The University of Michigan Policy for the Transfer of Human Data & Biospecimens to Industry and Non-Academic and Non-Governmental Entities is that patient/participant 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.
In addition, application of the policy ensures that the approach to sharing with industry is thoroughly documented and consistent across the organization.
This policy is important because:
- 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.
- The policy driven review process ensures transfer of the minimum necessary
The policy applies to Michigan Medicine patient/participant level human data and biospecimens transferred to for-profit or commercial entities, non-academic foundations, and professional societies. It does not apply to transfers to governmental agencies, other academic medical centers, universities, nor does it govern sharing of data for purposes of patient care or clinical trial site activity. The Oversight Committee follows the National Institutes of Health (NIH) definition of a clinical trial to determine if the sharing policy applies. Observational, non-interventional clinical data registries are not, by definition, clinical trials.
The Data Office for Clinical & Translational Research will facilitate investigators navigating the policy.