RT Journal Article SR Electronic T1 Ethics and methods in surgical trials JF Journal of Medical Ethics JO J Med Ethics FD BMJ Publishing Group Ltd and Institute of Medical Ethics SP 579 OP 583 DO 10.1136/jme.2008.028175 VO 35 IS 9 A1 C M Ashton A1 N P Wray A1 A F Jarman A1 J M Kolman A1 D M Wenner A1 B A Brody YR 2009 UL http://jme.bmj.com/content/35/9/579.abstract 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.