UCO IRB REVIEW DOCUMENTATION: Waiver of Informed Consent
If you are granting either a waiver of informed consent or a waiver of some or all of the elements
of the required informed consent procedure [45 CFR 46.116(d)], you must document the
following:
Check one
1. The research in its entirety involves no greater than minimal risk.
Yes
No
2. The waiver of consent will not adversely affect the rights and welfare of the
subjects.
Yes
No
3. It is not practicable to conduct the research without the waiver/alteration.
Yes
No
4. Whenever appropriate, subjects will be provided with additional pertinent
information after their participation.
Yes
No
If you answered Yes to all of the above, provide a brief description of the reason(s) the waiver is
necessary.
Check which of the following applies:
The entire consent is being waived
Only certain required element(s) are being waived (list those)
If a waiver is granted, the IRB will still require that subjects are provided with some form of
information about the research. Indicate which of the following it will be:
Written information sheet/summary
Verbal explanation
Other (specify)
IRB #________________
Reviewer _____________________________
Form Revised 5/17/10
Date ________________