ACCESSING GAIN DATA

The GAIN Database is within dbGaP, the database of Genotype and Phenotype. This database, which was developed and is operated by the National Library of Medicine’s National Center for Biotechnology Information (NCBI), archives and distributes data from studies that have investigated the relationship between phenotype and genotype, such as genome-wide association studies (GWAS).

dbGaP provides for two levels of access: open (available to anyone with no restrictions), and controlled (requiring preauthorization). The open-access section allows users to view general information about the GAIN studies, including study documents, such as protocols, as well as summaries of the genotype and phenotype data. With appropriate authorization, the controlled-access portion of the database provides for downloads of individual-level genotype and phenotype data that have been de-identified (i.e., the data contain no personal identifiers, such as name, etc.). Summary information for each project in the GAIN database is now available publicly in dbGaP.

It is anticipated that the first GAIN project dataset, a study of attention deficit and hyperactivity disorder, will be available on or about June 9, 2007. Data from the other five GAIN studies will be rolled out over the next six months as they become available.  Data requests may be made and processed for all of the studies beginning on May 25, 2007; however actual fulfillment of these requests will occur as each additional dataset requested becomes available in dbGaP.

How to request access to individual-level GAIN data

Beginning on or around May 2, 2007, researchers may request access to the individual-level data from GAIN studies through the dbGaP data access request system.

In order to obtain access to any of the individual-level datasets within the controlled access section of the GAIN Database, both the Principal Investigator (PI) making the request and a Signing Official (SO) at his or her institution will need to co-sign an online request for data access to be reviewed by the GAIN Data Access Committee. (Collaborators at other institutions will need to submit separate requests for co-submission with their SOs.)

There are two steps required to access individual-level GAIN data:

1) Become authenticated as a user of NIH research databases. 

To do this both the PI and the SO must first be registered with the NIH’s eRA Commons system.  The eRA Commons system is an online system used across NIH to authenticate and manage access privileges to various NIH systems for users who apply electronically to NIH for grants. (Please note: the eRA Commons accounts required to apply to access GAIN data are the same accounts used to apply for grants, so that PIs and SOs who already have this type of eRA account do not need to do anything further to make them applicable to the dbGaP controlled-access authorization process.) Information on applying for an eRA Commons account can be found at https://commons.era.nih.gov/commons/.

2) Review the open access information on available projects and make an electronic request to dbGaP for the specific datasets desired, using your eRA Commons ID.

Requests are made online via the dbGaP data access request system.  Complete instructions and information about the data access request process is available at: http://dbgap.ncbi.nlm.nih.gov/aa/dbgap_request_process.pdf.

All proposed research uses of GAIN data must be consistent with any data use limitations of the requested GAIN dataset. Information about any data use limitations is available in the dataset descriptions in the open-access and controlled-access sections of dbGaP.  In addition, PIs requesting access to the individual-level GAIN data and their SOs will need to make certain assurances regarding how GAIN data is used as part of their application.  These terms of use are documented in the GAIN Data Use Certification.

Inquiries

Questions about the content of the Data Access Request or the Data Access Request process may be directed to:

Emily L. Harris, PhD, MPH
Chair, GAIN Data Access Committee

National Human Genome Research Institute

gaindac@mail.nih.gov