Geisinger as the sIRB

Single IRB (sIRB is an arrangement established through an agreement (i.e. Reliance Agreement) between 2 or more sites engaged in human subjects research that designates 1 IRB with the responsibility of completing the ethical review for all sites participating in a multi-site study (i.e., the Single IRB). sIRB is mandated for most federally supported, multi-site, non-exempt human subjects research through the NIH Single IRB Policy and the Common Rule Cooperative Research Rule.

What are the possible benefits of Single IRB Review?

1. Consistency and standardization of the review process among all sites
2. Eliminates duplicative reviews
3. Faster and more efficient reviews and approval
4. Streamlined and simplified IRB review
5. Improved quality of review related to IRB member expertise
6. Reduction of work (at least for the relying sites)

What are the challenges of Single IRB review?

1. New and unfamiliar multifaceted processes and requirements
2. Lack of process harmonization between institutions
3. Duplication of effort/IRB review at local institutions
4. More work for the sIRB and the lead research team
5. Lack of resources and clear guidance
6. Unnecessary requests by relying sites

Overview of GIRB's sIRB process

Geisinger is generally willing to serve as the sIRB for both federally supported and non-federally supported multi-site research. To establish GIRB as the sIRB for a multi-site study, Investigators must first submit the Single IRB Intake Form and request GIRB's sIRB services. If agreeable, GIRB will provide a letter of support that includes an estimate of the sIRB costs associated with GIRB's services. Under most circumstances, GIRB will not provide sIRB services for exempt human subjects' research.

GIRB's comprehensive sIRB process is detailed in the Geisinger IRB Investigator's Guide for Geisinger Serving as the Single IRB document, below. The sIRB process is intended to be flexible to better accommodate various sIRB scenarios that may arise. GIRB's sIRB review is largely dependent upon the Relying Site Application, which is a fillable document that collects and maintains site-specific details that are necessary for sIRB review. The information collected includes details about local context, participant screening and recruitment, the consent process, site-specific differences in the study plan, vulnerable populations, HIPAA authorization and waivers, and much more. The Relying Site Application is intended to streamline the sIRB review by compiling and organizing all the site-specific information in one location.

Geisinger single IRB policies and procedures

• Geisinger IRB Investigator's Guide for sIRB
• Geisinger Single IRB Intake Form
• Geisinger Single IRB Fees
• Geisinger sIRB Relying Site Application
• Geisinger sIRB Relying Site Continuing Review Form

Geisinger as a relying institution

• Geisinger IRB Investigator's Guide for Relying on an External IRB
• Complying with Geisinger Consent Form Requirements when Geisinger is a Relying Institution