Data & Biospecimen Sharing

desktopUniversity of Michigan policy is that data and biospecimens should be collected under transparent, informed consent that permits and promotes the maximal use and value of the data and biospecimens consistent with the permission of the donors. When considering the sharing of data and biospecimens, U-M policy reinforces that…

  • Sharing expedites translation of research.
  • Our missions are facilitated by partnerships with outside entities.
  • Partnerships with industry provide many forms of value.
  • Our ethical responsibility is to inform research participants with whom their data/biospecimens will be shared; informed consents and agreements must be explicit about sharing with commercial entities and who may derive financial benefit.
  • Transfer the minimum necessary.

Sharing with other academic institutions and governmental organizations

When sharing with external non-profit collaborators, for instance on a multi-site project, the following are required:

  1. Data Sharing Agreement
  2. Unfunded Agreement in the eResearch Proposal Management System

Sharing with industry

CLICK HERE to view the 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. We’ll 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. Submission of the Data & Biospecimen Sharing Checklist to OoR-DataRelease-All@med.umich.edu.

  2. 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.

  3. Receipt of approval communication with indication of required contract terms and fees.

  4. Request to the appropriate central unit(s) for negotiation of the appropriate agreement through
    eResearchPlease attach approval communication as an uploaded document in the eRPM request.

Helpful links

Data & Biospecimen Sharing Policy Principles

Data & Biospecimen Sharing Policy FAQs

Data & Biospecimen Sharing Checklist

Handling Patient Data General Security Guidelines

Human Data & Biospecimen Release Committee

Data & Biospecimen Sharing Policy Workflow

Michigan Genomics Initiative Acknowledgement and Authorship Policy New!

 

Questions?

Contact us or call (734) 615-2100 

North Campus Research Complex, Building 400, 1600 Huron Parkway, Ann Arbor, MI 48105

A list of Data Office contacts is available in the Personnel Directory