Protecting Human Research Subjects
Research involving human subjects can pose complex ethical issues which require careful thought and consideration on the part of both researchers and research participants. Human Subjects Approval is done to protect the rights and welfare of study participants in a research project.
Impact evaluations should be conducted following the highest ethical standards. Compliance with local and international Institutional Review Boards (IRB) is key to meet this objective. It is important to research local regulations when the impact evaluation is being designed as local IRB approvals vary by country. IRB approval is required for studies:
- Interacting with human subjects for the purposes of research
- Collecting data on individuals including personally identifying information
- Using data collected from individuals that includes personally identifying information
Several members of the research team should be certified in conducting ethical research on human subjects. All surveys require informed consent from every respondent.
Human Subjects Research Certification
Who must be certified
All members of the research team who manage surveys and work with personally identified data must complete training on conducting research with human subjects. This can include, for example, principal investigators, research assistants, field coordinators, and survey firm staff.
How to obtain Human Subjects Research certification
Ethics certification is usually a prerequisite for IRB approval. Specific requirements vary, but two commonly accepted sources of certification are:
- The National Institute for Health (NIH), which offers a free course on Protecting Human Research Participants.
- The Collaborative Institutional Training Initiative (CITI), which offers a course on Human Subjects Research.
The courses cover the historical development of human subject protections, discuss the ethical issues involved in this type of research, and present the principles and regulations governing it. They are divided in modules, where reading material is provided, followed by a quiz. A minimum score is required to pass each module. Learners may complete the modules at their own pace. Certificates usually have expirations and must be renewed. The CITI certificate must be renewed every 3 years, whereas the expiration of the NIH depends. Note that the IRBs can also define a date past which the certificates are considered invalid.
What is an IRB approval
An Institutional Review Board is a group designated by an institution to review, approve, disapprove, or require changes in research involving human subjects. Its purpose is to ensure appropriate steps are taken to protect the rights and welfare of those subjects. An IRB approval is required for any study involving human subjects, with very few exemptions. In practice, exemptions only apply to continuing review, as an initial review must be submitted to obtain exemption. Additional IRB approvals may be required based on the local regulation. It is not uncommon to need more than one IRB approval. An IRB will request researchers about additional measures taken for studies that include vulnerable populations, such as pregnant women, prisoners, children, or economically or educationally disadvantaged people.
Where to seek IRB approval
International IRB approvals: The World Bank does not have an IRB. Typically, IRB approval is sought from partner academic / research organizations (e.g. universities of principal investigators, Innovations for Poverty Action). It is not uncommon to need more than one IRB approval, especially when researchers work in different institutions.
How to seek IRB approval
IRB applications can be quite demanding, especially those from institutions based in the countries where research is taking place. IRBs require submission of study design, study instruments, interview guides, data collection protocols, recruitment materials, and informed consent documents, among others. It can require extensive work to retrieve the information and submit it in the required format.
When to seek IRB approval
IRB approval must be sought at various stages:
- At the beginning of the study, before any research activity involving human participants begins (initial protocol review). Ideally, IRB approval should be sought once all survey instruments have been piloted and are finalized (a pilot that does not collect and store personally identifying information and is made to assess feasibility of the study protocols which will not contribute to generalizable knowledge is not considered research).
- Prior to implementing any change (amendment review). An amendment application must be submitted whenever any study design, informed consent procedures, or the investigator team within an IRB approved research protocol is revised. Amendments involving minor changes that pose no more than minimal risk to subjects will usually be reviewed on an expedited basis, other changes may need to be reviewed by the full Committee, at the next available IRB meeting.
- Every year, even if no study protocol has changed (continuing review). A continuing review must be submitted to report on progress of approved research in the format prescribed by the IRB, as risks to participants may evolve.
As a principle, all proposed changes to approved research must be prospectively reviewed and approved by the IRB (except where necessary to eliminate apparent immediate hazards to subjects). When submitting a project for review, allow enough time to ensure the non-interruption of studies. Consider that IRBs can make decisions in 3-5 days (commercial IRBs), 1 month (typical for university IRBs) or up to 4 months (institutions based in the countries where research is taking place). Finally, the IRB must be informed of any cases of unanticipated problems involving risks to participants or others, usually within 24 hours – 2 weeks, depending on the severity of the adverse events.
What is an informed consent
Obtaining informed consent means that an individual consents to participate to the research activities without undue inducement or any element of force, fraud, duress or any other form of constraint or coercion. Informed consent requires subjects to be given sufficient information on both the possible risks and the potential benefits of participation, allowing them to make informed decisions about whether to participate. Informed consent is essential to ethical research that respects the three principles of autonomy, beneficence, and justice.
- Autonomy means that each person should be given the respect, time, and opportunity necessary to make his or her own decisions, with adequate information and without undue pressure. It requires that vulnerable populations such as children and prisoners be protected.
- Beneficence is the duty to protect participants from harm and to ensure that they have equal opportunities to experience possible benefits of participation.
- Justice requires to treat all participants equitably and to distribute benefits and burdens fairly.
Informed consent is best thought as a teaching tool rather than a legal document. It is a process and not a form. Participants must be given the opportunity to discuss any questions or concerns before consenting. Thereafter, they need to be informed of any new information or adverse event that might affect their willingness to participate (through a revised consent document, if needed). The importance of informed consent cannot be overstated, and for this reason it is advisable to allocate at least 3 hours during the enumerator training to discuss its content and to practice it in front of the class and in pairs. The information must be presented in a language that the research subject can easily understand. Oral consent (no signature) might be approved by IRBs in certain cases. For minors, researchers should obtain the minor’s assent and the permission of a parent/guardian (assent = affirmative agreement to participate). Similarly, the language of the assent process should be age-appropriate.
Elements of informed consent
Waiver of one or more of its elements may be permitted by the IRB if appropriate, but informed consent should provide the participant with the following information:
- Purpose of the research, including what the study is about and why the participant was selected;
- Participation and withdrawal: participation is voluntary and the subject can refuse to answer any questions and can withdraw at any time without a penalty or loss of benefits to which s/he is otherwise entitled;
- Study procedures in chronological order (e.g. for surveys, the topics covered, the timing, and the duration);
- Risks and benefits, including a description of any reasonably foreseeable risks, discomforts, inconveniences, and how these will be managed and of any benefits to subjects and to society, or lack thereof (if the subject will not benefit from participation and the research only helps the public at large, this must be clearly stated);
- Payment for participation, including a mention of any payment or gift that will be provided to compensate participants for their time (provided that it not coercive in amount or method of distribution);
- Alternative to participation;
- Confidentiality, including a mention of anyone who will have access to the data and a brief description of how personal information and existing procedures to prevent unauthorized access;
- Identification of investigators, including names and contact details of Field Coordinator, survey firm staff, and of * Principal Investigators, and an invitation to contact them with any questions or concerns about the research;
- Name of the sponsor(s), when appropriate;
- Rights of research subjects, including contact details of the IRB (national IRB, if obtained, or others);
- Signature, including a statement that all described procedures have been understood and that any question has been answered, and that the respondent agrees to participate in this study;
- Name(s) of the principal researchers and sponsor(s) where appropriate;
- Expected duration of the subject's participation;
- Description of the procedures to be followed;
- Identification of any procedures which are experimental;
- Description of any reasonably foreseeable risks or discomforts to the subject;
- Description of any benefits to the subject or to others which may reasonably be expected from the research;
- Explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights;
- Statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;
- Statement that participation is voluntary, their right to decline to participate and to withdraw from the research once participation has begun and the subject may discontinue participation at any time without penalty.
The consent should also not contain any exculpatory language (language through which subjects waive any of their legal rights, or release the research team from liability for negligence). Finally, sufficient time must be allowed for subjects to consider participation.
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This article is part of the topic Research Ethics
MIT's Committee on the Use of Humans as Experimental Subjects (COUHES) offers examples of IRB applications, informed consent, and authorization forms.