January 9, 2023
PAR-24-067 - Prevention and Intervention Approaches for Fetal Alcohol Spectrum Disorders (R34 Clinical Trial Optional)
NOT-AA-23-002 - Notice of NIAAA Data-Sharing Guidance for Human Subjects Grants Research Funded by the National Institute on Alcohol Abuse and Alcoholism (NIAAA) [5th Revision]
NOT-OD-21-013 - Final NIH Policy for Data Management and Sharing
NOT-OD-21-014 - Supplemental Information to the NIH Policy for Data Management and Sharing: Elements of an NIH Data Management and Sharing Plan
NOT-OD-21-015 - Supplemental Information to the NIH Policy for Data Management and Sharing: Allowable Costs for Data Management and Sharing
NOT-OD-21-016 - Supplemental Information to the NIH Policy for Data Management and Sharing: Selecting a Repository for Data Resulting from NIH-Supported Research
NOT-OD-22-189 - Implementation Details for the NIH Data Management and Sharing Policy
NOT-OD-22-195 - New NIH "FORMS-H" Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2023
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
The purpose of this notice is to inform the extramural research community that NIAAA expects specific information in the Data Management and Sharing Plan (DMS Plan) to be included in NIAAA grant applications for due dates on or after January 25, 2023. These instructions will be included in all NIAAA Funding Opportunity Announcements going forward. In addition to the general NIH guidance regarding the information to include in the DMS Plan (NOT-OD-21-014, Supplemental Information to the NIH Policy for Data Management and Sharing: Elements of an NIH Data Management and Sharing Plan, and the NIH Data Management and Sharing Plan format page), NIAAA expects that the DMS Plan elements contain the following specific information:
Elements of the Data Management and Sharing Plan
Data Type:
This section should include details about the research subject, including species, sex, and cohort size. If specimens are collected from specimen sources, the type of specimen is to be listed, i.e., blood, tissue, urine, and whether the sample was collected in a prospective or retrospective time period
The data type specifies the nature of data: omics, medical and non-medical imaging, biological types (biochemical assays and biophysical such as X-ray and NMR, preclinical assays, electrophysiology), and phenotypic. Additional data to be included, i.e., associated metadata, epidemiology and surveillance, social/behavioral, clinical trials results, survey/questionnaire, and algorithms or simulations.
Standards:
For human subject data, a measure(s) of alcohol quantity and frequency is expected to be reported. Measures may include lifetime use, 30-day quantity and frequency, and/or maximum drinks per 24 hours. Demographic data should include sex, age, race, and ethnicity. Applicants are encouraged to consult the PhenX (https://www.phenxtoolkit.org/index.php) website and the Alcohol, Tobacco and Other Substances and the Demographics domains for protocols.
Studies that include animal models should include the alcohol exposure paradigm, age of the animal at the start and end of the alcohol exposure, a measure of alcohol consumption or exposure. A blood alcohol concentration measurement is recommended.
Data Preservation, Access, and Associated Timelines:
For additional information on submitting scientific data from studies with human subjects, see "Notice of NIAAA Data-Sharing Information for Human Subjects Grants Research Funded by the National Institute on Alcohol Abuse and Alcoholism (NIAAA) [5th Revision]" (NOT-AA-23-002). For data types without human subjects, applicants will provide the name(s) of the repositories where the scientific data and metadata will be archived.
Elizabeth Powell, PhD
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-0786
Email: [email protected]
and Human Services (HHS)
