Notice Number: NOT-MH-19-031
Release Date: July 25, 2019
National Institute of Mental Health (NIMH)
The purpose of this notice is to update and clarify NOT-MH-19-006 regarding NIMH support for clinical trials. NIH defines a 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” (NOT-OD-15-015).
NIMH supports clinical trials in the following manner:
Note: applications submitted to NIMH via these FOAs are expected to comport with NIMH’s experimental therapeutics model.
NIMH does not accept clinical trial applications that propose to test the safety or demonstrate efficacy or effectiveness of an intervention under the following parent FOAs and their re-issuances: PA-19-055 (R01), PA-19-091(R01 BESH), PA-19-054 (R21), and PA-19-092 (R21 BESH). Additionally, NIMH does not accept any type of clinical trial application submitted under FOAs that are “Clinical Trials Not Allowed,” including parent FOAs: PA-19-056 (R01), PA-18-350 (R21) PA-19-052 (R03), and their re-issuances. Clinical trial applications that are submitted in this manner will not be reviewed .
Please see additional information on the Support for Clinical Trials at NIMH webpage.
For AIDS-related clinical trials, please see NIMH Division of AIDS Research FOAs:https://www.nimh.nih.gov/about/organization/dar/aids-related-funding-opportunity-announcements-foas.shtml
Please direct all inquiries to: