The OSP proposal routing forms have been updated with a few new questions related to the NIH SIRB (Single IRB) requirement for multi-site human subjects research projects; however, until this has been completed, we are asking for all COs to please place a disclosure of the Single IRB requirement on the routing sheet, both paper and electronic.
You will notice this requirement at NIH FOA time. At this time, it is only for NIH FOA’s marked with the specific requirement for SIRB; however, that may change when the New Common Rule goes into effect (January 21, 2019) and may apply to all multi-site human subjects research projects regardless of funding.
Your compliance with this request is greatly appreciated. If you have any questions, please feel free to contact Kelly Winn in Georgia Tech's Office of Research Integrity Assurance.
NIH Single IRB Policy for Multi-site Research
Learn about policy expectation for the use of single IRBs for multi-site grant applications with due dates January 25, 2018 and beyond, and for contract solicitations published starting January 25, 2018.
Historically, in many multi-site studies, each site has its own IRB which conducts an independent review of studies involving human research participants. The use of a single IRB of record for multi-site studies that are conducting the same protocol will help streamline the IRB review process by eliminating the unnecessary repetition of those reviews across sites.
The goal of this policy is to enhance and streamline the IRB review process for multi-site research so that research can proceed as quickly as possible without compromising ethical principles and protections for human research participants.
For applications with due dates on or after January 25, 2018, and contract solicitations published on or after January 25, 2018, NIH expects that all sites participating in multi-site studies, which involve non-exempt human subjects research funded by the NIH, will use a single Institutional Review Board (sIRB) to conduct the ethical review required for the protection of human subjects.
This policy applies to the domestic sites of NIH-funded multi-site studies where each site will conduct the same protocol involving non-exempt human subjects research. It does not apply to career development, research training or fellowship awards. Implementation of the NIH sIRB policy is expected to reduce unnecessary administrative burdens and systemic inefficiencies while maintaining appropriate human subjects protections.
Applicants are expected to include a plan for the use of a sIRB in the grant applications and contract proposals they submit to the NIH (for due dates on or after January 25, 2018). https://grants.nih.gov/policy/clinical-trials/single-irb-policy-multi-site-research.htm
Kelly Winn, MS, CIP, RAC
Director of HRPP & Regulatory Affairs
Office of Research Integrity Assurance
Georgia Institute of Technology