7.3.1 Research Ethics Review
Jonathan Kimmelman, PhD
- To understand the rationale for prior independent review of clinical research
- To gain some appreciation into the central issues considered by research ethics boards when they review protocols
Cephalosporins are routinely administered during surgery for the prevention of post-operative wound infections. Dr. Tong has long preferred the use of a first generation cephalosporin in his surgical practice, believing that this type is as effective for infection control, and more inexpensive, than a broad spectrum cephalosporin like ceftizoxime. Other medical centres are increasingly switching to the latter type, and Dr. Tong has occasionally used ceftizoxime himself. Noting the lack of solid evidence indicating the superiority of broader spectrum cephalosporins, Dr. Tong proposes a study in which his patients will be randomized to receive either ceftizoxime or a first generation cephalosporin — cefazolin. Dr. Tong proposes to evaluate patients for infection at regular time intervals during recovery and 30 days after discharge from the hospital. The assignment of patients will be masked, as will their outcome assessment.
Dr. Tong feels that the requirement for submission to a research ethics board is a bureaucratic annoyance and an infringement on his professional autonomy. The study involves a side-by-side evaluation of two routine medical practices. There are no plausible grounds for expecting that the safety or efficacy of either treatment arm will vary significantly or that infection control will depart from the standard of care. All patients entering this trial will get closer monitoring for wound infections than typical surgical patients.
- Why does Dr. Tong need permission to give a drug to half of his patients but does not permission when he wants to give it to all of his patients?
- Why must this study undergo independent review through a research ethics board?
- What general factors should a research ethics board consider in reviewing a research protocol like this?
- Given the level of risk for Dr. Tong's proposal and the fact that both antibiotics are in routine use for surgical procedures, couldn't a patient's enrolment in the study be considered to be authorized by his or her consent to receive care?
- How might clinicians decide when an activity requires independent review and when fully informed consent should be sought?
- Nuremberg code: directives for human experimentation. In: Trials of war criminals before the Nuremberg military tribunals under control council law. Vol. 2, No. 10. Washington, D.C.: U.S. Government Printing Office; 1949. pp. 181–2. Available from: https://www.loc.gov/rr/frd/Military_Law/pdf/NT_war-criminals_Vol-II.pdf
- Levine, RJ. Ethics and the Regulation of Clinical Research, second edition, New Haven,CT: Yale University Press (1988)
- King, NM, Churchill LR. Letter: Is informed consent always necessary for randomized, controlled trials? N Engl J Med 1999; 341(6): 449-50.
- Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council, Social Science and Humanities Research Council. Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans. Section 7: Clinical Trials. Ottawa: Public Works and Government Services Canada, 2005.
- Appelbaum PS, Roth LH, Lidz CW, Benson P, Winslade W. False hopes and best data: consent to research and the therapeutic misconception. Hastings Center Report 1987; 17(2): 20–4.
- Casarett D, Karlawish JH, Sugarman J. Determining when quality improvement initiatives should be considered research: proposed criteria and potential implications. JAMA: Journal of the American Medical Association 2000; 283(17): 2275–80.
- Emanuel EJ, Wendler D, Grady C. What makes clinical research ethical? JAMA: Journal of the American Medical Association 2000; 283(20): 2701–11.
- Kass NE, Sugarman J, Faden R, Schoch-Spana M. Trust, the fragile foundation of contemporary biomedical research. Hastings Center Report 1996; 26(5): 25–9.
- Moreno JD. Goodbye to all that. The end of moderate protectionism in human subjects research. Hastings Center Report 2001; 31(3): 9–17.