Key Dates

Related Announcements

• October 7, 2022 - Notice of Data Sharing Policy for the National Institute of Mental Health. See NoticeNOT-MH-23-100.
• October 7, 2022 - Notice Announcing the Expectations for the Collection of Common Data Elements for HIV-Funded Research at the National Institute of Mental Health. See Notice NOT-MH-23-105.
• July 8, 2020 - Notice Announcing the National Institute of Mental Health (NIMH) Expectations for Collection of Common Data Elements. See Notice NOT-MH-20-067.
• June 4, 2020 - Notice Announcing the Availability of Common Data Elements for Research Related to the Public Health Emergency caused by Coronavirus Disease 2019 (COVID-19). See Notice NOT-MH-20-061.
• January 25, 2017 - Notice Announcing the Availability of Common Data Elements for Research Related to Early Psychosis. See Notice NOT-MH-17-009.
• September 29, 2015 - Notice Announcing the Availability of Common Data Elements for Research Related to Eating Disorders. See Notice NOT-MH-15-031.
• January 16, 2015 - Notice Announcing Data Harmonization for NIMH Human Subjects Research via the PhenX Toolkit. See Notice NOT-MH-15-009.

Issued by

National Institute of Mental Health (NIMH)

Purpose

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.

The Notice does not apply to following types of applications:

• Fellowship (F)
• Research Career Development (K)
• Training (T)
• Small Business (SBIR/STTR)
• Small Grants (R03)
• Education (R25)
• Dissertation Awards (R36).

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.

Details concerning the minimal list of data collection instruments based on participant characteristics can be found at https://www.nimh.nih.gov/funding/managing-your-grant/nimh-data-management-and-sharing-for-applicants-and-awardees.

Common Data Elements for All Research Participants

Two demographic measures, age and sex at birth, must be collected for all research participants. NIMH HIV-funded investigators are also expected to collect current data on gender identity.

Common Data Elements for Research Participants with a Mental Health Diagnosis

For research involving adults who have a mental health diagnosis or are part of a Research Domain Criteria (RDoC) relevant group, the expected data collection instruments include, a crosscutting assessment (DSM-5), a measure of impairment (WHODAS), and measures related to symptoms of anxiety (GAD-7) and depression (PHQ-9).  For research involving children or adolescents who have a diagnosis or are part of an RDoC relevant group, the expected data collection instruments include a crosscutting assessment (DSM-5 for youth), and a measure related to anxiety and depression (RCADS-25).

Common Data Elements for Research Participants without a Mental Health Diagnosis

For research involving adults who do not have a mental health diagnosis or are not part of an RDoC relevant group, the WHODAS must be collected.  Many of these applications use the Basic Experimental Studies Involving Humans (BESH) Notices of Funding Opportunities.  For research involving children who do not have a mental health diagnosis or are not part of an RDoC relevant group, there are no CDE requirements beyond the demographic measures (age, sex at birth).

Common Data Elements Related to HIV Research

Researchers conducting HIV-related research should contact the NIMH Division of AIDS Research (DAR) (see contact information below) about the applicability of the CDEs discussed in any of the sections above.

For applicants and awardees conducting HIV-related research funded by the NIMH, there is an additional set of HIV-related CDEs to collect.  These measures are related to HIV status (including assessment method and date of HIV diagnosis) and antiretroviral therapy (ART) or pre-exposure prophylaxis (PrEP) use (current use, assessment method, and date of initiation).  Details about these three instruments can be found at https://nda.nih.gov/nda/nimh-common-data-elements.

Where relevant, investigators pursuing HIV-related human subjects research are also encouraged to include one or more measures related to individual- or structural-level social determinants of health (SDoH; https://www.phenxtoolkit.org/collections/view/6).  The SDoH collection available in the PhenX Toolkit is especially useful for studies assessing how individual and structural SDoH influence HIV-related outcomes and contribute to health disparities.  Related to SDoH, we also encourage including measures assessing multilevel HIV-related (and intersectional) stigma and discrimination using the Stigma and Discrimination Research Toolkit.  We also recommend including one or more measures to assess post-traumatic stress disorder (PTSD), such as the PTSD Checklist (PCL-5) for adults and the Child PTSD Symptom Scale (CPSS-5 SR) for children or adolescents. These validated self-report measures are available from the International Society for Traumatic Stress Studies (https://istss.org/clinical-resources).  Finally, in recognition of the substantial NIMH DAR investment in research addressing the HIV prevention and care continua, we also encourage the use of relevant individual- or population-level measures of HIV biomedical regimen adherence, persistence, and retention and offer several measures that may be useful in future research (see the NIMH Data Archive; https://nda.nih.gov/).

Common Data Elements Related to Psychosis Research

Researchers working in the area of psychosis should consider collecting the Community Assessment of Psychic Experiences-Positive scale (P15). This measure is not required for NIMH supported researchers working in psychosis, but collecting this measure will facilitate data harmonization with psychosis research funded by and other funders of mental health research.

Additional Information

Applicants who do not plan to collect the expected CDEs must provide strong justification in their Data Management and Sharing Plan.  Research that might not require CDEs include:

• Studies focused on collecting data from those providing mental health services.
• Studies focused on tool/technology development when only a small group of participants are involved, for example, in providing feedback about the design features.
• Studies collecting data in regions or countries where a validated version of the CDEs are not available or where the copyright holder for the CDE has not approved a translation of the CDE.

The necessary funds for collecting and submitting these CDEs 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.

Recipients supported by NIMH are generally encouraged to reuse existing sociodemographic, clinical, or phenotypic measures rather than invent new ones.  Applicants are encouraged to consult the NIMH Data Archive which makes available over 5,000 different data dictionaries that can be reused or modified.  The PhenX Toolkit (https://www.phenxtoolkit.org/index.php) is another good source for NIH approved measures that might be appropriate for their research.  The SDoH collection (https://www.phenxtoolkit.org/collections/view/6) can be useful for many NIMH-funded studies in assessing how individual and structural SDoH influence health contribute to health disparities.

Inquiries

Please direct all inquiries to:

Please direct general inquiries to:

Gregory K. Farber, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-435-0778
E-mail: [email protected]

Please direct all inquiries for HIV-related NIMH applications to:

Lori A.J. Scott-Sheldon, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-792-2309
E-mail: [email protected]