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When to consider submitting an REP?
New data/biospecimen repository:
Investigators should submit an IRB Repository Application (REP) to cover storage and future use of identified data when creating a standalone repository or at the conclusion of a project.
Existing repositories (i.e., those previously approved by the IRB through a HUM):
Investigators should consult their IRB to determine if a REP application is needed.
USING THE U-M IRB SYSTEM
U-M Research Repositories
Research repositories (also called registries, banks, or libraries) are used to store data and/or biospecimens for future research use, either by the research team who collected them or to share with other researchers. Making previously-collected data and biospecimens available to the research community maximizes their utility and is increasingly a priority at both the national and institutional level. Research repositories that hold individually identifiable data or biospecimens are subject to IRB oversight.
"The IRB should review and approve a protocol specifying the conditions under which data and specimens may be accepted and shared, and ensuring adequate provisions to protect the privacy of subjects and the confidentiality of data." ~ Office of Human Research Protection's (OHRP) federal guidance
U-M Researchers & Repositories
U-M researchers may interact with repositories in three (3) different ways:
Collection of data and/or biospecimens from participants as part of a human subjects research project that are intended to be retained and shared for other future research. IRB review and approval for this data collection process in accomplished via the standard IRB application (HUM).
Creation of a U-M repository, involving procedures for the intake, storage, maintenance and distribution of data/biospecimens. IRB review and approval repositories in accomplished via a Repository Application (REP). See a description of the REP below. Once the U-M repository is approved, the REP can be linked to IRB applications (HUMs) to indicate that the study will contribute materials to the repository.
Secondary use of data/biospecimens obtained from a repository. IRB review and approval for projects involving the use of data/biospecimens from repository is governed by the identifiability of the data and is accomplished via the HUM application.
The IRB Repository Application (REP) is a brief online questionnaire/form that any member of the repository team can initiate within U-M's eResearch Regulatory Management (eRRM) system. It is designed to collect only the information necessary for IRB review of and oversight for a U-M repository, such as:
- A description of the data/biospecimens to be stored and distributed
- The identifiability of the data
- Information about the source of the data
- Plans for sharing the data
Researchers are required to complete a Repository Application Supplement and upload it into the REP to provide more details regarding the policies and procedures associated with the repository. This template (see Resources below) provides an outline of information that the IRB must review in order to approve the U-M repository.
IRB REP Review Process
The IRB considers the following key information when reviewing the repository application:
- The identifiability of the data and/or biospecimens stored by the repository
- The sensitivity of the data/biospecimens being stored or shared
- The data security procedures in place for intake, storage, and sharing
- The procedures for receiving materials into the repository, including consideration of the informed consent under which the data/biospecimens were collected or any data use agreements or material transfer agreements under which materials were transferred to U-M from another institution.
- The procedures for sharing materials, including confirmation that appropriate institutional agreements (e.g., data use agreements or material transfer agreements) will be used.
References and Resources
For questions regarding IRB Repository Application (REP) requirements (e.g., policy, procedure, science), contact:
For help using eResearch Regulatory Management, contact: