Ethical issues in surgical research

Thoracic Surgery Clinics

Volumn 15, Issue 4, 2005, Pages 543-554

  Miller, Franklin G ^a  

^a NATIONAL INSTITUTES OF HEALTH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANESTHETIC AGENT; ANTIBIOTIC AGENT; ANTINEOPLASTIC AGENT; CYCLOSPORIN; LOCAL ANESTHETIC AGENT; NARCOTIC AGENT; NEW DRUG; OPIATE; SEDATIVE AGENT; TRANQUILIZER;

ANGINA PECTORIS; ARTERY LIGATION; ARTHROSCOPIC SURGERY; ARTICLE; CANCER; CANCER CHEMOTHERAPY; CANCER RADIOTHERAPY; CLINICAL TRIAL; DOCTOR PATIENT RELATION; FETAL TISSUE TRANSPLANTATION; GRAFT REJECTION; HEALTH INSURANCE; HUMAN; INFECTION; INFORMED CONSENT; INTERNAL MAMMARY ARTERY; KNEE OSTEOARTHRITIS; LOW DRUG DOSE; MEDICAL CARE; MEDICAL ETHICS; MEDICAL RESEARCH; NONHUMAN; PARKINSON DISEASE; POSTOPERATIVE COMPLICATION; PRIORITY JOURNAL; QUALITY OF LIFE; RISK BENEFIT ANALYSIS; SIDE EFFECT; SURGICAL TECHNIQUE; WELLBEING;

EID: 25144496540     PISSN: 15474127     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.thorsurg.2005.06.008     Document Type: Review

References (55)

1. H.K. Beecher Surgery as placebo JAMA 176 1961 88 93
2. R. Horton Surgical research or comic opera: questions but few answers Lancet 347 1996 984
3. P. McCulloch, I. Taylor, and M. Sasako Randomized trials in surgery: problems and possible solutions BMJ 394 2002 1448 1451
4. R. Porter The greatest benefit to mankind 1998 WW Norton New York
5. L.A. Cobb, G.I. Thomas, and D.H. Dillard An evaluation of internal-mammary artery ligation by a double-blind technique N Engl J Med 260 1959 1115 1118
6. E.G. Dimond, C.G. Kittle, and J.E. Crockett Comparison of internal mammary artery ligation and sham operation for angina pectoris Am J Cardiol 5 1960 484 486
7. R.A. Deyo, and D.L. Patrick Hope or hype 2005 AMACOM Books New York
8. J.B. Moseley, K. O'Malley, and N.J. Petersen A controlled trial of arthroscopic surgery for osteoarthritis of the knee N Engl J Med 347 2002 81 88
9. B.K. van Staaij, E.H. van den Akker, and M.M. Rovers Effectiveness of adenotonsillectomy in children with mild symptoms of throat infection or adenotonsillar hypertrophy: open randomized trial BMJ 329 2004 651
10. G.M. Stirrat Ethics and evidence based surgery J Med Ethics 30 2004 160 165
11. J. Cassell Expected miracles: surgeons at work 1991 Temple University Press Philadelphia
12. R.S. McLeod Issues in surgical randomized controlled trials World J Surg 23 1999 1210 1214
13. A.M. Reitsma, and J.D. Moreno Surgical research: an elusive entity Am J Bioeth 3 2003 49 50
14. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research The Belmont Report 1979 US Government Printing Office Washington
15. C.E. Margo When is surgery research? Towards an operational definition of human research J Med Ethics 27 2001 40 43
16. A.M. Reitsma, and J.D. Moreno Ethical regulations for innovative surgery: the last frontier? J Am Coll Surg 194 2002 792 801
17. F.G. Miller, and D.L. Rosenstein The therapeutic orientation to clinical trials N Engl J Med 348 2003 1383 1386
18. Choosing a clinical trial. M.D. Anderson Cancer Center www.mdanderson.org Accessed March 14, 2003
19. P.S. Appelbaum, L.H. Roth, and C.W. Lidz False hopes and best data: consent to research and the therapeutic misconception Hastings Cent Rep 17 1987 20 24
20. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects JAMA 284 2000 3043 3045
21. B. Freedman Equipoise and the ethics of clinical research N Engl J Med 317 1987 141 145
22. B. Freedman, K.C. Glass, and C. Weijer Placebo orthodoxy in clinical research. II: Ethical, legal and regulatory myths J Law Med Ethics 24 1996 252 259
23. F.G. Miller, and H. Brody A critique of clinical equipoise: therapeutic misconception in the ethics of clinical trials Hastings Cent Rep 33 2003 19 28
24. F. Gifford The conflict between randomized clinical trials and the therapeutic obligation J Med Philos 11 1986 347 366
25. F.G. Miller, D.L. Rosenstein, and E.G. DeRenzo Professional integrity in clinical research JAMA 280 1998 1449 1454
26. E.J. Emanuel, D. Wendler, and C. Grady What makes research ethical? JAMA 283 2000 2701 2711
27. F.G. Miller Sham surgery: an ethical analysis Am J Bioeth 3 2003 41 48
28. J.E. Frader, and D.A. Caniano Research and innovation in surgery L.B. McCullough J.W. Jones B.A. Brody Surgical ethics 1998 Oxford University Press New York 216 241
29. P.A. Clark Placebo surgery for Parkinson's diseases: do the benefits outweigh the risks? J Law Med Ethics 30 2002 58 68
30. A.J. London, and J.B. Kadane Placebos that harm: sham surgery controls in clinical trials Stat Methods Med Res 11 2002 413 427
31. T.B. Freeman, D.E. Vawter, and P.E. Leaverton Use of placebo surgery in controlled trials of a cellular-based therapy for Parkinson's disease N Engl J Med 341 1999 988 991
32. R. Macklin The ethical problem with sham surgery in clinical research N Engl J Med 341 1999 992 996
33. W. Dekkers, and G.B. Boer Sham neurosurgery in patients with Parkinson's disease: is it morally acceptable? J Med Ethics 27 2001 151 156
34. G.R. Gillett Unnecessary holes in the head IRB 23 2001 1 6
35. C. Weijer I need a placebo like I need a hole in the head J Law Med Ethics 30 2002 69 72
36. R.L. Albin Sham surgery controls: intracerebral grafting of fetal tissue for Parkinson's disease and proposed criteria for use of sham surgery controls J Med Ethics 28 2002 322 325
37. Advisory Committee on Human Radiation Experiments Final report 1995 US Government Printing Office Washington
38. C.R. Freed, P.E. Greene, and R.E. Breeze Transplantation of embryonic dopamine neurons for severe Parkinson's disease N Engl J Med 344 2001 710 719
39. J.C. Fletcher Sham neurosurgery in Parkinson's disease: ethical at the time Am J Bioeth 3 2003 54 56
40. J.B. Moseley, N.P. Wray, and D. Kuykendall Arthroscopic treatment of osteoarthritis of the knee: a prospective, randomized, placebo-controlled trial. Results of a pilot study Am J Sports Med 24 1996 28 34
41. S. Horng, and F.G. Miller Is placebo surgery ethical? N Engl J Med 347 2002 137 139
42. A.A.M. Gerritsen, H.C.W. de Vet, and B.J.P.M. Scholten Splinting vs surgery in the treatment of carpal tunnel syndrome JAMA 288 2002 1245 1251
43. L. Lasagna The controlled clinical trial: theory and practice J Chronic Dis 1 1955 353 367
44. E. Ernst, and K.L. Resch Concept of true and perceived placebo effects BMJ 311 1995 551 553
45. A. Hrobjartsson, and P.C. Gotzsche Is the placebo powerless? N Engl J Med 344 2001 1594 1602
46. A.G. Johnson Surgery as a placebo Lancet 344 1994 1140 1142
47. T.J. Kaptchuk, P. Goldman, and D.A. Stone Do medical devices have enhanced placebo effects? J Clin Epidemiol 53 2000 786 792
48. D.E. Moerman, and W.B. Jonas Deconstructing the placebo effect and finding the meaning response Ann Intern Med 136 2002 471 476
49. Department of Health and Human Services. Protection of human subjects. 45 CFR §46 (1991)
50. L.G. Criscione, J. Sugarman, and L. Sanders Informed consent in a clinical trial of a novel treatment for rheumatoid arthritis Arthritis Rheum 49 2003 361 367
51. E. Kodish, M. Eder, and R.B. Noll Communication of randomization in childhood leukemia trials JAMA 291 2004 470 475
52. J. Flory, and E. Emanuel Interventions to improve research participants' understanding in informed consent for research: a systematic review JAMA 292 2004 1593 1601
53. F.G. Miller, and T.J. Kaptchuk Sham procedures and the ethics of clinical trials J R Soc Med 97 2004 576 578
54. D. Wendler, and F.G. Miller Deception in the pursuit of science Arch Intern Med 164 2004 597 600
55. S.D. Ramsey, and S.D. Sullivan Evidence, economics, and emphysema: Medicare's long journey with lung volume reduction surgery Health Aff (Millwood) 24 2005 55 65