• We are sorry, but NCBI web applications do not support your browser and may not function properly. More information
Logo of jmedethJournal of Medical EthicsCurrent TOCInstructions to authors
J Med Ethics. Feb 2001; 27(1): 40–43.
PMCID: PMC1733339

When is surgery research? Towards an operational definition of human research

Abstract

The distinction between clinical practice and surgical research may seem trivial, but this distinction can become a complex issue when innovative surgeries are substituted for standard care without patient knowledge. Neither the novelty nor the risk of a new surgical procedure adequately defines surgical research. Some institutions tacitly allow the use of new surgical procedures in series of patients without informing individuals that they are participating in a scientific study, as long as no written protocol or hypothesis exists. Institutions can justify this practice by viewing human research in narrow terms as an activity outlined in a formal protocol. Application of limited definitions, however, erodes patients' rights and risks losing public confidence in how biomedical research is conducted. I propose an operational definition of human research also be recognised. Enforcing more rigid and less ambiguous guidelines of human research may curtail enrolment into some studies, but it will also protect patients from being used as subjects without their knowledge.

Key Words: Experimental surgery • innovative surgery • medical ethics • surgical research

Full Text

The Full Text of this article is available as a PDF (70K).

Selected References

These references are in PubMed. This may not be the complete list of references from this article.
  • Ellis GB. Keeping research subjects out of harm's way. JAMA. 1999 Nov 24;282(20):1963–1965. [PubMed]
  • Lyon J. Experimenting with humans. Part 2: Innovation or exploitation? Second Opin. 1988;(8):10–42. [PubMed]
  • Dossetor JB. Innovative treatment versus clinical research: an ethics issue in transplantation. Transplant Proc. 1990 Jun;22(3):966–968. [PubMed]
  • Ward CM. Surgical research, experimentation and innovation. Br J Plast Surg. 1994 Mar;47(2):90–94. [PubMed]
  • Love JW. Drugs and operations. Some important differences. JAMA. 1975 Apr 7;232(1):37–38. [PubMed]
  • Spodick DH. Numerators without denominators. There is no FDA for the surgeon. JAMA. 1975 Apr 7;232(1):35–36. [PubMed]
  • Bonchek LI. Sounding board. Are randomized trials appropriate for evaluating new operations? N Engl J Med. 1979 Jul 5;301(1):44–45. [PubMed]
  • Bunker JP, Hinkley D, McDermott WV. Surgical innovation and its evaluation. Science. 1978 May 26;200(4344):937–941. [PubMed]
  • Waring GO., 3rd A cautionary tale of innovation in refractive surgery. Arch Ophthalmol. 1999 Aug;117(8):1069–1073. [PubMed]
  • Bulger RE. Toward a statement of the principles underlying responsible conduct in biomedical research. Acad Med. 1994 Feb;69(2):102–107. [PubMed]
  • Woodward B. Challenges to human subject protections in US medical research. JAMA. 1999 Nov 24;282(20):1947–1952. [PubMed]

Articles from Journal of Medical Ethics are provided here courtesy of BMJ Group

Formats:

Related citations in PubMed

See reviews...See all...

Cited by other articles in PMC

See all...

Links

  • PubMed
    PubMed
    PubMed citations for these articles

Recent Activity

Your browsing activity is empty.

Activity recording is turned off.

Turn recording back on

See more...