by James Lyons-Weiler, PhD, Popular Rationalism, ©2024
(Jul. 11, 2024) — PUBLIC NOTICE: CONTRA FDA, The IPAK-EDU IRB, established this year, will require informed consent despite investigators’ appearances or opinions that the investigative procedures constitute “minimal risk.” We also call on all IRBs to hold investigators to appropriate standards regardless of FDA’s Congressionally approved and lawfully lax position.
The concept of informed consent in medical practice and research has evolved significantly over centuries, shaped by landmark legal cases, ethical codes, and regulatory policies.
Early Legal Precedents: Establishing the Need for Consent
The journey began in the 18th century with the case of Slater v. Baker and Stapleton (1767). Richard Slatter had fallen from his horse and broken his leg in several places. The leg healed ungracefully. In this case, surgeons performed a bone-setting procedure without the patient’s consent, leading to a ruling in favor of the patient.
According to Miller, “The defendant surgeons were accused in court of disuniting (rebreaking) the callus (the temporary bony tissue that connects fractured bones) in Slatter’s recently healed broken leg. The court concluded that, without Slatter’s consent, they had rebroken his leg and that their motivation was probably to use a new device on the leg that would have constituted an experiment in the eyes of the court. At trial, an unidentified woman witness described the device as a ‘heavy steel thing that had teeth.’ The court expressed the reasons for the requirement of consent in surprisingly modern terms – ‘indeed it is reasonable that a patient should be told what is about to be done to him, that he may take courage and put himself in such a situation as to enable him to undergo the operation…’” SLATER V. BAKER AND STAPLETON (C.B. 1767): UNPUBLISHED MONOGRAPHS BY ROBERT D. MILLER.
This case established an early precedent that medical practitioners must obtain consent before performing procedures, highlighting the importance of patient autonomy and laying the groundwork for future developments in informed consent.
The principle of informed consent was further reinforced in the early 20th century with Mohr v. Williams (1905) and Pratt v. Davis (1905). In Mohr v. Williams, a surgeon operated on the patient’s left ear instead of the right ear, as initially consented. The court found that the surgeon had violated the patient’s rights by performing an unauthorized procedure. Similarly, in Pratt v. Davis, a surgeon performed a hysterectomy without explicit consent from the patient; the procedure was an experimental treatment for her epilepsy. Both cases emphasized the necessity of obtaining specific consent for medical procedures, reinforcing the legal requirement for informed consent and patient autonomy.
The Introduction of Informed Consent: Salgo v. Leland Stanford Jr. University Board of Trustees (1957)
The legal doctrine of informed consent was formally introduced in Salgo v. Leland Stanford Jr. University Board of Trustees (1957). In this case, the patient suffered complications from a diagnostic procedure without being fully informed of the risks. The court’s ruling emphasized the necessity of informing patients about the risks involved in medical procedures, thus formally establishing the term “informed consent” in legal discourse. This landmark case underscored the importance of patient understanding and decision-making in medical practice.
Ethical Codes: Setting Standards for Human Research
The atrocities of World War II highlighted the need for ethical standards in medical research, leading to the development of the Nuremberg Code (1947). This code, formulated in response to the unethical medical experiments conducted during the war, laid down fundamental principles such as the voluntary consent of human subjects and the necessity to avoid unnecessary physical and mental suffering in experiments. The Nuremberg Code set the foundation for ethical standards in human experimentation and underscored the critical importance of voluntary consent.
Building on the principles of the Nuremberg Code, the Declaration of Helsinki (1964) was formulated by the World Medical Association to provide ethical guidelines for medical research involving human subjects. The Declaration emphasized respect for individuals and their right to make informed decisions, the necessity for research to be based on a thorough knowledge of scientific literature, and the requirement for research protocols to undergo review by an independent ethics committee. The Declaration of Helsinki set global standards for ethical principles in medical research, reinforcing the necessity of informed consent.
Addressing Ethical Breaches: The Tuskegee Syphilis Study and the Belmont Report
The infamous Tuskegee Syphilis Study (1932-1972), where untreated syphilis was studied in African American men without their informed consent, highlighted severe ethical breaches in research. The public outrage and ethical concerns arising from this study led to significant policy changes and increased oversight of research ethics. The study’s fallout profoundly influenced the development of modern moral standards, underscoring the critical importance of informed consent and protecting research participants.
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