Institutional Review Board Oversight Policy

Central Biorepository
Jun 15, 2017 12:00 pm

This policy is to ensure that Central Biorepository (“CBR”) operations, and research projects facilitated by the CBR, undergo appropriate ethics committee review to protect human research subjects.

  • Policy

    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:

    1. Current documented approval from IRBMED;
    2. Current documented approval from another IRB registered with the U.S. Department of Health and Human Services Office for Human Research Protections;
    3. Current documented approval from another appropriate ethics committee, only if the project is not subject to U.S. federal regulations;
    4. A letter of determination that the project does not meet an applicable definition of human subjects research; or
    5. 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.

  • References and Definitions

    45 C.F.R. 46 (2009)

  • History of Policy

    A. Original Approval Date: 10/16/2014 (approval by vote of CBR Governance Committee)

    B. Revisions

    1. 05/18/2015: Reformatted with no substantive changes.
    2. 06/15/2017:.Reapproved on routine review with no substantive changes.
  • Approval on behalf of the UMMS CBR Governance Committee

    Signed by: Victoria Blanc, Director of University of Michigan Medical School Central Biorepository on 15 June 2017
    (original signed document on file at CBR)


Contact us at CBR-Requests@med.umich.edu or 734-647-8809 

2800 Plymouth Road, NCRC Building 60, Room 1661, Ann Arbor, MI 48109-2800

Edited By: dagi@umich.edu
Last Updated: February 15, 2024 3:40 PM