Consent and HIPAA Privacy Rule Authorization Policy

A. Advance consent and HIPAA Privacy Rule authorization. The CBR will store biospecimens only if they have been collected via a consent and authorization process that meets all legal and institutional requirements. To be valid under this policy, consent and authorization must have been granted voluntarily by individuals capable of consenting, or by an appropriate surrogate, after the individual or surrogate has been informed of all available material information regarding the proposed research activity. If an Institutional Review Board (IRB) and/or HIPAA Privacy Board determines that consent/authorization are not required for the project, a project representative must show documentation of the waiver(s) issued by the committee(s).

B. Permissible secondary uses of biospecimens. Any biospecimen held by the CBR will be distributed for secondary research use only if the use is compatible with any prior consent/authorization(s) given by the donor from whom the biospecimen is derived. IRB interpretation of prior permissions will be sought when necessary.

C. Information to be disclosed to prospective donors. Investigators who acquire biospecimens from individual donors at the University of Michigan for deposit into the CBR are required, except with CBR Director and IRB approval, to seek permission for unspecified future research by employing the CBR consent/authorization templates, which are based on U-M templates for repository projects. The CBR templates will be updated as necessary by CBR personnel and/or IRBMED staff to ensure they meet all relevant laws, regulations, professional and ethical standards, and CBR policies. Except when a waiver of consent/authorization is approved by the IRB or a HIPAA privacy board, investigators seeking consent/authorization from individual donors at the University of Michigan for deposit into the CBR are required, as permitted by funding and other agreements, to disclose the following to prospective donors:

1. That donation to the CBR is voluntary and one’s healthcare will not be affected by the decision not to participate.
2. That donors agree to any and all future research uses to which donated samples might be put via the CBR.
3. A description of any additional procedures necessary for donation to the CBR.
4. An explanation of how materials and data will be coded or de-identified, as applicable.
5. An explanation of confidentiality protections to be implemented and their limits.
6. That donated specimens will be linked to medical information about the donor.
7. That donated biospecimens and linked data may be shared with other researchers at U-M and elsewhere.
8. That research data may be posted in public databases.
9. That researchers may perform whole genome sequencing using donated biospecimens.
10. That, and how, the donor may withdraw from participation.
11. That even upon donor request, biospecimens and data no longer in the CBR’s possession cannot be destroyed.
12. That the donor is granting permission to be re-contacted regarding their willingness to participate in research that requires additional information or tissue samples from them.
13. That the donor is granting permission to be re-contacted in the event that an investigator wishes to ask for more samples or information, to inform a donor of something the investigator has learned about them or their sample, or to ask them to participate in another research study based on their enrollment in the biorepository.
14. That donated biospecimens and data may be used by for-profit companies in the development of commercial products.
15. That donors will not receive compensation for commercialized value of research that results from donated tissues or data.
16. A description of protections and limitations of the U.S. Department of Health and Human Services Certificate of Confidentiality, as long as such a Certificate is in effect for the CBR.

D. Further communication about CBR research. To allow donors to continue receiving information about the research to which they have contributed, the CBR will publicize general information on its website about the research projects conducted using CBR biospecimens.

E. Documentation of consent and authorization. The CBR will document the provision of consent or assent provided by a donor and any restrictions to use of biospecimens. The CBR will not acquire or possess signed copies of consent or authorization forms.

F. Management of consent and authorization for minors. Projects that contribute biospecimens obtained from minors will be asked to describe their plans to either:

1. obtain consent from those subjects when they become adults; or
2. seek from an appropriate ethics committee or IRB waiver of consent that will be in effect at the time of donor majority and that contemplates any secondary research uses facilitated by the CBR.

G. Withdrawal of consent/authorization. The CBR will honor, to the fullest extent possible and in accord with documented terms of donor consent, donor requests that biospecimens derived from the donor and data associated with the donor not be used in further research.

A. Development of consent/authorization documents.

1. During the initial application process, projects that will use the CBR in creation and management of a biospecimen resource will be provided with Informed Consent templates approved for use with the CBR, and other informational documents as needed, for use in prospective collection of biospecimens.
2. For projects with previous or pending IRB approval at the University of Michigan, CBR staff will access prior approved consent documents through the eResearch system. For projects that do not, CBR staff will request copies of any prior consent and other relevant documents.
3. CBR staff will work with the contributing project team to develop versions of the templates for their project, as requested.
4. The project team will include the resulting documents in an application or amendment for IRB review and approval.

B. Tracking of consent and authorization. Contributing projects will be asked to provide any and all documents that bear on allowable future uses of any CBR materials, except those documents contained in the U-M eResearch system. Each unique version of such documents may be reviewed and cataloged in the CBR laboratory information management system so that applicable restrictions and allowances that pertain to any given CBR materials can be identified.

C. Verification that proposed Secondary Uses are compatible with consent, authorization, and other agreements. CBR staff may receive and administer proposals for Secondary Uses of CBR materials. As candidate biospecimens for distribution are identified, the restrictions and allowances associated with those specimens will be reviewed, and a description of these will be provided, as necessary, to the investigator(s) who contributed the specimens to the CBR and/or the Oversight Committee(s) responsible for deciding on the Use Proposal.

D. Withdrawal of permission by the donor. Donors who wish to withdraw their materials from further research may contact either the PI of the particular project to which they contributed biospecimens or the CBR Director. Contributing projects and the CBR will forward such requests to each other. Donor withdrawal of permission for future research will result in destruction of all specimens held in the CBR derived from the donor. Disposal of the biospecimens will be recorded in the CBR laboratory information management system.

45 CFR Part 46 (2018)

45 CFR Parts 160, 162, and 164

University of Michigan Medical School Policy for Governance of University of Michigan Medical School Research Biorepositories

U-M Biorepository Consent templates

A. Original Approval Date

July 16, 2015

B. Revision History

1. 01/26/2016:
   • §II.A edited to allow for post-collection consent processes that have been approved by an IRB.
2. 03/19/2018:
   • §lll(D) edited to clarify that all biospecimens are destroyed following withdrawal of consent. 
   • Appendix; Incorporated Decision Chart: “Determining whether proposed secondary uses are compatible with prior consent” into policy
3. 04/21/2023:
   • Removed Decision Chart “Determining whether proposed secondary uses are compatible with prior consent” from policy as an appendix, and discontinued CBR’s authority to review consent permissions on behalf of secondary user.
   • Added a requirement to disclose possibility of whole genome sequencing to biorepository research participants.
   • General clarification of language for consistency with revisions cited above.
   • Updated references, formatting and header and footer. Changes are highlighted in yellow.

Signed by: Victoria Blanc, Director of University of Michigan Medical School Central Biorepository on 23 April 2023
(original signed document on file at CBR)