7.1 Legal and Ethical Foundations of Informed Consent
2 min read•july 24, 2024
has evolved from paternalistic medicine to patient . Key legal cases like Schloendorff and Canterbury shaped requirements for and patient understanding. This shift emphasizes shared decision-making and respect for patient rights in healthcare.
Ethical principles like autonomy and underpin informed consent practices. Professional organizations play a crucial role in setting standards and guidelines. These ensure healthcare providers obtain proper consent, balancing patient rights with medical expertise.
Historical and Legal Context
Historical development of informed consent
Top images from around the web for Historical development of informed consent
File:PARAMOUNT Eli Lilly Informed Consent Document.djvu - Wikimedia Commons View original
Is this image relevant?
Hippocratic Oath - wikidoc View original
Is this image relevant?
File:PARAMOUNT Eli Lilly Informed Consent Document.djvu - Wikimedia Commons View original
Is this image relevant?
Hippocratic Oath - wikidoc View original
Is this image relevant?
1 of 2
Top images from around the web for Historical development of informed consent
File:PARAMOUNT Eli Lilly Informed Consent Document.djvu - Wikimedia Commons View original
Is this image relevant?
Hippocratic Oath - wikidoc View original
Is this image relevant?
File:PARAMOUNT Eli Lilly Informed Consent Document.djvu - Wikimedia Commons View original
Is this image relevant?
Hippocratic Oath - wikidoc View original
Is this image relevant?
1 of 2
- Hippocratic Oath emphasized beneficence in ancient medical ethics
- Paternalistic approach dominated early 20th century medicine limited patient involvement in decisions
- Nuremberg Code (1947) established voluntary consent in human experimentation shifted mid-20th century practices
- Declaration of Helsinki (1964) outlined ethical principles for medical research furthered patient protections
- Patient autonomy movement late 20th century to present promoted shared decision-making model
- Medical education and practice incorporated informed consent principles improved patient-centered care
Legal cases for consent requirements
- (1914) established right to self-determination in medical treatment
- Salgo v. Leland Stanford Jr. University Board of Trustees (1957) introduced term "informed consent" into legal lexicon
- Natanson v. Kline (1960) defined physician's duty to disclose risks clarified legal obligations
- Canterbury v. Spence (1972) established "reasonable patient" standard for information disclosure
- Truman v. Thomas (1980) extended informed consent to include risks of refusing treatment broadened scope
Ethical and Professional Considerations
Ethical principles of informed consent
- Autonomy respects individual decision-making upholds right to refuse treatment (Do Not Resuscitate orders)
- Beneficence acts in patient's best interest balances with patient autonomy (recommending life-saving surgery)
- Non-maleficence avoids harm to patients requires disclosing potential risks and side effects (discussing chemotherapy side effects)
- Justice ensures fair distribution of healthcare resources promotes non-discriminatory practices (equal access to clinical trials)
- Veracity demands truthfulness in communication requires full disclosure of relevant information (explaining treatment success rates)
Professional organizations in consent practices
- American Medical Association provides Code of Medical Ethics guidelines offers continuing education on informed consent
- American Nurses Association outlines Nursing Code of Ethics provisions issues position statements on patient rights
- Joint Commission sets accreditation standards for healthcare organizations enforces patient-centered communication requirements
- American Hospital Association created Patient's Bill of Rights promotes best practices for obtaining informed consent
- Specialty medical societies develop discipline-specific guidelines (oncology, pediatrics) establish research ethics committees
Key Terms to Review (17)
American Medical Association (AMA) Code of Medical Ethics: The American Medical Association (AMA) Code of Medical Ethics is a comprehensive set of guidelines and principles established by the AMA to help physicians navigate ethical dilemmas in their practice. It emphasizes the importance of patient welfare, autonomy, and informed consent, providing a framework for ethical decision-making in medical care. This code is crucial for ensuring that healthcare professionals uphold high ethical standards, particularly in the context of patient interactions and treatment decisions.
Autonomy: Autonomy refers to the right of individuals to make informed, independent decisions about their own lives and healthcare. This principle is central to ethical and legal standards in healthcare, ensuring that patients have the freedom to choose their treatments based on their values, preferences, and understanding of their medical conditions.
Battery: Battery is the intentional and unlawful physical contact with another person that causes harm or offense. In the context of healthcare, it refers to any unauthorized touching of a patient, which can occur even if no injury results from the contact. Understanding battery is crucial for recognizing the boundaries of consent and the legal implications of medical interventions.
Beneficence: Beneficence is the ethical principle that obligates healthcare providers to act in the best interest of patients, promoting their well-being and preventing harm. It emphasizes actions that contribute positively to the health and welfare of individuals, and serves as a foundation for various aspects of healthcare practice and legal considerations.
Comprehension: Comprehension refers to the ability to understand and interpret information, especially in the context of receiving and processing complex data. It is crucial in the context of informed consent as it ensures that individuals can fully grasp the implications of medical procedures or treatments, enabling them to make informed decisions about their healthcare.
Disclosure: Disclosure refers to the process of providing necessary information to patients regarding their medical treatment, procedures, risks, and alternatives, which is essential for informed consent. It involves a clear and comprehensive communication of relevant details that enable patients to make knowledgeable decisions about their healthcare. Ensuring proper disclosure not only fulfills legal obligations but also reinforces ethical principles in healthcare by promoting patient autonomy and trust.
Express consent: Express consent is a clear and direct agreement given by a patient for a specific medical procedure or treatment, communicated verbally or in writing. This form of consent emphasizes the importance of patient autonomy and the right to make informed decisions regarding their healthcare. It is a critical component of the informed consent process, ensuring that patients understand the risks, benefits, and alternatives before agreeing to proceed with treatment.
Health Insurance Portability and Accountability Act (HIPAA): The Health Insurance Portability and Accountability Act (HIPAA) is a federal law enacted in 1996 to protect patient privacy and secure personal health information while ensuring that individuals can maintain their health insurance coverage when changing jobs. HIPAA's regulations establish standards for the electronic exchange, privacy, and security of health information, impacting various aspects of healthcare, from medical malpractice to patient rights and informed consent.
Implied consent: Implied consent refers to a legal concept where a person's consent is inferred from their actions or the circumstances, rather than being explicitly stated. In healthcare, this often occurs in situations where a patient’s behavior suggests they agree to a treatment or procedure, such as rolling up their sleeve for a blood draw. Understanding implied consent is crucial as it ties into the broader concepts of valid informed consent and the legal and ethical foundations that govern patient autonomy and decision-making.
Informed Consent: Informed consent is a legal and ethical requirement in healthcare that ensures patients have the right to make knowledgeable decisions about their medical treatment. It involves providing patients with clear information about their diagnosis, treatment options, risks, benefits, and alternatives so they can voluntarily agree to a procedure or intervention.
Medical malpractice: Medical malpractice refers to a legal cause of action that occurs when a healthcare professional deviates from the accepted standard of care in the treatment of a patient, leading to harm or injury. This concept is crucial in understanding how the legal system addresses negligence within the healthcare context, particularly in terms of the responsibilities and expectations placed on medical professionals.
Patient Self-Determination Act: The Patient Self-Determination Act (PSDA) is a federal law enacted in 1990 that mandates healthcare providers to inform patients about their rights to make decisions regarding their own medical care, including the right to accept or refuse treatment. This law aims to ensure that patients are aware of their options and encourages them to participate actively in their healthcare decisions, fostering informed consent, ethical decision-making, and the use of advance directives.
Reasonable person standard: The reasonable person standard is a legal principle used to determine how a typical person would act in a given situation, serving as a benchmark for evaluating conduct in negligence cases. This standard assesses whether an individual's actions align with what is deemed acceptable by societal norms, focusing on whether a reasonable person would have acted similarly under comparable circumstances. Understanding this concept is crucial for evaluating the validity of informed consent and the ethical and legal responsibilities of healthcare providers.
Schloendorff v. Society of New York Hospital: Schloendorff v. Society of New York Hospital is a landmark legal case from 1914 that established the principle of informed consent in medical practice. The case arose when a woman underwent surgery without her consent and later sued the hospital for battery, leading to the court's recognition of the necessity for patients to give informed consent before undergoing medical procedures. This case laid the groundwork for understanding patient autonomy and the ethical responsibilities of healthcare providers.
Standard of care: Standard of care refers to the degree of attention, caution, and prudence that a reasonable healthcare professional would exercise in similar circumstances. It serves as a benchmark for evaluating the quality of care provided by healthcare professionals and is critical in determining liability in medical malpractice cases.
Substituted judgment: Substituted judgment is a legal and ethical principle used when a person is unable to make decisions for themselves, typically due to incapacity or illness. This principle allows a surrogate decision-maker to make choices based on what the individual would have decided if they were capable, reflecting their values and preferences. It emphasizes the importance of honoring the autonomy of patients even when they cannot voice their wishes directly.
World Medical Association Declaration of Helsinki: The World Medical Association Declaration of Helsinki is a set of ethical principles regarding human experimentation and clinical trials. It serves as a cornerstone for ensuring the rights, safety, and well-being of research participants, emphasizing the importance of informed consent and the necessity for ethical oversight in medical research.