Notice of Online Data Submission and Access to the National Institutes of Health (NIH) database of Genotypes and Phenotypes (dbGaP)

Notice Number: NOT-OD-14-065

Key Dates
Release Date: March 5, 2014

Related Announcements
None

Issued by
National Institutes of Health (NIH)

Purpose

Intent of dbGaP Online System

NIH has developed an online system intended to reduce the burden for researchers and their institutional officials to register studies and access data in dbGaP.  The online system uses time-saving features, such as pull-down and scrolling menus to fill data fields, and text fields that allow investigators to cut and paste information from other sources.  Where possible, data fields are automatically filled with information from other sources, such as eRA Commons, which provides the investigator’s name, institution, and Institutional Signing Official. 

Study Registration

As stipulated in the 2007 Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (GWAS), all investigators who receive NIH funding to conduct genome-wide analyses of genetic variation are expected to make their data available for secondary research through the NIH GWAS data repository (i.e., dbGaP).  Submitting investigators are expected to provide basic study information such as the type of data that will be submitted to dbGaP and a description of the study, as well as a certification that includes any limitations on the secondary use of the data as determined by the informed consent (e.g., the data cannot be shared with for-profit companies, the data can be used only for research of particular diseases). 

Investigators wishing to register studies in dbGaP should contact their Program Officer/Director and NIH Institute or Center (IC) Genomic Program Administrator (GPA) to discuss the project, data sharing plan, and certification process.  The GPA from the sponsoring IC initiates the dbGaP study registration process (i.e., provides the investigator’s name, Program Officer’s/Director’s name, study name, and grant number).  Rather than the GPA entering the basic study information as was previously done, the online dbGaP registration system will send an email to the investigator with instructions to complete the online study registration.  After verification by the GPA, the investigator receives an accession number for the study and previews the data prior to release.  Upon approval by the submitting investigator, dbGaP publishes the study on the dbGaP website. 

Data Access

Investigators interested in conducting secondary research with dbGaP controlled-access data can apply directly through dbGaP using the online system and must be granted permission from the relevant NIH Data Access Committee(s) (DACs) to access the data.  As part of the application process, researchers must provide information such as a description of the proposed research use of the requested data, a data security plan, and a Data Use Certification agreement.  If approved by the relevant DAC(s), investigators have access to the data for one year and must submit a project renewal request annually, or complete a project close-out process if the data will no longer be used.  Project renewals and close-outs include progress updates that provide information about publications, presentations, and intellectual property based on the research conducted, as well as any data security or data management incidents.  The online access system allows all approved investigators to submit a progress update and renew or close-out their project in a single step instead of separate steps, as was previously required.

Additional Information

Tutorials on the online forms for study registration and data access are available at dbGaP:

- dbGaP: Complete a Study Registration
https://www.youtube.com/watch?v=gIjN0Er39us&feature=youtu.be

- dbGaP:  Apply for Controlled Access Data
http://www.youtube.com/watch?v=-3tUBeKbP5c

- dbGaP: Renew Authorized Access
http://www.youtube.com/watch?v=PG9D5mUouXg

- dbGaP: Close Out a Controlled Access Project
http://www.youtube.com/watch?v=i85gl937ZPA

Inquiries

Please direct all inquiries to:

Erin Luetkemeier, Ph.D.
Office of the Director
Telephone: 301-496-9838
Email: GWAS@mail.nih.gov
Website: http://gwas.nih.gov/

 

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