Ethics and methods in surgical trials

Research output: Contribution to journalArticle

C. M. Ashton, N. P. Wray, A. F. Jarman, J. M. Kolman, D. M. Wenner, B. A. Brody

This paper focuses on invasive therapeutic procedures, defined as procedures requiring the introduction of hands, instruments, or devices into the body via incisions or punctures of the skin or mucous membranes performed with the intent of changing the natural history of a human disease or condition for the better. Ethical and methodological concerns have been expressed about studies designed to evaluate the effects of invasive therapeutic procedures. Can such studies meet the same standards demanded of those, for example, evaluating pharmaceutical agents? This paper describes a research project aimed at examining the interplay and sometimes apparent conflict between ethical standards for human research and standards for methodological rigor in trials of invasive procedures. The paper discusses how the authors plan to develop a set of consensus standards that, if met, would result in substantial and much-needed improvements in the methodological and ethical quality of such trials.

Original languageEnglish (US)
Pages (from-to)579-583
Number of pages5
JournalJournal of Medical Ethics
Volume35
Issue number9
DOIs
StatePublished - Sep 1 2009

PMID: 19717699

PMCID: PMC2736392

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Standard

Ethics and methods in surgical trials. / Ashton, C. M.; Wray, N. P.; Jarman, A. F.; Kolman, J. M.; Wenner, D. M.; Brody, B. A.

In: Journal of Medical Ethics, Vol. 35, No. 9, 01.09.2009, p. 579-583.

Research output: Contribution to journalArticle

Harvard

Ashton, CM, Wray, NP, Jarman, AF, Kolman, JM, Wenner, DM & Brody, BA 2009, 'Ethics and methods in surgical trials' Journal of Medical Ethics, vol. 35, no. 9, pp. 579-583. https://doi.org/10.1136/jme.2008.028175

APA

Ashton, C. M., Wray, N. P., Jarman, A. F., Kolman, J. M., Wenner, D. M., & Brody, B. A. (2009). Ethics and methods in surgical trials. Journal of Medical Ethics, 35(9), 579-583. https://doi.org/10.1136/jme.2008.028175

Vancouver

Ashton CM, Wray NP, Jarman AF, Kolman JM, Wenner DM, Brody BA. Ethics and methods in surgical trials. Journal of Medical Ethics. 2009 Sep 1;35(9):579-583. https://doi.org/10.1136/jme.2008.028175

Author

Ashton, C. M. ; Wray, N. P. ; Jarman, A. F. ; Kolman, J. M. ; Wenner, D. M. ; Brody, B. A. / Ethics and methods in surgical trials. In: Journal of Medical Ethics. 2009 ; Vol. 35, No. 9. pp. 579-583.

BibTeX

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title = "Ethics and methods in surgical trials",
abstract = "This paper focuses on invasive therapeutic procedures, defined as procedures requiring the introduction of hands, instruments, or devices into the body via incisions or punctures of the skin or mucous membranes performed with the intent of changing the natural history of a human disease or condition for the better. Ethical and methodological concerns have been expressed about studies designed to evaluate the effects of invasive therapeutic procedures. Can such studies meet the same standards demanded of those, for example, evaluating pharmaceutical agents? This paper describes a research project aimed at examining the interplay and sometimes apparent conflict between ethical standards for human research and standards for methodological rigor in trials of invasive procedures. The paper discusses how the authors plan to develop a set of consensus standards that, if met, would result in substantial and much-needed improvements in the methodological and ethical quality of such trials.",
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RIS

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T1 - Ethics and methods in surgical trials

AU - Ashton, C. M.

AU - Wray, N. P.

AU - Jarman, A. F.

AU - Kolman, J. M.

AU - Wenner, D. M.

AU - Brody, B. A.

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AB - This paper focuses on invasive therapeutic procedures, defined as procedures requiring the introduction of hands, instruments, or devices into the body via incisions or punctures of the skin or mucous membranes performed with the intent of changing the natural history of a human disease or condition for the better. Ethical and methodological concerns have been expressed about studies designed to evaluate the effects of invasive therapeutic procedures. Can such studies meet the same standards demanded of those, for example, evaluating pharmaceutical agents? This paper describes a research project aimed at examining the interplay and sometimes apparent conflict between ethical standards for human research and standards for methodological rigor in trials of invasive procedures. The paper discusses how the authors plan to develop a set of consensus standards that, if met, would result in substantial and much-needed improvements in the methodological and ethical quality of such trials.

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ID: 3403944