The IRB ensures that informed consent will be sought from each prospective participant or the participant's legally authorized representative, in accordance with, and to the extent required by 45 CFR 46.116 and 21 CFR 50.20. In addition, the IRB ensures that informed consent will be appropriately documented, in accordance with, and to the extent required by 45 CFR 46.117 and 21 CFR 50.27. The IRB ensures, as part of its review, that the information in the consent document and process is consistent with the research plan.
Informed consent is understood as an on-going process which starts with the initial presentation of a research activity to a prospective subject by the investigator and continues through the research activity until the subject ends his/her participation or the study closes. Research subjects are rarely aware of research activities prior to an initial presentation by the principal investigator or a member of a principal investigator’s research team. The initial phase of consent requesting participation in a research activity commonly begins with the first contact between the subject and the investigator. Many subjects make their decision regarding whether to participate in research during this initial contact. As a result, the greatest potential for misunderstanding exists in the initial consent process. Researchers must provide sufficient time for a potential subject to reflect on the nature of participation during the important initial presentation of a research activity. When subjects are presented with numerous research and clinical options, the consent process must include a clear description of the possible known ramifications resulting from each option presented. Subjects must also be made aware of the possibility of unforeseen risks resulting from participation in the research project. The presentation must not include specific “leading” information about whether to participate in any particular project.
By providing a potential subject with information understandable to the subject in an initial session regarding complex research issues, potential subjects should have an improved comprehension of the elements within the consent form and provide a more informed consent for participation in the research.
The second step in the consent process is the presentation of the consent forms to the subject.