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Analogous to clinical ethics consultation, Research Ethics Consultation (REC) describes a formal way for researchers to solicit and receive expert ethical guidance related to biomedical research. The first REC service was at the National Institutes of Health (NIH) Clinical Center in 1997[1]. Today, most REC services are found at academic institutions, and the majority of current services were originally launched in response to the 2006 NIH Clinical and Translational Science Award program, as applicants to that program were required to have procedures in place to address ethical concerns raised by their research[2].
While still a young discipline with no explicit standards, individuals serving as research ethics consultants are expected to be familiar with research ethics and ethical analysis; knowledgeable about the applicable regulations, laws, and policies; and ideally also have some biomedical research experience and scientific expertise[3] .
REC is distinct from related services, such as those of Institutional Review Boards, in that it is typically available at any point during a study (planning, conducting, interpreting, or disseminating results), and can relate to any ethical question. While little is known about the range and distribution of topics put forth for REC, such services may be particularly important and useful for studies of known regulatory and ethical uncertainty (e.g. assessment of minimal risk in pediatric studies) and frontier research for which there is little if any regulation or expert consensus[4]. The recommendations that result from the consultation are non-binding, meaning that the researcher may choose to follow the recommendation, or to pursue a different approach.
Institutional REC Websites (United States):[edit]
Medical University of South Carolina
Mount Sinai School of Medicine
University of Arkansas for Medical Sciences
University of California Irvine
University of California San Diego
University of California San Francisco
University of Illinois, Chicago
or http://bioethics.unc.edu/consultation/ University of North Carolina at Chapel Hill
University of Rochester Medical Center
University of Southern California
University of Texas Medical Branch
University of Texas San Antonio
See also[edit]
- Institutional Review Board
- Ethics Committee (European Union)
- Human experimentation in the United States
- IRB: Ethics & Human Research
- Informed consent
- Data Monitoring Committees
- Office for human research protections
- Ethical problems using children in clinical trials
- National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
References[edit]
- ^ Emanuel, EJ (Dec 1998). "The blossoming of bioethics at NIH". Kennedy Inst Ethics J. 8 (4): 455–66. doi:10.1353/ken.1998.0030. PMID 11657322.
{{cite journal}}: CS1 maint: date and year (link) - ^ Danis, Marion (2012). Research Ethics Consultation: A Casebook. USA: Oxford University Press. ISBN 978-0199798032.
- ^ Cho, M. K.; Tobin, S. L.; Greely, H. T.; McCormick, J.; Boyce, A.; Magnus, D. (2008). "Strangers at the benchside: Research ethics consultation". Am J Bioeth. 8 (3): 4–13. doi:10.1080/15265160802132951. PMC 2585006. PMID 18570086.
{{cite journal}}: CS1 maint: date and year (link) - ^ Havard, M.; Cho, M. K.; Magnus, D. (2012). "Triggers for research ethics consultation". Sci Transl Med. 4 (118): 118cm1. doi:10.1126/scitranslmed.3002734. PMID 22277965.
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