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  4. NIH-supported research and the Revised Common Rule

NIH-supported research and the Revised Common Rule

Is any of your human subject research NIH-supported? If so, please review the newly released NIH notice about implementation of the final rule on the federal policy for protection of human subjects for a recap of how the Revised Common Rule (RCR) will affect your projects. Two changes in particular are specific to NIH-funded or -supported projects.

First, IRBs will no longer have to review the entire NIH grant application (hallelujah! there is much rejoicing in the IRB office over that change, and PIs who no longer have to upload grant applications are also probably pretty happy about it).

Also, informed consent forms for NIH-funded or -supported clinical trials* will be required to be posted on a public federal website after “recruitment closes and no later than 60 days after the last study visit. [*A clinical trial, per the RCR, is a “research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.”]

Please click on the link above to read the full notice.

Posted by Edith Paal on January 4, 2019

Filed Under: Institutional Review Board Members

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