Key Dates

Related Announcements

• June 9, 2022 - Research Opportunities for New and "At-Risk" Investigators to Promote Workforce Diversity (R01 Clinical Trial Optional). See NOFO PAR-22-181

Issued by

National Institute of Mental Health (NIMH)

Purpose

The purpose of this Notice is to clarify project eligibility for Notice of Funding Opportunity (NOFO) PAR-22-181 “Research Opportunities for New and ”At-Risk" Investigators to Promote Workforce Diversity (R01 Clinical Trial Optional)".

The Notice of Funding Opportunity (NOFO) currently reads:

Section I. Funding Opportunity Description

Specific Areas of Research Interest: 

NIMH

The mission of the National Institute of Mental Health (NIMH) is to transform the understanding and treatment of mental illnesses through basic and clinical research, paving the way for prevention, recovery, and cure. NIMH supports research on topics that include basic neuroscience and behavioral science, and translational application of brain and behavior relationships in healthy and diseased states. Mental disorders may be defined according to existing diagnostic criteria or along dimensions of neurobehavioral functioning according to the NIMH Research Domain Criteria (RDoC) framework. If existing diagnostic criteria are to be used, investigators should include plans for addressing heterogeneity within the diagnostic category or categories. Applications considered for funding by the NIMH must fall within the areas of priority detailed in the NIMH Strategic Plan and the NIMH Strategic Research Priorities. It is recommended that investigators contact NIMH Scientific/Research staff well in advance of submitting applications to discuss the match to NIMH priorities. NIMH supports mechanistic clinical trials that focus on biomarker studies that may provide information about physiological function, target engagement of therapeutics, and/or the impact of therapeutic responses. These types of studies do not have as a primary aim to establish the efficacy or effectiveness of the intervention.

NIMH considers two major categories of mechanistic trials (though there may be others):

1. Mechanistic clinical trials using an intervention of known efficacy. These clinical trials utilize an efficacious intervention to investigate the pathophysiology, and/or psychopathology of mental disorders or the mechanisms of therapeutic responses; and to advance biomarkers of basic neurobiological processes. In such studies: (1) the primary aims do not involve establishing efficacy/effectiveness, and (2) the intervention chosen has already been demonstrated to have efficacy.
2. Mechanistic clinical trials utilizing an experimental manipulation: These studies utilize experimental manipulation and are primarily focused on understanding brain function in healthy individuals or those with mental disorders by measuring responses to the experimental manipulation. They are not intended to inform on the improvement of the health status of the individual or a group of individuals either by better understanding the mechanism of action of an intervention or a measurable improvement in health.

See the “Consolidated Notice on NIMH Clinical Trials Policies,”NOT-MH-20-105, for a summary of NIMH’s polices on support for mechanistic clinical trials.

The Notice of Funding Opportunity (NOFO) has been modified to read: (change shown in bold italics):

Section I. Funding Opportunity Description

Specific Areas of Research Interest: 

NIMH

The mission of the National Institute of Mental Health (NIMH) is to transform the understanding and treatment of mental illnesses through basic and clinical research, paving the way for prevention, recovery, and cure. NIMH supports research on topics that include basic neuroscience and behavioral science, and translational application of brain and behavior relationships in healthy and diseased states. Mental disorders may be defined according to existing diagnostic criteria or along dimensions of neurobehavioral functioning according to the NIMH Research Domain Criteria (RDoC) framework. If existing diagnostic criteria are to be used, investigators should include plans for addressing heterogeneity within the diagnostic category or categories. Applications considered for funding by the NIMH must fall within the areas of priority detailed in the NIMH Strategic Plan and the NIMH Strategic Research Priorities. It is recommended that investigators contact NIMH Scientific/Research staff well in advance of submitting applications to discuss the match to NIMH priorities. For this NOFO, NIMH only accepts the following types of clinical trials: mechanistic trials using an intervention of known efficacy and Basic Experimental Studies with Humans (BESH). Mechanistic clinical trials focus on biomarker studies that may provide information about physiological function, target engagement of therapeutics, and/or the impact of therapeutic responses. These types of studies do not have as a primary aim to establish the efficacy or effectiveness of the intervention. 

See the “Consolidated Notice on NIMH Clinical Trials Policies,” NOT-MH-23-375, for a summary of NIMH’s policies on support for mechanistic clinical trials, and https://www.nimh.nih.gov/funding/clinical-research for further information on support of clinical trials at the NIMH 

For more information, refer to Diversity R01 for New and “At-Risk” Investigators.

All other aspects of the PAR-22-181 remain the same.

Inquiries

Please direct all inquiries to:

Brittany Haynes, Ph.D.
National Institute of Mental Health (NIMH)
Phone: (301) 496-2767
Email: brittany.haynes@nih.gov