Revisions to the Common Rule

The U.S. Department of Health and Human Services and fifteen other Federal Departments and Agencies have issued revisions to the Federal Policy for the Protection of Human Subjects (the Common Rule).

Good Clinical Practice Training

NIH released a policy establishing the expectation that all NIH-funded investigators and staff who are involved in the conduct, oversight, or management of clinical trials should be trained in Good Clinical Practice (GCP), consistent with principles of the International Conference on Harmonisation (ICH) E6

Single IRB

NIH has issued a policy “establishing the expectation that all sites participating in multi-site studies involving non-exempt human subjects research funded by the National Institutes of Health (NIH) will use a single Institutional Review Board.”