PURPOSE This document describes the procedures for the review and certification of studies that must comply with the NIH Genomic Data Sharing (GDS) Policy or the NIH Genome Wide Association Studies Policy. , , and for more information. LEVEL OF REVIEW NIH 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 data to 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: Full Committee Review For applications that require review by a full committee, the request for GDS certification will be reviewed by the full committee. Modifications to existing approved research are brought to the full 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). Expedited Review For applications that qualify for expedited review (per 45 CFR 46.110 21 CFR 56.110), the request for GDS certification will be reviewed by a designated member of the IRB. This is applicable to initial submissions as well as to modifications of existing approved research. Not Subjects Research Requests for GDS certification of data from a research study that does not involve human subjects will be reviewed for a not human subjects determination and GDS certification in tandem by a designated member of the IRB. External Review Requests 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.
PURPOSE This document describes the procedures for the review and certification of studies that must comply with the NIH Genomic Data Sharing (GDS) Policy or the NIH Genome Wide Association Studies Policy. , , and for more information. LEVEL OF REVIEW NIH 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 data to 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: Full Committee Review For applications that require review by a full committee, the request for GDS certification will be reviewed by the full committee. Modifications to existing approved research are brought to the full 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). Expedited Review For applications that qualify for expedited review (per 45 CFR 46.110 21 CFR 56.110), the request for GDS certification will be reviewed by a designated member of the IRB. This is applicable to initial submissions as well as to modifications of existing approved research. Not Subjects Research Requests for GDS certification of data from a research study that does not involve human subjects will be reviewed for a not human subjects determination and GDS certification in tandem by a designated member of the IRB. External Review Requests 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.
SOP-Genomic-Data-Sharing-Certification-HSD-Procedures.docx