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Research ethics consultation: ethical and professional practice challenges and recommendations
Richard R Sharp1, Holly A Taylor, Margaret A Brinich
1R.R. Sharp is director, Biomedical Ethics Program, Mayo Clinic, Rochester, Minnesota. H.A. Taylor is associate professor, Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, and core faculty, Johns Hopkins Berman Institute of Bioethics, Baltimore, Maryland. M.A. Brinich is editor-in-chief, Lakewood Observer, Lakewood, Ohio. M.M. Boyle is clinical research coordinator, MDS/MPN Group, Transplantation Biology Department, Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington. M. Cho is professor, Stanford Department of Pediatrics, and associate director, Stanford Center for Biomedical Ethics, Stanford University, Stanford, California. M. Coors is associate professor, Department of Psychiatry, Center for Bioethics and Humanities, Anschutz Medical Campus, Aurora, Colorado. M. Danis is section head, Ethics and Health Policy, Department of Bioethics, National Institutes of Health Clinical Center, Bethesda, Maryland. M. Havard is a medical student, University of Cincinnati College of Medicine, Cincinnati, Ohio. D. Magnus is professor of medicine and biomedical ethics, professor of pediatrics, and director, Stanford Center for Biomedical Ethics, Stanford University, Stanford, California. B. Wilfond is director, Treuman Katz Center for Pediatric Bioethics, Seattle Children's Research Institute, and professor and chief, Division of Bioethics, Department of Pediatrics, University of Washington School of Medicine, Seattle, Washington.
Research ethics consultation (REC) services aid investigators and IRBs in navigating complex biomedical research ethics. This paper addresses challenges in REC, offering strategies to enhance service quality and ethical oversight.
Area of Science:
- Biomedical research ethics
- Translational research oversight
- Clinical investigation
Background:
- Biomedical research complexity and translational research pace have increased, creating novel ethical issues.
- Academic medical centers have established research ethics consultation (REC) services to address these challenges.
- REC services assist with research design, ethical deliberation, and regulatory oversight.
Purpose of the Study:
- To establish consensus on the primary aims and policies for REC services.
- To identify and address key ethical and professional practice challenges in REC.
- To present practical strategies for enhancing REC service quality.
Main Methods:
- Drawing on experiences from a Clinical and Translational Science Award Research Ethics Consultation Working Group.
- Identifying three major challenges: managing multiple institutional roles, handling sensitive information, and communication with requestors.
- Developing practical strategies to address identified challenges.
Main Results:
- Identified challenges in managing dual roles, protecting sensitive data, and effective communication.
- Proposed strategies to mitigate these challenges and improve REC service delivery.
- Highlighted the need for clear expectations regarding REC aims and policies.
Conclusions:
- Formalizing REC services requires clear aims and policies to maximize their potential.
- Addressing challenges in roles, information management, and communication is crucial for effective REC.
- Implementing practical strategies can enhance the quality and impact of REC services in biomedical research.
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