June 4, 2020
NOT-MH-20-047,Notice of Special Interest (NOSI) regarding the Availability of Administrative Supplements and Urgent Competitive Revisions for Mental Health Research on the 2019 Novel Coronavirus
NOT-AG-20-022,Notice of Special Interest (NOSI): NIA Availability of Administrative Supplements and Revision Supplements on Coronavirus Disease 2019 (COVID-19)
NOT-MD-20-019, Notice of Special Interest (NOSI): Competitive and Administrative Supplements for the Impact of COVID-19 Outbreak on Minority Health and Health Disparities
National Institute of Mental Health (NIMH)
The purpose of this Notice is to extend the data-harmonization effort at the National Institute of Mental Health (NIMH) announced in NOT-MH-15-009 to research protocols pertaining to the public health emergency caused by Coronavirus Disease 2019 (COVID-19), the disease caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2).
NIMH has already made a significant investment in a data repository to hold human subjects data related to mental illness and related fields. This repository allows data from multiple sources to be aggregated and easily accessed by the research community. However, the data repository is most useful when research laboratories collect data using the same set of data elements. With this Notice, NIMH offers guidance on the use of consensus-derived common data elements (CDEs) pertaining to mental health outcomes that were previously discussed in NOT-MH-15-009and a set of newly available measures regarding experiences during the COVID-19 public health emergency and exposures to the SARS-CoV-2 virus (the virus that causes COVID-19). The goal of this Notice is to reduce proliferation of one-off survey items and to facilitate data integration, collaboration, and comparisons across data sets.
A. CDEs pertaining to mental health outcomes of the COVID-19 public health emergency
The consensus-derived CDEs pertaining to mental health outcomes available via the PhenX Toolkit Mental Health Research Collection [https://www.phenxtoolkit.org/index.php?pageLink=browse.conceptualgroups&id=2910&breadcrumbs=2910] remain the expected standard for all human subject mental health studies. NIMH grantees/applicants are strongly encouraged to incorporate the Core Collection of measures and, where relevant, specialty measures related to suicide [https://www.phenxtoolkit.org/sub-collections/view/3] and post-traumatic stress psychopathology, including PTSD [https://www.phenxtoolkit.org/sub-collections/view/4], into research protocols pertaining to the mental health outcomes of the COVID-19 public health emergency. By encouraging the use of consensus-derived CDEs for measuring mental health outcomes, NIMH aims to promote sharing, comparison, and integration of data to best advance understanding of the mental health impact of the COVID-19 public health emergency. NIMH grantees/applicants are strongly discouraged from further proliferation of measures – i.e., using alternative measures to collect similar data (instead of the PhenX measures) without strong justification. Collecting alternative measures in addition to the PhenX measures might be useful to answer some research questions.
B. Publicly available measures pertaining to non-mental-health experiences during the COVID-19 public health emergency and exposures to SARS-CoV-2
With this Notice, NIMH also highlights the availability of a set of measures pertaining to experiences during the COVID-19 public health emergency and exposures to SARS-CoV-2, available via the NIH Public Health Emergency and Disaster Research Response (DR2) [https://dr2.nlm.nih.gov/], established and hosted by the National Institute of Environmental Health Sciences (NIEHS) and the National Library of Medicine (NLM). Included within these collections are measures to assess perceived benefits of and compliance with public health strategies to mitigate virus spread and measures to assess the extent to which individuals or their families deployed as front-line or ‘essential’ workers, have been exposed to and/or exhibit symptoms of COVID-19, or have been diagnosed with or suffered physical health complications from the virus. Additional secondary effects measures of disruptions in daily activities (e.g., work, social interaction, travel, physical activity) and perceptions of healthcare, financial, and food security during the COVID-19 public health emergency, among others, are also included. Consistent with NIMH efforts to facilitate data integration, collaboration, and comparisons across samples, NIMH strongly encourages grantees/applicants who are interested in characterizing and/or understanding COVID-19 related experiences and exposures to select existing survey items or protocol modules, and strongly discourages the establishment of additional COVID-19 specific experiences and exposures measures, without strong justification. Notably, some modules within the DR2 additionally contain measures which address mental health outcomes of the COVID-19 public health response or of exposure to SARS-CoV-2. Though NIMH encourages the use of DR2 measures that pertain to non-mental health experiences and exposures to COVID-19, NIMH continues to expect that the consensus-derived CDEs pertaining to mental health outcomes available via the PhenX Toolkit Mental Health Research Collection described above will remain the standard for measurement of mental health outcomes in all human subject mental health studies, including research examining the mental health impacts of the COVID-19 public health emergency. To the extent that researchers may be interested in additional domains not covered by previous consensus collections, we encourage the consideration of additional items or measures from large-scale surveys (e.g., All of Us, ABCD, Wellcome Trust, CRISIS questionnaire), which may be located using the DR2 webpage.
Additional information on the use of CDEs in mental health research on the COVID-19 public health emergency
NIMH recognizes that researchers may have longstanding data collection protocols that do not incorporate the recommended measures. In such situations, it may be necessary to collect data using more than one measure to ensure compatibility with legacy data as well as to allow data from multiple laboratories to be easily aggregated as the field moves forward. Researchers may also want to include additional measures of a construct to best address their hypotheses. This Notice does not preclude the use of measures in addition to the CDEs that have been established, though, as stated above, does discourage the establishment of new mental health outcome measures or COVID-19 specific experiences and exposure measures without strong justification.
In order to meet the immediate needs and address this specific public health crisis in a timely manner, NIMH expects that applications submitted for funding two weeks or more after publication of this Notice will incorporate these measures in all research proposed that involves human participants and addresses the COVID-19 public health emergency. Applicants who are submitting to any of the COVID-19 Notices of Special Interest that NIMH is participating in (see Related Announcements above) should plan to adopt the mental health outcome CDEs and/or the non-mental-health COVID-19 experience/exposure measures listed above for collection in ongoing studies.
By advocating the use of these common measures and aggregating the data in a common data repository, NIMH aims to optimize the value of this research and further accelerate and enhance our understanding of mental illness, while advancing a culture of scientific collaboration.
Gregory K. Farber, Ph.D.
National Institute of Mental Health