NIMH Expectations for Collection of Common Data Elements
The purpose of this Notice is to update the National Institute of Mental Health (NIMH) expectations for collection of Common Data Elements (CDEs) for mental health human subjects research supported by the NIMH. Unless NIMH stipulates otherwise during the negotiation of the terms and conditions of an award, this Notice applies to all grant applications involving human research participants submitted on or after April 1, 2025. NOT-MH-20-067 and NOT-MH-23-105 will be enforced for applications submitted on or before March 31, 2025.
NIMH in consultation with the Wellcome Trust and other funders of mental health research, has identified a minimal list of data collection instruments for use by all mental health researchers conducting clinical research to facilitate and harmonize mental health research data. These measures have been selected using either the PhenX consensus process (https://www.phenxtoolkit.org/collections/view/1) or the International Consortium for Health Outcomes Measurement (ICHOM) (https://www.ichom.org/resource-library/category/condition-specific-resources/depression-anxiety/) with additional consideration for successful use of the measures in various countries.