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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


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

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Selected References

These references are in PubMed. This may not be the complete list of references from this article.
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Articles from Journal of Medical Ethics are provided here courtesy of BMJ Group


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