NIH Genomic Data Sharing | Human Subject Research Office | University of Miami

NIH Genomic Data Sharing (GDS) Certification

 The GDS Policy applies to all National Institutes of Health (NIH) funded research that generates large-scale human or nonhuman genomic data and of these data for subsequent research. If your research involves large-scale genomic data and the NIH is funding it through a grant, contract, or cooperative agreement, you must comply with the policy. 

 

Large-scale data include: 

  • genome-wide association studies (GWAS),

  • single nucleotide polymorphisms (SNP) arrays, and

  • genome sequence, transcriptomic, metagenomic, epigenomic, and gene

 

 Contact your NIH Program Officer as early as possible to discuss data-sharing expectations and timelines for a proposed study.

 

 OVPRS and IRB Roles

Under the GDS Policy, individuals who provided the samples for the research must know that the research will use their samples for genetic and genomic research. They must also know that researchers will share data from the research broadly for secondary research. The IRB and institutions must certify that the consent document adequately informed research participants.

 

 

Consent Form Requirements 

  • For tissue collected before January 22, 2015 – The language should not prohibit data-sharing.

  • For tissue collected after January 22, 2015 – The language should describe data-sharing. Click Here for guidance.

  • For new studies or modifications, include the template language from Part 3, Genomic Data Sharing language from the Biomedical Template Consent Document.

 

The Institutional Review Board (IRB) and institution must also consider whether sharing the data will place individuals at risk because they are part of:

  • A small sample size,

  • An isolated or identified geographic region,

  • A rare disease community, or

  • A group with potentially stigmatizing traits.

 

Investigator Requirements

  • Include a Genomic Data Sharing Plan in your proposal.

  • Provide a more detailed sharing plan to the NIH with your Just-In-Time submission.

  • Ensure your consent form complies with the GDS Policy.

  • Submit the following to hsro@miami.edu:
    • Completed GDS Certification Form;
    • Copies of all approved consent documents.
    • If you will use biological samples collected for another purpose, obtain a copy of the consent form that was used to acquire the samples from the individuals who donated them.

  • The Human Subject Research Office (HSRO) will review the documentation and forward it to the Vice Provost for Research (VPR) for signature with the IRB's opinion on whether the data sharing requirements are appropriately met.

  • Once the Vice Provost’s signature has been obtained, the certification will be returned to the Principal Investigator.

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