Vanderbilt University Process for Requesting Access to Human Genomic Data

Vanderbilt University Process for Requesting Access to Human Genomic Data

UsingNIH Database of Genotypes and Phenotypes (dbGaP)

To request access to any individual-level human datasets within the controlled-access of dbGaP orother NIH-designated repositories, investigators and the Signing Official at the requestinginvestigator’s institution co-sign a data access request (DAR), which will be reviewed by an NIHData Access Committee (DAC).

Investigator submits a Project Request through the NIH Commons. Janiece Harrison should be selected as the Signing Official (SO) for Vanderbilt University. When Sponsored Programs Administration (SPA) is notified by NIH of the request, SPA will contact Vanderbilt University Information Technology (VUIT) and provide VUIT with the name of the project, project PI and project IT manager.

VUIT will contact the project IT manager to review NIH Security Best Practices for Controlled-Access Data Subject to the NIH Genomic Data Sharing (GDS) Policy. The VUIT security team will meet with the project IT manager to insure that there is a plan to meet local and central IT requirements.

VUIT notifies SPA that security practices are acceptable.

The project PI and project IT manager complete and sign a VANDERBILT UNIVERSITY dbGaP Data Access Certification Form and submit to SPA.

SPA reviews and approves the dbGaP Data Access Certification Form.

SPA approves the request through NIH Commons on behalf of Vanderbilt University. The investigatorand Vanderbilt (acting through the SO) sign a Data Use Certification (DUC) agreeingto the NIH terms of access for the dataset. DACs make decisions based primarily on conformityof the proposed research use to the data use limitations specified in the Institutional certificationprovided by the submitting institution. If the DAR is approved, the requestor is granted accessto a dataset for one year. At the end of the one year period, users can request access for anadditional year through a renewal process, or close out the project.

Investigators and their institutions that are approved to download data from NIH-designatedrepositories are expected to abide by the NIH Genomic Data User Code of Conduct through theiragreement to the DUC.

At the time of project closeout, the Investigator should submit a closeout request in dbGaP. VUIT will confirm that data destruction has occurred in accordance with dbGaP requirements. SO will approve the closeout request in dbGaP.