NOT-MH-23-375: Consolidated Notice on NIMH Clinical Trials Policies

Consolidated Notice on NIMH Clinical Trials Policies

Notice Number:

NOT-MH-23-375

Key Dates

Release Date:

September 14, 2023

Related Announcements

May 10, 2021 - NINDS Exploratory Neuroscience Research Grant (R21- Clinical Trial Optional). See PA-21-219
March 31, 2021 - Research on Autism Spectrum Disorders (R01-Clinical Trial Optional). See PA-21-201
March 30, 2021 - Research on Autism Spectrum Disorders (R21-Clinical Trial Optional). See PA-21-200
March 30, 2021 - Research on Autism Spectrum Disorders (R03-Clinical Trial Optional). See PA-21-199
October 5, 2020 - Consolidated Notice on NIMH Clinical Trials Policies. See NOT-MH-20-105 - RESCINDED
May 7, 2020 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Basic Experimental Studies with Humans Required). See PA-20-196
May 7, 2020 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Required). See PA-20-194
May 5, 2020 - Research Project Grant (Parent R01 Clinical Trial Required). See PA-20-183
May 5, 2020 - Research Project Grant (Parent R01 Basic Experimental Studies with Humans Required). See PA-20-184
April 8, 2019 - Oversight and Monitoring of Clinical Research funded by the NIMH. See NOT-MH-19-027
December 21, 2018 - 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. See NOT-MH-19-006
October 23, 2014 - Notice of Revised NIH Definition of “Clinical Trial”. See NOT-OD-15-015

Issued by

National Institute of Mental Health (NIMH)

Purpose

This notice replaces NOT-MH-20-105 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 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 NOFOs and their re-issuances: PA-20-183 (R01 CT Required), PA-20-184 (R01 BESH), PA-21-201 (Autism R01), PA-21-219, (NINDS R21), PA-20-194 (R21 CT Required), PA-20-196 (R21 BESH), PA-21-200 (Autism R21), PA-21-199 (Autism R03). Non-mechanistic trials submitted to these NOFOs and assigned to NIMH will be returned prior to peer review.

NIMH supports clinical trials according to the following guidance:

Studies that test or confirm efficacy/effectiveness/safety/pharmacodynamic or neurodynamic effects (to establish dosing) of an intervention may be submitted to:
- NIMH-specific Clinical Trials NOFOs
- Selected Notices of Funding Opportunity (NOFOs) that allow clinical trials applications (i.e., designated as either “Clinical Trials Optional” or “Clinical Trials Required”), such as:
  - NIMH initiated NOFOs;
  - NOFOs 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: The above guidance applies to all applications that involve preventive, therapeutic, and services interventions. Applications submitted to NIMH via these NOFOs are expected to comport with NIMH’s experimental therapeutics approach (see Support for Clinical Trials at NIMH – Applicant FAQs, Q8).

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:
- Parent NOFOs and their re-issuances: PA-20-183 (R01 CT Required), PA-20-184 (R01 BESH), PA-20-194 (R21 CT Required), PA-20-196 (R21 BESH) – please see the following resource for more details on BESH studies: https://grants.nih.gov/policy/clinical-trials/besh.htm
- Selected NOFOs and their reissuances that specify only mechanistic and/or BESH trials are accepted: PA-21-219, (NINDS R21), PA-21-201 (Autism R01), PA-21-200 (Autism R21), PA-21-199 (Autism R03).

Please see additional information on the Support for Clinical Trials at NIMH webpage.

Investigators submitting clinical trial 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".

Applicants are strongly encouraged to contact NIMH program staff prior to submission.

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:

Christopher Gordon
National Institute of Mental Health (NIMH)
Telephone: 240-627-3867
Email: cgordon1@mail.nih.gov