Prisma Health IRB Reliance
The National Institutes of Health (NIH) announced its single policy mandate in 2016 with an effective date of January 25, 2018. This policy mandates Single IRB (sIRB) review for most multisite, nonexempt human subjects research the agency funds.
The Office of Human Research Protections (OHRP) requires review as part of the 2018 Common Rule [45 CFR 46.114(b)], similar to the NIH policy, expanding this requirement for most multisite research funded or conducted by the federal government. The Common Rule also requires that institutions that rely on an IRB operated by another organization to document this arrangement, referred to as a “Reliance Agreement”.
The HRPP Director is responsible for determinations related to appropriateness of ceding a review and those external IRB’s that are utilized for the purpose.
Reliance Agreement Requirements
Prisma Health will rely on external IRB organizations for review of research conducted at Prisma Health facilities and by Prisma Health investigators providing:
- The reviewing IRB is AAHRPP accredited, or comparable requirements are met;
- A current reliance agreement, either in the form of a Master Agreement or a Single Study Agreement, has been fully executed;
- A Request to “Cede” Review to an external organization has been submitted and approved prior to engaging in any agreements for external review;
- All Prisma Health requirements for the conduct of research have been met.
To request the feasibility of establishing a reliance agreement contact:
Janice Piazza, MSN, MBA
Director, Office of Human Research Protection
Janice.Piazza@PrismaHealth.org
Submit a Cede Request in IRBNet
To submit a Cede Request, please create a new project within IRBNet. Answer each applicable question on the Request to Cede Cover Sheet and attach the cover sheet to your submission package within the designer page of IRBNet. The Request to Cede Cover Sheet can be found in IRBNet Forms and Templates. Include with your submission the Protocol for the project and any available Informed Consent Forms. Submit your request to the applicable committee as an “Other” submission.
Master Reliance Agreements
Prisma Health has current Master Reliance Agreements in place with:
- WCG (formally WIRB).
- Advarra.
Prisma Health is also a participant in the SMART IRB Reliance program. This participation allows for more efficient single study reliance with other participating SMART IRB members. This process is more specifically utilized for single study reliance for federally funded studies.
Please note that Reliance Agreements can only be executed at the Institutional level by the HRPP Director and must be signed by the Institutional Official. They can not be executed at the department of program level.