OF BIOETHICS CORE PROJECTS, 6/1/17 5/31/18 A. Ethics of Human Subjects Research: Administrative Support, Education, and Consultation for the NHGRI Institutional Review Board IRB infrastructure Maintained system of records for 113 active NHGRI intramural research protocols as required per 45CFR46.115. o Thirteen protocols were closed recently, many of which were folded into a new omnibus repository protocol for ongoing analysis of samples and data. o Note that 9 of these protocols are from institutes other than NHGRI (NIEHS=4; NIDCR=1; NLM=1; CC=1, NINDS=1; MD=1), including a number of gene transfer protocols and clinical trials. Provided systematic pre-review and protocol development guidance for four new intramural protocols. Reviewed and processed 131 protocol amendments (including 121 by expedited review). 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. Updated IRB website. (www.genome.gov/10005807) Developed/coordinated IRB and Scientific Review Committee calendars. Produced and distributed agendas, review packets, and minutes for monthly IRB meetings. Participated in/regularly attended NIH Human Subjects Research Advisory Council (HSRAC), NIH IRB Professional Administrators Committee (IPAC), and Intramural Clinical Research Steering Committee (ICRSC) meetings. Participated as the NHGRI Association for the Accreditation of Human Research Protection Programs (AAHRPP) designated contact responsible for updating and implementing SOPs, data collection, and other activities associated with applying for and successfully achieving re-accreditation of the NIH Intramural Human Research Protection Program. Education and consultation for IRB members Planned and facilitated combined retreat for members of the newly formed General Medicine #1 IRB, which includes select members from the NHGRI IRB, to address topics of relevance to the combined portfolio and changing infrastructure, including the ethics of transplantation research and disclosure of secondary genomic research findings. 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 exome and genome sequencing into new or existing protocols. o Coordinated with NHGRI Protocol Services Center that provides scientific writing support to investigators. Facilitated the scheduling of training and support for the migration of protocol data from PTMS to new NIH iRIS system. Oriented JHU/NIH genetic counseling training program students to the 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. Expanded the reach of research ethics training and capacity building initiatives through partnerships with NIH Tribal Health Research Office, IRB professional organizations such as PRIM&R, Indian Health Service, and the National Congress of American Indians. o Served on the PRIM&R Core Conference Planning Committee. o Selected to moderate plenary session on Sovereignty in Research for 2017 annual PRIM&R Advancing Ethical Research conference. B. Responsible Conduct of Research Education Per PHS Policy, facilitated mandatory DIR-wide discussion modules (2017: Socially Responsible Science) with a total of 329 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 exome and genome sequencing in their protocols. Served on the NHGRI Genomic Data Sharing Policy Implementation Working Group. Served on the NIH embryonic stem cell administrative review committee. 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 re-consent, and tribal perspectives on research ethics, forensic use of genomic data, emerging reproductive technologies, prenatal genome sequencing.
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