Skip to main content

Ethical Principles in Surgical Research

  • Chapter
Principles and Practice of Research
  • 72 Accesses

Abstract

Research ethics is as integral a part of scientific judgment as clinical ethics is of clinical judgment (2). Many ethical issues in research arise from a failure to think as rigorously about the conditions for ethical consistency as about those for scientific validity. The ethical principles governing all surgical, clinical, and biomedical research with human subjects are fundamentally the same. They have been listed and discussed in numerous documents and countless publications over the past 40 years (3–10).

“The surgical act is just too powerful and too dangerous to be loosed on an unsuspecting public in the hands of a surgeon who uses only his cerebellum.” (1)

Judah Folkman, M.D.

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

Chapter
USD 29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD 74.99
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

References

  1. Folkman J. Surgical research: a contradiction in terms? J Surg Res 1984; 36: 298.

    Article  Google Scholar 

  2. Pellegrino ED. The anatomy of clinical judgments: some notes on right reason and right action. In: Engelhardt H, Tristram Jr., Spicker SF, Towers B. Editors. Clinical judgment: a critical appraisal. Dordrecht-London-Boston: D. Reidel Publishing Company, 1979: 169–195.

    Chapter  Google Scholar 

  3. Bankowski Z, Howard-Jones N. Human experimentation and medical ethics. Geneva: CIOMS, 1982.

    Google Scholar 

  4. Beecher HK. Research and the individual. Boston: Little, Brown and Company, 1970.

    Google Scholar 

  5. Freund PA, editor. Experimentation with human subjects. New York: George Braziller, 1970.

    Google Scholar 

  6. Gray BH. Human subjects in medical experimentation. New York-Toronto: John Wiley & Sons, 1975.

    Google Scholar 

  7. Katz J. Experimentation with human beings. New York: Rüssel Sage Foundation, 1972.

    Google Scholar 

  8. Levine R. Ethics and regulation of clinical research. Baltimore-Munich: Urban & Schwarzenberg, 1981.

    Google Scholar 

  9. Shapiro SH, Louis TA. Editors. Clinical trials. New York: Marcel Dekker, Inc., 1983.

    Google Scholar 

  10. WHO and CIOMS. Proposed international guidelines for biomedical research involving human subjects. Geneva: CIOMS 1982.

    Google Scholar 

  11. Sackett DL. Bias in analytic research. J Chron Dis 1979; 32: 60.

    Article  Google Scholar 

  12. Toulmin S. How medicine saved the life of ethics. Perspect Biol Med 1982; 25: 736–750.

    PubMed  Google Scholar 

  13. Fried C. Medical experimentation. Amsterdam, Oxford: North Holland Publishing Co., 1974; 151: 101–104.

    Google Scholar 

  14. Green FHK. Quoted by Jackson DM. Moral responsibility in clinical research. Lancet, 1958; 1:903. This reference comes from Feinstein AR. Clinical Biostatistics: XXVI. Medical ethics and the architecture of clinical research. Clin Pharmacol Ther, 1974; 15: 320.

    Google Scholar 

  15. Gilbert JP, McPeek B, Mosteller F. Statistics and ethics in surgery and anesthesia. Science 1977; 198: 684–689.

    Article  PubMed  CAS  Google Scholar 

  16. Silverman WA. The lesson of retrolental fibroplasia. Scientific American 1977; 236: 100–107.

    Article  PubMed  CAS  Google Scholar 

  17. Bernard C. An introduction to the study of experimental medicine. Translated by Greene HC. U.S.A.: Henry Schuman, Inc., 1949; 101: 1–261.

    Google Scholar 

  18. Engelhardt HT Jr. Bioethics in the Peoples Republic of China. Hast Cent Rpt 1980; 10: 8.

    Article  Google Scholar 

  19. The Nuremberg Code. Trials of war criminals before the Nuremberg military tribunals under control council law, no. 10, vol. 2 Washington, D.C.: U.S. Government Printing Office, 1949;181–182. Reprinted in Levine, Robert, Ethics and Regulation of Clinical Research, Appendix 3. (See reference 8 above); included as Appendix A in this textbook.

    Google Scholar 

  20. World Medical Association Declaration of Helsinki: Recommendations guiding medical doctors in biomedical research involving human subjects. Reprinted in Levine, Robert, Ethics and Regulation of Clinical Research, Appendix 4. (See reference 8 above).

    Google Scholar 

  21. Anderson WF, Fletcher JC. Gene therapy in human beings: when is it ethical to begin? N Engl J Med 1980; 303: 1293–1297.

    Article  PubMed  CAS  Google Scholar 

  22. Cline MJ, Mercola KE. The potential of inserting new genetic information. N Engl J Med 1980; 303: 1297–1300.

    Article  PubMed  Google Scholar 

  23. Editorial, Gene therapy: how ripe the time? Lancet 1981; 1: 196–197.

    Google Scholar 

  24. Grobstein C, Flower M. Gene therapy: proceed with caution. Hast Cent Rpt 1984; 14: 13–17.

    Article  CAS  Google Scholar 

  25. Wade N, UCLA. Gene therapy racked by friendly fire. Science 1980; 210: 509–511.

    Article  PubMed  CAS  Google Scholar 

  26. Rutstein DD. The ethical design of human experiments. In Freund. Paul A, editor. Experimentation with human subjects, 383–401. (See Reference 5 above.)

    Google Scholar 

  27. Sackett DL. The competing objectives of randomized trials. N Engl J Med 1980; 303: 1059–1060.

    Article  PubMed  CAS  Google Scholar 

  28. Frederickson DS. Welcoming remarks, national conferences in clinical trials methodology. Clin Pharmacol Ther 1979; 25: 630–631.

    Google Scholar 

  29. Zelen M. A new design for randomized clinical trials. N Engl J Med 1979; 300: 1242–1245.

    Article  PubMed  CAS  Google Scholar 

  30. Feinstein AR. An additional basic science for clinical medicine: I. the constraining fundamental paradigms. Ann Int Med 1983; 99: 393–397.

    CAS  Google Scholar 

  31. Feinstein AR. An additional basic science for clinical medicine: IV. the development of clini-metrics. Ann Int Med 1983; 99: 843–848.

    CAS  Google Scholar 

  32. Woodward FP. Informed consent of volunteers: a direct measurement of comprehension and retention of information. Clin Res 1979; 27: 248–252.

    PubMed  CAS  Google Scholar 

  33. Dickens BM. The modern law on informed consent. Modern Medicine of Canada 1982; 37: 706–710.

    Google Scholar 

  34. Reibl v. Hughes. 1980;2 S.C.R.:882.

    Google Scholar 

  35. Cancer research campaign working party on breast conservation, informed consent: ethical, legal, and medical implications for doctors and patients who participate in randomised clinical trials. Br Med J 1983;286:1117–1121.

    Google Scholar 

  36. Beecher HK. Ethics and clinical research. N Engl J Med 1966; 274: 1354–1360.

    Article  PubMed  CAS  Google Scholar 

  37. Jonsen AR. Do no harm. Ann Int Med 1978; 88: 827–832.

    CAS  Google Scholar 

  38. Feinstein AR. Clinical biostatistics: XLI. hard science, soft data, and the challenges of choosing clinical variables in research. Clin Pharmacol Ther 1977; 22: 485–498.

    PubMed  CAS  Google Scholar 

  39. Feinstein AR. Clinical biostatistics: XXVI. medical ethics and the architecture of clinical research. Clin Pharmacol Ther 1974; 15: 316–334.

    PubMed  CAS  Google Scholar 

  40. Dresser R. Book Reviews: Dodds WJ, Barbara F, Orlans, editors. 1982, Scientific perspectives on animal welfare, Academic Press. New York: 131 pp. J Med Philos 1984; 9: 423–425.

    Google Scholar 

  41. Naverson J. Animal rights. Can J Phil 1977; VII: 161–178.

    Google Scholar 

  42. Regan T, Singer P. Animal rights and human obligations. Englewood Cliffs: Prentice Hall, 1976.

    Google Scholar 

  43. Rowan AN, Rollin BE. Animal research—for and against: a philosophical, social, and historical perspective. Perspect Biol Med 1983; 27: 1–17.

    PubMed  CAS  Google Scholar 

  44. Singer P. Animal liberation. New York: Random House, 1975.

    Google Scholar 

  45. Mcintosh A. Animal rights and medical research. Future Health, Winter 1985: 10–11.

    Google Scholar 

  46. Editorial. Animal experiments. Br Med J 1982; 284: 368–369.

    Article  Google Scholar 

  47. Lane-Petter W. The place and importance of the experimental animal in research. Proceedings of the Royal Society of Medicine 1972; 65: 343–344.

    PubMed  CAS  Google Scholar 

  48. Russell JC, Secord DC. Holy dogs and the laboratory: some Canadian experiences with animal research. Perspect Biol Med 1985; 28: 374–381.

    PubMed  CAS  Google Scholar 

  49. Broncheck LI. Are randomized trials appropriate for evaluating new operations? N Engl J Med 1979; 301: 44–45.

    Article  Google Scholar 

  50. Chalmers TC. Randomized clinical trials in surgery. In Varco, RL, Delaney JP, editors. Controversy in surgery. Philadelphia: W.B. Saunders and Company, 1976: 3–11.

    Google Scholar 

  51. Feinstein AR. The scientific and clinical tribulations of randomized clinical trials. Clin Res 1978; 26: 241–244.

    Google Scholar 

  52. Haines SJ. Randomized clinical trials in the evaluation of surgical innovation. J Neurosurg 1979; 51: 5–11.

    Article  PubMed  CAS  Google Scholar 

  53. Loop FD. A surgeon’s view of randomized prospective studies. J Thorac Cariovasc Surg 1979; 78: 161–165.

    CAS  Google Scholar 

  54. Spodick DH. Randomized controlled clinical trials. The Behavioral Case. JAMA 1982; 247: 2258–2260.

    Article  PubMed  CAS  Google Scholar 

  55. Spodick DH et al. Standards for surgical trials. Ann Thorac Surg 1979; 27: 284.

    Article  PubMed  CAS  Google Scholar 

  56. Van der Linden W. On the generalization of surgical trials results. Acta Chir Scand 1980; 146: 229–234.

    PubMed  Google Scholar 

  57. Feinstein AR. An additional basic science for clinical medicine. II. The limitations of randomized trials. Ann Int Med 1983; 99: 544–550.

    PubMed  CAS  Google Scholar 

  58. Feinstein AR. An additional basic science for clincial medicine. III. The Challenges of comparison & measurements. Ann Int Med 1983; 99: 705–712.

    PubMed  CAS  Google Scholar 

  59. Fisher LD, Kennedy JW. Randomized surgical clinical trials for treatment of coronary artery disease. Controlled Clinical Trials 1982; 3: 235–258.

    Article  PubMed  CAS  Google Scholar 

  60. Merlo G. Surgical trial: possibilities and objections. Eur surg Res 1984; 16: 1–4.

    Article  PubMed  CAS  Google Scholar 

  61. Editorial, Blindness in surgical trials. Lancet 1980; 1: 1229–1230.

    Google Scholar 

  62. Van der Linden W. Pitfalls in randomized surgical trials. Surgery 1980; 87: 258–262.

    PubMed  Google Scholar 

  63. Moore FD. Perspectives, Surgery. Perspect Biol Med 1982; 25: 698–720.

    PubMed  CAS  Google Scholar 

  64. Dudley HAF. The controlled clinical trial and the advance of reliable knowledge: an outsider looks in. Br Med J 1983; 237: 957–960.

    Article  Google Scholar 

  65. Norman C. Clinical trial stirs legal battles. Science 1985; 227: 1316–1318.

    Article  PubMed  CAS  Google Scholar 

  66. Fyfe IM. The randomized clinical trial: panacea or placebo? Can Med Assoc J 1984; 131: 1336–1339.

    PubMed  CAS  Google Scholar 

  67. EC/IC Bypass Study Group. Failure of extracranial—intracranial arterial bypass to reduce the risk of ischemic stroke: results of an international randomized trial. N Engl J Med 1985; 313: 1191–1200.

    Article  Google Scholar 

  68. Spodick DH. Randomize the first patient: scientific, ethical, and behavioral bases. Am J Cardiol 1983; 51: 916–917.

    Article  PubMed  CAS  Google Scholar 

  69. Editorial. Managing severe head injury—doing more and faring worse? Lancet 1980, 1: 1229.

    Google Scholar 

  70. McKinlay JB. From promising report to standard procedure: seven stages in the career of a medical innovation. Milbank Mem 1981; 59: 374–411.

    Article  CAS  Google Scholar 

  71. Feilding LP, et al. Surgeon-related variables and the clinical trial. Lancet 1978; 11: 778–779.

    Article  Google Scholar 

  72. Hill Sir Austin Bradford. Medical ethics and controlled trials. Br Med J 1963; 1: 1043–1049.

    Article  Google Scholar 

  73. Eisenberg L. The social imperatives of medical research. Science 1977; 198: 1105–1110.

    Article  PubMed  CAS  Google Scholar 

  74. Angell M. Patients’ preferences in randomized clinical trials. N Engl J Med 1984; 310: 1385–1387.

    Article  PubMed  CAS  Google Scholar 

  75. Brewin TB. Consent to randomized treatment. Lancet 1982; 11: 919–921.

    Article  Google Scholar 

  76. Sade RM, Miller III, Clinton M. Letter. N Engl J Med 1983; 308: 344.

    Google Scholar 

  77. Dudley HAF. Informed consent in surgical trials. Br Med J 1984; 289: 937–938.

    Article  CAS  Google Scholar 

  78. Taylor K, Margolese RG, Soskolne CL. Physicians’ reasons for not entering eligible patients in a randomized clinical trial of adjuvant surgery for breast cancer. N Engl J Med 1984; 310: 1363–1367.

    Article  PubMed  CAS  Google Scholar 

  79. Editorial. Consent: how informed? Lancet 1984; 1: 1445–1447.

    Google Scholar 

  80. Ellenberg SS. Randomization designs in comparative clinical trials. N Engl J Med 1984; 310: 1404–1408.

    Article  PubMed  CAS  Google Scholar 

Download references

Authors

Editor information

Editors and Affiliations

Rights and permissions

Reprints and permissions

Copyright information

© 1986 Springer-Verlag New York Inc.

About this chapter

Cite this chapter

Roy, D.J., Black, P., McPeek, B. (1986). Ethical Principles in Surgical Research. In: Troidl, H., Spitzer, W.O., McPeek, B., Mulder, D.S., McKneally, M.F. (eds) Principles and Practice of Research. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-96942-3_14

Download citation

  • DOI: https://doi.org/10.1007/978-3-642-96942-3_14

  • Publisher Name: Springer, Berlin, Heidelberg

  • Print ISBN: 978-3-642-96944-7

  • Online ISBN: 978-3-642-96942-3

  • eBook Packages: Springer Book Archive

Publish with us

Policies and ethics