Skip to main content
SpringerLink
Log in

Ethics of Clinical Trials

  • Chapter
  • First Online:
Success in Academic Surgery: Clinical Trials

Part of the book series: Success in Academic Surgery ((SIAS))

  • 1591 Accesses

Abstract

The ethical framework for clinical research is built upon guidelines and regulations that emerged as a result of numerous historical atrocities toward human subjects in the name of science such as the Nuremberg Trial, the Jewish Chronic Disease Hospital, the Willowbrook study, and the Tuskegee syphilis study. The fundamental pillars of research ethics are informed consent, beneficence, and justice, which are based on the Belmont Report. Clinical investigators have a responsibility to protect human subjects by upholding collaborative partnership, social value, scientific validity, fair participant selection, favorable risk-benefit ratio, independent review, informed consent, and respect for participants. In partnership with the subjects and their communities, through disclosure of conflicts of interest, and utilizing valid scientific methods, trust in and among the medical community can be strengthened and science can continue to advance.

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

Access this chapter

Log in via an institution
Chapter
USD 29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD 59.99
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

References

  1. Vollmann J, Winau R. Informed consent in human experimentation before the Nuremberg code. BMJ. 1996;313:1445–7.

    Article  PubMed  CAS  Google Scholar 

  2. Taylor T. Opening statement of the prosecution, December 9, 1946. In: Annas GJ, Grodin MA, editors. The Nazi doctors and Nuremberg Code: human rights in human experimentation. New York: Oxford University Press; 1992.

    Google Scholar 

  3. Department of Health and Human Services, National Institutes Health and Office for Human Research Protections. The Nuremberg Code. Available from: http://www.hhs.gov/ohrp/archive/nurcode.html. Updated 7 2005; Cited 13 Dec 2012.

  4. Ashcroft RE. The Declaration of Helsinki. In: Emanuel EJ, editor. The Oxford textbook of clinical research ethics. New York: Oxford University Press; 2008. p. 141–8.

    Google Scholar 

  5. Porter JP, Koski G. Regulations for the protection of humans in research in the United States: the common rule. In: Emanuel EJ, editor. The Oxford textbook of clinical research ethics. New York: Oxford University Press; 2008. p. 156–67.

    Google Scholar 

  6. Robinson WM, Unruh BT. The hepatitis experiments at the Willowbrook State School. In: Emanuel EJ, editor. The Oxford textbook of clinical research ethics. New York: Oxford University Press; 2008. p. 80–5.

    Google Scholar 

  7. Beecher HK. Ethics and clinical research. N Engl J Med. 1966;274(24):1354–60.

    Article  PubMed  CAS  Google Scholar 

  8. Beauchamp TL. The Belmont Report. In: Emanuel EJ, editor. The Oxford textbook of clinical research ethics. New York: Oxford University Press; 2008. p. 149–55.

    Google Scholar 

  9. Department of Health and Human Services, National Institutes Health and Office for Human Research Protections. Food and Drug Administration. Available from: http://www.hhs.gov/ohrp/humansubjects/fda/index.html. Cited 13 Dec 2012.

  10. Idanpaan-Heikkila JE, Fluss SS. International ethical guidance from the Council for International Organizations of Medical Sciences. In: Emanuel EJ, editor. The Oxford textbook of clinical research ethics. New York: Oxford University Press; 2008. p. 168–73.

    Google Scholar 

  11. Emanuel EJ, Wendler D, Grady C. An ethical framework for biomedical research. In: Emanuel EJ, editor. The Oxford textbook of clinical research ethics. New York: Oxford University Press; 2008. p. 123–35.

    Google Scholar 

  12. Department of Health and Human Services, National Institutes Health and Office for Human Research Protections. The Common Rule, Title 45 (Public Welfare), Code of Federal Regulations, Part 46 (Protection of Human Subjects). Available from: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html. Updated 15 Jan 2010; Cited 13 Dec 2012.

  13. Angelos P. The ethical challenges of surgical innovation for patient care. Lancet. 2010;376(9746):1046–7.

    Article  PubMed  Google Scholar 

  14. Brody BA, Ashton CM, Liu D, Xiong Y, Yao X, Wray NP. Are surgical trials with negative results being interpreted correctly? J Am Coll Surg. 2013;216(1):158–66.

    Article  PubMed  Google Scholar 

  15. Department of Health and Human Services, Office Human Research Protections. Protecting Human Research Subjects: Institutional Review Board Guidebook. Available from: http://www.hhs.gov/ohrp/archive/irb/irb_guidebook.htm. Updated 1993; Cited 13 Dec 2012.

  16. Fried C. Medical experimentation: personal integrity and social policy. New York: American Elsevier; 1974.

    Google Scholar 

  17. Joffe S, Truog RD. Equipoise and randomization. In: Emanuel EJ, editor. The Oxford textbook of clinical research ethics. New York: Oxford University Press; 2008. p. 245–60.

    Google Scholar 

  18. Miller FG. Recruiting research participants. In: Emanuel EJ, editor. The Oxford textbook of clinical research ethics. New York: Oxford University Press; 2008. p. 397–403.

    Google Scholar 

  19. Meltzer LA, Childress JF. What is fair participant selection? In: Emanuel EJ, editor. The Oxford textbook of clinical research ethics. New York: Oxford University Press; 2008. p. 377–85.

    Google Scholar 

  20. Agrawal M, Emanuel EJ. Phase I oncology research. In: Emanuel EJ, editor. The Oxford textbook of clinical research ethics. New York: Oxford University Press; 2008. p. 356–66.

    Google Scholar 

  21. Bowen AJ. Models of institutional review board function. In: Emanuel EJ, editor. The Oxford textbook of clinical research ethics. New York: Oxford University Press; 2008. p. 552–9.

    Google Scholar 

  22. Kant I. Groundwork for the metaphysics of morals (1785). New Haven: Yale University Press; 2002.

    Google Scholar 

  23. Capron AM. Legal and regulatory standards of informed consent in research. In: Emanuel EJ, editor. The Oxford textbook of clinical research ethics. New York: Oxford University Press; 2008. p. 613–32.

    Google Scholar 

  24. Wendler D. The assent requirement in pediatric research. In: Emanuel EJ, editor. The Oxford textbook of clinical research ethics. New York: Oxford University Press; 2008. p. 661–9.

    Google Scholar 

  25. Karlawish JHT. Emergency research. In: Emanuel EJ, editor. The Oxford textbook of clinical research ethics. New York: Oxford University Press; 2008. p. 280–9.

    Google Scholar 

  26. Lemmens T. Conflict of interest in medical research. In: Emanuel EJ, editor. The Oxford textbook of clinical research ethics. New York: Oxford University Press; 2008. p. 747–57.

    Google Scholar 

  27. Gelsinger PL. Uninformed consent: the case of Jesse gelsinger. In: Lemmens T, Waring DR, editors. Law and ethics in biomedical research: regulation, conflict of interest, and liability. Toronto: University of Toronto Press; 2006. p. 12–32.

    Google Scholar 

  28. Steinbrook R. The gelsinger case. In: Emanuel EJ, editor. The Oxford textbook of clinical research ethics. New York: Oxford University Press; 2008. p. 110–20.

    Google Scholar 

  29. Albert T, Wager E. How to handle authorship disputes: a guide for new researchers. In: White C, editor. The COPE report 2003: annual report of the Committee on Publication Ethics. London: Wiley; 2004. p. 32–4. Available from: http://publicationethics.org/files/u2/2003pdf12.pdf. Cited 18 Dec 2012.

  30. Kim SY, Millard RW, Nesbit P, Cox C, Caine ED. Potential research participants’ views regarding researcher and institutional financial conflicts of interest. J Med Ethics. 2004;30:73–9.

    Article  PubMed  CAS  Google Scholar 

  31. Angelos P, Murphy TF, Sampson H, Hollings DD, Kshettry V. Informed consent, capitation, and conflict of interest in clinical trials: views from the field. Surgery. 2006;140:740–8.

    Article  PubMed  Google Scholar 

  32. International Committee of Medical Journal Editors. Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Ethical Considerations in the Conduct and Reporting of Research: Authorship and Contributorship. 2005. Available from: http://www.icmje.org/ethical_1author.html. Cited 18 Dec 2012.

  33. Office of Science and Technology Policy, Executive Office of the President. Federal Policy on Research Misconduct; Preamble for Research Misconduct Policy; Notification of Final Policy. Fed Regist. 2000;65(235):76260–4.

    Google Scholar 

  34. Resnik DB. Fraud, fabrication, and falsification. In: Emanuel EJ, editor. The Oxford textbook of clinical research ethics. New York: Oxford University Press; 2008. p. 787–94.

    Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Department of Surgery and MacLean Center for Clinical Medical Ethics, University of Chicago, 5841 S. Maryland Avenue, MC 6040, Chicago, IL, 60637, USA

    Jukes P. Namm

  2. Department of Surgery and MacLean Center for Clinical Medical Ethics, University of Chicago, 5841 S. Maryland Avenue, MC 4052, Chicago, IL, 60637, USA

    Peter Angelos

Authors
  1. Jukes P. Namm
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Peter Angelos
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Peter Angelos .

Editor information

Editors and Affiliations

  1. Department of Surgery, Johns Hopkins, Baltimore, USA

    Timothy M. Pawlik

  2. Department of Surgery,, Duke University School of Medicine,, Durham, North Carolina, USA

    Julie A. Sosa

Rights and permissions

Reprints and permissions

Copyright information

© 2014 Springer-Verlag London

About this chapter

Cite this chapter

Namm, J.P., Angelos, P. (2014). Ethics of Clinical Trials. In: Pawlik, T., Sosa, J. (eds) Success in Academic Surgery: Clinical Trials. Success in Academic Surgery. Springer, London. https://doi.org/10.1007/978-1-4471-4679-7_13

Download citation

  • DOI: https://doi.org/10.1007/978-1-4471-4679-7_13

  • Published:

  • Publisher Name: Springer, London

  • Print ISBN: 978-1-4471-4678-0

  • Online ISBN: 978-1-4471-4679-7

  • eBook Packages: MedicineMedicine (R0)

Publish with us

Policies and ethics

Search

Navigation