U-M Medical School Procedures Governing Human Data & Biospecimen Transfers to Industry or Non-Academic & Non-Governmental Entities

1. When individual-level patient/participant data or biospecimens are to be transferred to for-profit or commercial entities, non-academic foundations, and professional societies, the transfer is subject to 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 (refer to Addendum I).
2. To initiate the review process, the principal investigator(s), or designee, must provide the information required by the Data Office for Clinical & Translational Research (DOCTR), including:
   1. project overview;
   2. details of the data/biospecimens to be transferred, including review of any sponsoring entity terms and conditions under which the data/specimen were collected and approval from the appropriate biorepository oversight committee, if applicable;
   3. IRB application (HUM#) as well as copies of all the IRB-approved versions of the informed consent covering the time frame of the collection of the data/biospecimens being transferred;
   4. draft budget; and
   5. draft sponsor agreement or term sheet, as applicable.
3. DOCTR will collate all the required information and materials for submission to the Medical School Human Data & Biospecimen Release Committee.
4. The Medical School Human Data & Biospecimen Release Committee will review the information and make a recommendation to the Dean of the Medical School to approve or decline the transfer based on adherence to the policy principles. The Committee may recommend approval contingent upon specific conditions or agreement terms. Should the Committee decline the submission, DOCTR will facilitate working with Health Information Technology & Services (HITS), the IRB, and/or Regulatory Affairs to determine whether the investigator has alternative options within the guidelines of this policy and in accordance with appropriate human subjects and privacy protections to proceed. The investigator may resubmit the revision to the Medical School Human Data & Biospecimen Release Committee for consideration.
5. The Dean of the Medical School has final authority to approve or decline the transfer.
6. U-M central unit(s) will negotiate the agreement based on the standard language and terms that have been established between the Medical School and central campus.
7. Exceptions to the standard terms and/or changes in the scope of or amendments to the project that impact the data and/or biospecimens to be transferred require review by a designee of the Medical School Human Data & Biospecimen Release Committee and Medical School Dean’s Office approval.

1. When individual-level patient/participant data or biospecimens are to be transferred to for-profit or commercial entities, non-academic foundations, and professional societies, the transfer is subject to review and approval by the Medical School Human Data & Biospecimen Release Committee and the Dean of the Medical School prior to any applicable IRB approval and requesting that the appropriate central unit(s) negotiate an agreement (refer to Addendum II).
2. If an investigator conceives of a project that includes transfer of individual-level patient/participant data or biospecimens or is approached by an industry or a non-academic/non-governmental entity regarding a project that includes transfer of individual-level human data or biospecimens, consultation with the Data Office for Clinical & Translational Research (DOCTR) is required to aid in adhering to this policy. DOCTR will assist the investigator with:
   1. Determining whether aggregate, summary level data can be transferred or defining the minimum data elements and/or biospecimens to be transferred.
   2. Determining the rationale for and scope of the transfer and whether data analyses could be performed within a HIPAA compliant U-M computing environment.
   3. Determining the source(s) of data/biospecimens and, when appropriate, approval from the appropriate biorepository oversight committee.
   4. Identifying any potential conflicts of interest.
   5. Advising on de-identification, coding, limited data set, and honest broker strategies.
   6. Advising on encryption/transfer safeguards.
   7. Advising on IRB sections to be completed and consent language.
   8. Informing of standard Medical School contract terms and language requirements.
   9. Informing of cost recovery requirements and facilitating engagement with the Medical School Business Development team, Innovation Partnerships, or Office of Research and Sponsored Projects, as needed.
3. In collaboration with the principal investigator, DOCTR will collate all the required information and materials for submission to the Medical School Human Data & Biospecimen Release Committee.
4. The Medical School Human Data & Biospecimen Release Committee will review the information and make a recommendation to the Dean of the Medical School to approve or decline the transfer based on adherence to the policy principles. The Committee may recommend approval contingent upon specific conditions or agreement terms. Should the Committee decline the submission, the investigator may revise the proposed project and resubmit to the Committee for further consideration.
5. The Dean of the Medical School has final authority to approve or decline the transfer.
6. U-M central unit(s) will negotiate the agreement based on the standard language and terms that have been established between the Medical School and central campus.
7. Exceptions to the standard terms and/or changes in the scope of or amendments to the project that impact the data and/or biospecimens to be transferred require review by a designee of the Medical School Human Data & Biospecimen Release Committee and Medical School Dean’s Office approval.

The Medical School preferred standard contract language should include:

1. Data/biospecimen ownership remains with U-M, with the potential for a non-exclusive license;
2. Recipient cannot attempt re-identification;
3. Recipient must contact U-M if identifiers are detected;
4. Derivatives or secondary use are not allowed without U-M written approval;
5. Recipient cannot redistribute or resell data/biospecimens transferred from U-M;
6. Return or destruction of U-M transferred data set and/or biospecimens is required after completion of the purpose of the transfer or term of agreement, with the potential to extend the term of the contract upon mutual written agreement (e.g., in support of FDA filing); and
7. Requirements survive changes in ownership of entity.

1. Prior to transfer, the investigator will notify DOCTR who will verify that the data/biospecimens to be transferred comply with the terms of the Medical School and IRB approval.
2. DOCTR will provide oversight to ensure appropriate safeguards and secure data transfer in accordance with all applicable laws, regulations, policies, and approvals.
   1. DOCTR may execute the data transfer on behalf of the investigator, or
   2. The investigator may execute the data transfer upon confirmation from DOCTR that the methodology being used adheres to appropriate safeguards and current standards.

U-M human data and biospecimens transferred to an external entity under this policy shall take into consideration the following forms of compensation for the university providing these resources, including faculty expertise and “know how,” for the benefit of the external entity and society:

1. Recovery of the costs incurred by the principal investigator or unit to prepare and transfer the samples, including the prevailing university indirect cost rate when  applicable.
2. Assessment of 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. This fee will be reviewed annually.
3. Medical School Business Development and/or the Office of Technology Transfer shall determine the fair market value of the asset(s), as applicable, 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.

“In-kind” contributions and “added value,” which includes, but is not limited to, data, information, or derivatives returned to U-M that enhances the original material transferred or service(s) or product(s) provided to U-M by the external entity, may be recognized in lieu of monetary considerations, either in part or in full, depending on unique circumstances.  This determination will be made by the Medical School Dean’s Office in partnership with the department and principal investigator.

After recovery of direct expenses, monetary consideration for the fair market component generated from the transfer of human data and biospecimens that are outside the scope of the U-M Technology Transfer Policy (SPG 303.04) will support further investment in the research mission. Distribution of revenue from transfers associated with licensing of intellectual property is governed under the U-M Technology Transfer Policy (SPG 303.04).

When applicable, the Medical School will distribute the fair market component received from each transfer of human data and specimens with the parties as outlined below:

Up to the first $300,000
50% to the Principal Investigator(s) or Program’s* discretionary account(s)
25% to the Principal Investigator(s) Department(s)
25% to the Medical School

After $300,000
25% to the Principal Investigator(s) or Program’s* discretionary account(s)
25% to the Principal Investigator(s) Department(s)
50% to the Medical School

*Collections may occur as a result of a programmatic activity involving many investigators over time (e.g., Cancer Center disease programs, NIH-funded SPORE, department-based collections, etc.) and cannot be attributable to a single investigator. As such, the distribution will be returned to the “Program” to support further investment in the Program’s research.

• SPG 303.05 Policy for Research with Human Participants
• SPG 303.04 University of Michigan Technology Transfer Policy
• SPG 601.12 Institutional Data Resource Management Policy
• SPG 602.05 Use and Release of Donor and Alumni Information
• University of Michigan Medical School (UMMS) Policy Governing Tissue Sample Collection, Ownership, Usage, and Disposition within all UMMS Research Biorepositories
• Regents Bylaw 11.48 Patient/Client Records: “The University of Michigan Hospitals and Health Centers: Disclosure of Hospitals’ and Health Centers’ Records