Ethical issues in surgical research

Canadian Journal of Surgery

Volumn 53, Issue 2, 2010, Pages 133-136

  McDonald, Patrick J ^a   Kulkarni, Abhaya V ^b   Farrokhyar, Forough ^c   Bhandari, Mohit ^c  

^a UNIVERSITY OF MANITOBA   (Canada)

^b UNIVERSITY OF TORONTO   (Canada)

^c MCMASTER UNIVERSITY   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 77950851181     PISSN: 0008428X     EISSN: 14882310     Source Type: Journal    
DOI: None     Document Type: Article

References (37)

1. Beecher HK. Surgery as placebo. A quantitative study of bias. JAMA 1961;176:1102-7.
2. Annas G, Grodin M, editors. The Nazi doctors and the Nuremberg Codes: human rights in human experimentation. New York (NY): Oxford University Press; 1995.
3. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. Available: www.wma.net/en/ 30publicauons/10policies/b3/index.html (accessed 2010 Jan. 26).
4. Beauchamp T, Childress J. Principles of biomedical ethics. New York (NY): Oxford University Press; 2001.
5. Failure of extracranial-intracranial arterial bypass to reduce the risk of ischemic stroke. Results of an international randomized trial. The EC/IC Bypass Study Group. N Engl J Med 1985;313:1191-200.
6. Cobb LA, Thomas GI, Dillard DH, et al. An evaluation of internal- mammary-artery ligation by a double-blind technic. N Engl J Med 1959;260:1115-8.
7. Moseley JB, O'Malley K, Petersen NJ, et al. A controlled trial of arthroscopic surgery for osteoarthritis of the knee. N Engl J Med 2002;347:81-8. (Pubitemid 34753477)
8. Beneficial effect of carotid endarterectomy in symptomatic patients with high-grade carotid stenosis. North American Symptomatic Carotid Endarterectomy Trial Collaborators. N Engl J Med 1991;325:445-53.
9. Solomon MJ, McLeod RS. Should we be performing more randomized controlled trials evaluating surgical operations? Surgery 1995;118:459-67.
10. McKneally MF. Ethical problems in surgery: innovation leading to unforeseen complications. World J Surg 1999;23:786-8.
11. Emanuel EJ, Wendler D, Grady C. What makes clinical research ethical? JAMA 2000;283:2701-11. (Pubitemid 30337334)
12. Freedman B. Equipoise and the ethics of clinical research. N Engl J Med 1987;317:141-5. (Pubitemid 17092151)
13. Weijer C, Shapiro SH, Cranley Glass K. For and against: clinical equipoise and not the uncertainty principle is the moral underpinning of the randomised controlled trial. BMJ 2000;321:756-8.
14. Miller FG. Ethical issues in surgical research. Thorac Surg Clin 2005; 15:543-54.
15. Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, Social Sciences and Humanities Research Council of Canada. Tri-Council Policy Statement: ethical conduct for research involving humans. Ottawa (ON); 1998 (with 2000, 2002 and 2005 amendments). Available: http://pre.ethics.gc.ca/eng/policy-politique/tcps-eptc/(accessed 2010 Jan. 23).
16. Bernstein M, Bampoe J. Surgical innovation or surgical evolution: an ethical and practical guide to handling novel neurosurgical procedures. J Neurosurg 2004;100:2-7. (Pubitemid 38017808)
17. Margo CE. When is surgery research? Towards an operational definition of human research. J Med Ethics 2001;27:40-3.
18. Burger I, Sugarman J, Goodman SN. Ethical issues in evidence- based surgery. Surg Clin North Am 2006;86:151-68. (Pubitemid 43143204)
19. Rohrich RJ. Ethical approval of clinical studies, informed consent, and the Declaration of Helsinki: what you need to know. Plast Reconstr Surg 2007;119:2307-9.
20. Stirrat GM. Ethics and evidence based surgery. J Med Ethics 2004; 30:160-5.
21. Freeman SR, Lundahl K, Schilling LM, et al. Human research review committee requirements in medical journals. Clin Invest Med 2008; 31:E49-54. (Pubitemid 351272180)
22. Amdur RJ, Biddle C. Institutional review board approval and publication of human research results. JAMA 1997;277:909-14. (Pubitemid 27123952)
23. Block MI, Khitin LM, Sade RM. Ethical process in human research published in thoracic surgery journals. Ann Thorac Surg 2006;82:6-11, discussion 11-2.
24. Reitsma AM, Moreno JD. Ethical regulations for innovative surgery: The last frontier? J Am Coll Surg 2002;194:792-801.
25. Kulkarni AV. The challenges of evidence-based medicine: a philosophical perspective. Med Health Care Philos 2005;8:255-60.
26. Wetterslev J, Thorlund K, Brok J, et al. Trial sequential analysis may establish when firm evidence is reached in cumulative meta-analysis. J Clin Epidemiol 2008;61:64-75. (Pubitemid 350245732)
27. Abelson R. Financial ties are cited as issue in spine study. The New York Times2008 Jan. 30; Sect A:1. Available: www.nytimes.com/2008/01/30/business/ 30spine.html (accessed 2010 Jan. 23).
28. Thompson DF. Understanding financial conflicts of interest. N Engl J Med 1993;329:573-6.
29. Zuckerman JD, Prasarn N, Kubiak EN, et al. Conflict of interest in orthopaedic research. J Bone Joint Surg Am 2004;86-A:423-8.
30. Okike K, Kocher MS, Mehlman CT, et al. Conflict of interest in orthopaedic research. An association between findings and funding in scientific presentations. J Bone Joint Surg Am 2007;89:608-13.
31. Bekelman JE, Li Y, Gross CP. Scope and impact of financial conflicts of interest in biomedical research: a systematic review. JAMA 2003; 289:454-65. (Pubitemid 36119966)
32. Weinfurt KP, Dinan MA, Allsbrook JS, et al. Policies of academic medical centers for disclosing financial conflicts of interest to potential research participants. Acad Med 2006;81:113-8.
33. Cooper RJ, Gupta M, Wilkes MS, et al. Conflict of interest disclosure policies and practices in peer-reviewed biomedical journals. J Gen Intern Med 2006;21:1248-52. (Pubitemid 44665332)
34. Freed CR, Greene PE, Breeze RE, et al. Transplantation of embyronic dopamine neurons for severe Parkinson's disease. N Engl J Med 2001; 344:710-9.
35. Miller FG. Sham surgery: an ethical analysis. Am J Bioeth 2003;3:41-8.
36. Horng S, Miller FG. Ethical framework for the use of sham procedures in clinical trials. Crit Care Med 2003;31(Suppl):S126-30. (Pubitemid 36379556)
37. Macklin R. The ethical problems with sham surgery in clinical research. N Engl J Med 1999;341:992-6. (Pubitemid 29441557)