January 9, 2023
NOT-AA-18-009 - RESCINDED - Notice of Data-Sharing Requirement for Human Subjects Grants Research Funded by the National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NOT-AA-18-010 - RESCINDED - Revised: Notice of NIAAA Data-Sharing Policy for Human Subjects Grants Research Funded by the National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NOT-AA-19-020 - RESCINDED - Notice of NIAAA Data-Sharing Policy for Human Subjects Grants Research Funded by the National Institute on Alcohol Abuse and Alcoholism (NIAAA) [2nd Revision]
NOT-AA-22-003 - RESCINDED - Notice of NIAAA Data-Sharing Guidance for Human Subjects Grants Research Funded by the National Institute on Alcohol Abuse and Alcoholism (NIAAA) [3rd Revision]
NOT-AA-22-011 - RESCINDED - Notice of NIAAA Data-Sharing Guidance for Human Subjects Grants Research Funded by the National Institute on Alcohol Abuse and Alcoholism (NIAAA) [4th Revision]
NOT-OD-14-124 - NIH Genomic Data Sharing Policy
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-22-195 - New NIH "FORMS-H" Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2023
NOT-OD-22-189 - Implementation Details for the NIH Data Management and Sharing Policy
NOT-AA-23-001 - Notice of Guidance for Data Management and Sharing Plans for the National Institute of Alcohol Abuse and Alcoholism
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
The purpose of this Notice is to revise and replace the current NIAAA language for Data Sharing requirements (NOT-AA-22-011), to align with the NIH Policy for Data Management and Sharing (NOT-OD-21-013). This Notice applies to all grant applications and awards that involve human subject research for due dates on or after January 25, 2023 and applies to all Funding Opportunity Announcements (FOAs) in which NIAAA participates. NOT-AA-22-011 will continue to be in effect for all applications for due dates up to January 24, 2023.
Applications submitted to or assigned to NIAAA on or after January 25, 2023 must follow the Final NIH Policy for Data Management and Sharing (NOT-OD-21-013) and provide a Data Management and Sharing (DMS) Plan. For grants involving human subject data, NIAAA expects the data to be submitted to the NIAAA-sponsored data repository, the NIAAA Data Archive (NIAAADA), as outlined in this Notice. These instructions will be included in all NIAAA FOAs going forward. Per NOT-OD-22-195, the DMS Plan should be included in the “Other Plan(s)” attachment field of the PHS 398 Research Plan Form. Applicants to NIAAA are strongly encouraged to provide specific information described in Notice of Guidance for Data Management and Sharing Plans for the National Institute of Alcohol Abuse and Alcoholism (NIAAA) (NOT-AA-23-001)
Compliance with the expectations specified in the DMS Plan, as approved by NIAAA prior to award, will become a term and condition in the Notice of Award and will be monitored by NIAAA throughout the duration of the award.
While all applications that generate scientific data (see List-of-Activity-Codes-Applicable-to-DMS-Policy) must abide by the NIH Policy for Data Management and Sharing (NOT-OD-21-013), awards made using the following activity codes, while expected to include a DMS Plan in the grant application, are not required to deposit data into the NIAAADA specifically, but they are welcome to do so:
Further information about the NIH Data Management and Sharing policy can be found at sharing.nih.gov and in NOT-OD-22-189.
Widespread data sharing by research communities adds significant value to research and accelerates the pace of discovery. NIAAA has a data-sharing initiative to create a data repository of future NIAAA-funded studies that include human subjects. This repository is called the NIAAA Data Archive (NIAAADA). NIAAA-funded investigators conducting human subjects research are expected to submit de-identified, individual-level data to this data archive. Non-NIAAA funded investigators with alcohol-related data are welcome to deposit their data to the NIAAADAif they are willing to adhere to the archive’s data sharing terms and conditions.
NIAAA is using an established informatics infrastructure, hosted and managed by the National Institute of Mental Health (NIMH) Data Archive (NDA), to enable the sharing and use of data collected from human subjects. At present, this NIMH Data Archive (NDA) is a single, cloud-based data infrastructure comprised of harmonized datasets from multiple research communities, each of which has a distinct website and access governance. The current NDA data repositories are: the NIMH Data Archive, the Adolescent Brain Cognitive Development Study (ABCD), the Connectome Coordination Facility (CCF), the Osteoarthritis Initiative (OAI), the Accelerating Medicines Partnership - Schizophrenia (AMP SCZ), and the Helping to End Addiction Long-Term Initiative (HEAL).
Another data repository has been created for the NIAAADA, and the NIAAADA website serves as the portal for NIAAA-related data submissions and access housed within the NDA. Grant applicants are strongly encouraged to review this website prior to submitting a human-subjects grant application to NIAAA.
The NIAAADA accepts only electronic, de-identified data from human subjects studies. This includes data from clinical trials, epidemiological surveys, human laboratory investigations, and other types of studies involving human subjects.
This Notice does not supersede the general NIH Genomic Data Sharing Policy (NOT-OD-14-124, NOT-OD-22-198). However, this Notice does continue to mandate that the NIAAADAserve as the repository for all genomic data funded by NIAAA unless NIAAA agrees to a different data archive during the negotiation of the terms and conditions of the grant award. NIAAA expects that studies with GWAS data will also submit these data to the Psychiatric Genomics Consortium. Awardees who are collecting human genomic data will register with dbGaP. After registration, all data (including but not limited to clinical, genomic, imaging, and phenotypic data) will be deposited in the NIAAADA. A link to the NIAAADA collection will be added to the dbGaP registration. Aggregating the genomic data in a single cloud-based data archive will facilitate the re-analysis, replication, and additional analyses of these important data sets. Physical biosamples will not be included in the NIAAADA, but reference numbers to biosamples will be included in the NIAAADA.
Data Sharing Procedures
Data submitted to the NIAAADA must be de-identified by the investigator prior to submission. Submitted data are subjected to algorithms that check for basic data accuracy. Any problematic data items are summarized in a report and returned to the investigator for corrective action, if necessary, before data are accepted. To facilitate correction of problematic data, NIAAA expects raw data to be deposited close to the time it is collected, generally every 6 months until data collection is complete.
Data will be shared with the general research community at the time of an associated publication, or the end of the award/support period, whichever comes first. The data will be made available for sharing with the general research community via the NIAAADA website. Investigators at institutions with a Federal Wide Assurance (FWA) will be able to gain access to NIAAADA data by submitting a data access request in accordance with applicable NIAAADA policies. Data requests will be reviewed and granted by an NDA Data Access Committee.
Prior to applying for a grant, investigators should review the planning section of the NIAAADA website. Applicants are strongly encouraged to use clinical and phenotypic data collection instruments/data dictionaries that have already been defined rather than create new versions of those data dictionaries. There are several required data collection instruments, mostly related to demographic and sample information, that must be used by all researchers for data harmonization purposes. Applicants should also plan to collect the data needed to generate global unique identifiers (GUIDs) for each study subject. Informed consent documents should describe how study data will be shared with NIAAADA and the research community.
NIMH Data Archive (NDA) Sharing
The following is a summary of tasks and expectations related to submitting data to the NIAAADAhoused within the NIMH Data Archive (NDA). More detailed information can be found in NIAAADA Data Sharing Terms and Conditions. Investigators are expected to:
Costs associated with submitting data to the NIAAADA should be included in grant applications as outlined in the NIH Application Guide. A cost estimation tool for data sharing is available for this purpose. Researchers should use that tool when preparing budgets for applications submitted to NIAAA.
Daniel E. Falk, Ph.D
National Institute on Alcohol Abuse and Alcoholism (NIAAA)