The National Institutes of Health (NIH) Policy on the use of a Single Institutional Review Board of Record (sIRB) for Multi-Site Research establishes the expectation that all sites participating in multi-site studies involving non-exempt human subjects research funded by the NIH will use a sIRB to conduct the required ethical review for the Protection of Human Subjects.
Although the effective date is not until September 25, 2017, many institutions are preparing to align themselves with the expectations of this policy.
As an experienced provider of sIRB services, BRANY’s AAHRPP accredited IRB can help institutions and researchers by performing a comprehensive and ethical review of research protocols in accordance with applicable regulations and the NIH’s sIRB policy, including:
- Conducting IRB review of the protocol and inform consent forms for all participating sites
- Facilitating IRB Authorization Agreements for sites
- Serving as Privacy Board when requested by participating site
- As applicable, coordinating with participating sites the process for reviewing and reporting conflicts of interest disclosed by site personnel
- Maintaining records of IRB proceedings as required by applicable regulations
- Pertinent documents are available to Lead Institutions and participating sites 24/7 via IRBManager (BRANY IRB’s secure, electronic IRB management system)
- NIH’s sIRB policy includes requirements for facilitating communication between participating sites and the sIRB. BRANY IRB can configure notifications and customize communication workflows regarding sIRB reviews and determinations to participating sites’ needs (e.g., notifications to institutional designees in addition to researchers).
- Reporting to participating sites, and regulatory agencies as applicable, any unanticipated problems, serious/continuing non-compliance, or suspensions/terminations of IRB approval.
BRANY IRB’s model for the last 19-years has emulated that of a “single IRB” for multisite research, and we have worked diligently over the years to design and customize specific processes to keep researchers, institutions and key personnel at various sites connected to all pertinent research matters throughout the course of a research study. We are eager to partner with organizations to create customized single IRB solutions that result in high quality human subject protection, while also adding operational efficiencies to your research.
To learn more about how investigators and institutions can work with sIRBs, please contact Carmela Houston-Henry.