Notice of Change in Eligibility for Projects Proposing Clinical Trials Submitted to RFA-MH-15-600 "NIMH Biobehavioral Research Awards for Innovative New Scientists (NIMH BRAINS) (R01)

Notice Number: NOT-MH-15-023

Key Dates
Release Date: July 17, 2015

Related Announcements

Issued by
National Institute of Mental Health (NIMH)


On June 11, 2014, the NIMH issued Funding Opportunity Announcement (FOA) RFA-MH-15-600 “NIMH Biobehavioral Research Awards for Innovative New Scientists” (NIMH BRAINS) (R01). This Notice announces a change to language regarding clinical trials research.

The following sections of the FOA are revised accordingly:

Part 2. Section I. Research Scope and Goals

Current Language:
Note that applications proposing any type or stage of clinical trial will not be considered responsive to this FOA. 

Revised Language:
Applications proposing clinical trials will be allowed if they respond to the experimental medicine approach to intervention development and testing described in the NIMH Policy for Submission of Applications Containing Clinical Trials NOT-MH-14-007. Under this approach, throughout all phases of intervention development and testing (i.e., from the development of novel interventions through effectiveness testing) projects should be designed to assess the relationship between underlying disease processes and the mechanisms of action through which an intervention produces therapeutic change. Accordingly, applicants that plan to utilize a clinical trial design, are required to propose studies that test 1) whether the intervention's intended targets were engaged and 2) a specific mechanism of action. Thus, intervention trials should be designed so that results, whether positive or negative, will provide information of high scientific utility and will inform decisions about whether further development or testing of the intervention is indicated. Applications submitted to this FOA that do not meet the requirements for NIMH clinical trials described in NOT-MH-14-007 will not be reviewed.

Part 2. Section 3.1. Eligible Applicants

Current Language:
Applications proposing a clinical trial will not be accepted.

Revised Language:
Applications proposing clinical trials will be accepted if they conform to the requirements specified in NOT-MH-14-007.

Potential applicants who anticipate developing or testing interventions that focus on measuring target engagement and mechanism of action are strongly advised to contact the Scientific/Research Contact for this FOA regarding the match between an application, current NIMH priorities, and the unique goals of this FOA.

All other aspects of the FOA remain unchanged.


Please direct all inquiries to:

Kathleen C. Anderson
National Institute of Mental Health (NIMH)
Telephone: 301-443-5944