Single IRB (sIRB) review
Dartmouth Health is willing to rely on an external IRB when federally mandated, required by sponsors, or on a case-by-case basis. Relying on another site or institution’s IRB is established by reliance agreements. A reliance agreement is an agreement between two or more institutions that allows an institution’s IRB to rely on another institution’s IRB for review of human subjects’ research.
If a study is funded by the Department of Health & Human Services (HHS) or National Institutes of Health (NIH), having one IRB conduct the IRB review for all study sites may be required by the single IRB policy, also known as the sIRB policy.
While there are federal policies that require a sIRB for federally funded studies, in order for any study to be eligible for sIRB review, the overall study must be non-exempt, meaning that the overall study must be reviewed at the expedited or convened IRB level.
Commercial IRBs are independent, pay-per-service IRBs that conduct ethical and regulatory review for human subjects research. We have agreements in place with the following most often used commercial IRBs.
Advarra is fully accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP) and serves thousands of institutions as well as the top pharmaceutical, biotech, medical device, and Clinical Research Organization companies. Advarra is headquartered in Columbia, Maryland, with several other offices across the United States and in Canada.
Biomedical Research Alliance of New York (BRANY)
Biomedical Research Alliance of New York (BRANY) is a national organization that supports sponsors and investigators involved in research in a wide variety of therapeutic areas, medical devices, biologic and diagnostic trials. BRANY is AAHRPP accredited and has over 20 years of experience as an IRB for multi-site and local research studies
WIRB Copernicus Group (WCG)
WCG (formerly WIRB) is the oldest and most experienced independent IRB in America. The Board has provided review services for the research of more than 10,000 investigators in over 30 countries, and in all 50 United States. Visit the WCG's IRB & IBC Resource Center.
Benefits of using a commercial IRB
There are many benefits to using a commercial IRB for certain types of studies, especially sponsor-initiated multi-site studies. Some of these benefits include:
- Ensuring compliance with current and future regulatory requirements to use a single IRB review model for collaborative research
- Improving time to approval, since commercial IRBs meet frequently and can quickly approve studies while still complying with regulatory requirements
- Enhancing oversight, as both the commercial IRB and Dartmouth Health have responsibility for ensuring compliance and safety of human participants