NHGRI/DIR Bioethics Core

National Human Genome Research Institute

Investigators

Linked publications, trials & patents

Abstract

I. I. SUMMARY OF BIOETHICS CORE PROJECTS, 6/1/21 5/31/22 A. Ethics of Human Subjects Research/NIH Intramural Institutional Review Board IRB Navigation and Support Supported a total of 76 NHGRI intramural IRB-reviewed protocols in various stages of implementation, excluding 27 that were determined to be exempt from IRB review and ten that were determined not to involve human subjects. Three new protocols were approved with a remaining five still under review/draft. A total of ten 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 eight new protocols and six quadrennial reviews. Capacity Building for Research Ethics Oversight Renewed MOU with NIH Tribal Health Research Office (THRO) for a two-year part time detail to focus on the development of policies, procedures, and training mechanisms to enhance the ethical conduct of Tribal research. Expanded existing partnership with Public Responsibility in Medicine & Research (PRIM&R) 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 (2021: Science Under Pressure) with a total of 354 intramural researchers and staff. Particular efforts were successfully made this year to ensure maximal participation of trainees; NHGRI was commended by the Agency Intramural Research Integrity Officer (AIRIO) for achieving 93% trainee compliance. 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-lead for NHGRI Racial and Ethnic Equity Plan (REEP) Working Group. Finalized report from an NIH intramural working group to develop a comprehensive IRB guidance regarding the return of genomic research results after receiving IRB and Medical Executive Committee (MEC) approval. Currently working with the IRB Office on implementation of the new guidance, in consultation with stakeholders 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. Participated and continue to participate on All of Us ELSI Brain Trust advisory group as a member of the planning team. o 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. o One book chapter & 16 papers published/accepted (since June 2020); 13 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 disrupted operations across NIH, the NHGRI Bioethics Core has been able to be 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, both remote and on campus. We also 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. Core staff 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. With the retirement of Victoria Willits at the end of 2021, we were successful at reassigning tasks to ensure continuous staff coverage of all key roles that are critical to the Cores functioning. Nancy Mickey is providing administrative support for purchasing, travel, and training logistics; while Brenton Yanos has assumed responsibility for the management of the SRC.