Publish And Be Damned

A practical guide to informed consent to treatment

BMJ 2001; 323 doi: https://doi.org/10.1136/bmj.323.7327.1464 (Published 22 December 2001) Cite this as: BMJ 2001;323:1464
  1. Andrew D Oxman (andrew.oxman@labmed.uio.no), directora,
  2. Iain Chalmers, directorb,
  3. David L Sackett, directorc
  1. a Health Services Research Unit, National Institute of Public Health, Postboks 4404 Nydalen, 0403, Oslo, Norway
  2. b UK Cochrane Centre, Oxford OX2 6HE
  3. c Trout Research and Education Centre at Irish Lake, Markdale, ON, Canada N0C 1H0
  1. Correspondence to: A D Oxman
  • Accepted 1 November 2001

A year ago BMJ Publications released a 350 page tome that many people will regard as the last word on informed consent to treatment.1 What is missing from this otherwise comprehensive compendium is a practical guide for clinicians at the coalface. In an effort to overcome this deficit we have generated a menu of alternative styles of informed consent. The first five options relate to consent for treatment within randomised controlled trials, and the final six are options for use in routine clinical practice. We are confident that our menu will help frontline clinicians and patients in practice. It may also help medical ethicists in theory.

Summary points

Many alternative styles of informed consent to treatment exist, along with much theory, a few principles, and different standards of consent within and outside randomised trials, but concise practical advice about the available alternatives is not readily accessible

We have assembled a menu of options to help frontline clinicians and patients to select whichever form of consent meets their particular needs and circumstances

Consent to treatment within randomised controlled trials

Human sacrifice randomised controlled trial consent

“The research ethics committee that approved this trial on your behalf would like you to know that future generations might (or might not) appreciate it if you would put your life at risk by joining this trial. Although we will keep your individual trial results confidential (especially if they run contrary to our hypothesis) and you are free to insist on conventional treatment or withdraw at any time, let's face it—you are a human guinea pig. The investigators responsible for the study may have conducted a systematic review of relevant previous studies to see whether one of the alternative treatments has already been shown to be superior, but this sort of evidence is beyond the interest and competency of our local research ethics committee, which is primarily interested in protecting …

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