Information about multi-site research
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Setting up and getting approval for a multi-site study is different from doing so for a study conducted solely at the NIH and reviewed by the NIH IRB…
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The typical IRB review process involves the NIH study team implementing the protocol at the NIH site and submitting it for NIH IRB review. However, M…
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A Reliance Agreement tells you which institution's Institutional Review Board (IRB) will act as the Reviewing IRB and which one will cede its IRB rev…
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SMART IRB is not an IRB. It is a master reliance agreement with an accompanying reliance platform and resources that together offer a roadmap for sin…
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The information on this page is for NIH study teams who want to submit a new multi-site protocol to the NIH IRB, with NIH acting as the Reviewing IRB…
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This page explains the steps that NIH Study Teams need to take if they plan to use an external IRB to review their research activities on a protocol.
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The NIH is willing to rely on the Advarra or WCG IRBs and has an existing Reliance Agreement with both.
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If you are leaving the NIH but want to continue to be involved in an NIH study, and need IRB oversight of your research activities, there are several…
Templates
NIH Protocol Addendum Template When NIH Is The Reviewing IRB
Model Consent Template when NIH is the Lead Site
NIH Local Context Consent Template for use at the NIH CC
NIH Local Context Consent Template for use at NIH CC for CIRB
NIH Local Context Consent Template for use at NIH CC for CIRB_Spanish
Consent Library