What is the Policy for the Transfer of Human Data & Biospecimens to Industry and Non-Academic and Non-Governmental Entities?
The policy governs Michigan Medicine’s approach to sharing of patient-level data and biospecimens with industry, and non-academic and non-governmental entities. The main goal of the policy is to ensure that data and biospecimens shared with industry are 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
When did the new policy go into effect? What if I already have a project in process?
The policy came into effect July 1st, 2018. Whatever point you are in your project, the Data Office for Clinical & Translational Research team will work with your team on the next steps to take.
What does this policy apply to?
The policy applies to Michigan Medicine 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.
When do transfers now need to be reviewed and approved?
When individual-level patient/study participant data or biospecimens are to be transferred, the transfer is subject to review and approval by the Medical School Human Data & Biospecimen Release Committee on behalf of the Dean of the Medical School prior to requesting that the appropriate central unit(s) negotiate an agreement. The approval of the transfer will likely include requirements for specific contract terms and data fees that should be incorporated during the planning process.
The Data Office will facilitate investigators navigating the policy. Contact us or call (734) 615-2100.
Who comprises the Data Release Committee?
- Steve Kunkel, Ph.D., Interim Executive Vice Dean for Research, Interim Chief Scientific Officer, co-chair
- Ray Hutchinson, M.D., Associate Dean for Regulatory Affairs, co-chair
- Sachin Kheterpal, M.D., M.B.A., Associate Dean for Research IT
- Teri Grieb, Ph.D., Senior Director for Research & Chief of Staff
- Judy Birk, J.D., Director for IRBMed
- Vici Blanc, Ph.D., Director, Central Biorepository
- Tiana Korley, J.D., Associate General Counsel
- Kelly Sexton, Ph.D., Associate VPR – Technology Transfer and Innovation Partnerships
- Craig Reynolds, Executive Director of Research & Sponsored Projects
- Kayte Spector-Bagdady, J.D., MBioethics, Assistant Professor, Department of Obstetrics & Gynecology
- Sheryl Flanagan, Ph.D., Data Protections Coordinator, Data Office for Clinical & Translational Research
- Faculty at-large
- Staffed by Data Office: Erin Kaleba, M.P.H., Director for the Data Office for Clinical & Translational Research
Consultants to Committee:
- Drew Bennett, M.B.A., Associate Director Software Licensing, Technology Transfer
- Patrick Wood, J.D., Assistant Managing Project Representative, Office of Research & Sponsored Projects
- Mike Ranella, M.B.A., M.P.H., Business Development Associate Director, Fast Forward Medical Innovation
If my clinical trial is sponsored by industry, does it need review by the Data Release Committee?
No, clinical trials are excluded from this policy.
What if the data I am sharing are completely de-identified?
The Data Release Committee will need to review the project if the data to be shared are at an individual patient level; even if de-identified.
What if the data I plan to share is aggregate counts, not individual patient-level?
Aggregate counts do not need to be reviewed by the Data Release Committee and can proceed with the existing data sharing agreement and contract terms.
What financial considerations must be made, including my costs of collecting and transferring the data and tissue? Any fees involved in the transfer of data/biospecimens?
Human data and biospecimens transferred to an external entity under the new transfers to industry policy must take into consideration the following three (3) forms of compensation in your external budget for the university providing these resources, These fees should be determined and accounted for prior to presenting any budget to the sponsor for negotiation.
- Recovery of the costs incurred by the principal investigator or unit to prepare and transfer the samples. This would be budgeted as direct costs to support the preparation and transfer and additionally be subject to the prevailing university indirect cost rate for the project.
- A universal Medical School transfer fee to defray historical and ongoing infrastructure and operational costs related to the enterprise acquisition, maintenance, and management of human data and biospecimens. The minimum fee is set at $5,000 (inclusive).
- This fee should be represented as a single, total cost amount and must be negotiated as a fixed fee in the external budget.
- Internally, you will divide the $5,000 recovery between direct costs and indirect costs at the prevailing university indirect cost rate for the project. If you need help with reflecting this budget item, we recommend working with the Grant Services & Analysis Office.
- Medical School Business Developers in Fast Forward Medical Innovation and/or the Office of Technology Transfer shall determine fair market value, as applicable, and will provide an additional valuation that must be included in your budget. The valuation will be vary depending on the nature of the transfer, including the size and scope of the transfer, the age/duration of the collection, the rarity of biospecimens and/or participant population, and other relevant factors and at all times in accordance with applicable laws, rules, and regulations.
When your project is reviewed by the Data Release Committee, you will receive specific instructions on the second and third budget items and be put in contact with members of FFMI or OTT to continue with the valuation process needed prior to budgeting.
Which aspects of my project will the Data Release Committee be reviewing?
The committee will review:
- Patient consent language; is it explicit for sharing with companies?
- Conflict of Interest
- IRB approval; has approval been obtained? Does an application need to be submitted?
- Data details; are the data de-identified, limited data set, full PHI?
- Language in agreement of proper handling of sensitive data, how it should be destroyed upon completion of the project, etc.
- Cost recovery
REFERENCES AND RESOURCES
Precision Health at the University of Michigan Policy on Access to Genomic, Health, and Summary Data, Biospecimens, and Re-contact of Research Participants Enrolled in the Michigan Genomics Initiative