Highlighted version(s) for IRB review
The IRB will review every consent version on which the data submission is relying (every version that was or will be signed by a subject whose data will be submitted). If some or all of the data submitted relies on previously obtained consent, study teams may have to prepare multiple prior versions for IRB review.
Upload in question 44.1 upload a copy of each relevant consent version, highlighting sections that are relevant to genomic data sharing:
- Genetic research or analysis
- Specific permissions or restrictions
- Subsequent use and sharing of the data
- Risks to individuals, families and groups or populations associated with submission of data to the repository
- Whether participants’ individual-level data will be shared through unrestricted or controlled-access repositories
Initial application (HUM) submitted as a “projects lacking immediate plans” (Umbrella)
For an Initial application (HUM) submitted as a “projects lacking immediate plans” (Umbrella) application type, the consent draft may be limited to Section 4 of the IRBMED Standard Consent Template, delineating the required information about genomic data sharing. (Full consent draft not required at this time.) Upload in question 44.1.
New consent or re-consent
- Upload in question 10-1.1 consent(s) to be signed in the future without highlighting.
- Upload in question 44.1 Highlighted version(s) for IRB review
For studies proposing to use genomic data from cell lines or clinical specimens that were created or collected after January 25, 2015, 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, even if the cell lines or specimens are de-identified. For detailed guidance, see NIH Genomic Data Sharing Policy(pp5-6) and NHGRI Informed Consent for Genomics Research website (including sample language).
Existing consent, or specimens previously created or collected without consent
Upload in question 44.1 Highlighted version(s) for IRB review
The eResearch application should include (preferably as part of the Detailed Genomic Data Sharing Plan from Proposal) an explanation whether prior consent is adequate to current NIH standards. If it is not adequate, also include a plan for re-consent of some or all subjects, and/or justification why re-consent is not feasible.
In the event some specimens were not associated with a research consent document, the IRB will consider alternative information, as it is available, for compliance with the NIH standards. See NIH Genomic Data Sharing Policy (pp5-6).