NHGRI/DIR Bioethics Core

National Human Genome Research Institute

Investigators

Linked publications, trials & patents

Abstract

I. SUMMARY OF BIOETHICS CORE PROJECTS, 6/1/20 5/31/21 A. Ethics of Human Subjects Research/NIH Intramural Institutional Review Board IRB Navigation and Support For the period between June 01, 2020 to May 31, 2021 Supported a total of 77 NHGRI intramural protocols in various stages of implementation, including 17 that were determined to be exempt from IRB review and 7 that were determined not to involve human subjects. This number dropped from last year because of study closures and/or reclassifications; a total of 120 protocols have closed in the last year. Provided leadership (e.g., chairing weekly meetings, participate in bi-weekly IRB leadership meetings) and membership (participating in at least 1 meeting per month) to the NIH Intramural IRB. 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. Handled all submissions to the NHGRI Ethics Office to avoid/address investigator conflicts of interest. Tracked all required human subjects research training across NHGRI investigators engaged in NIH IRB-reviewed human subjects research. Participated as the NHGRI AAHRPP designated contact to support maintenance of accreditation of the NIH Intramural Human Research Protection Program. 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 of protocols and consent forms. Provided significant and systematic pre-review of initial protocol submissions, amendments, and continuing reviews to address substantive issues prior to formal IRB submission. Coordinated SRC review for 6 new protocols and 8 quadrennial reviews. Capacity Building for Research Ethics Oversight Established an MOU with NIH Tribal Health Research Office for a 1-year part time detail to focus on the development of policies, procedures, and training mechanisms to enhance the ethical conduct of Tribal research. Participated in monthly U.S. Tribal IRB/RRB Discussion Group Nurtured existing partnerships with PRIM&R, Indian Health Service, and the National Congress of American Indians to strengthen collaborative research ethics training and capacity building initiatives B. Responsible Conduct of Research Education for NHGRI Researchers Per PHS Policy, facilitated mandatory DIR-wide discussion modules (2020: Data, Project and Lab Management, and Communication) with a total of 332 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. NIH-Wide Education, Consultation, and Service Finalizing a report from an NIH intramural working group to develop a consistent IRB policy regarding the return of genomic research results after receiving IRB and MEC approval. Currently working with the IRBO on implementation of the new policy, in consultation with stakeholders across the NIH IRP. Participated in and provide administrative support for EAWG-OSP Sub-Committee on Harmonizing NIH Informed Consent Language Options for Broad Data Sharing. Served on the NHGRI Genomic Data Sharing Policy Implementation Working Group. Participate on All of Us ELSI Brain Trust advisory group as a member of the planning team. Led facilitation of multiple consultations on topics relating to expanding enrollment minors and people who lack capacity. Served on the NIH embryonic stem cell administrative review committee. Serve as the bioethics representative on the OSMB for the extramural NHLBI Bassinet to Bedside research program. Participated as attending ethicists in Clinical Centers Ethics Consultation Service. Represented NHGRI on the Clinical Center/MEC Ethics Committee. Taught several sessions for the Department of Bioethics annual NIH-wide course on the Ethical and Regulatory Aspects of Clinical Research the First Year Fellows Bioethics Seminar. Led regular ethics sessions with the medical genetics fellows. D. Research and Evaluation Led program of research that focuses on a broad range of emerging ethical issues related to the conduct of genomic research o 2 book chapters & 19 papers published/accepted (since June 2020); 5 currently under review; 10 empirical and conceptual projects in active status o Research activities supported by both NHGRI and CC funded postbacs/postdocs Invited to collaborate on a variety of research projects on the intersections between research ethics, health disparities, priority setting, and pandemic-related issues II. CURRENT ISSUES AND RECENT CHANGES Although COVID-19 has significantly disrupted research and operations throughout the NIH, the NHGRI Bioethics Core has been able to be fully functional and productive via telework and use of virtual meeting technologies. The Core expects to be able to continue to provide the same levels of service to NHGRI DIR investigators in the upcoming year, whether remote or on campus. We also expect that COVID-19 will continue to influence the nature of the Bioethics Cores work substantially, both in terms of the nature of consultation and support of DIR investigators as well as the topics of our own research. Members of the Core have been participating in a wide range of research projects, NIH initiatives, and community conversations on antiracism, inclusion, and diversity, which are consistent with our overall mission to create a culture that promotes the ethical principles of equity and justice.