Cecily Zamora
The principle of informed consent was first publicly recorded in the 1957 case Salgo v Leland Stanford Jr University Board of Trustees. The plaintiff, Mr Martin Salgo, sued the university medical centre for lack of disclosure of the potential risk of a procedure that resulted in permanent paralysis of his lower limbs. While Salgo v Leland Stanford Jr University Board of Trustees was the first case to use the term informed consent, the principle of patient autonomy that underpins it was established in a series of four judicial decisions in the early 20th century, including Mohr v Williams and Pratt v Davis in 1905, and Rolater v Strain and Schloendorff v Society of New York Hospital.
| Characteristics | Values |
|---|---|
| Landmark Cases | Mohr v Williams, Pratt v Davis, Rolater v Strain, Schloendorff v Society of New York Hospital, Randall v. United States, Salgo v Leland Stanford Jr University Board of Trustees, Canterbury v Spence |
| Established | Legal precedent of patient autonomy, principle of "informed consent" |
| Basis | Requirement for informed consent in medicine and research |
| Patient's Right | To be informed of risks and benefits of procedures, alternatives, their role in treatment, and their right to refuse treatment |
| Physician's Responsibility | To obtain informed consent, disclose all pertinent information about risks and benefits, and ensure patient's consent is informed |
| Applicability | Beyond healthcare, e.g., research, disclosure of medical information, high-risk sports and recreational activities |
| Variations | Definitions and standards vary across states and jurisdictions |
| Exceptions | Patient's mental incompetence, medical emergencies, therapeutic privilege exception |
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The Nuremberg Code
The origin of the Nuremberg Code can be traced back to pre-World War II German politics, particularly during the 1930s and 1940s. Starting in the mid-1920s, German physicians, often proponents of racial hygiene, were accused of unethical medical practices by the public and the medical society. The trial's verdict, delivered on August 19, 1947, outlined six points that defined legitimate medical research. These original six points were revised into ten, and these ten points became the Nuremberg Code.
The Code represents the first explicit attempt to regulate the ethical conduct of research experiments with human subjects. It is considered a cornerstone of clinical research and bioethics, influencing numerous international ethics statements in the following decades. The Code outlines the need for voluntary consent, stating that "the voluntary consent of the human subject is absolutely essential". This marked a significant shift in the concept of informed consent, which had begun to emerge as a legal and regulatory concept following the investigation of Nazi war crimes at the end of World War II.
Despite its influence, the Nuremberg Code has not been officially accepted as law by any nation or as official ethics guidelines by any association. Its legal force remains unclear, and it has been criticized for lacking clarity and for its uncompromising language. However, it is still regarded as a landmark document in medical ethics, providing a framework for research on human subjects and influencing global human rights.
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Patient autonomy
The principle of patient autonomy is a cornerstone of the concept of informed consent. Patient autonomy refers to the right of individuals to make decisions about their own bodies and medical treatments, without undue influence from medical professionals or other authorities. This principle has been established and solidified through several landmark legal cases, primarily involving female plaintiffs, in the early 20th century.
One of the earliest cases that laid the foundation for patient autonomy was Mohr v Williams in 1905. Subsequently, Rolater v Strain and Schloendorff v Society of New York Hospital further established and solidified the principle. These cases recognised the importance of patients' consent and their right to be informed about the risks and alternatives of medical procedures.
The concept of informed consent gained prominence in the context of assault and battery in civil tort procedures. In the past, physicians have been found guilty of assault and battery when they failed to obtain consent from patients before performing medical procedures. The evolution of informed consent law has shifted the legal analysis from an allegation of battery to one of negligence. Courts now characterise the lack of informed consent as negligence on the part of the physician to disclose necessary information to patients.
The case of Randall v. United States explored the extent of physicians' responsibility to inform patients of the risks of medical procedures. The court found that physicians have a duty to fully disclose the risks associated with the procedures, allowing patients to make informed decisions based on their own values and goals. The Canterbury case further emphasised that physicians need only disclose information that a reasonable person would find necessary when making an informed decision.
The evolution of the concept of informed consent has been intertwined with the right of women to consent to procedures on their own bodies. Notably, the 1957 case of Salgo v Leland Stanford Jr University Board of Trustees publicly recorded the term "informed consent" for the first time. Mr Martin Salgo, the plaintiff, sued the university medical centre for lack of disclosure of the potential risk of paralysis from a translumbar procedure.
Informed consent is now recognised as an ethical and legal principle in medicine and research. It is codified in both national and international law, with physicians having a mandatory obligation to understand and uphold the informed consent process. While obtaining informed consent is crucial, there are exceptions. For example, if an individual is deemed unable to provide consent due to incompetence or mental illness, another person may be authorised to consent on their behalf. Additionally, in emergency situations, the doctrine of implied consent permits treatment without explicit consent to prevent harm or death.
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Competency to consent
The ability to give informed consent is governed by a general requirement of competency. In common law jurisdictions, adults are presumed competent to consent. This presumption can be rebutted in circumstances of mental illness or other incompetence. This may be prescribed in legislation or based on a common-law standard of inability to understand the nature of the procedure.
In cases of incompetent adults, a health care proxy makes medical decisions. In the absence of a proxy, the medical practitioner is expected to act in the patient's best interests until a proxy can be found. In some jurisdictions, this is a strict standard. For example, in much of the US, minors are generally presumed incompetent to consent, but depending on their age and other factors, they may be required to provide informed assent.
Children who are legally emancipated, and in certain situations, such as decisions regarding sexually transmitted diseases or pregnancy, or for unemancipated minors who are deemed to have medical decision-making capacity, may be able to provide consent without the need for parental permission depending on the laws of the jurisdiction the child lives in. The American Academy of Pediatrics encourages medical professionals to seek the assent of older children and adolescents by providing age-appropriate information to help empower them in the decision-making process.
Informed consent is an applied ethics principle that a person must have sufficient information and understanding before making decisions about accepting risk. Pertinent information may include the risks and benefits of treatments, alternative treatments, the patient's role in treatment, and their right to refuse treatment. In most systems, healthcare providers have a legal and ethical responsibility to ensure that a patient's consent is informed.
The concept of informed consent has evolved significantly with regard to both the practice of medicine and research conducted with human volunteers. The principle of "informed consent" remained nameless and not legally binding until the term was first publicly recorded in the court documents for the 1957 case Salgo v Leland Stanford Jr University Board of Trustees. The plaintiff in the case, Mr Martin Salgo, had arteriosclerosis of the aorta and underwent a translumbar procedure to evaluate its extent. During the procedure, a contrast agent was injected into his aorta to identify blockages, which resulted in permanent paralysis of his lower limbs. Mr Salgo sued the university medical center and its chief surgeon for a lack of disclosure of this potential risk.
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Parental consent
Informed consent is a legal term that means a person is aware of the facts of a situation (such as a surgical procedure) and the risks involved before agreeing to it. The concept of informed consent has evolved significantly with regard to both the practice of medicine and research conducted with human volunteers. The principle of "informed consent" remained nameless and not legally binding until the term was first publicly recorded in the court documents for the 1957 case Salgo v. Leland Stanford Jr. University Board of Trustees.
Physicians and medical researchers have a moral and legal obligation to obtain parental consent for pediatric patients. Parental consent improves the relationship between healthcare providers and caregivers, establishing a trusting dialogue and a positive physician-patient relationship. It is essential for medical evaluation, treatment, and research involving children. In some situations, parental consent may not be required, especially in emergency conditions where the child's life is in imminent danger and the parents are unavailable.
In the context of research, seeking informed consent from both children and their parents or caregivers is central to an ethical approach that respects children's rights. Children must have an understanding of the research and their participation in it, and their consent must be given voluntarily and without coercion. It is important to note that children's understanding of research and their willingness to participate may evolve as the study progresses, and they should have the right to withdraw their consent at any stage.
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Negligence
Informed consent is an ethical principle that requires individuals to have sufficient information and understanding to make decisions about accepting risks. This principle is particularly important in healthcare, where it is both a legal and ethical responsibility for healthcare providers to ensure that a patient's consent is informed.
The evolution of informed consent in law has been relatively recent, with its roots in the early 20th century. A series of four judicial decisions laid the foundation for the principle of patient autonomy, with the first two cases being Mohr v Williams and Pratt v Davis in 1905. Two subsequent cases, Rolater v Strain and Schloendorff v Society of New York Hospital, further solidified the concept of patient autonomy, forming the basis for the requirement of informed consent in medicine and research.
While these early cases established the legal framework for informed consent, the term itself was first publicly recorded in the 1957 case Salgo v Leland Stanford Jr University Board of Trustees. In this case, the plaintiff, Mr Martin Salgo, underwent a translumbar procedure during which a contrast agent was injected into his aorta to identify blockages. The procedure resulted in permanent paralysis of his lower limbs, and Mr Salgo sued the university medical centre for failing to disclose this risk.
The evolution of informed consent continued with the case of Randall v United States, which explored the extent to which patients must be informed about their medical condition, treatment options, and the risks associated with medical procedures. The court found that physicians have an obligation to fully inform patients of the risks, enabling patients to weigh these risks in light of their own values and goals.
The legal analysis of medical informed consent has evolved from an allegation of battery to an allegation of negligence. Currently, the courts characterise the lack of informed consent as a matter of negligence on the part of the physician to disclose necessary information to patients. Negligence in this context requires the establishment of four elements for the liability of the physician-defendant:
- A duty of the physician to meet a particular standard of care;
- A breach of that duty;
- An injury caused by the breach; and
- Damages resulting from the injury.
Physicians have a duty to disclose all pertinent information about the risks and benefits of the procedure, as well as the risks of alternative treatments, to enable patients to make knowledgeable decisions. This duty is not absolute, and there are situations where nondisclosure may be excused, such as medical emergencies, the patient's mental incompetence, or when disclosure would adversely affect the patient's condition or recovery.
Informed consent is now codified in both national and international law, and it is essential for protecting patients' rights and ensuring that they are the final decision-makers regarding their own bodies and medical procedures.
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Frequently asked questions
Informed consent is an applied ethics principle that a person must have sufficient information and understanding before making decisions about accepting risk. This includes information about the risks and benefits of treatments, alternative treatments, the patient's role in treatment, and their right to refuse treatment.
The principle of "informed consent" became legally binding in 1957 with the case Salgo v Leland Stanford Jr. University Board of Trustees. The plaintiff, Mr. Martin Salgo, sued the university medical center and its chief surgeon for lack of disclosure about the risks of the procedure.
Some other important cases include Randall v. United States, Mohr v. Williams, Pratt v. Davis, Rolater v. Strain, and Schloendorff v. Society of New York Hospital.
The concept of informed consent emerged after World War II during the investigation of Nazi war crimes. The Nuremberg Code, set forth by an international tribunal, established 10 basic rules for the conduct of human experiments.
