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 2009-10, this involved maintaining a system of records for more than 80 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.

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National Human Genome Research Institute
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Splinter, Kimberly; Hull, Sara Chandros; Holm, Ingrid A et al. (2018) Implementing the Single Institutional Review Board Model: Lessons from the Undiagnosed Diseases Network. Clin Transl Sci 11:28-31
Hull, Sara Chandros; Wilson Diné, David R (2017) Beyond Belmont: Ensuring Respect for AI/AN Communities Through Tribal IRBs, Laws, and Policies. Am J Bioeth 17:60-62
Doernberg, Sam; Hull, Sara Chandros (2017) Harms of Deception in FMR1 Premutation Genotype-Driven Recruitment. Am J Bioeth 17:62-63
Chen, Stephanie C; Berkman, Benjamin E; Hull, Sara Chandros (2017) Recontacting participants for expanded uses of existing samples and data: a case study. Genet Med 19:883-889
Gliwa, Catherine; Yurkiewicz, Ilana R; Lehmann, Lisa Soleymani et al. (2016) Institutional review board perspectives on obligations to disclose genetic incidental findings to research participants. Genet Med 18:705-11
Darnell, Andrew J; Austin, Howard; Bluemke, David A et al. (2016) A Clinical Service to Support the Return of Secondary Genomic Findings in Human Research. Am J Hum Genet 98:435-41
Bayefsky, Michelle J; White, Amina; Wakim, Paul et al. (2016) Views of American OB/GYNs on the ethics of prenatal whole-genome sequencing. Prenat Diagn 36:1250-1256
Koretzky, Maya; Bonham, Vence L; Berkman, Benjamin E et al. (2016) Towards a more representative morphology: clinical and ethical considerations for including diverse populations in diagnostic genetic atlases. Genet Med 18:1069-1074
Lomax, Geoffrey P; Hull, Sara Chandros; Isasi, Rosario (2015) The DISCUSS Project: Revised Points to Consider for the Derivation of Induced Pluripotent Stem Cell Lines From Previously Collected Research Specimens. Stem Cells Transl Med 4:123-9
Grady, Christine; Eckstein, Lisa; Berkman, Ben et al. (2015) Broad Consent for Research With Biological Samples: Workshop Conclusions. Am J Bioeth 15:34-42

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