Regulatory & Governance

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 biospecimens and data after reviewing the Central Biorepository Information sheet and signing the consent form below:

• Biorepository Information Sheet Template (October 2021)
• Biorepository Consent/Authorization Template (October 2021)

These documents were developed in collaboration with IRBMED, UMHS 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

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. Click here, to view a list of members of the Central Biorepository Covernance Committee.

Here is our full list of policies to review:

• Acknowledgement and Authorship Policy
• Institutional Review Board Oversight Policy
• Use and Distribution of Biospecimens and Data Policy
• Establishment of New Biospecimen Collections Policy
• Consent and HIPAA Privacy Rule Authorization Policy
• Privacy and Confidentiality Protections for Individual-Level Data Policy

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

Sharing with Industry

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.