NHGRI/DIR Bioethics Core

National Human Genome Research Institute

Investigators

Linked publications, trials & patents

Abstract

SUMMARY OF BIOETHICS CORE PROJECTS I. IRB Navigation and Support • Supported NHGRI intramural IRB-reviewed protocols in various stages of implementation, excluding protocols exempt from IRB review and those that were determined not to involve human subjects. New protocols underwent Office of the Clinical Director (OCD) concept clearance and were approved by the IRB. • Provided leadership (chairing meetings; participating in bi-weekly IRB leadership meetings; serving on policy working groups) to the NIH Intramural IRB. • Worked closely with the NHGRI Technology Transfer Office to advise on the appropriateness of 93 material transfer agreements (MTAs) and information transfer agreements (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 training for NHGRI investigators engaged in IRB-reviewed 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. • Assisted investigators in understanding new and revised protocol-related policies and procedures, the most relevant of which regard recruitment practices, reportable events, regulatory protections for vulnerable populations, investigator responsibilities, human subjects research training, ancillary reviews, new IRBO templates for IRB-related actions, and IRB submission requirements. • Provided significant and systematic pre-review of initial protocol submissions, modifications, and continuing reviews to address substantive issues prior to formal IRB submission; worked with study team members on the writing/editing of clinical research protocols and informed consent forms, ensuring complete submission packets for IRB review and approval, good clinical practice guidelines, and proper study management techniques. • Assisted new investigators in learning protocol management tracking system, PROTECT. • Coordinated Scientific Review Committee (SRC) review for new protocols and quadrennial reviews, as well as annual SRC reviews for all open NHGRI protocols. • Managed offboarding for clinical protocol clearance of NHGRI employees. • Served as NHGRI liaison to NIH Office of Research Support and Compliance (ORSC) Protocol Navigator group and Office for Human Subjects Research Protections (OHSRP) PROTECT IT support. II. Implementation of NIH Data Management and Sharing (DMS) Policy • Served on NHGRI DMS Governance Committee (previously referred to as the Genomic Data Sharing Governance Committee) o Worked with committee to clarify and streamline the DMS Plan approval and Institutional Certification processes within the Office of the Scientific Director. o As delegated by the NIH Intramural IRB in 2020, consulted on appropriateness of all types of human data being submitted to repositories, as well as secondary uses of those data, based on consistency with NIH DMS policy and the consent of the original study participants, as applicable. o Supported determinations regarding whether proposed access to genomic summary results (GSR) is appropriate or not for specific studies. o Served on NIH Data Management and Sharing Expert Panel, which is charged with assisting ICs with assessment of especially challenging scenarios related to interpretation and application of the DMS Policy. III. “Responsible Conduct of Research” Education for NHGRI Researchers • Per PHS Policy, facilitated mandatory DIR-wide discussion modules with intramural researchers and staff. Particular efforts were made this year to continue ensuring maximal participation of trainees. o 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. IV. Other IC- and NIH-Wide Education, Consultation, and Service • Participated on All of Us ELSI Brain Trust advisory group as a standing member of the planning team. o Led facilitation of multiple consultations on topics such as reconsent when pediatric subjects become adults, and expanding enrollment to include minors and people who lack capacity. • Served as the bioethics representative on the Observational Safety Monitoring Board (OSMB) for the extramural NHLBI Bassinet to Bedside research program. • Participated as attending ethicist on Clinical Center’s 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 ethics case discussions with the medical genetics fellows. V. Capacity Building for Research Ethics Oversight • Expanded existing Tribal Research Ethics Capacity-building Consortium (TRECC) partnership with NHGRI Training, Diversity, and Health Equity (TiDHE) Office, NIH Tribal Health Research Office (THRO), Indian Health Service, and Public Responsibility in Medicine & Research (PRIM&R) to strengthen collaborative research ethics training and capacity. • Served on NIH Tribal Health Research Coordinating Committee (THRCC) subcommittee to develop an Indigenous Data Sovereignty Policy; served on a working group of the NIH IRB and THRO to develop a new policy for the ethical review of Tribal research. • Consulted with Intramural investigators about appropriate engagement with various global Indigenous communities prior to initiating genomic research protocols. VI. Research and Evaluation • Led program of research focusing on a broad range of emerging ethical issues related to the conduct of genomic research. o 9 manuscripts published/accepted (since June 2024); 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 regarding the intersections between research ethics, population descriptors, health disparities, public engagement, priority setting, and pandemic-related issues.