A. The CBR will operate subject to initial and continuing review by the U-M Medical School Institutional Review Boards (“IRBMED”).
B. The CBR will accept biospecimens and/or data only from research projects with one of the following:
- Current documented approval from IRBMED;
- Current documented approval from another IRB registered with the U.S. Department of Health and Human Services Office for Human Research Protections;
- Current documented approval from another appropriate ethics committee, only if the project is not subject to U.S. federal regulations;
- A letter of determination that the project does not meet an applicable definition of human subjects research; or
- Sufficient evidence to support a determination that the project does not meet an applicable definition of human subjects research.
C. The CBR can make determinations as to whether secondary research projects requesting use of CBR specimens and/or data are subject to U.S. federal regulations of human subjects research and IRB oversight.
D. CBR biospecimens and/or data will be made available only to research projects determined not to be human subjects research or which have current approval.