***IMPORTANT: NIH CLINICAL TRIAL FUNDING OPPORTUNITY ANNOUNCEMENT and UPDATED DEFINITION OF CLINICAL TRIAL***
The NIH Clinical Trial Funding Opportunity Announcement policy requires all applications with due dates on/after January 25, 2018 involving clinical trials be submitted through a FOA specific to clinical trials. More information on this will be provided by ORA over the upcoming weeks.
New Definition for Clinical Trials:
Applications with due dates on or after January 25, 2018 that meet NIH’s definition of a clinical trial that are not submitted in response to a clinical trial specific FOA will be returned without review. When determining whether proposed research meets the definition of a clinical trial there are four questions that investigators need to ask:
1. Does the study involve human participants?
2. Are the participants prospectively assigned to an intervention?
3. Is the study designed to evaluate the effect of the intervention on the participants?
4. Is the effect that will be evaluated a health-related biomedical or behavioral outcome?
If the answer to all four questions is yes, NIH considers the research a clinical trial. NIH has provided a tool to assist in making this determination which can be accessed at https://grants.nih.gov/ct-decision/index.htm.
Additional Information:
The Office of Clinical Research (OCR) and Office of Sponsored Programs (OSP) will be providing further information over the upcoming weeks. This information will be shared through this newsletter and the OSP and OCR websites as well as presentations with researchers and RAS. Please watch upcoming newsletters for further information.
The information released by NIH is limited, at this point. As further information is released it will be shared with the Emory Research Community. Some information is currently available at https://grants.nih.gov/policy/clinical-trials.htm. Additional details (e.g., on clinical trial specific forms and requirements) are available in a recent blog from Dr. Mike Lauer, NIH Deputy Director for Extramural Research. If you have questions regarding the implementation of these changes, please direct them to your RAS Administrator or Kerry Peluso at kpeluso@emory.edu.