Until release of the REP application, IRBs processed repository reviews and approvals in the eResearch system only through the “human subject study” (HUM) application. As such, many existing repositories have HUM approvals.
HUM applications continue to provide valid approval for all activities described in the approved application. This includes HUM applications for repository activities, or for research studies with repository components. HUM approval satisfies the registration requirement for repositories subject to the “Medical School Governing UMMS Research Biorepositories Policy” (available through PolicyStat).
Over time, many ongoing repositories should expect to submit an REP application, for instance, at the time of Continuing Review for the HUM. Consult with your IRB staff as to when/whether this is appropriate for your repository.
In some cases, an REP may entirely supplant an HUM and the HUM can then be terminated. This is particularly likely if ongoing and future repository activities are limited to storage, maintenance, and distribution for “secondary uses” of data/biospecimens.
In other cases, when data/biospecimen collection continues, or when the repository is an additional aim in a specific research study, the HUM application will continue to remain active, but should be Amended to minimize duplication of information with the REP. Amendment also provides an opportunity to begin using the Specialty Biorepository Informed Consent Template + informational sheet, if appropriate.