title: Research ethics consultation: ethical and professional practice challenges and recommendations.
abstract: The complexity of biomedical research has increased considerably in the last decade, as has the pace of translational research. This complexity has generated a number of novel ethical issues for clinical investigators, institutional review boards (IRBs), and other oversight committees. In response, many academic medical centers have created formal research ethics consultation (REC) services to help clinical investigators and IRBs navigate ethical issues in biomedical research. Key functions of a REC service include assisting with research design and implementation, providing a forum for deliberative exploration of ethical issues, and supplementing regulatory oversight. As increasing numbers of academic research institutions establish REC services, there is a pressing need for consensus about the primary aims and policies that should guide these activities. Establishing clear expectations about the aims and policies of REC services is important if REC programs are to achieve their full potential. Drawing on the experiences of a Clinical and Translational Science Award Research Ethics Consultation Working Group, this article describes three major ethical and professional practice challenges associated with the provision of REC: (1) managing multiple institutional roles and responsibilities, (2) managing sensitive information, and (3) communicating with consultation requestors about how these issues are managed. The paper also presents several practical strategies for addressing these challenges and enhancing the quality of REC services.
authors.affiliation: R.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.
authors.forename: Richard R
authors.initials: RR
authors.lastname: Sharp
authors.forename: Holly A
authors.initials: HA
authors.lastname: Taylor
authors.forename: Margaret A
authors.initials: MA
authors.lastname: Brinich
authors.forename: Mary M
authors.initials: MM
authors.lastname: Boyle
authors.forename: Mildred
authors.initials: M
authors.lastname: Cho
authors.forename: Marilyn
authors.initials: M
authors.lastname: Coors
authors.forename: Marion
authors.initials: M
authors.lastname: Danis
authors.forename: Molly
authors.initials: M
authors.lastname: Havard
authors.forename: David
authors.initials: D
authors.lastname: Magnus
authors.forename: Benjamin
authors.initials: B
authors.lastname: Wilfond
mesh_terms: D000046:Academic Medical Centers / Q000941:ethics; D035843:Biomedical Research / Q000941:ethics*; D003219:Confidentiality / Q000941:ethics*; D033061:Ethics Consultation / Q000941:ethics*; D032984:Ethics, Research; D006801:Humans; D009014:Morals; D011364:Professional Practice / Q000941:ethics*; D012108:Research Personnel / Q000941:ethics*; D057170:Translational Research, Biomedical