Education And Debate

Influence of the law on risk and informed consent

BMJ 2003; 327 doi: (Published 25 September 2003) Cite this as: BMJ 2003;327:731
  1. Dennis J Mazur, professor of medicine (
  1. 1Medical Service (P3-MED), Department of Veterans Affairs Medical Center, 3710 SW US Veterans Hospital Road, Portland, Oregon 97201, USA
  2. 2Oregon Health and Sciences University

    Patients are now routinely given information on risks of treatment as part of informed consent. This has occurred partly in response to legal judgments, but further issues continue to be raised by modern medicine and research that need to be approached proactively

    Obtaining informed consent is now a routine part of both clinical practice and research, but the focus on giving information about risk has evolved differently in each setting. Whereas the law has played a large part in determining how informed consent is handled in clinical practice, consent in clinical research has been codified in international regulations and is much more formalised. I describe the evolution of informed consent in clinical care and clinical research and discuss the aspects that are still controversial.

    Evolution of consent in clinical practice

    In clinical care, disclosure of risk developed from the obligation on doctors to obtain their patients' consent before intervening medically. In absence of emergency, doctors who acted without their patients' consent were initially accused of battery or intentional harm and later of negligence. Gradually the notion of consent evolved into informed consent, with the emphasis being on information about risks.

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    US Supreme Court


    The professional standard of consent to treatment has been espoused as a judicial concept since a British case in 1767.1 In that case the physician initially set the patient's femoral fracture in accordance with practice at the time but at a follow up visit rebroke the healing fracture and placed the rebroken bone in a mechanical device with teeth. Physicians called into court to testify reported that physicians usually secured their patients' consent before embarking on a medical intervention, but there was little said in the judge's written opinion about what should be said to patients before an experimental intervention, as opposed to a clinical intervention. The judge concluded that …

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