NOT-MH-14-007: NIMH Policy for Submission of Applications Containing Clinical Trials

NIMH Policy for Submission of Applications Containing Clinical Trials

Notice Number: NOT-MH-14-007

Key Dates
Release Date: February 25, 2014

Issued by
National Institute of Mental Health (NIMH)

Purpose

The purpose of this Notice is to inform NIMH grant applicants that, beginning with applications submitted for the June 5, 2014 submission date and all subsequent applicable deadlines, NIMH will not accept R01, R21, or R03 applications that include clinical trials of potential therapies for mental disorders, under the NIH parent R01 Funding Opportunity Announcement (FOA) PA-13-302, NIH parent R21 FOA PA-13-303, and NIH Parent R03 FOA PA-13-304, and subsequent reissuances of these FOAs. A clinical trial is a prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical, behavioral or services interventions (drugs, treatments, devices, preventive interventions, service delivery models, or new ways of using known drugs, treatments, devices, preventive interventions, or service delivery models). Clinical trials are used to determine whether new biomedical, behavioral, or services interventions are safe, tolerable, effective and/or efficacious.

Applications submitted to NIMH that contain a clinical trial must respond to one of the following NIMH FOAs (and subsequent reissuances of these FOAs) specifically designed for clinical trials: First in Human and Early Stage Clinical Trials of Novel Investigational Drugs or Devices for Psychiatric Disorders (U01) PAR-14-107 Exploratory Clinical Trials of Novel Interventions for Mental Disorders (R21/R33) RFA-MH-15-300; Exploratory Clinical Trials for Novel Interventions for Mental Disorders (R33) RFA-MH-15-310; Pilot Effectiveness Studies and Services Research Grants (R34) RFA-MH-15-330; Clinical Trials to Test the Effectiveness of Treatment, Preventive, and Services Interventions (R01) RFA-MH-15-320; and Clinical Trials to Test the Effectiveness of Treatment, Preventive, and Services Interventions (Collaborative R01) RFA-MH-15-325.

NIMH will continue to accept applications through other current or future FOAs that seek clinical trials and are either published by NIMH or by other NIH Institutes and Centers but in which NIMH has chosen to participate. Please note that while NIMH will continue to accept trials in response to these other FOAs, our highest priority is for the areas outlined in our new announcements (link to FOAs). Funding priority will be consistent with the stated research goals and priorities relevant to clinical trials as outlined in the clinical trial FOAs. Applicants considering clinical trials are encouraged to review the NIMH clinical trials website and contact NIMH Program Officials regarding the match between a potential application and current priorities. This guidance is also applicable to Career Development Award (K) and SBIR/STTR applicants with a clinical trial focus.

An application submitted in response to the NIH parent R01, parent R21, or parent R03 FOA may not include a clinical trial within the aims; such applications will not be accepted by NIMH. Applications excluded from this requirement are those that utilize a clinical trial component in which an FDA-approved biomedical treatment for an indicated mental disorder is being used in a pharmacological/device study or an "otherwise known treatment" for an indicated mental disorder is being used in behavioral/psychosocial study, in order to examine potential novel biomarkers of treatment response for the intervention, rather than to test for efficacy. An "otherwise known treatment" is defined as an intervention for which there are at least two studies from two independent research groups that found the intervention efficacious. NIMH encourages applicants considering such an application to consult with NIMH Program Officials prior to submission. Such applications may be submitted to the parent R01 or, potentially, the parent R21 FOA.

If there is doubt as to whether a clinical trial may be submitted under a particular FOA, please send an inquiry to NIMHclinicalTrials@mail.nih.gov.

This policy does not apply to applications submitted for the NIMH AIDS program.

Inquiries

Please direct all inquiries to: NIMHClinicalTrials@mail.nih.gov