October 5, 2020
NOT-MH-19-031- Consolidated Notice on NIMH Clinical Trials Policies - RESCINDED
NOT-MH-19-027 - Oversight and Monitoring of Clinical Research funded by the NIMH
NOT-OD-15-015 - Notice of Revised NIH Definition of “Clinical Trial”
NOT-MH-19-006 - NIMH Acceptance of Clinical Trial Applications under the Parent R01 and R21 Clinical Trial Required, or Basic Experimental Studies Involving Humans (BESH) Announcements is Limited to Mechanistic Clinical Trials
PA-20-183 - Research Project Grant (Parent R01 Clinical Trial Required)
PA-20-184 - Research Project Grant (Parent R01 Basic Experimental Studies with Humans Required)
PA-20-194 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Required)
PA-20-196 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Basic Experimental Studies with Humans Required)
PA-18-358 - NINDS Exploratory Neuroscience Research Grant (R21- Clinical Trial Optional)
PA-18-401 - Research on Autism Spectrum Disorders (R01-Clinical Trial Optional)
PA-18-400 - Research on Autism Spectrum Disorders (R21-Clinical Trial Optional)
PA-18-399 - Research on Autism Spectrum Disorders (R03-Clinical Trial Optional)
PA-20-185 - NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)
PA-18-350 - NIMH Exploratory/Developmental Research Grant (R21 Clinical Trial Not Allowed)
PA-20-200 - NIH Small Research Grant Program (Parent R03 Clinical Trial Not Allowed)
National Institute of Mental Health (NIMH)
This notice replaces NOT-MH-19-031 and clarifies NIMH support for clinical trials involving preventive, therapeutic, and services interventions. 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 according to the following guidance:
Note: applications submitted to NIMH via these FOAs are expected to comport with NIMH’s experimental therapeutics approach (see Support for Clinical Trials at NIMH – Applicant FAQs, Q1).
NIMH does not accept clinical trial applications that propose to test the safety or demonstrate pharmacodynamic or neurodynamic effects (to establish dosing), or demonstrate efficacy or effectiveness of an intervention under the following parent FOAs and their re-issuances: PA-20-183 (R01 CT Required), PA-20-184 (R01 BESH), PA-20-194 (R21 CT Required), and PA-20-196 (R21 BESH).
NIMH does not accept any type of clinical trial application submitted under FOAs that are “Clinical Trials Not Allowed,” including parent FOAs: PA-20-185 (R01), PA-18-350 (R21), PA-20-200 (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.
Adult translational research:
Developmental translational research:
Studies focused on mechanisms in effectiveness/services research:
Mechanistic studies in healthy humans:
Studies focused on induced pluripotent stem cell biology:
Studies focused on HIV: