October 7, 2022
Effective Date: January 25, 2023
NOT-MH-23-100, Notice of Data Sharing Policy for the National Institute of Mental Health
NOT-MH-20-067, Notice Announcing the National Institute of Mental Health (NIMH) Expectations for Collection of Common Data Elements
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-15-009, Notice Announcing Data Harmonization for NIMH Human Subjects Research via the PhenX Toolkit.
NOT-MH-19-033, Notice of Data Sharing Policy for the National Institute of Mental Health
National Institute of Mental Health (NIMH)
The purpose of this Notice is to supplement NOT-MH-23-100 and inform applicants and awardees conducting HIV-related research funded by the NIMH of the expectation to collect Common Data Elements (CDEs) for human subjects research unless NIMH stipulates otherwise during the negotiation of the terms and conditions of an award. This Notice applies to all HIV-related grant applications and awards involving human research participants submitted on or after January 25, 2023, and applies to all Funding Opportunity Announcements (FOAs) issued or participated in by the NIMH. Applicants who do not plan to collect the expected CDEs must provide strong justification in the Data Management and Sharing Plan (see NOT-MH-23-100) included in the application. NIMH may seek further information regarding the collection of CDEs prior to an award.
The Division of AIDS Research (DAR) has identified a minimal list of data collection instruments that would be ideal for use in HIV-related research. These measures have been selected in consultation with international funders of mental health research as well as consideration of successful measures used in large-scale HIV-related domestic and international research consortia. The NIMH also considered measures that have successfully been used across multiple cultural contexts and with non-English speaking populations.
Details concerning the use and inclusion of CDEs in NIMH-funded research can be found here: NIMH Data Sharing for Applicants and Awardees. For HIV-related research involving adults, investigators are expected to collect demographic measures (age, sex assigned at birth, current gender), HIV status (including assessment method and date of HIV diagnosis), antiretroviral therapy (ART) or pre-exposure prophylaxis (PrEP) use (current use, assessment method, and date of initiation), and validated assessments for anxiety (General Anxiety Disorder-7 [GAD-7]) and depression (Patient Health Questionnaire-9 [PHQ-9]). For HIV-related research involving children or adolescents, investigators are expected to collect demographic measures (age, sex assigned at birth, current gender), HIV status (including assessment method and date of HIV diagnosis), ART or PrEP use (current use, assessment method, and date of initiation), and a validated measure assessing anxiety and depression (Revised Children’s Anxiety and Depression Scale-25 [RCADS-25]).
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 measure 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/).
All grantees supported by NIMH are generally encouraged to use existing sociodemographic, behavioral, clinical, or phenotypic measures rather than develop new ones if an appropriate measure already exists for the population of interest. Therefore, HIV-related applicants are encouraged to first consult the NIMH Data Archive (https://nda.nih.gov/) or PhenX toolkit for available measures and assessments that might be appropriate for their research.
Lori A.J. Scott-Sheldon, Ph.D.
National Institute of Mental Health (NIMH)