NOT-AA-18-010: RESCINDED - Revised: Notice of NIAAA Data-Sharing Policy for Human Subjects Grants Research Funded by the National Institute on Alcohol Abuse and Alcoholism (NIAAA)

RESCINDED - Revised: Notice of NIAAA Data-Sharing Policy for Human Subjects Grants Research Funded by the National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Notice Number: NOT-AA-18-010

Key Dates
Release Date: June 4, 2018 (Rescinded July 31, 2019)

Also applies to all NIH-wide FOA's where NIAAA is a participating IC.

Issued by
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Purpose

This revised Notice replaces NOT-AA-18-009 to correct the title by replacing the phrase "of Data-Sharing Requirement" by of NIAAA Data-Sharing Policy .

The purpose of this notice is to inform prospective applicants responding to the above referenced Funding Opportunity Announcements (FOAs) of a new policy whereby the National Institute on Alcohol Abuse and Alcoholism (NIAAA) will expect investigators and their institutions to provide basic plans for submitting grant-related human subjects data to a NIAAA-sponsored data repository, as outlined in this Notice. These plans should be included in the Data Sharing Plan located in the Resource Sharing Plan section of grant applications. This applies to all grant applications (new and resubmitted) that include human subject research, except Fellowship (F), Training (T), Small Business (SBIR/STTR), and Education (R25) grants.

The NIAAA data-sharing policy outlined below will go into effect beginning with grant applications (new and resubmitted) that will be submitted starting with the 2019 Cycle I due date (January 25 - March 16, 2019; for activity code-specific due dates (see: https://grants.nih.gov/grants/how-to-apply-application-guide/due-dates-and-submission-policies/due-dates.htm ).

Overview

Widespread data sharing by research communities adds significant value to research and accelerates the pace of discovery ( https://grants.nih.gov/grants/guide/notice-files/NOT-AA-17-005.html). NIAAA intends to begin a new data-sharing initiative to create a data repository of future NIAAA-funded studies that include human subjects. This repository will be called the NIAAA Data Archive (NIAAA_DA). NIAAA-funded investigators conducting human subjects research will be 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 as well. 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 will use an established informatics infrastructure, hosted and managed by the National Institute of Mental Health (NIMH), to enable the sharing and use of data collected from human subjects. At present, this NIMH Data Archive (NDA) is a single Oracle database. It draws from five different websites serving a variety of research communities. The five websites are: the National Database for Autism Research ( http://ndar.nih.gov, NDAR), the National Database for Clinical Trials Related to Mental Illness ( http://ndct.nimh.nih.gov, NDCT), the Research Domain Criteria Database ( http://rdocdb.nimh.nih.gov, RDoc db), the Adolescent Brain Cognitive Development Study Data Repository ( https://data-archive.nimh.nih.gov/abcd, ABCD), and the Connectome Coordination Facility ( https://data-archive.nimh.nih.gov/ccf, CCF).

A sixth website will be created for the NIAAA_DA and will serve as the portal for NIAAA-related data submissions and access.

Applicable Data

The NIAAA_DA will accept only electronic, de-identified data from human subjects studies (for a definition of human subjects see: https://humansubjects.nih.gov/glossary). This will include data from clinical trials, epidemiological surveys, human laboratory investigations, and other types of studies involving human subjects. Databases with significant genomic data (e.g., genome-wide association studies (GWAS), medical sequencing, molecular diagnostic assays), however, are expected to be deposited to one of the dbGaP repositories ( https://www.ncbi.nlm.nih.gov/gap), while most of the phenotypic data are expected to be deposited to the NIAAA_DA . Likewise, physical biosamples will not be included in the NIAAA_DA, but reference numbers to both biosamples and genomic data 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 will be subjected to algorithms that check for basic data accuracy. Any problematic data items will be 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 made available for sharing with general research community 2 years after the grant end date on the Notice of Award (or 2 years after the end date of a no-cost-extension, should it be issued). 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. 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 (see https://ndar.nih.gov/access.html for sample policies). Data requests will be reviewed and granted by a NIAAA Data Access Committee.

NIMH Data Archive (NDA) Sharing

The following is a summary of tasks and expectations related to submitting data to the NIMH Data Archive (NDA). The purpose of this summary is to provide an overview of data submission and data sharing via the NDA. This list only provides a summary of tasks. More detailed information can be found in the 7/1/2015 version of the NDA Data Sharing Terms and Conditions document.

Investigators are expected to:

Obtain Informed Consent that allows for broad sharing of each research subject’s de-identified data.
Collect Personally Identifiable Information (PII) from research subjects that will allow for the creation of the NDA NDA Global Unique Identifier (GUID), a de-identified subject ID, which is required for submission of data to the NDA.
Request an NDA Account with access to use the GUID Tool.
Complete and submit an NDA Data-Sharing Agreement (DSA) within 6 months of the Notice of Award (NoA) issue date.
Review the NDA Data Definition for the measures/experiments expected and define the project's data definition harmonized to that standard.
Work with NDA staff to define any undefined measures in accordance with NDA best practices.
Specify the expected measures to be collected by the project in the Data Expected tab of the NDA Collection and its data-sharing schedule within 6 months of NoA issue date, in accordance with the applicable terms and conditions of award.
Create a GUID for each research subject using the NDA GUID tool.
Submit data on or before the NDA submission due dates (January 15th and July 15th each year), in accordance with the applicable terms and conditions of award.
Address any post submission quality assurance and quality control ( QC/QC) checks that have been identified by the NDA.
Create an NDA Study, linking a result from a publication, pipeline, or discovery prior to it being published or made public.
Specify the Digital Object Identifier (DOI) from the NDA Study in any publication or presentation so the result and the underlying data will be linked permanently.
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 athttps://ndar.nih.gov/contribute_cost_estimation.html. 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 ( https://www.niaaa.nih.gov/grant-funding/application-process/administrative-supplements) to cover data-submission costs.

Policy Implementation

To allow investigators to prepare and budget appropriately, the NIAAA data-sharing policy outlined here will go into effect beginning with grant applications (new and resubmitted) having a 2019 Cycle I due date (January 25- March 16, 2019; for activity code-specific due dates see: https://grants.nih.gov/grants/how-to-apply-application-guide/due-dates-and-submission-policies/due-dates.htm). Accordingly, NIAAA expects that all grant applications involving human subjects submitted for funding on or after the 2019 Cycle I due date, include plans for submitting data to the NIAAA_DA. Specifically, NIAAA expects investigators and their institutions to provide basic plans for following this Notice in the Data Sharing Plan located in the Resource Sharing Plan section of grant applications. All applications, regardless of the amount of direct costs requested for any one year, should address plans for following this Notice in the Data Sharing Plan. Compliance with this Data Sharing Plan 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.

Inquiries

Please direct all inquiries to:

For technical assistance with data submission please contact [email protected]

For other inquiries please contact:

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