Research ethics: Ethics and methods in surgical trials

Journal of Medical Ethics 35 (9):579-583 (2009)
  Copy   BIBTEX

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.

Other Versions

No versions found

Similar books and articles

A defense of surgical procedures regulation.Mattia Andreoletti & Federico Bina - 2022 - Theoretical Medicine and Bioethics 43 (2-3):155-168.

Analytics

Added to PP
2010-09-13

Downloads
330 (#74,427)

6 months
93 (#62,225)

Historical graph of downloads
How can I increase my downloads?

Author Profiles

Danielle M. Wenner
Carnegie Mellon University
Jacob Kolman
Rice University

References found in this work

No references found.

Add more references