- 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.
Effective 1/25/15, the GDS Policy applies to the following:
- NIH-funded research that generates human or non-human genomic data (e.g. SNP arrays, genome sequencing, RNA sequencing, transcriptomic, metagenomics, epigenomic and gene expression data, GWAS studies) from more than 100 individuals.
- Studies that are not NIH-supported but plan to submit genotype/phenotype data to one of the following NIH Supported repositories:
- Database of Genotypes and Phenotypes (dbGaP)
- Gene Expression Omnibus (GEO)
- Sequence Read Archive (SRA)
- Cancer Genomics Hub (CaHUB)
- When the genomic data is generated without NIH funds (unless the researcher voluntarily requests submission to one of NIH-supported repositories)
- When NIH-funded projects involve instrument calibration exercises, statistical or technical methods development, or the use of genomic data for control purposes, such as for assay development
- When the following funding is requested: Institutional Training Grants (T32s, T34s, T35s, and TL2s), Career Development Awards (Ks), Individual Fellowships (Fs), Resource Grants and Contracts (Ss), linked awards derived from previously reviewed applications, or facilities or coordinating centers funded through related initiatives to provide genotyping, sequencing, or other core services in support of GDS
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):
- State explicitly that data will be sent to NIH for GDS, and describe the genotype and phenotype data to be sent
- Indicate whether data will be collected PROSPECTIVELY or, if the PI is submitting a modification to an ongoing study, whether the investigator wishes to submit data that has ALREADY been collected. NIH expects that ALL data collected after 1/25/15 was consented according to the GDS-required criteria (see consent form template)
- Specify if data shared with the NIH for GDS Policy will be for broad use or limited to specific diseases or conditions
Studies that plan to contribute to NIH GDS repositories should have IRB approval for specimen collection for future research and/or specimen repository/bank administration. In the "Procedures" section, check "Yes" when asked if the study involves these activities and fill out the applicable section(s) regarding specimen collection and banking that follow.
- Plans for maintaining privacy in the research setting: Specify that a random, unique code will be assigned to the data sent to NIH to protect participant privacy and confidentiality, and that identifiers will not be sent to the NIH.
- Possible consequences to subjects resulting from loss of privacy: Describe risks of broad sharing, risks to individuals, families and groups.
Consent Form Requirements and GDS Consent Form Checklist
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).
There are two options:
- Use the existing consent templates that include the GDS required language, or
- Develop your own verbiage and upload the NIH GDS consent checklist to document that all of the required elements are included.
Submit the NIH GDS consent checklist to document that all of the required elements are included to meet GDS Policy data submission requirements.
We may use your genetic information and some medical record data to do research in the future. We will remove your name and other personal information before sharing it with other researchers. We may share this information with other scientists or companies not at UCSF or SFVAHCS (if this study involves SFVAHCS). This information may be put into an unrestricted or controlled access government health research database. Even though no personal information will be included, we cannot guarantee that no one will ever be able to use this information to identify you.
[Include the following paragraph if IDENTIFIABLE genetic data will be stored for future research. This should be very rare. Best practice is to anonymize or de-identify data whenever possible.]
If you change your mind about your genetic data that can be linked to you being used for future research, tell the Principal Investigator. This person’s contact information is on Page 1 of this form. The study team will destroy any data they still have that can be linked to you. We cannot destroy data that has already been shared with other researchers.
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.
Resources
If you have questions, contact the HRPP office at 415-476-1814.