Notice Number: NOT-OD-16-147
Release Date: September 16, 2016
National Institutes of Health (NIH)
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. This means that the NIH will no longer accept clinical trial applications through "parent" FOA announcements or through other FOAs that are not specifically designed to accept clinical trials. The purpose of this policy is to improve our 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 1 .
Over the past few years, the NIH began taking steps to enhance its management and oversight of clinical trials. One recommendation NIH is implementing is the use of clinical trials-specific FOAs. Some NIH Institutes and Centers already require clinical trials to be submitted in this manner, and this will now be implemented across the NIH. The NIH recognizes that there is great breadth and diversity to the types and topics for clinical trials, and the Institutes and Centers will retain the flexibility to determine how best to design funding opportunities for clinical trials for their communities.
This FOA policy will apply to all applications involving one or more clinical trials (see definition), including applications that involve a combination of studies that are clinical trials as well as studies that are not. These latter “hybrid” FOAs include applications that will involve a combination of trial and non trial aims. These and other types of trial applications will also be submitted to clinical trial-specific FOAs if the combination studies involve a NIH defined clinical trial.
The target effective date for the NIH Policy on Funding Opportunity Announcement (FOA) for Clinical Trials is September 27, 2017. All applications with receipt dates on or after the effective date with plans to conduct clinical trials must be submitted in response to a clinical trial-specific FOA. After that date, applications planning a clinical trial that are submitted to a non-clinical trial FOA will be returned without review.
Please direct all inquiries to:
Clinical Trials Program
Office of the Director
Office of Extramural Programs
Office of Extramural Research
National Institutes of Health
1 NIH defines clinical trial as 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 those interventions on health-related biomedical or behavioral outcomes. See https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-015.html and http://osp.od.nih.gov/office-clinical-research-and-bioethics-policy/clinical-research-policy/clinical-trials