Repository Overview

Researchers at U-M have established many repositories with a wealth of data and available specimens.  The University is committed to facilitating existing and new repositories to support research and to promote the effective use of University resources, consistent with the Medical School’s Strategic Research Initiative.

To this end, a “REP” application in the eResearch Regulatory Management (eRRM) system facilitates oversight of repositories.  This supplements the existing “HUM” application for oversight of human subjects research studies. The REP application and Application Supplement Form capture information required for IRB oversight and for compliance with University policies on data and physical security and on repository governance.

• Elements and Uses of a Repository
• FAQ: Repository Application (REP)
• Decision tree
• Tips on the REP Application and Supplement Form
• Responsibility for REP Oversight and Compliance
• U-MIC IRB Board Tip: IRB Oversight for Data and/or Biospecimen Repositories

IRBs and other review committees

• IRBMED
• IRB-HSBS
  • IRB-HSBS Repository guidance
• Conflict of Interest (COI) Committees review disclosures that report an outside interest or activity to determine whether the interest could directly and significantly affect the staff or faculty member’s research.
• Institutional Biosafety Committee (IBC) provides oversight for recombinant DNA (rDNA) work.

University-wide resources

• ORSP Data Sharing Specialist provides guidance in drafting data sharing plans for proposals, data use agreements (DUA), and data management plans
• ITS Sensitive Data Guide supports informed decisions on where to safely store and share sensitive data using UM IT services.
• PEERRS courses provide training required per university, state, and federal regulations regarding responsible conduct of research (RCR). This includes courses on human subjects protection.
• OSEH Research Health & Safety (RH&S) promotes research safety and assures sound laboratory management.

UMHS resources

• UMMS Research Biorepositories Policy (available through PolicyStat)
• UMHS Central Biorepository provides a standardized, safe and monitored environment for the processing, storage and distribution of high-quality normal and diseased biospecimens annotated with detailed clinical and laboratory data.
• UMMS Data Office for Clinical and Translational Research serves as a
  common portal for researchers to request and gain access to electronic health record data for use in research. It also processes data sharing agreements for use of electronic health record data in research.

• OHRP Issues to Consider in the Research Use of Stored Data or Tissues
• NIH Research Repositories, Databases, and the HIPAA Privacy Rule