During the past year, the National Institutes of Health (NIH) has instituted new requirements for studies involving clinical trials and human subjects, as well as new forms that go into effect for NIH applications with deadlines on or after January 25, 2018. Representatives from the Office of the VP for Research, the Research Protections Office, Sponsored Projects Administration, and the Office of Clinical Trials Research presented two training sessions in November, 2017 to help Principal Investigaors prepare for this transition. The slides are presented here:
For due dates on or after January 25, 2018, NIH will require that all applications involving one or more clinical trials be submitted through a Funding Opportunity Announcement (FOA) specifically designed for clinical trials. The purpose of this policy is to improve NIH's ability to identify proposed clinical trials, ensure that key pieces of trial-specific information are submitted with each application, and uniformly apply trial-specific review criteria.