Informed Consent: A Historical Perspective On Patient Rights

Informed consent is a principle in medical ethics and law that states a person must have sufficient information and understanding before making decisions about accepting risk, such as medical care. The history of informed consent can be traced back to a series of four judicial decisions in the early 20th century that laid the foundation for patient autonomy. The term informed consent was first publicly recorded in the 1957 court case Salgo v. Leland Stanford Jr. University Board of Trustees. However, the concept of informed consent remained nameless and non-legally binding until the Nuremberg Code, a set of guidelines for the conduct of human experiments, was established in 1947. The Nuremberg Code emphasized the importance of voluntary consent and set forth a series of basic rules for obtaining informed consent, including the need for sufficient knowledge and comprehension on the part of the individual. In the United States, informed consent was codified into law through statutes at 45 CFR 46 and 21 CFR 50 of the Code of Federal Regulations. Today, informed consent is widely recognized as a crucial component of clinical practice and clinical research, with institutional review boards in place to ensure the ethical validity of studies involving human subjects.

Informed consent in the US

Informed consent is a principle in medical ethics, medical law, and other fields, that an individual must have sufficient information and understanding before making decisions about accepting risk, such as medical care. This principle applies more broadly than healthcare intervention, for example, to conduct research, to disclose a person's medical information, or to participate in high-risk sporting and recreational activities.

In the US, definitions of informed consent vary, and the standard required is generally determined by the state. These standards in medical contexts are formalised in the requirement for decision-making capacity and professional determinations in these contexts have legal authority. For one to qualify as possessing decision-making capacity, the following conditions must be met:

• Choice: the ability to provide or evidence a decision.
• Understanding: the capacity to apprehend the relevant facts pertaining to the decision at issue.
• Appreciation: the ability of the patient to give informed consent with concern for, and belief in, the impact the relevant facts will have upon oneself.
• Reasoning: the mental acuity to make the relevant inferences from, and mental manipulations of, the information appreciated and understood to apply to the decision at hand.

Impairments to reasoning and judgement that may preclude informed consent include intellectual or emotional immaturity, high levels of stress, severe mental disorder, intoxication, severe sleep deprivation, dementia, or coma.

Informed consent is codified in US law via the statutes at 45 CFR 46 and 21 CFR 50 of the Code of Federal Regulations. The most comprehensive modifications to the Common Rule—the Federal Policy for the Protection of Human Subjects—since its adoption in 1991 were enacted in 2018.

The concept of informed consent has a relatively short history, beginning with a series of four judicial decisions in the early 20th century that laid the foundation for the principle of patient autonomy. These cases were:

• Mohr v Williams (1905)
• Pratt v Davis (1905)
• Rolater v Strain
• Schloendorff v Society of New York Hospital (1914)

The doctrine of informed consent also relates to professional negligence and establishes a breach of the duty of care owed to the patient. In the US, informed consent can be overridden in emergency medical situations pursuant to 21CFR50.24.

For an individual to give valid informed consent, three components must be present: disclosure, capacity, and voluntariness. Disclosure requires the researcher to supply each prospective subject with the information necessary to make an autonomous decision and also to ensure that the subject adequately understands the information provided. Capacity pertains to the ability of the subject to both understand the information provided and form a reasonable judgement based on the potential consequences of his/her decision. Voluntariness refers to the subject's right to freely exercise his/her decision-making without being subjected to external pressure such as coercion, manipulation, or undue influence.

Informed consent in international law

The principle of informed consent is a cornerstone of medical ethics and medical law, and it is also codified in both national and international law. In the context of international law, the term "free consent" is used in the International Covenant on Civil and Political Rights, which was adopted by the United Nations in 1966. Article 7 of this covenant explicitly prohibits experiments conducted without the "free consent to medical or scientific experimentation" of the subject.

The concept of informed consent has evolved significantly over time, with a series of judicial decisions in the early 20th century laying the foundation for the principle of patient autonomy. Notably, the landmark cases of Schloendorff v. Society of New York Hospital (1914) and Salgo v. Leland Stanford Jr. University Board of Trustees (1957) legally established the requirement for informed consent in medical procedures and research.

In the international arena, the investigation of Nazi war crimes during World War II played a pivotal role in shaping the ethical conduct of human experiments. The Nuremberg Code, established in 1947, emphasizes the importance of voluntary consent in research, stating that individuals must have "sufficient knowledge and comprehension" to make an "understanding and enlightened decision."

The World Medical Association's Declaration of Helsinki (1964) and the work of medical ethicist Henry Beecher further contributed to the development of international standards for human subjects research protections. Additionally, the public outcry against the Tuskegee Syphilis Study in the 1970s led to the creation of the National Research Service Award Act and the establishment of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.

The Belmont Report, published in 1979, identified critical concepts for informed consent in research, including information, comprehension, and voluntariness. It emphasized the need to provide specific details about the research procedure, purposes, risks, benefits, and alternatives.

Informed consent in international research presents unique challenges, particularly in developing countries. Communal decision-making is common in many cultures, and factors such as literacy, access to medical care, and understanding of complex issues vary across different societies. Therefore, strategies for obtaining informed consent must be adapted to respect cultural, socioeconomic, and educational differences while ensuring that individuals have the necessary information to make informed decisions.

To summarize, informed consent is a fundamental principle in international law, enshrined in the International Covenant on Civil and Political Rights. Its evolution has been influenced by judicial precedents, ethical guidelines, and public outcry over unethical research practices. The Nuremberg Code and the Belmont Report have been particularly influential in shaping international standards for informed consent in human subjects research.

Informed consent in medical ethics

Informed consent is a principle in medical ethics that upholds a patient's right to have sufficient information and understanding before making decisions about accepting risk, such as their medical care. It is a cornerstone of patient-centred care and medical ethics, serving both ethical and legal purposes by safeguarding patient rights, fostering transparency, and promoting trust between health care professionals and patients.

History

The concept of informed consent has its roots in the broader evolution of ethical practices and legal standards surrounding patient autonomy. In the early 20th century, medical practice was largely paternalistic, with physicians making decisions on behalf of patients without necessarily informing them of the details. The term "informed consent" emerged in the 1950s, and serious discussions about its meaning and ethics began around 1972.

The concept began to take shape in response to several landmark legal cases, including the 1914 case of Schloendorff v. Society of New York Hospital, where the court ruled that "every human being of adult years and sound mind has the right to determine what shall be done with his own body". This ruling established the principle that patients must agree to medical procedures.

In the mid-20th century, unethical medical experiments, such as the Tuskegee Study and Nazi human experiments during World War II, further emphasised the need for stringent consent standards. The development of the Nuremberg Code and the Declaration of Helsinki also played a significant role in solidifying informed consent as a foundational ethical requirement in both research and clinical practice.

Elements of Informed Consent

The key elements of informed consent include:

• Disclosure of information: Patients must be provided with relevant information about the nature of the procedure, risks, benefits, and alternatives.
• Competency of the patient: The patient must be competent to make a voluntary decision, understanding the information presented and the potential consequences of their decision.
• Voluntariness: The patient's consent must be free from coercion and external pressure, such as manipulation or undue influence.
• Understanding: The patient must demonstrate comprehension of the relevant facts and their impact on their decision.

Challenges and Exceptions

Despite its importance, there are several challenges and exceptions to obtaining informed consent:

• Lack of patient comprehension: Complex medical jargon and varying levels of health literacy can lead to patients agreeing to procedures without fully understanding the risks and benefits.
• Cultural differences: In some cultures, collective decision-making or consulting a family patriarch is preferred, and written consent may be seen as a sign of mistrust.
• Power dynamics: The unequal power relationship between patients and physicians can make it difficult for patients to assert their preferences or ask questions.
• Time pressures: Rushed consent processes in medical settings may leave patients feeling uninformed or uncertain.
• Changing medical circumstances: Evolving medical conditions, such as the COVID-19 pandemic, may require updates to consent forms to reflect new risks and uncertainties.
• Incomplete disclosure: Ethical concerns arise when information is withheld or downplayed, or when all available treatment options are not presented.
• Patients with impaired decision-making capacity: Assessing the ability to provide informed consent can be complex for patients with cognitive impairments, mental health conditions, or severe illnesses. In these cases, the involvement of surrogates or legal guardians may be necessary.
• Exceptions to informed consent: Informed consent may be waived in emergencies, when the patient is incapacitated, or when there is a voluntary waiver of consent.

Documentation

Documentation of informed consent is crucial, and it should be tailored to the individual needs of the patient, considering factors such as literacy level, cultural background, and emotional state. Visual aids, simplified language, and interpreters can enhance understanding. Electronic informed consent (eConsent) offers benefits such as enhanced accessibility and the ability to integrate multimedia tools. However, challenges remain in ensuring equitable access and addressing data privacy and security concerns.

In summary, informed consent is a fundamental principle in medical ethics, protecting patient autonomy and promoting trust in the healthcare system. It requires clear communication and understanding between healthcare professionals and patients, ensuring that patients are fully informed about the risks, benefits, and alternatives before making decisions about their medical care.

Informed consent in the Indian context

Informed consent is a principle in medical ethics that grants a person the right to sufficient information and understanding before making decisions about accepting risk, such as medical care. In the Indian context, informed consent was practically non-existent until the Consumer Protection Act was applied to the medical profession. Now, doctors and patients are becoming more aware of this concept, and patients are better informed of their rights.

Informed consent is seen more as a legal requirement than an ethical obligation in India. An adult patient has complete autonomy over their body and can consent to any form of medical treatment without fear of being overruled. However, complete patient autonomy is restricted in certain circumstances. For instance, despite accepting the notion of complete patient autonomy, courts worldwide are reluctant to legally accept active euthanasia.

Valid consent is necessary before any medical treatment and can be implied, as in the case of a general physician's treatment involving physical examination and administering injections. The consent practiced in Indian hospitals, particularly public ones, where patients are asked to sign a form stating their willingness for any form of treatment, is a blanket consent of questionable legal validity. To give informed consent, the patient must have the required information.

True and informed consent has been differentiated by courts in India and other Commonwealth countries for a long time. This is evident from cases such as L. B. Joshi v T. R. Godbole and Ram Bhiharital v Dr. Srivatsava. However, American and Canadian courts have taken a more liberal, patient-oriented view compared to the doctor-oriented approach of British and Indian courts.

In the Indian context, a review of various legal issues and case laws may help remove the confusion surrounding informed consent. For example, in Dr Thomas v Smt. Elisa, the court held that it is the doctor's ethical and legal duty to treat a patient to the best of their ability, and lack of valid consent is not a constraint in life-threatening situations.

The debate about informed consent in India needs to move from the legal aspect to the domain of ethics. Unless ethical standards in the profession are enforced, medico-legal aspects of informed consent will continue to be a concern for doctors.

Informed consent violations

Informed consent is a principle in medical ethics, medical law, and other fields, which states that a person must have sufficient information and understanding before making decisions about accepting risk, such as agreeing to medical treatment. Informed consent violations can occur when this principle is not upheld, and can have serious consequences for patients. Here are some examples of informed consent violations:

• Wrong site/wrong patient surgery: This involves physicians operating on the wrong part of the body or the wrong patient, which is a fundamental breach of informed consent.
• Lack of disclosure: Doctors must discuss potential risks and complications with patients, and these must be included on consent forms. Failure to do so constitutes a violation.
• Complications: If a patient experiences complications that were not properly disclosed or were made to seem less serious than they are, this can constitute a violation.
• Unauthorized treatment: Performing a medical procedure without a patient's consent is a clear violation of informed consent.
• Deception: Withholding vital information or misrepresenting the nature of a procedure can invalidate informed consent.

Informed consent is a critical component of the doctor-patient relationship and helps ensure that patients are actively involved in their medical treatment decisions. Violations of informed consent can have legal, ethical, and financial repercussions for medical professionals and can cause significant harm to patients. To avoid violations, it is essential for healthcare providers to adhere to the legal and ethical standards of informed consent and ensure that patients understand the risks and benefits of proposed treatments.

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