- Overview
- Submitting an NIH Proposal and Just-In-Time (JIT) Materials
- IRB Application Requirements
- Consent Form Requirements and GDS Policy Consent Form Checklist
- Certification Letter for NIH
- Resources
Overview
This guidance applies to the Genomic Data Sharing (GDS) Policy. Additional information can be found at the NIH Genomic Data Sharing (GDS) website.
NIH has strict standards for IRB review and informed consent for the data they will accept for inclusion in GDS data repositories.
The IRB is now required to review investigators' requests to submit data to the NIH data repositories and must also certify that the informed consent that was obtained from subjects was consistent with NIH requirements for sharing genomic data. In addition, virtually all NEW grant applications that request NIH funding for genomic research must incorporate, as part of the NIH application, a genomic data sharing plan that is consistent with GDS policy. Because of the additional time required for IRB review, as well as the need to incorporate specific sharing language in their consent forms, contact the IRB as early as possible.
Submitting an NIH Proposal and Just-In-Time (JIT) Materials
1. Work with your Research Service Coordinator if the Funding Opportunity Announcement requires IRB review and approval of the consent form content prior to application submission. Work with your study coordinator to provide a basic plan for following the GDS policy, located in the Resource Sharing Plan section of funding applications.
- Genomic Data Sharing Plans Guidance
- Genome-Wide Association Studies Data-Sharing Guidance
- Genome-Wide Association Studies Data-Sharing Example
- If broad sharing of genomic data is not possible, include an explanation
2. Work with your Research Service Coordinator to complete documentation in response to a Just-In-Time request from NIH:
- An IRB approval letter for your human subjects protocol
- An Institutional GDS Data Submission Certification letter signed by the HRPP Director, which verifies that the consent form meets the GDS criteria
Submit these documents to your OSR (Office of Sponsored Research) Research Services Coordinator, who will generate the Institutional Certification. Include the signed Institutional Certification with your JIT submission.
IRB Application Requirements
Include the following information in these sections of the IRB Application (either as part of a new study or to modify an approved study to GDS):
The IRB has developed a NIH GDS Policy Consent Checklist that specifies the informed consent elements for studies to meet GDS Policy data submission requirements. For multi-center research, submit a copy of this checklist for each consent form and also submit a copy of the consent form from the other sites. Submit this checklist to IRB at the time of your request for a GDS data submission certification letter if your study does not include the IRB recommended language (below).
If any of the required consent elements are missing, the NIH may not accept the data, or may place limitations on subsequent use of the submitted data. Furthermore, NIH will not accept GDS Policy data from studies that did not obtain consent from the participants (after 1/25/2015), including studies where the local IRB granted a waiver of consent to collect this data.
For previously approved research, if the approved consent form omitted several of the required GDS Policy elements, the IRB may have to conclude that the original consent is not adequate for submission to the GDS Policy data repository and subsequent sharing for research. It may become necessary for the investigator to seek explicit re-consent participants.
Certification Letter for NIH
When you have received IRB approval for the GDS data submission and are ready to submit data to NIH under the GDS Policy, the IRB will provide a signed data submission certification letter to the investigator.