Informed Consent

As outlined in the Belmont Report of 1979, the core elements underlying the ethical treatment of research participants are autonomy (respect for persons), beneficence, and justice. Providing adequate information and obtaining active consent for research participation are central to autonomy and respect for persons. Acknowledging the importance of autonomy requires that every potential research participant must be afforded adequate time and opportunity to make his or her own informed and voluntary decision about whether or not he or she wishes to participate in a research study. This requires the provision of adequate information about the study and, in theory, also requires that no pressure be exerted to participate. The principle of autonomy also requires that special protections be given to potentially vulnerable populations such as minors, the mentally ill, or prisoners. Individuals in these groups may be in a position of increased potential for coercion (e.g. prisoners) or may be less capable of understanding information that would enable them to make an informed decision about study participation.

Informed consent includes the process by which research participants gain an understanding of the procedures, risks, and benefits that may be associated with their taking part in a study. In virtually all surveys, the key elements of “voluntary” and “informed” consent can be provided in a concise way at the beginning of a telephone or face-to-face interview, in a cover letter for a self-administered survey, or in the introductory screen of a Web or other electronic survey. This is true regardless of level of risk and is consistent with the contemporary view of consent as an ongoing process rather than a paper document. The main elements of consent include the following:

• An explanation of the purpose(s) of the study
• An indication of the approximate amount of time it will take to complete the study
• A description of what the respondents will be asked to do
• A description of any foreseeable risks or discomforts, if any
• A description of any direct benefits to the respondents or others
• A statement describing the extent to which responses will be confidential
• A statement of the voluntary nature of participation

Contact information should also be available for questions about the research and about respondent rights. This information can be provided upon request for telephone surveys and should be included in the written introductory information in face-to-face, self-administered, and electronic modes.

Consent can be obtained from adult respondents who can understand the benefits and risks of the survey. Except in the special cases where parental permission itself could pose risks (e.g. studies of child abuse), parental permission must be obtained prior to administration of a survey to a minor, and assent (agreement to participate) should be obtained from the child or other nonadult. The age of majority is typically 18 but varies slightly in the United States from state to state.

Special challenges exist for studies being conducted by or for someone with authority or special power over potential respondents (e.g. teachers, supervisors, employers, physicians). In these cases, it is particularly important that the respondent recruitment procedures evidence no coercion, either explicit or implicit. Researchers must make a clear distinction between research questions and issues arising out of the authority relationship. To avoid the perception of undue influence or coercion, persons with authority over potential respondents should not recruit participants themselves if they will have knowledge about who did and did not participate or will have access to individual responses.

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