NHGRI/DIR Bioethics Core

National Human Genome Research Institute

Investigators

Linked publications & trials

Abstract

I. SUMMARY OF BIOETHICS CORE PROJECTS, 6/1/22 - 7/31/23 A. Ethics of Human Subjects Research/NIH Intramural Institutional Review Board i. IRB Navigation and Support Supported a total of 91 NHGRI intramural IRB-reviewed protocols in various stages of implementation, excluding five protocols exempt from IRB review and two that were determined not to involve human subjects. Four new protocols were approved with a remaining three still under review/draft. A total of two 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 one 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 IRB-related submissions to the NHGRI Ethics Office to avoid/address investigator conflicts of interest. Tracked required human subjects research training across NHGRI investigators engaged in NIH IRB-reviewed human subjects research. Participated as the designated NHGRI contact for Association for the Accreditation of Human Research Protection Programs (AAHRPP) planning 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 Scientific Review Committee (SRC) review for four new protocols and five quadrennial reviews. ii. Capacity Building for Research Ethics Oversight Expanded Tribal Research Ethics Capacity-building Consortium (TRECC) efforts to develop collaborative research ethics training and capacity building initiatives related to respecting Tribal Sovereignty within the NIH Data Management and Sharing Policy and models of Tribal IRB review. B. Responsible Conduct of Research Education for NHGRI Researchers Per PHS Policy, facilitated mandatory DIR-wide discussion modules (2022: Use of Human Biospecimens and Informed Consent) with a total of 357 intramural researchers and staff. Particular efforts were made this year to continue ensuring maximal participation of trainees. 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. IC- and NIH-Wide Education, Consultation, and Service Served and continue to serve as team co-lead for NHGRI Racial and Ethnic Equity Plan (REEP) Working Group. Implemented comprehensive IRB guidance regarding the return of genomic research results, in consultation with IRB staff, members, and research teams across the NIH IRP. Served on the NHGRI Genomic Data Sharing Governance Committee; will continue to serve on Data Management and Sharing Committee that has been tapped to address NIH policies regarding a broader range of data types. Collaborated with and continue to collaborate with NHGRI Training, Diversity, and Health Equity (TiDHE) Office on a variety of initiatives to expand training opportunities for TCUs and Tribal IRBs. Participated and continue to 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 and continue to serve on the NIH embryonic stem cell administrative review committee. Served and continue to serve as the bioethics representative on the Observational Safety Monitoring Board (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. 9 papers published/accepted (since June 2022); 14 empirical and conceptual projects in active status. 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 disrupted operations across NIH, the NHGRI Bioethics Core has been able to be functional and productive in a hybrid work environment. We expect that COVID-19 will continue to shape the nature of the Bioethics Cores work to some extent, both in terms of responsive consultation and support of DIR investigators as well as the topics of our own research. With the reorganization of the Bioethics Core into the newly formed Office for Scientific Core Facilities, corresponding adjustments were made to ensure adequate program support for purchasing, travel, trainees, and other administrative functions.