2018年1月25日 · NIH-funded or -supported studies conducting multi-site or cooperative research may need to have a single IRB (sIRB), if any of the following apply: *As of January 20, 2020, studies subject to the Revised Common Rule Cooperative Research Provision (45 CFR 46.114 (b)) must use a single IRB as required by the terms and conditions of award.

2025年2月3日 · It provides guidance on the 2018 Requirements set forth in 45 CFR 46.114 (b) (1) that require any institution located in the United States engaged in cooperative research to rely on approval by a single institutional review board (IRB) for that portion of the research that is conducted in the United States, with some exceptions as described at ...

The policy defines multi-site research as a subset of collaborative research that requires the use of a single IRB. It is important to identify when a project must comply with the NIH policy because there are specific, NIH requirements that must be present in the grant or contract applications for studies subject to this policy that do not ...

Federally-funded cooperative research projects subject to the revised Common Rule must use a single IRB. All domestic sites must use a single IRB of record to review human subjects research when participating in NIH supported multi-site studies whether that support comes from a grant, cooperative agreement, contract, or the NIH IRP.

The basis for the single IRB model is to allow multiple sites that are conducting the same protocol to use a single IRB for review, instead of using multiple IRBs to review the research at the sites individually. The single IRB model has been in use for many years, across a wide variety of studies and circumstances..

This regulation requires that as of January 20, 2020, for all multi-site clinical research that include more than one domestic site and obtain initial IRB approval on or after January 20, 2020, the domestic sites must be overseen by a single IRB (45 CFR 46.114).

The Revised Common Rule includes a Cooperative Research (Single IRB) requirement for all Common Rule Agencies. This requirement applies to federally funded or supported non-exempt human subjects research that involves multiple institutions.

2023年6月19日 · Cooperative research projects involving more than one institution are expected to follow a single IRB (sIRB) model as required by the Common Rule or by contract. Roles and responsibilities of participating sites in multi-site research are defined in this guidance.

In 2016, the National Institutes of Health (NIH) announced a new policy requiring the use of a single IRB (sIRB) for the review of most NIH-funded, multisite human subjects research [1]. The policy became effective in January 2018 and was soon followed by a similar mandate that was incorporated into the revised Common Rule (45 CFR 46.114).

2018年1月25日 · Single IRB is a model of IRB review that is intended to streamline and reduce administrative burden on IRBs reviewing multisite studies. In a single IRB model, one IRB serves as the reviewing IRB or “IRB of Record” and the participating site (pSite) IRBs serve as …