1PURPOSE
1.1This document describes the procedures forthe review and certification of studies that must comply with the NIH Genomic Data Sharing(GDS) Policyor the NIH Genome Wide Association Studies Policy.
1.2SeeSOP Request for Genomic Data SharingCertification - Investigators, GUIDANCE: Genomic Data Sharing, WORKSHEET: Genomic Data Sharing Certificationand WORKSHEET: Consent Requirements and Expectations for Genomic Data Sharingfor more information.
2LEVEL OF REVIEW
2.1NIH requires that an IRB, privacy board, and/or equivalent body review and certify an investigator’s proposal for the submission of large-scale human or non-human genomic datato NIH Data Repositories. UW interprets this to mean that the review may be done by the full (convened) committee or by a designated member of the IRB, as follows:
2.1.1Full Committee Review
2.1.1.1For applicationsthat require review by a full committee, the requestfor GDS certification will be reviewed by the full committee. Modifications to existing approved researchare brought to the full board when appropriate, but may be reviewed by expedited procedures when they meet the definition of a Minor Change is met (see SOP Modifications Section 3.1).
2.1.2Expedited Review
2.1.2.1For applicationsthat qualify forexpedited review (per 45 CFR 46.110 21 CFR 56.110), the requestfor GDS certificationwill be reviewed by a designated member of the IRB. This is applicable to initial submissions as well as to modifications of existing approved research.
2.1.3Not Human Subjects Research
2.1.3.1Requests for GDS certification of data from a research study that does not involve human subjects will be reviewed for a not human subjectsdetermination and GDS certification in tandem by a designated member of the IRB.
2.1.4External Review
2.1.4.1Requests for GDS certification of data from a research study for which the University of Washington is relying on the IRB review of another institution by means of an IRB Authorization Agreement (including cooperative agreements and agreement/contracts with a central IRB) are reviewed by a designated member of the UW IRB.
3PROCEDURES
3.1Review Assignment.
3.1.1In general, the Team Operations Lead (TOL) is assigned items requiring GDS certification. However, the TOL may delegate this responsibility to an Administrator when:
3.1.1.1The item involves the prospective collection of data (i.e. no retrospective data);
3.1.1.2The UW IRB (as opposed to the IRB of another institution) is responsible for the review and approval of the consent form(s); and,
3.1.1.3The researchers have chosen to use the template GDS consent language or language very close to it.
3.2Required Documents.
3.2.1Upon receipt of a request for certification, the responsible HSD staff member will verify that the necessary documents have been included perSOP Requestfor Genomic Data Sharing Certification - Investigators.
3.3Review of Certification Request
3.3.1The Genomic Data Sharing (GDS) section of the WORKSHEET: Genomic Data Sharing Certification,GUIDANCE: Genomic Data SharingandWORKSHEET: Consent Requirements and Expectations for Genomic Data Sharing are used by the IRB or designated reviewer to review the request for GDS certification regardless of whether the review is conducted by the Full Committee, Expedited Procedures, as aNot Human Subjects Determination, or External Review.
3.3.2Any request for an exception to UW consent requirements for compelling scientific reasons must be sent to an Assistant Director of Operations or the HSD Director for approval. This approval should be documented in an email or a note to file.
3.4Non-certification
3.4.1Concurrence from an Assistant Director of Operations must be sought before the lead researcher and the Office of Sponsored Programs (OSP) are informed that a data sharing plan does not meet the certification criteria.
3.4.1.1If the certification criteria cannot be met, the certification letter is not sent and instead PI and OSP are sent an email explaining why the criteria are not met.
3.5Institutional Certification
3.5.1The staff member assigned to the item will draft a GDS certification letter, using the NIH Institutional Certification templates for Extramural Investigators on the NIH website.Letters are addressed to the appropriate Genomic Program Administrator.
3.5.2For certifications associated with a grant:
3.5.2.1The staff member sends the certification letterby email to OSP at and to the PI.
3.5.2.2The PI is instructed to sign the letter and return the signed letter to OSP.
3.5.2.3 OSP reviews the certification and submits with JIT materials in eRA Commons to NIH. If after award, OSP will sign and submit to NIH.
3.5.3For certifications that are not associated with a grant:
3.5.3.1If the certification is not associated with a grant application, the documents are sent to an ADO who will forward them to the OSP Director for signature.
3.6File Documentation
3.6.1The documents below are uploaded to Zipline in Shared Regulatory Documents or in the Purple Folder in the Paper file.
3.6.1.1The Email to OSP and the lead researcher
3.6.1.2The unsigned GDS certification/non-certification letter
3.7Data Entry Steps
3.7.1Follow the data entry steps as outlined in the DORA reference manual or the Zipline Instructions for Staff, as applicable.
4MATERIALS
4.1WORKSHEET: Genomic Data Sharing Certification
4.2GUIDANCE: Genomic Data Sharing
4.3SOP Request for Genomic Data Sharing Certification - Investigators
4.4ZIPLINE SUPPLEMENT: Genomic Data Sharing
4.5WORKSHEET: Consent Requirements and Expectations for Genomic Data Sharing
5REFERENCES
5.1NIH GDS FAQs
5.2NIH Genome-Wide Association Studies (GWAS) Policy
5.3NIH Genomic Data Sharing (GDS) Policy
5.4NIH GWAS FAQs
5.5NIH Points to Consider for IRBs and Institutions in their Review of Data Submission Plans for Institutional Certifications under NIH’s Policy for Sharing Data in NIH supported or Conducted Genome-Wide Association Studies
5.6Supplemental Information to the NIH Genomic Data Sharing Policy
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