The NIH issued the Genomic Data Sharing (GDS) Policy effective January 25, 2015. The policy applies to all NIH-fund research that generates large-scale human genomic data, regardless of the funding level, as well as the future use of the data. The policy includes the NIH’s expectations and requirements for the broad sharing of genomic data. Grants applications and IRB protocols should include details of the required data sharing plan. In general, consent documents should include language that allows for the broad future sharing of genomic data. The NIH recognizes that there will be instances where broad sharing may not be appropriate and the policy outlines the exceptions. Investigators should become familiar with the information provided by the NIH to facilitate writing the grant, IRB protocol, and consent(s) available at http://gds.nih.gov/03policy2.html. More specific information may be found on the University’s Office of Research website at http://www.research.pitt.edu/reference-resources.
Genomic Repository Submission Process (dbGaP/Other NIH-designated repository)
The IRB OSIRIS protocol and consent should include consistent information on the plan to share the genomic data. The University’s process involves two steps: 1) IRB Affirmation per NIH requirements 2) Once obtained, this document is provided to the University’s Office of Research who will issue the required Institutional Certification for the actual submission of the data to the repository.
IRB Affirmation - Investigators must complete the application for IRB Affirmation (NIH-designated Genomic Data Repository form). All versions of the consent used throughout the study must be included with the application and emailed to AskIRB@pitt.edu. The IRB will review the protocol and consent(s) and use their discretion to evaluate the appropriateness of genomic data submission per the NIH policy requirements noted below:
- The protocol for the collection of genomic and phenotypic data is consistent with 45 CFR Part 46
- Data submission and subsequent data sharing for research purposes are not inconsistent with the informed consent of study participants from whom the data were obtained
- Consideration was given to risks to individual participants and their families associated with data submitted to NIH-designated data repositories and subsequent sharing
- To the extent relevant and possible, consideration was given to risks to groups or populations associated with submitting data to NIH-designated data repositories and subsequent sharing
- The investigator’s plan for de-identifying datasets is consistent with the standards outlined in the GDS Policy
Once the review process is complete, the IRB will provide the investigator with the IRB Affirmation Letter for submission to the Office of Research. The IRB letter will include appropriate future use of data as well as any restrictions based on consent language review. In general, the review process may take up to two weeks. However, investigators should not expect rapid IRB review in regards to long-ongoing studies with multiple protocol/consent versions.
Consent Guidance - Please note the below information from the NIH GDS Policy (Section 4 – Informed Consent)
For studies initiated after the effective date of the GDS Policy, NIH expects investigators to obtain participants’ consent for their genomic and phenotypic data to be used for future research purposes and to be shared broadly. The consent should include an explanation about whether participants’ individual-level data will be shared through unrestricted- or controlled-access repositories.
For studies proposing to use genomic data from cell lines or clinical specimens that were created or collected after the effective date of the Policy, NIH expects that informed consent for future research use and broad data sharing will have been obtained even if the cell lines or clinical specimens are de-identified.
An excellent resource for genomic research considerations and model consent language may be found at http://www.genome.gov/27559024.