Regulatory & Governance

Icon of check marked clipboard

Regulatory

The Central Biorepository complies with federal regulations and other applicable standards and operates under approval from the UMMS Institutional Review Boards (IRBMED). Our IRB-approved program sets standards and processes to provide regulatory support and guidelines for all Central Biorepository users-- those depositing new materials and those requesting existing materials.    

Informed Consent

Central Biorepository donors give broad consent for future use and distribution of biological specimens and data after reviewing the Central Biorepository Information sheet and signing the consent form below:

These documents were developed in collaboration with IRBMEDUMHS Compliance, and other experts across campus, and should be included in the IRB application for the study.

Certificate of Confidentiality

The National Institutes of Health (NIH) has issued the Central Biorepository a Certificate of Confidentiality for the protection of individual-level data that would identify research participants. The certificate applies to all data associated with or derived from biospecimens collected under the Central Biorepository, and is available for use by all investigators doing research with these data.

Governance

Icon of stacked paper

Central Biorepository policies are established by the Governance Committee. Policies encourage use of the Central Biorepository and collaboration among University of Michigan investigators while ensuring that all research using our resources meets the highest ethical, regulatory, and scientific standards. 

Representatives from programs that contributing biospecimens play a decision-making role in determining appropriate secondary uses of Central Biorepository biospecimens. Here is our full list of policies to review:

The Governance Committee is comprised of the following stakeholders:

  • Biorepository Director (ex officio)
  • Senior Associate Dean for Research (ex officio)
  • Associate Dean for Regulatory Affairs (ex officio)
  • Associate Dean for Clinical and Translational Research and Director of MICHR (ex officio)
  • Associate Vice President for Research – Research Policy and Compliance (ex officio)
  • Several rotating faculty-at-large 

Need help establishing a biorepository? Want information on how to request samples? Schedule your consultation now!

Sharing with Industry arrows

CLICK HERE to view the new University of Michigan Policy for the Transfer of Human Data & Biospecimens to Industry and Non-Academic and Non-Governmental Entities. (U-M level 1 authentication is required to view this policy in Research A-Z.)

When individual-level patient/participant data or biospecimens are to be transferred to an external for-profit organization, please download and complete the Data & Biospecimen Sharing Checklist and submit to OoR-DataRelease-All@med.umich.edu. The Data Office will then follow up to assist with your request for approval from the Medical School Human Data & Biospecimen Release Committee. The following are required for a successful request for data or biospecimen sharing with industry:

  1. Review and approval by the Medical School Human Data & Biospecimen Release Committee and the Dean of the Medical School prior to requesting that the appropriate central unit(s) negotiate an agreement.
  2. Data Sharing Agreement with the external organization.
  3. Unfunded Agreement in the eResearch Proposal Management System.

Get more information about this new policy on the Data Office website.

CAP Accredited

 

Questions?

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

North Campus Research Complex, Building 60-1660, 2800 Plymouth Road, Ann Arbor, MI 48105

A list of Central Biorepository contacts is available in the Personnel Directory