Informed consent is a process with the goal of respecting the research subject's dignity. The process does this by attending to the subject's right to deliberate and to make a knowing decision whether to cooperate with the investigator's research interest.
Please note: Research that qualifies for "exempted from further review" status does not require the use of an informed consent document, although the researcher may wish to use one as part of their communication with participants. However, all researchers must submit a protocol following the instructions for requesting exemption from further review in order for the IRB to determine whether or not such status will be granted.
The college requires that every researcher (whether student, faculty or staff) conducting non-exempt research secure the informed consent of any human subject used in research before involving that subject in the research project. Every potential subject who is a physically and mentally able adult must provide consent to participate in the research prior to the initiation of the actual research. Federal regulations define an adult as anyone at least 18 years old. The ideas of mental and physical normalcy revolve around the ability of the subject to provide truly informed and voluntary consent. If a person varies from this norm due to age or disability, special safeguards, described later, are required.
Researchers must ensure that the circumstances under which consent is sought will provide the subjects (or their representatives) with sufficient opportunity to consider whether or not to participate in the proposed research. The circumstances must minimize the possibility that the subjects will experience coercion or undue influence. The situation of the subjects may, in certain cases, be inherently coercive; i.e., their freedom of choice may be restricted by the nature of their employment, age, associations with others, place of residence (prisons, mental hospitals) and mental or physical capacities. Subjects in these categories need not be excluded from research; rather, researchers must make a special effort to ensure that potential subjects are given every opportunity to exercise free choice in consenting to participate in a research project.
The informed consent document communicates to the prospective research subject the purpose, procedures, risks and benefits of the study; the subject's rights in participating in the research; and the freedom to decline to participate without penalty. The consent document also allows the subject to obtain further information and answers to questions related to the study. The consent form, therefore, serves as a written summary of the proposed research and provides a reference for both the subject and the researcher. Please see sample form templates.
The IRB may waive part or all of the normal consent requirements if certain criteria are met. More details on waivers of written (not oral) informed consent.
If oral consent is necessary (e.g. due to limited literacy, telephone interview, etc.) the subject or his/her legal representative will be asked to sign a short form stating that the basic consent form elements have been orally presented. Both the short consent form and the oral presentation must be approved by the IRB. The IRB might require that a witness must also be present for this presentation and sign both the short form and a written summary of the oral presentation. The subject or his/her legal representative must receive a copy of both signed documents. See Oral Consent Guidance for sample template.