study but not for the randomisation, preventing psychological distress [ 14 ].

In follow-up studies, the nested consent model ( e.g. for single cohort studies) or cohort multiple RCTs model ( e.g. for multiple cohort studies) is applied. In these variants, patients give their consent for prospective follow-up; however, they remain blinded to any randomised experimental interventions [ 15 ].

In trials using the model of “consent to postponed information”, the informed consent process is carried out after the study is completed [ 16 ].

All these RCT types aim to avoid unnecessary stress in patients who will not receive the new promising experimental treatment. Moreover, these clinical study designs do not affect the standard therapeutic approach or infringe the rights of the patients in the control group; therefore, the clinical trial can proceed without obtaining informed consent [ 8 ].

RCTs that omit informed consent entirely

Based on the fact that patients are assigned to standard care interventions, no informed consent is sought either in low-risk pragmatic RCTs [ 17 ] or in prompted optional randomisation trials [ 18 , 19 ]. However, in a low-risk pragmatic RCT, patients do not have the possibility to choose one of the two standard treatments, whereas in a prompted optional randomisation trial, both the researchers and the enrolled patients can choose one type of treatment over another, despite the randomisation results [ 6 ].

Special needs: vulnerable patients

A “vulnerable population” is defined as a disadvantaged community subgroup unable to make informed choices, protect themselves from inherent or intended risks, or keep their own interests safeguarded [ 20 ]. In the health domain, “vulnerable populations” refers to physical vulnerability ( e.g. pregnant women, fetuses, children, orphans, students, employees, prisoners, the military, and those who are chronically or terminally ill), psychological vulnerability (cognitively and intellectually impaired individuals) and social vulnerability (those who are homeless, from ethnic minorities, are immigrants or refugees) [ 20 ].

Due to a compromised free will and inability to make conscious decisions, several ethical dilemmas (related to communications, privacy and treatment) often arise when research involves these populations. Guaranteeing protection of rights, safety, data privacy and confidentiality of vulnerable subjects are prerogatives of good clinical practice, and law dispositions are regulated and strictly monitored by the applicable authorities [ 21 ].

Physical vulnerability

For a long time, pregnant women were excluded from clinical research because of their “vulnerability”. Although pregnant women are able to make informed and conscious choices, they have been considered “vulnerable” due to the potential risks to the fetus, who is also considered as a “patient” [ 22 ]. More recently, with the consideration of pregnant women as “scientifically complex” rather than “vulnerable” subjects, it has been permitted to involve this category in research trials [ 23 ]. The “scientific complexity” reflects both ethical and physiological complexity. The ethical aspects are secondary to the need to find a balance between interests of the fetus and the mother. The physiological aspects are strictly related to the pregnancy status [ 24 ].

Research studies involving pregnant women and fetuses have to satisfy specific federal regulations ( table 2 ). The following appropriate precautions should be taken in research studies involving pregnant women: no pregnant woman may be involved as a subject in a human clinical research project unless the purpose of the research is to meet the health needs of the mother and the fetus will be placed at risk only to the minimum extent necessary to meet such needs, or the risk to the fetus is minimal [ 25 ].

Table 2

Conditions to be met in research studies involving pregnant women and fetuses

Researchers can enrol pregnant women only when the mother and/or the father are legally competent. In fact, the consent to participate in research may be either self-directed (only the mother’s consent is required) or made with the guidance of the woman’s partner. However, the father’s consent need not be obtained when: 1) the research activity is directed to the health needs of the mother; 2) the father’s identity is doubtful; 3) the father is absent; or 4) a pregnancy from rape has occurred [ 26 ]. The consent signature requirements from the mother and father are summarised in table 3 . Once the informed consent is obtained, the pregnant women will be included into any phase of the study unless the research project will be compromised or the patient’s health (mother and/or fetus) will be in danger.

Table 3

Consent signature requirements for pregnant women and children

# : consent requirements are the same whether the risk is “no more than minimal” or “more than minimal”.

Medical students and employees, who take part in numerous aspects of patient care in primary, secondary and tertiary care settings, are often invited to participate in human studies as volunteers. Frequently, the requesting researcher is their supervisor or instructor, who may push them to participate in the study, which can negatively influence their decision and also violate the consent legitimacy. Therefore, in order to protect these subjects against “coercion” or “undue influence”, when an investigator wishes to recruit medical students or employees, they must first obtain IRB approval for inclusion in the study of these vulnerable subgroups [ 27 ].

Prisoners, defined as any individual involuntarily confined or detained in a penal institution, are considered as “vulnerable” because they may be coerced into study participation, and also, due to both cognitive and psychiatric disorders, they can show an impaired ability to provide voluntary informed consent [ 28 ]. To protect this population, the Office for Human Research Protections has stipulated federal regulations according to which the only studies that may involve prisoners are those with independent and valid reasons for involving them ( table 4 ) [ 25 ].

Table 4

Studies that may involve prisoners

Due to the context of war in which they work, as well as the critical care setting in which they are treated, military subjects often receive medical care and/or participate in biomedical research under an “implied consent” condition. Moreover, the superior–subordinate relationship contributes to favour coercion or undue influence, making this population vulnerable [ 29 ]. To curb this phenomenon and to ensure that participation is truly voluntary, the US Dept of Defense agencies have adopted requirements similar to those that govern medical research that applies to the civilian population. Accordingly, the medical research recruitment session happens in the absence of superiors, and the informed consent is obtained prior to participating in a medical research study. The presence of an ombudsman guarantees and verifies that the participation is voluntary and that the information provided during recruitment is complete, accurate and clear. A payment as an incentive is acceptable but it must not be used to legitimise a coercive interference. Additional protection is provided to students at service academies, especially those aged <18 years. However, when emergency research is conducted or the research study advances the development of a medical product needed by the armed forces, informed consent will not be required [ 29 ].

Psychological vulnerability

Mental disability may compromise the self-determination and decision-making capacities [ 30 ]. Researchers interested in enrolling individuals with cognitive disorders are invited to apply different strategies to promote a better understanding of information-gathering processes. Simplifying the questions and content, adopting supportive technologies, using a more simple language, and spending more time for the information process have been suggested as useful and valid measures. When all these strategies prove to be insufficient, the investigators are required to obtain consent from a legally authorised representative [ 30 ].

Social vulnerability

Similarly to other vulnerable populations, research involving the homeless, ethnic minorities, immigrants and refugees is regulated by laws and specific procedures. Cultural and language differences, “undocumented” migrant status, and the precarious legal positions of these subjects raise several ethical issues, such as whether the participation is truly voluntary, or there are unrealistic expectations, or any benefits for their “status”.

Obtaining informed consent in these groups is extremely complex. A friendly procedure has been identified as the best way to adequately involve these vulnerable groups. A health centre or community building could represent an accessible location. The reimbursement of travel expenses for applicants can be a valid solution to obtain a representative sample for the clinical research. Clear and simple language, emphasising confidentiality, with the help of professional interpreters, can tempt migrants to sign the consent form. Lastly, the possibility of receiving something back in return for their contribution may enable successful enrolment of migrants in research [ 31 ].

Special needs: children

Because of their young age as well as their limited emotional and intellectual abilities, children are considered to be legally incompetent to give valid informed consent; thus, to enrol a child in a research study, the permission by at least one parent or legal representative is mandatory ( table 3 ). For subjects aged <18 years, biological or adoptive parents or legal guardians (persons having both legal capacity and responsibility) can give consent on behalf of their child, exercising free power of choice without any form of coercion. While married mothers and fathers both have parental responsibility, unmarried parents can exert parental responsibility only if they are named individually on the child’s birth certificate. Also, divorced parents maintain parental responsibility, but it is necessary to know to whom the child’s custody has been assigned [ 32 ]. However, on this matter, the European laws and regulations are not harmonised and several discrepancies are present in each country [ 33 ].

Despite potential benefits for the research subjects, the failure of parents to give consent (or their refusal to give consent) is not a rare circumstance [ 34 ]. It can be the case that researchers are dealing with underage parents, so that, although underage parents are responsible for representing their children, as minors themselves they are not considered to be sufficiently mature; therefore, they will be not able to give valid consent. Literacy and socioeconomic levels have been identified as the most common reasons for parental non-response [ 34 ]. Clarity and adequate explanation of research information materials should be part of effective planning to overcome language and social barriers.

In clinical studies in which the adopted methodology constitutes “less than minimal risks” for children, passive parental consent represents a possible way to more easily obtain informed parental consent [ 34 ]. Furthermore, parents can be informed with regard to a possible study involving their children, and, at the time of data collection, only the child’s assent is required. In fact, although the child’s decision-making capacity and understanding of the research project in which he/she will be involved may be limited, the Medical Research Council have shown that, when study details are provided and communicated in a clear and adequate manner, the child can be able to reach a decision and participate consciously in the research [ 35 ]. “Assent” is the term coined to express the child’s willingness to participate in clinical trials despite their young age. The “assent” should include and respect the following key points: 1) helping the child to acquire disease awareness; 2) explaining the potential impact of the experimental treatment; 3) evaluating the child’s ability to understand and adapt to new situations or challenges; and 4) positively influencing the patient’s willingness to participate in clinical trials [ 36 ]. Although the “assent” is not mandatory for research offering a direct benefit for the child, it arises from the need to respect paediatric research subjects [ 37 ]. The evaluation of the capacity to provide the “assent” is based on developmental stage, intellectual abilities and life or disease experience. Usually, the cut-off age of 7 years is used for the beginning of logical thought processes and rational decision making [ 38 ]. However, “assent” for children aged <7 years can be also required once the ability to read and write has been verified [ 32 ]. Figures 1 and ​ and2 2 summarise the parental and assent permission requirements, respectively.

Flow chart of parental permission requirements.

Flow chart of child assent requirements.

When conducting clinical research, the obtaining of informed consent is required. Informed consent is a procedure through which a competent subject, after having received and understood all the research-related information, can voluntarily provide his or her willingness to participate in a clinical trial. However, when it is impracticable to obtain consent, and the research does not infringe the principle of self-determination and also provides significant clinical relevance, the researcher is legally authorised to proceed without informed consent. Furthermore, in order to preserve the self-determination and decision-making rights, specific law dispositions are applied when vulnerable populations are enrolled in clinical trials.

Self-evaluation questions

• a) Diagnosis
• b) Risks and benefits of treatment
• c) Alternatives to treatment
• d) Family’s wishes
• a) When a minor is considered as emancipated
• b) When a patient is found to be incompetent
• c) When immediate treatment is necessary to prevent death or permanent impairment
• d) When the subject is aged >18 years
• a) Minor is married or divorced
• b) Minor on active duty in the US armed forces
• c) Minor is considered self-sufficient by a court
• d) Minor having a son

Suggested answers

• All research conducted on humans must be pre-emptively accepted by the subjects themselves through the procedure known as informed consent.
• Voluntary expression of consent and adequate information disclosure about the research are critical and essential elements of the informed consent process.
• When specific circumstances occur, informed consent can be waived: if it is impracticable to obtain consent, if the research does not infringe the principle of self-determination, and if the research provides significant clinical relevance.
• Participation of vulnerable patients in clinical trials is regulated by specific law dispositions.

Conflict of interest: None declared.

Writing A Consent Form

Below are some useful tips on writing a consent form for your proposed subject population. The procedures for obtaining consent should be documented on the Consent tab of the protocol application.

Coercion  - The subject must be given the opportunity to consent or not consent without the intervention of any element of force, fraud, trickery, duress, coercion, or undue influence on the subject’s decision. Payments & credits should be pro-rated & not withheld until completion. Any payment or class credit must be appropriate to the tasks involved and the subject population.

Compensation  - Compensation payments must be pro-rated or provided in full even if a subject withdraws from the study early. If the payment includes a  lottery , participants must be at least 18 years of age to participate and be entered into the lottery and payment (e.g. prorating) cannot be withheld until the completion of the study. A participant may withdraw from a study and still be entered into a lottery. Approximate odds of winning need to be included in the consent form.

Class Credit  - Any project where class credit is involved must be open to all members of the class AND there must be a non-research option to obtain the same credit for the same amount of effort. The Psych & Geography pools are currently the only pools at UCSB whose procedures are codified and do not need to be documented in this form. All other use of class credit & non research alternatives must be documented in the ORahs protocol application on the Consent tab.

Elements of Consent  - Consent forms should include all the required elements of informed consent and additional elements (if applicable), unless a waiver of consent is requested, justified, and approved by the IRB.

Identifiable data  - Consent for using identifiable data (e.g., video recordings) must be obtained, unless a waiver is requested, justified, and approved by the HSC. If participants are to be recorded or photographed, they must be informed as to how this media may be used (e.g., used in conferences, presentations, publications, shared with other researchers). The use of check boxes is recommended for varying levels of consenting to participate. If there are informational risks to the participant, additional safeguards may need to be put in place. These should be described in the risk tab and discussed in the participant consent. The disposition of identifiable data should be described in the consent form. Identifiable data may be retained indefinitely or destroyed. The consent form should describe if/when identifiable data will be destroyed and how such data will be protected and how it will be used or shared.

Language  - Consent forms should be written in the 2nd person (i.e., "you are") and in a language that is clear, concise, and understandable to the subject population. This includes both reading level and language (e.g, English, Spanish, French). Field specific jargon should be avoided and all concepts should be explained in lay terms. For studies involving multiple subject populations (e.g., children and adults), multiple consent forms are required and must be tailored to the reading and comprehension level(s) of the subject populations to be enrolled.

Translation  - If the subject population involves individuals who speak a different language, consent forms should be translated into the target language and translated back into English by two different individuals to ensure that the appropriate concepts are being conveyed. Using a translator app, such as Google translate should not be used to translate consent forms.

Other Helpful Hints  -

• Avoid using terms such as "agree to" or "certify understanding".
• Only use the consent form that is approved in the ORahs application.
• Think about how you would explain this project in a conversation with someone who was not familiar with your research or field.
• If social security numbers are required to process payment to human subjects participants, then this should be included in the consent form.
• Any alterations or changes to the approved protocol must be reviewed and approved by the HSC prior to initiation.

Consent forms must be signed by the subject, and/or by the parent or legal guardian UNLESS a waiver of documentation or consent is requested, justified & approved. Signed consent forms must be stored securely in your UCSB Department.

 For information on requesting a waiver of documentation or consent, visit the  Waiver of Consent or Documentation page .

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Neag School of Education

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