July 8, 2020
NOT-MH-20-061, Notice Announcing the Availability of Common Data Elements for Research Related to the Public Health Emergency caused by Coronavirus Disease 2019 (COVID-19)
NOT-MH-19-033, Notice of Data Sharing Policy for the National Institute of Mental Health
NOT-MH-17-009, Notice Announcing the Availability of Common Data Elements for Research Related to Early Psychosis
NOT-MH-15-031, Notice Announcing the Availability of Common Data Elements for Research Related to Eating Disorders
NOT-MH-15-009, Notice Announcing Data Harmonization for NIMH Human Subjects Research via the PhenX Toolkit
National Institute of Mental Health (NIMH)
The purpose of this Notice is to announce 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 a grant award, this Notice applies to all grant applications involving human research participants submitted after October 1, 2020 . Applicants who do not plan to collect the expected CDEs should explain the rationale in the Resource Sharing Plan section of the application or potentially when Just in Time information is submitted. NIMH may seek further information regarding CDEs prior to award. The necessary funds for collecting and submitting these CDE data from all research participants to the NIMH Data Archive (NDA) should be included in the requested budget. A cost estimator (https://nda.nih.gov/ndarpublicweb/Documents/NDA_Data_Submission_Costs.xlsx) is available to facilitate the calculation of these costs.
The Notice does not apply to following types of applications:
The National Institute of Mental Health (NIMH), in consultation with the Wellcome Trust and other funders of mental health research, has identified a minimal list of data collection instruments that would be ideal for use by all mental health researchers conducting clinical research to facilitate and harmonize mental health data collection. 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.
Details concerning the minimal list of data collection instruments based of participant characteristics and disorders can be found at
https://www.nimh.nih.gov/funding/managing-your-grant/nimh-data-sharing-for-applicants-and-awardees.shtml. For research involving adults, the expected data collection instruments include demographic measures (age, sex at birth), a crosscutting assessment (DSM-5), a measure of impairment (WHODAS), and measures related to anxiety and depression (PHQ-9, GAD-7). For research involving children or adolescents, the expected data collection instruments include demographic measures (age, sex at birth), a crosscutting assessment (DSM-5 for youth), and a measure related to anxiety and depression (RCADS-25).
Awardees supported by NIMH are generally encouraged to reuse existing demographic, clinical, or phenotypic measures rather than invent new ones. Applicants are encouraged to first consult PhenX (https://www.phenxtoolkit.org/index.php) website for measures that might be appropriate for their research. Investigators seeking measures related to the social determinants of health are encouraged to consider the PhenX Toolkit Social Determinants of Health Collection (SDOH, https://www.phenxtoolkit.org/collections/view/6). The SDOH collection consists of 19 protocols comprised of one Core and two Specialty collections. The use of the SDOH collection is especially useful for study designs that assess how individual and structural SDOH influence health and contribute to health disparities.