Faculty Handbook

32. Faculty Research

32.4. Informed Consent

1. Except where specifically waived or altered by the IRB under Sections 116(e) and (f), or 117(c) of the Federal Policy, all human subject research will require written informed consent, in language understandable to the subject (or the subject's legally authorized representative), including the following basic elements per Section 116(a) and (b) of the Federal Policy:

1. Identification as research; purposes, duration, and procedures; procedures which are experimental.

2. Reasonably foreseeable risks or discomforts.

3. Reasonably expected benefits to the subject or others.

4. Alternative procedures or treatments, if any, that might be advantageous to the subject.

5. Extent of confidentiality to be maintained.

6. Whether compensation or medical treatment are available if injury occurs (if more than minimal risk).

7. Whom to contact for answers to questions about the research, subjects' rights, and research-related injury.

8. Participation is voluntary; refusal to participate, or discontinuation of participation, will involve no penalty or loss of benefits to which subject is entitled.

9. When appropriate, additional elements per Section 116(e) and (f) of the Federal Policy.