IRB Update Volume 4, Issue 9, September 2014
Obtaining a Waiver of Documentation of Informed Consent
Investigators may apply for a waiver of documentation of informed consent if the research meets one of the two following conditions according to 45 CFR 46.117 & 21 CFR 56.109(c)(1):
Condition 1 (both must be true):
- The research presents no more than minimal risk.
- The research involves procedures that do not require written consent when performed outside of a research setting.
Condition 2 (all must be true):
- The principal risks are those associated with a breach of confidentiality concerning the subject’s participation in the research.
- The consent document is the only record linking the subject with the research.
- Each participant will be asked whether the participant wants documentation linking the participant with the research, and the participant’s wishes will govern.
- The study is not FDA regulated.
If your study meets either of the above conditions, you can apply for a waiver of documentation of informed consent in the IRBaccess application form. Remember to also indicate in the proposal document that you are “requesting a waiver of documentation of informed consent” and to modify any consent documents accordingly (i.e., remove signature lines).
Contact your IRB Program Coordinator to determine if a waiver of documentation of informed consent is appropriate for your study.
When is a Subject Signature Not Required?
The following are typical examples in which an Investigator may obtain informed consent from subject(s) without requiring a written signature.
- Research in contexts and cultures in which signing documents is considered inappropriate.
- Research in populations with low literacy.
- Research on sensitive topics or incriminating behavior.
- Interviews that are not conducted face-to-face, e.g., Skype, email, etc.
- Anonymous surveys.
- Surveys distributed online where obtaining a physical signature is impractical.
ORS is hosting the following educational session for DRCs:
RC 501 – DRC Workshop
3:00 – 4:30 PM
Please check the ORS news page and TXClass for future offerings.
Upcoming Meeting Date(s)
The next IRB Full Board meeting is: November 17, 2014.
The deadline to upload required documents is: October 29, 2014.
Visit the IRB Meeting Deadlines and Dates page for the 2014 schedule.
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