REQUEST FOR
WAIVER OF INFORMED CONSENT
In order to be eligible for a waiver of informed consent, you must meet all the criteria outlined below:
1. Does the proposed research, in its entirety, involve greater than minimal risk?
(Minimal risk is defined as the probability and magnitude of harm or discomfort anticipated in the research
which are not greater in and of themselves than those ordinarily encountered in daily life or during the
performance of routine physical or psychological examinations or tests.)
____Yes. If yes, your study is ineligible for waiver of informed consent under 45 CFR 46.116(d).
____No.
If no, go to question 2 below.
2. Could the proposed research be practically carried out without the waiver?
____Yes. If yes, your study is ineligible for waiver of informed consent.
____No. If no, please explain in the space below and continue with question 3 below:
3. Will the requested waiver of informed consent affect the rights and welfare of the subjects?
____Yes. If yes, your study is ineligible for waiver of informed consent.
____No. If no, please explain in the space below and continue with question 4 below:
4. When Appropriate, will pertinent information be provided to subjects later?
____Yes. If yes, please explain in the space below.
____No. If no, your study is ineligible for waiver of informed consent.
Signature of PI: _________________________________________Date:_______________________________
APPROVED/DISAPPROVED
Chair, IRB_____________________________________________Date:_______________________________