Consolidated Notice on NIMH Clinical Trials Policies
Notice Number:
NOT-MH-20-105

Key Dates

Release Date:

October 5, 2020

Related Announcements

NOT-MH-19-031- Consolidated Notice on NIMH Clinical Trials Policies - RESCINDED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)

Issued by

National Institute of Mental Health (NIMH)

Purpose

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:

  • Studies primarily focused on testing or confirming efficacy/effectiveness/safety/pharmacodynamic or neurodynamic effects (to establish dosing) of an intervention may be submitted to:
    • NIMH-specific Clinical Trials FOAs
    • 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).
  • Investigators submitting clinical trials applications to NIMH are expected to follow the guidance outlined in NOT-MH-19-027, "Oversight and Monitoring of Clinical Research funded by the NIMH".

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 FAQsQ1).

  • Mechanistic Trials -- which are designed to understand a biological or behavioral process, the pathophysiology of a disease, biomarkers for a disease or response to an intervention with previously established efficacy or the mechanism of action of an established intervention (see NOT-MH-19-006 for further details and examples) -- may be submitted to:

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.

Inquiries

Please direct all inquiries to:

Adult translational research:

Mi Hillefors, M.D., Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-2738
Email: mi.hillefors@nih.gov

Developmental translational research:

Julia Zehr, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-1617
Email: zehrj@mail.nih.gov

Studies focused on mechanisms in effectiveness/services research:

Joel Sherrill, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-2477
Email: jsherril@mail.nih.gov

Mechanistic studies in healthy humans:

Andrew Rossi, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-1576
Email: rossia@mail.nih.gov

Studies focused on induced pluripotent stem cell biology:

David Panchision, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-5288
Email: panchisiond@mail.nih.gov

Studies focused on HIV:

Pim Brouwers, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 240-627-3863
Email: pb56u@nih.gov


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices