Informed Consent

Before involving any human subject in a research study, the research team must obtain informed consent from each individual. Informed consent means that the research team must clearly mention all possible risks and benefits to an individual from participating in a study, either in a pilot or as a respondent in the actual study. Based on this information, the individuals then must agree to participate without any use of force, fraud, or illegitimate incentives beyond those that are approved for use in research. Another aspect of informed consent is that the human subjects can withdraw their consent at any point during the study. The form for obtaining informed consent is one of the first elements of drafting survey instruments (or questionnaires).

Read First

• Informed consent is a critical component of ethical research.
• The research team should allocate at least 3 hours to the topic of informed consentduring enumerator training
• All human subjects must provide informed consent before any research activity begins.
• A human subject is any individual about whom the research team collects data through an intervention, or interaction with the individual.

Informed Consent and Ethics

Informed consent is essential to ethical research, which upholds the 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 subjects from harm and to ensure that they have equal opportunities to experience possible benefits of participation.
• Justice requires to treat all subjects equitably and to distribute benefits and burdens fairly.

The following sections explain how to implement informed consent in a manner that properly upholds these three principles.

Protocols

The process of informed consent is guided by a project-specific consent form with which all subjects of the study are presented. In a standard household survey, the enumerator will read or present the consent form to the subject. The consent form must advise subjects of any information or adverse event that might affect their willingness to participate. The consent form must be presented in a language that the research subject can easily understand. Subjects must then be given the opportunity to discuss any questions or concerns before consenting.

The research team must give subjects sufficient time to consider whether they want to participate. If subjects choose to consent, they provide their signature. Oral consent (i.e. no signature) might be approved by IRB in certain cases. For minors, researchers should obtain the minor’s informed consent as well as and the permission of a parent/guardian. In these cases, the language of the informed consent process should be age-appropriate.

The importance of informed consent cannot be overstated; 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 pairs and in front of the class.

Elements of Informed Consent

The informed consent should provide the subject with information on all of the following points below. Note that the IRB may permit a waiver of one or more of its elements upon request.

• Purpose of the research, including what the study is about and why the subject was selected
• Participation and withdrawal information, stating that participation is voluntary and the subject can refuse to answer any questions and/or withdraw at any time without a penalty or loss of benefits to which s/he is otherwise entitled
• A description of the study procedures in chronological order (i.e. for surveys, the topics covered, the timing, and the duration)
• Identification of any procedures that are experimental
• Expected duration of the subject’s participation
• Risks and benefits, including a description of any reasonably foreseeable risks, discomforts, inconveniences, and how these will be managed; as well as a description 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 subjects for their time, provided that the payment or gift is 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 the procedures for maintaining confidentiality of records identifying the subject
• Identification of investigators, including names and contact details of Field Coordinator, survey firm staff, and of Principal Investigators
• Explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights
• Name of the sponsor(s), when appropriate
• Rights of research subjects, including contact details of the IRB (national IRB, if obtained, or others)
• If consent given, a signature of subject, 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

The consent should not contain any exculpatory language through which subjects waive any of their legal rights or release the research team from liability for negligence.

Related Pages

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Additional Resources

• Berk Özler (World Bank), Research with adolescents: Issues surrounding consent
• Berk Özler (World Bank), Taking Ethics Seriously: Response #1
• Harvard, Sample interview consent form from the Department of Economics
• ICPSR (University of Michigan), Recommended Informed Consent Language for Data Sharing
• London School of Economics, Guidelines on informed consent
• Martin Ravallion (World Bank), Taking Ethical Validity Seriously
• United States Department of Health & Human Services (HHS), Informed Consent Checklist