PT  - JOURNAL ARTICLE
AU  - C M Ashton
AU  - N P Wray
AU  - A F Jarman
AU  - J M Kolman
AU  - D M Wenner
AU  - B A Brody
TI  - Ethics and methods in surgical trials
AID  - 10.1136/jme.2008.028175
DP  - 2009 Sep 01
TA  - Journal of Medical Ethics
PG  - 579--583
VI  - 35
IP  - 9
4099  - http://jme.bmj.com/content/35/9/579.short
4100  - http://jme.bmj.com/content/35/9/579.full
SO  - J Med Ethics2009 Sep 01; 35
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.