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Informed Consent and Consent Forms

The purpose of informed consent is to ensure that research subjects fully understand the nature of their proposed participation in research and consent willingly to take part. Informed consent addresses the "respect for persons" principle of the Belmont Report.  As stated in the Belmont Report " Respect for persons requires that subjects, to the degree that they are capable, be given the opportunity to choose what shall or shall not happen to them. This opportunity is provided when adequate standards for informed consent are satisfied. While the importance of informed consent is unquestioned, controversy prevails over the nature and possibility of an informed consent. Nonetheless, there is widespread agreement that the consent process can be analyzed as containing three elements: information, comprehension and voluntariness."

Further, the informed consent process provides the researcher with a legally effective record of the consent of subjects.

The informed consent process is not just a form, but a process whereby the researcher knows that potential participants are fully informed and that the project is carried out in accordance with the description provided to participants.

University of Richmond researchers who work with human subjects will have access to a variety of CITI training programs on the subject of informed consent.  In addition, this website provides examples of informed consent model forms and forms that have been approved by the IRB.

According to OHRP, "The basic required elements of informed consent can be found in the HHS regulations at 45 CFR 46.116(a). OHRP also has a tips sheet for informed consent available at http://www.hhs.gov/ohrp/policy/ictips.html.

The regulations require that the following information must be conveyed to each subject: a statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject’s participation, a description of the procedures to be followed, and identification of any procedures which are experimental;

1. a description of any reasonably foreseeable risks or discomforts to the subject;

2. a description of any benefits to the subject or to others which may reasonably be expected from the research;

3. a disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;

4. a statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;

5. for research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;

6. a discussion of the proposed uses of the research (e.g. for classroom use only; for publication or presentation; other uses),

7. an explanation of whom to contact for answers to pertinent questions about the research and research subjects’ rights, and whom to contact in the event of a research-related injury to the subject; and

8. a statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

Additional elements are described at 45 CFR 46.116(b).

Consent Forms Required for Video/Photographic and Audio Recording

Additional steps are required for recordings of research subjects, as recordings always entail the collection of individually identifiable information.  An IRB consent form for recordings can be found at with other consent form examples.  An example of a video consent/release form can be found at the Communications Office website.

Questions?

Please address any questions regarding consent forms to the IRB Chair.  The IRB Chair is also available by phone (484-1565) and at the IRB Office (118 Richmond Hall).