UCO IRB REVIEW DOCUMENTATION: Waiver of Documentation
If you are granting a waiver of the requirement to obtain a signed consent form, you must
document the following:
Check one
1. The entire consent (or elements) was waived under 45 CFR 46.116(d).
Yes
No
2. The only record linking the subject and the research is the consent document
and the principal risk is from a breach of confidentiality. Subjects are asked
if they want documentation and their wishes will govern.
Yes
No
3. The research involves no more than minimal risk and involves no procedure
for which written consent is normally required outside of the research context.
Yes
No
4. It is not practicable to conduct the research without the waiver.
(i.e. internet survey)
Yes
No
5. The participant population is too young to give consent.
Yes
No
If you answered “yes” to any of the above, provide a brief description of the reason(s) the
waiver is necessary.
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)
For office use only
IRB #________________
Reviewer _____________________________
Form revised 4/3/13
Date ________________