A repository is a collection of information and/or biospecimens whose organizers
- May receive information/biospecimens from multiple sources
- Maintain the information/biospecimens over time
- Control access to and use of information/biospecimens by multiple individuals and/or for multiple purposes, which may evolve over time.
A repository may receive information/biospecimens from research and/or non-research "primary collections." Multiple IRB-approved HUM studies may deposit information/biospecimens into a single repository registered via the REP. Among other responsibilities, the repository should have adequate procedures for recording and verifying any restrictions on future use, including but not limited to informed consent.
A repository maintains the information/biospecimens over time. Among other responsibilities, the repository should have adequate procedures for
- Data security
- Physical storage
- Sustaining the repository over time, including managing financial and physical resources
Many existing repositories at U-M already have approval through an HUM application. New repositories should be registered through the REP application in eRRM. (See also "Previously approved repository" and "New repository" questions at FAQ: Repository application). Repositories maintaining identifiable private information and/or identifiable biospecimens require IRB approval. Repositories maintaining strictly de-identified or anonymous data/specimens may receive a "Not Regulated" determination upon registration. Depending on the amount and complexity of data/biospecimens stored, a governance or oversight committee may be appropriate for the repository, for example to review applications for use of materials, make decisions about the allocation of rare resources (primarily biospecimens), and/or resolve disputes.
“Medical School Governing UMMS Research Biorepositories Policy” (available through PolicyStat) Section II, D requires an oversight committee for every biorepository "established with the express intent of sharing biospecimens or samples outside the department or beyond collaboration with its creator/s." This requirement applies whenever the repository is funded by a UMMS Department, it operates in UMMS space, or the creator of the repository holds even a partial appointment in the Medical School Faculty. (See also "UMMS policy" questions at FAQ: Repository application).
A repository distributes information/biospecimens for multiple research uses over time. Some repositories are intended only for use by a select few investigators. Some repositories intend limited purposes for their information/biospecimens. Others are available for general use to any qualified investigators and for a wide variety of scientific investigations. Among other responsibilities, the repository should have adequate policies/procedures for
- verifying that a proposed use is consistent with restrictions imposed at collection of information/biospecimens.
- ensuring security and confidentiality of data/biospecimens during transfer/release
- identifying and managing proposed research uses that present especially high risk to subjects or groups of which they are members