NOT-AA-23-002: Notice of NIAAA Data-Sharing Information for Human Subjects Grants Research Funded by the National Institute on Alcohol Abuse and Alcoholism (NIAAA) [5th Revision]

Notice of NIAAA Data-Sharing Information for Human Subjects Grants Research Funded by the National Institute on Alcohol Abuse and Alcoholism (NIAAA) [5th Revision]

Notice Number:

NOT-AA-23-002

Key Dates

Release Date:

January 9, 2023

Related Announcements

PAR-24-067 - Prevention and Intervention Approaches for Fetal Alcohol Spectrum Disorders (R34 Clinical Trial Optional)

NOT-AA-18-009 - RESCINDED - Notice of Data-Sharing Requirement for Human Subjects Grants Research Funded by the National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NOT-AA-18-010 - RESCINDED - Revised: Notice of NIAAA Data-Sharing Policy for Human Subjects Grants Research Funded by the National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NOT-AA-19-020 - RESCINDED - Notice of NIAAA Data-Sharing Policy for Human Subjects Grants Research Funded by the National Institute on Alcohol Abuse and Alcoholism (NIAAA) [2nd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NOT-AA-22-003 - RESCINDED - Notice of NIAAA Data-Sharing Guidance for Human Subjects Grants Research Funded by the National Institute on Alcohol Abuse and Alcoholism (NIAAA) [3rd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NOT-AA-22-011 - RESCINDED - Notice of NIAAA Data-Sharing Guidance for Human Subjects Grants Research Funded by the National Institute on Alcohol Abuse and Alcoholism (NIAAA) [4th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

Issued by

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Purpose

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 (NIAAA_DA), 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 NIAAA_DA specifically, but they are welcome to do so:

Small Business STTR (R41/R44, U41/U44), SBIR (R43/R44, U43/U44),
Education (R25)

Further information about the NIH Data Management and Sharing policy can be found at sharing.nih.gov and in NOT-OD-22-189.

Overview

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 (NIAAA_DA). 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 NIAAA_DAif 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 NIAAA_DA, and the NIAAA_DAwebsite 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.

Applicable Data

The NIAAA_DAaccepts 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 NIAAA_DAserve 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 NIAAA_DA. A link to the NIAAA_DAcollection 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 NIAAA_DA, but reference numbers to biosamples will be included in the NIAAA_DA.

Data Sharing Procedures

Data submitted to the NIAAA_DAmust 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 NIAAA_DAwebsite. Investigators at institutions with a Federal Wide Assurance (FWA) will be able to gain access to NIAAA_DAdata by submitting a data access request in accordance with applicable NIAAA_DApolicies. 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 NIAAA_DAwebsite. 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 NIAAA_DAand the research community.

NIMH Data Archive (NDA) Sharing

The following is a summary of tasks and expectations related to submitting data to the NIAAA_DAhoused within the NIMH Data Archive (NDA). More detailed information can be found in NIAAA_DAData Sharing Terms and Conditions. Investigators are expected to:

Obtain Informed Consent that allows for broad sharing of the research subjects de-identified data.

Collect Personally Identifiable Information (PII) from research subjects that will allow for the creation of the NDA GUID (a de-identified subject ID).

Create a NDA Account with access to the GUID Tool.

Complete and submit a Data Submission Agreement (DSA) within 6 months of the Notice of Award (NoA) issue date.

Create a list of data items to be collected in the project in the Data Expected tab of the NDA Collection within 6 months of NoA issue date.

Create a GUID for each research subject using the NDA GUID tool.

Format and submit data according to the NDA Data Dictionary and/or work with NDA staff to define an appropriate data structure, if one does not already exist.

Submit data on or before the NDA submission due dates (April 1 and October 1 each year) in accordance with the applicable Data Sharing Terms and Conditions of award.

Perform QA/QC checks on data within 4 months after the submission due dates and address any issues identified by the NDA.

Share data in accordance with the default NIAAA_DAdata sharing schedule in accordance with the applicable Data Sharing Terms and Conditions of award.

Upload supporting documents that allow future analysts to effectively use the data, including: study protocols, assessment schedules, operating procedures, original assessment instruments (if not proprietary), and analytic/statistical algorithms used to derive variables in publications.

Create an NDA Study, linking relevant publications to submitted data at the time of publication, and use the appropriate Digital Object Identifier (DOI) and Acknowledgement template in these publications.

Submit a statement of progress on data sharing in non-competing renewals and progress reports. Further instructions are available in the RPPR Instruction guide under section C.5.b. Resource Sharing. Refer to specific Tutorials about data submission and sharing via the NDA or refer to the data sharing planning section where the data will be shared.

Budgeting

Costs associated with submitting data to the NIAAA_DAshould 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.

Inquiries

Please direct all inquiries to:

Daniel E. Falk, Ph.D
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-0788
Email: falkde@mail.nih.gov