Repository applications have launched

July 30, 2015  //  FOUND IN: Announcements, Updates & Resources

Repository Application (REP) is a new submission type available in eResearch Regulatory Management (eRRM) for oversight of U-M data/biospecimen research repositories. The new application went live on Monday, July 27.

A research data or tissue bank, or research repository, stores, maintains and distributes data and/or biospecimens to enable future research. New repositories should request IRB approval through an REP application for intake, storage, maintenance and distribution of data and/or biospecimens. ?In some cases, a REP replaces a Human Subject Study (HUM) application; in others, it is an adjunct to one or more HUM "collection applications." Repositories previously approved under a HUM application will in some cases be asked by IRB staff to transition to a REP, if it may simplify or clarify oversight.

For step-by-step instructions on submitting a Repository Application, see the eRRM Training webpage ("Repository Application" fan-out arrow near bottom of page).

For further information on the IRB implementation of oversight through Repository Applications, on regulatory and policy background for repository oversight, and for additional U-M resources on repositories, please visit the IRBMED website Repository Overview and sub-pages (such as Responsibility for REP Oversight and Compliance and FAQ: Repository Application (REP), and others).