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BMJ 2003;327:731-734 (27 September), doi:10.1136/bmj.327.7417.731
Dennis J Mazur, professor of medicine1,2
1 Medical Service (P3-MED), Department of Veterans Affairs Medical Center, 3710 SW US Veterans Hospital Road, Portland, Oregon 97201, USA, 2 Oregon Health and Sciences University dennis.mazur@med.va.gov
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
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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.
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 Credit: KENNETH LAMBERT/AP
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