Applies to: Reliance System
Who can submit. Any Reliance System user whose institution allows it — study team members at the lead or a relying site, IRB/HRPP staff, or anyone the institution designates. The system is designed to be investigator-driven, but institutions that prefer their IRB office to submit can restrict the permission.
Before you start
- Confirm every engaged institution is a Version 3.0 Participating Institution — check the Participating Institutions page. A site that has not joined V3.0 cannot be included until it does.
- Talk to your institution's SMART IRB Point of Contact, especially about which IRB should review. Contact details are on the same page.
- Gather the information below. Only add sites that are ready to enter the arrangement — you can add more later.
What you will enter
- PI information: the Overall PI's Home Institution (from the list), name and email; phone and degrees optional.
- Study information: title (up to 255 characters), brief description (up to 1,000), protocol number and NCT number if you have them, and the reason(s) you are requesting the proposed Reviewing IRB. The proposed Reviewing IRB defaults to the Overall PI's Home Institution; change it if a sponsor or network has designated another.
- Documents (PDF only, under 10 MB each): the research protocol narrative (required; up to two per request); consent templates and other documents as applicable. Documents can be added or replaced later, for the life of the study, by Reviewing IRB staff and research personnel at the Overall PI's home institution.
- Funding: funder, primary awardee institution, and funding type (optional).
- Sites: for each engaged site, the Site Investigator's name and email, the research activities and subject populations at that site, and any other personnel who should have access to the request. Once a site is added, that site's Site Admins and listed personnel can review and correct its details themselves, up until the site's reliance determination.
Submitting. Review the request summary and select Submit. Site Admins at the Home Institution are notified to begin the pre-check, and you can follow progress on your dashboard. Full walkthrough: Create a new reliance request user guide.
After the determination, the Reviewing IRB takes over — the Reliance System is not an IRB submission system, so submit your protocol through the Reviewing IRB's own process. See After the reliance determination.
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