Notice Number: NOT-AA-18-010
Release Date: June 4, 2018
Also applies to all NIH-wide FOA's where NIAAA is a participating IC.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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 ).
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 (NIAAADA). 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 NIAAADA as well. The data in the NIAAADA 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 NIAAADA and will serve as the portal for NIAAA-related data submissions and access.
The NIAAADA 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 NIAAADA . Likewise, physical biosamples will not be included in the NIAAADA, but reference numbers to both biosamples and genomic data 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 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 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 (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:
Costs associated with submitting data to the NIAAADA 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 NIAAADA 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.
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 NIAAADA. 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.
Please direct all inquiries to:
For technical assistance with data submission please contact NDAhelp@mail.nih.gov
For other inquiries please contact: