APPLYING THE sIRB POLICY TO YOUR NEXT NIH PROPOSAL
EFFECTIVE JANUARY 25th, 2018
The National Institutes of Health (NIH) is issuing a policy on the use of a single Institutional Review Board (IRB) for multi-site research to establish the expectation that a single IRB (sIRB) of record will be used in the ethical review of non-exempt human subjects research protocols funded by the NIH that are carried out at more than one site in the United States.
The goal of this policy is to enhance and streamline the IRB review process in the context of multi-site research so that research can proceed as effectively and expeditiously as possible. For projects that are non-NIH funded or not funded studies the FAU policy is to avoid the burden of multiple IRB reviews. The process will be applied to all research conducted at FAU except on those projects where federal, tribal or state law, regulation or policy prohibits the review by a single IRB.
What this means:
- In the NIH application/proposal for research funding, the applicant/offeror is expected to submit a plan describing the use of a single IRB to serve as IRB of record for all study sites.
- The PI will need to select the sIRB, which can be pre-determined by the study sponsor or grant, established by prior arrangement (e.g. network central IRB), be the IRB from the lead PI's institution, or be selected based on expertise in the study area (e.g. type of procedures to be performed or subject population).
- SMART IRB, an NIH initiative, does not serve as the IRB of record but rather provides online reliance system to request, track and document reliance agreements. SMART IRB is a platform for communications between researchers and IRBs.