What is Reliant Review?
Reliant IRB Review is a process that allows clinical investigators to collaborate across institutions in an efficient, streamlined fashion. A single institution provides the IRB review for a research project that involves multiple sites.The IRBthat performs the review is designatedthe “IRB of Record”(IRBR).The collaborating organization(s) that agrees to accept the review of the IRBR, is designated as the “Relying IRB” (RIRB).
What are the goals of the Reliant Review?
The Institutional Review Boards at the participating institutions hope to decrease investigator burden by streamlining the IRB review process for collaborative research. The IRB professional staff at the IRB of Record will assist interested investigators in the preparation and submission of a request for Reliant IRB Review.
What are the benefits of Reliant Review for clinical trials?
- Streamlines multi-center research between organizations, with the goal of growing collaborative research
- Increases the start of new clinical trials and accelerating collaborative research opportunities between organizations
- Reduces investigator burden while maintaining the integrity of IRB review
- Creates an electronic IRB process which is accessible and transparent
How does Reliant IRB Review work?
IRB of Record
IRB of Record
- Investigator requests a Reliant IRB Review (with initial review or an amendment)
- New Reliant IRB Review created
- Reliant IRB Review is sent to relying IRB(s)
- Reliant IRB Review is accepted
- Reliant IRB Review is approved or disapproved
- Institutional Requirements Review:
- Send to reviewer for approval;
- Reviewer submits review;
- Replying IRB Administrator sends letter and sets approval date for RIRB
- The study documents are maintained in the HUB
- RIRB can perform administrative actions (close RR, add documents, etc.)
What are the key elements of Reliant Review?
- A single IRB submission to the IRB of record
- Electronic HUB with all study documents and reviews from IRB of record
- A brief request form
- Online review by all named IRB(s) with the ability to request additional site specific information
What will the IRB of Record upload as part of a Reliant Review?
- The application/protocol from IRB of Record
- The approval notices and letters from IRB of Record
- The minutes (if applicable) from IRB of Record
- Consent documents required regulatory determinations
What will the Relying IRB (RIRB) do as part of a Reliant Review?
- Review the submitted application and approve or disapprove is, notifying the Investigator and IRB of Record of their decision
- Issue an approval letter
- Record the date the Reliant Review was approved at RIRB organization
- Place the approved consent language on their template and stamp it
- The only changes allowed are the addition of language pertaining to persons to contact at the RIRB organization with questions and concerns, and subject injury language