The NHGRI Bioethics Core supports the NHGRI intramural research program by providing infrastructure and training related to the NHGRI Institutional Review Board (IRB), coordinating annual Responsible Conduct of Research educational sessions, moderating bioethics rounds at the clinical genetics case conference, and representing NHGRI within the Clinical Centers ethics consultation service and Ethics Committee. In addition, the Core is available to address emergent bioethics education and consultation needs for the DIR. The Bioethics Core is responsible for ensuring that NHGRI is compliant with the regulations, policies, and guidelines governing the ethical conduct of federally-funded human subjects research (e.g,. 45 CFR 46). This is especially relevant in the context of NIHs current plans to seek accreditation of its IRB program; the Core is responsible for ensuring that NHGRI policies and practices meet the standards set forth by the accrediting body. The Core provides the administrative infrastructure for the NHGRI IRB. In FY16, this involved maintaining a system of records for 114 active NHGRI IRB-reviewed intramural research protocols, per 45 CFR 46.115 and the NIH Federal-Wide Assurance. This included processing of new protocol submissions, continuing and triennial reviews, terminations, amendments, adverse events, and deviations/violations. The Core continues to refine the electronic protocol submission and distribution application (PTMS) to streamline the IRB infrastructure, simplify the review process for investigators, and reduce the volume of paperwork associated with the process. The Core regularly consults with DIR investigators on the development and revisions of their protocols and consent forms for the IRB. This includes a formal pre-review process of all new protocol submissions as well as ad hoc guidance at any stage in the submission and review process. The Core advises investigators who have questions concerning regulations and procedures related to the submission and review of their protocols (for the NHGRI IRB as well as other IRBs to which they may need to submit their protocols), and synthesizes and disseminates new information regarding policy and procedural changes in the review/approval process. Bioethics Core responsibilities over the past year have included ongoing implementation of the NIH Genomic Data Sharing policy as well as the new DIR Human Data Sharing policy, establishing the IRBs role in relation to the FDAs regulation of genomic sequencing as an investigational device, and functioning as the central IRB of record for the Undiagnosed Diseases Network. In addition, staff has continued to expand IRB membership and educational opportunities for IRB members, consult with investigators, streamline IRB processes, and be involved in research ethics oversight capacity-building activities with other institutions. The Core continues to receive many consultation requests around next generation sequencing, data sharing, and management of incidental genetic findings, and well as an increasing numbers of consults related to the conduct of clinical intervention protocols.
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