- Regulated research projects when simultaneously requesting a Waiver of Informed Consent or a Waiver of Documentation of Informed Consent.
- Projects that are not otherwise subject to IRBMED oversight because they are either:
- Exempt under OHRP or FDA regulations, but study team members will be accessing PHI.
- Not-Regulated under OHRP or FDA regulations, but study team members will be accessing PHI
Projects that are considered to be Not-Regulated under OHRP or FDA regulations include (but are not limited to) the following:
- Investigator certifications for reviews of PHI preparatory to research submitted in the eResearch application.
- Investigator certifications for research involving decedents’ information submitted in the eResearch application.
- In consultation with other units (e.g., the UMHS Privacy Office and DRDA), any use or disclosure of limited data sets under data use agreements.
- Case studies.
Update Approved by IRBMED Chairs and Director: October 14, 2011
Website Updated: April 18, 2011