Related Announcements

NOT-AA-18-009 - RESCINDED - Notice of Data-Sharing Requirement for Human Subjects Grants Research Funded by the National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NOT-AA-18-010 - RESCINDED - Revised: Notice of NIAAA Data-Sharing Policy for Human Subjects Grants Research Funded by the National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NOT-AA-19-020 - RESCINDED - Notice of NIAAA Data-Sharing Policy for Human Subjects Grants Research Funded by the National Institute on Alcohol Abuse and Alcoholism (NIAAA) [2nd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

Issued by

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Purpose

This revised Notice replaces NOT-AA-18-009, NOT-AA-18-010 and NOT-AA-19-020 .

The purpose of this notice is to inform prospective applicants of a policy whereby the National Institute on Alcohol Abuse and Alcoholism (NIAAA) expects investigators and their institutions to provide plans for submitting grant-related human subjects data to a NIAAA-sponsored data repository, the NIAAA Data Archive (NIAAA_DA), as outlined in this Notice. These plans should be included in a NIAAA Data Archive Data Sharing Plan (NIAAA_DA DSP) located in the Resource Sharing Plan section of grant applications. Applicants are strongly encouraged to use the NIAAA_DA DSP template for this purpose. The portion of that plan dealing with data must include: 1) a brief summary of the assessment schedule, 2) a listing of proposed data collection instruments (assessments) that do not currently exist in the NDA (if applicable), and 3) the proposed schedule for running the data validation tool once data collection begins. Compliance with the NIAAA_DA DSP will become a special term and condition in the Notice of Award. The Institutional Certification (for sharing human data) should also be provided prior to award, along with any other Just-in-Time information.

This policy applies to all NIAAA grant applications (new and resubmitted) that include human subjects research and all Funding Opportunity Announcements (FOAs) in which NIAAA participates, regardless of the amount of direct costs requested in any year. The policy, however, does not apply to the following types of applications:

• Fellowship (F)
• Training (T)
• Small Business (SBIR/STTR & Cooperative Agreements)
• Education (R25)
• Conferences (R13/U13)

The NIAAA data-sharing policy outlined below is effective for grant applications (new and resubmitted) submitted starting with the 2022 Cycle I due date (January 25 - March 16, 2022; see activity code-specific due dates) and going forward. Accordingly, NIAAA expects that all grant applications involving human subjects submitted for funding on or after the 2022 Cycle I due date include a NIAAA_DA DSP.

Overview

Widespread data sharing by research communities adds significant value to research and accelerates the pace of discovery. NIAAA has begun a new 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_DA if they are willing to adhere to the archive’s data sharing terms and conditions . The data in the NIAAA_DA will be catalogued and made available to the general research community after an embargo period of exclusive access following the end date of the research award.

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), and the Accelerating Medicines Partnership - Schizophrenia (AMP SCZ).

A sixth data repository has been created for the NIAAA_DA and the NIAAA_DA website, which 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_DA 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. Excluded from this requirement are studies that meet the human subjects research exemption criteria as defined by NIH

This Notice substantially changes the data sharing expectations for genomic data and for data related to biosamples and genomic data. This Notice does not supersede the general NIH Genome Data Sharing Policy. However, this Notice does mandate that the NIAAA_DA serve 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_DA collection will be added to the dbGaP registration. Aggregating the genomic data in a single cloud-based data archive will facilitate the re-analysis 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_DA 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 2 years after the grant end date on the initial Notice of Award. This 2-year embargo period will provide study investigators with protected time to publish from the study data. After the embargo, the data will be made available for sharing with the general research community via the NIAAA_DA website. However, if a manuscript using study data is accepted for publication prior to the 2-year embargo, the study data specifically used in that manuscript will be shared with the general research community at the time of publication. Investigators at institutions with a Federal Wide Assurance (FWA) will be able to gain access to NIAAA_DA data by submitting a data access request in accordance with applicable NIAAA_DA policies. Data requests will be reviewed and granted by a NIAAA Data Access Committee.

Prior to applying for a grant, investigators should review the planning section of the NIAAA_DA 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 NIAAA_DA and the research community.

NIMH Data Archive (NDA) Sharing

The following is a summary of tasks and expectations related to submitting data to the NIAAA_DA housed within the NIMH Data Archive (NDA). More detailed information can be found in NIAAA_DA Data 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_DA data 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_DA should be included in grant applications. 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.

Although the data-submission policy applies only to new and resubmitted grant applications, investigators with active NIAAA awards involving human subjects who wish to submit to the NIAAA_DA should consult with their Program Officer about the possibility of obtaining an administrative supplement to cover data-submission costs as described in the NIAAA Administrative Supplement Kiosk.

Inquiries

Please direct all inquiries to:

Daniel E. Falk, Ph.D
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-0788
Email: [email protected]