Notice Number: NOT-MH-19-031

Key Dates
Release Date: July 25, 2019 (Rescinded October 5, 2020)

NOT-MH-20-105
PA-18-350
PA-18-399
PA-18-400
PA-18-401
PA-19-052
PA-19-054
PA-19-055
PA-19-056
PA-19-091
PA-19-092
NOT-MH-19-006
NOT-MH-19-055

Issued by
National Institute of Mental Health (NIMH)

Purpose

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:

• Studies primarily focused on testing or confirming Efficacy/Effectiveness/Safety of an intervention may be submitted to:
  • NIMH-specific Clinical Trials RFAs
  • Selected Funding Opportunity Announcements (FOAs) that allow clinical trials applications (i.e., designated as either Clinical Trials Optional or Clinical Trials Required ), such as:
    • NIMH initiated FOAs;
    • FOAs from other Institutes/Centers on which NIMH participates;
    • Parent Announcements for Career Development Awards (K), Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR).

Note: applications submitted to NIMH via these FOAs are expected to comport with NIMH’s experimental therapeutics model.

• Mechanistic Trials, which are designed to understand a biological or behavioral process, the pathophysiology of a disease, biomarkers for a disease or response to treatment, or the mechanism of action of an intervention (see NOT-MH-19-006 for further details and examples) may be submitted to:
  • Selected FOAs that specify mechanistic trials required/optional (e.g., PA-18-401 (Autism R01), PA-18-400 (Autism R21), PA-18-399 (Autism R03)
  • Parent FOAs and their re-issuances: PA-19-055 (R01), PA-19-091 (R01 BESH), PA-19-054 (R21), PA-19-092 (R21 BESH);

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:

Inquiries

Please direct all inquiries to:

NIMH Clinical Trial Contacts