OF BIOETHICS CORE PROJECTS, 6/1/18 5/31/19 A. Ethics of Human Subjects Research: Administrative Support, Education, and Consultation for the NHGRI Institutional Review Board IRB infrastructure Over the course of the past year, Bioethics Core staff joined with NHLBI IRB analysts to assume responsibility for maintaining a system of records and ethical oversight for a total of 434 protocols, 102 (23%) of which were NHGRI protocols. o A total of 1,947 IRB-related actions were approved in the past year, 359 (18%) of which were for NHGRI protocols. Worked closely with the NHGRI Technology Transfer Office to advise on the appropriateness of specific MTAs and ITAs on a case-by-case basis for materials and data derived from human subjects under NHGRI IRB-approved protocols, and to implement use of new NIH-wide attestation form and policy that was modeled heavily after the collaborative approach that the NHGRI Bioethics Core and TTO had already been using together for many years. Updated IRB website (www.genome.gov/10005807) Produced and distributed agendas, review packets, and minutes for monthly IRB meetings. Developed a more streamlined pathway via protocol navigation for securing DEC Clearance prior to IRB review. Participated in/regularly attended NIH Human Subjects Research Advisory Council (HSRAC), and NIH IRB Professional Administrators Committee (IPAC). These meetings have evolved into a monthly IC liaison meeting, IRB chair meeting, and IRBO staff meetings at which Core staff continue to represent NHGRI. Participated as the NHGRI AAHRPP designated contact responsible for updating and implementing SOPs, data collection, and other activities associated with maintaining accreditation of the NIH Intramural Human Research Protection Program. Education and consultation for NHGRI investigators Consulted with NHGRI investigators on a wide range of emergent (and sometimes urgent) ethical and regulatory concerns raised by the design and implementation of their protocols. Consulted with investigators in the development and revision of protocols and consent forms o Provided significant and systematic pre-review of initial protocol submissions and substantial amendments to identify substantive ethical and administrative issues prior to formal IRB submission. o Consulted on proposals to incorporate whole-exome and genome sequencing into new or existing protocols. Oriented JHU/NIH genetic counseling training program students to the new IRB process. Education and training for IRB professionals Directed the NIH IRB internship program, which trains IRB administrators and professionals from targeted institutions (from low and middle-income countries and tribal communities) in the ethical and regulatory aspects of clinical research ethics and in the operation and management of IRBs. o Hosted interns from Nigeria, Zambia, and Indonesia in Fall 2018, plus did ongoing work with former intern from Blackfeet Nation, Montana. Expanded the reach of research ethics training and capacity building initiatives through partnerships with NIH Tribal Health Research Office, PRIM&R, Indian Health Service, and the National Congress of American Indians o Served on the PRIM&R Core Conference Planning Committee o Attended joint South Central Foundation and NHGRI workshop on genomic research with Alaska Native communities in Anchorage, Alaska. B. Responsible Conduct of Research Education Per PHS Policy, facilitated mandatory DIR-wide discussion modules (2018: Implicit and Explicit Biases in the Research Setting) with a total of 351 intramural researchers and staff. Represented NHGRI on the NIH Committee on Scientific Conduct and Ethics, which develops the cases that are included in the annual training modules and adjudicates reported cases of research misconduct in the NIH intramural research program. C. Clinical Bioethics Education and Consultation Consulted with DIR investigators and IRBs about the ethics of proposed uses of whole exome and genome sequencing in their protocols. Chaired a committee of NIAID intramural researchers to develop an institute-wide set of policies about returning genetic results. Served on the NHGRI Genomic Data Sharing Policy Implementation Working Group. Invited to attend ELSI workshop for the All of Us program (June 2019). Served on the NIH embryonic stem cell administrative review committee. Serve as the bioethicist and intramural representative on Exceptions Subcommittee for the NIH Single IRB Policy. Serve as the bioethics representative on the OSMB for the extramural NHLBI Bassinet to Bedside research program. Served on the committee tasked with reexamining CC policies about advanced directives Appointed to serve on the NIH chimera policy review committee. Participated as attending ethicists in Clinical Centers Ethics Consultation Service. Represented NHGRI on the Clinical Center/MEC Ethics Committee. Taught sessions on incidental genomic research findings and research with stored tissues for Department of Clinical Bioethics annual NIH-wide training course on the Ethical and Regulatory Aspects of Clinical Research and on ethical issues in genetic testing for the Bioethics Fellows Seminar. Gave lectures on a variety of topics to a number of intramural IRBs, research teams, and community groups. D. Research and Evaluation Continued research to assess IRB practices and IRB members perspectives regarding the management and return of incidental genetic research findings, waivers of informed consent Continue to publish on a wide range of genomics and society related topics, including genetic privacy laws, regulation of genetic testing, incidental findings, the right not to know, genomic data sharing policies, prenatal genome sequencing, pediatric reconsent, tribal perspectives on research ethics and DTC ancestry testing, forensic use of genomic data, and emerging reproductive technologies. Received highly favorable evaluations via the 2019 Clinical Centers Department of Bioethics Board of Scientific Counselors review.

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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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