Change to NIMH Policy for Recruitment of Participants in Clinical Research

Notice Number: NOT-MH-16-013

Key Dates
Release Date:   May 23, 2016

Related Announcements
RFA-MH-17-614
RFA-MH-17-602
RFA-MH-17-604
RFA-MH-17-606

Issued by
National Institute of Mental Health (NIMH)

Purpose

The purpose of this notice is to notify NIMH applicants/offerors about an update to the NIMH Policy for Recruitment of Participants in Clinical Research.  Since 2005, NIMH has required investigators conducting clinical research studies with 150 or more subjects submit a recruitment plan with cumulative tri-annual recruitment milestones (see NOT-MH-05-13).  Investigators are expected to submit reports on actual recruitment progress three times a year, April 1, August 1, and December 1.

What’s Changing:  For competing applications/proposals awarded on or after October 1, 2016, the NIMH Policy for the Recruitment of Participants in Clinical Research applies to all NIMH extramural-funded clinical research studies proposing to enroll 150 or more subjects per study, and all clinical trials, regardless of size.

The NIH definition of clinical research is available at https://grants.nih.gov/grants/glossary.htm#C.  See NOT-OD-15-105 for the NIH definition of “clinical trial,” revised October 2014.

Reason for the Change:  Effective clinical research relies on the ability of researchers to meet recruitment goals. This policy will allow NIMH staff to more effectively monitor the recruitment of participants in NIMH-sponsored clinical trials and other clinical research studies.

For more information on the NIMH Policy for Recruitment of Participants in Clinical Research see http://www.nimh.nih.gov/funding/grant-writing-and-application-process/nimh-policy-for-the-recruitment-of-participants-in-clinical-research.shtml.

Inquiries

Please direct all inquiries, including questions about whether or not your study is considered a clinical trial, to nimhrmr@mail.nih.gov.