The Legal History of Informed Consent
The Legal History of Informed Consent

Summary/Abstract: Human experiments during the national socialist and communist eras remind us that medical research involving human subjects should have legal limitations. Nowadays, in medical malpractice cases, instead of simple medical consent, the informed consent of the patient or a proxy is required to exculpate the health care provider sub judice. The origin of these types of medical consent is discussed with special regard to their development before and during the twentieth century. Simple medical consent appeared in England in the Slater v. Baker and Stapleton case of 1767. The legal history of medical consent dates back to at least the eighteenth century, although informed consent arose as late as in the Nuremberg Code and was literally called “informed consent” in the Salgo v. Leland Stanford Jr University Board of Trustees case of 1957 in the US. Despite the international rules of informed consent in effect in medical research involving human subjects and in health care provision, we still find countries with medico-legal cultures differing from Western norms. For example, the Confucian style of informed consent in China, involving the family’s role in granting or declining informed consent, sometimes collides with the expectations of the Food and Drug Administration in the US or those of the European Medicines Agency in the EU. Moving different medico-legal cultures closer to each other should be an important objective of both international lawmakers and national legislators.

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