All Michigan Medicine patient and research participant data and biospecimens are resources owned by the Regents of the University of Michigan (U-M) and are governed by university policies and procedures. This policy applies to Michigan Medicine human data and biospecimens transferred to for-profit or commercial entities, non-academic foundations, and professional societies. The policy does not apply to transfers to government agencies and other academic medical centers, universities, and research institutes, nor does it govern sharing of data for purposes of patient care or clinical trial site activity.
A. Data/biospecimen sharing expedites translation of research into knowledge, practice, and products that improve human health and wellbeing.
B. As a research institution, our goal to advance medical science and the health of the communities we serve is facilitated through partnerships with external entities, including other medical centers, universities, governmental agencies, foundations, and industry.
C. Productive and equitable partnerships with industry provide many forms of value to U- M and society. Relationships that encourage partnership with regard to data/biospecimens, innovation, personnel, and dissemination have the ability to support our core missions of research, patient care, and education.
D. Michigan Medicine recognizes its ethical responsibility to inform participants with whom their data and biospecimens will be shared as well as to ensure that transfers of data/biospecimens occur in accordance with appropriate human subjects and privacy approvals and protections. To that end, informed consents and agreements must be explicit about sharing with a commercial entity and who may derive financial benefit.
E. Every effort should be made to transfer the minimum information and/or biospecimens. When possible aggregate, summary-level patient and participant data should be transferred or the analyses performed within HIPAA compliant U-M computing environments, as available.
F. Data and biospecimens, whether collected, acquired, stored, or managed, are assets of the Regents of the University of Michigan and Michigan Medicine, not individual investigators.
G. U-M retains ownership of all data/biospecimens transferred. Recipients of transfers may not re-identify, retain, package, or sell Michigan Medicine human data or biospecimens or their derivatives without express written approval from U-M.
H. U-M human data and biospecimens transferred under this policy should recover appropriate value, including defraying historical acquisition costs, capturing maintenance costs, recovering preparation and transfer costs, and securing the market value for the resource(s), as applicable.
I. The benefit/risk assessment and approval of the valuation of transfers will be governed at the level of the Medical School, not by individual faculty or departments.