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:
- That donation to the CBR is voluntary and one’s healthcare will not be affected by the decision not to participate.
- That donors agree to any and all future research uses to which donated samples might be put via the CBR.
- A description of any additional procedures necessary for donation to the CBR.
- An explanation of how materials and data will be coded or de-identified, as applicable.
- An explanation of confidentiality protections to be implemented and their limits.
- That donated specimens will be linked to medical information about the donor.
- That donated biospecimens and linked data may be shared with other researchers at U-M and elsewhere.
- That research data may be posted in public databases.
- That researchers may perform whole genome sequencing using donated biospecimens.
- That, and how, the donor may withdraw from participation.
- That even upon donor request, biospecimens and data no longer in the CBR’s possession cannot be destroyed.
- 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.
- 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.
- That donated biospecimens and data may be used by for-profit companies in the development of commercial products.
- That donors will not receive compensation for commercialized value of research that results from donated tissues or data.
- 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:
- obtain consent from those subjects when they become adults; or
- 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.