Informed Consent: When Did We Start Seeking Permission?

Informed consent is a principle in medical ethics and law that requires a person to have sufficient information and understanding before making decisions about accepting risk, such as agreeing to medical treatment. The history of informed consent can be traced back to a series of judicial decisions in the early 20th century that established the principle of patient autonomy. The term informed consent first appeared in 1957, and serious discussion of the concept began around 1972. The idea of informed consent has evolved over time, with an increasing focus on the quality of a patient's understanding of the information presented to them and their right to authorise or refuse medical interventions. Informed consent is now codified in both national and international law, with the United Nations' International Covenant on Civil and Political Rights, adopted in 1966, including the term free consent.

The evolution of informed consent in medicine and research

Ancient Roots and Early History

Ancient medical texts, such as the Hippocratic Corpus, focused on the obligation of physicians to provide medical benefits and protect patients from harm. Managing patient information was seen as a matter of prudence, with no hint of consent or self-determination. This perspective continued through the medieval and early modern periods, with medical ethics dominated by the principle of "First, do no harm."

In the 18th and 19th centuries, figures like Benjamin Rush and John Gregory advocated for patient education and disclosure of information. However, their goal was not informed consent but rather patient compliance with physician recommendations. Thomas Percival's "Medical Ethics" (1803) further solidified the idea of benevolent deception, prioritizing patient benefit over truth-telling.

19th Century and the Emergence of Consent Practices

The first champion of patients' rights to information was Worthington Hooker, who opposed the prevalent model of benevolent deception. In surgery, consent-seeking practices emerged in the mid-19th century, driven by concerns about medical reputation, malpractice suits, and practicality. However, these consents were not yet meaningful informed consents as we understand them today.

In research, the 19th century saw numerous experiments conducted on slaves and servants without their consent. However, a notable exception was the work of American army surgeon Walter Reed, who obtained consent for his yellow fever experiments in Cuba around 1900.

Early 20th Century and Legal Recognition

The legal history of informed consent began to take shape in the early 20th century, with a series of court cases that established the principle of self-determination and the right to refuse medical treatment. The 1914 case of Schloendorff v. Society of New York Hospital was particularly influential, legally establishing the principle of patient autonomy.

Mid-20th Century and Growing Awareness

In the 1950s and 1960s, a series of legal cases brought the concept of informed consent to the forefront. The landmark decision in Salgo v. Leland Stanford Jr. University Board of Trustees (1957) introduced the term "informed consent," emphasizing the need for patients to be adequately informed about the risks and alternatives of treatment. This was followed by Natanson v. Kline (1960), which established the duty of disclosure and set a precedent for negligence charges in informed consent cases.

During this period, physicians' awareness of informed consent grew, and empirical studies indicated an increase in consent-seeking practices in certain medical specialties. However, there was also resistance, with many doctors viewing informed consent requirements as a legal nuisance or inconsistent with good patient care.

Late 20th Century and Beyond: A Moral and Legal Issue

The 1970s marked a turning point, with informed consent gaining recognition as a moral and legal issue. Three court decisions in 1972—Canterbury v. Spence, Cobbs v. Grant, and Wilkinson v. Vesey—were particularly influential, emphasizing the patient's right to self-decision and information. This led to a broader discussion about the ethical principles underlying informed consent, with the U.S. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research developing an abstract schema that gave informed consent a major role.

The 1980s saw a proliferation of books, journal articles, and laws related to informed consent, further solidifying its importance in moral and legal thinking about medicine. Empirical evidence suggests that consent procedures, such as obtaining signatures on consent forms and disclosing information about risks and alternatives, became more widely adopted during this time. However, the process of soliciting informed consent often fell short of truly respecting patients' decisional authority.

In conclusion, the evolution of informed consent in medicine and research has been a gradual process, with ancient roots but more recent formal recognition and legal standing. While there have been significant advancements, the history of informed consent continues to unfold as society grapples with complex ethical issues surrounding individual liberties, social equality, and the role of technology in healthcare.

Informed consent in the US

Informed consent is a principle in medical ethics, medical law, media studies, and other fields that a person must have sufficient information and understanding before making decisions about accepting risk, such as in their medical care. In the US, definitions of informed consent vary, and the standard required is generally determined by the state.

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. The first two cases, Mohr v Williams and Pratt v Davis, both took place in 1905 and established the principle of patient autonomy. In both cases, the court found that the surgeon should have obtained consent before performing surgery. The third case, Rolater v Strain, extended the findings of the first two cases to similar situations in which surgeons performed procedures that the patient had explicitly objected to. The final case, Schloendorff v Society of New York Hospital, was decided in 1914 and legally established the principle of patient autonomy.

Informed consent was first recorded in the court documents for the 1957 case Salgo v Leland Stanford Jr University Board of Trustees. The plaintiff in the case sued the university medical centre and its chief surgeon for lack of disclosure of the potential risk of a procedure. The court directed that each physician must exercise practical insight in completely divulging potential procedural hazards and that physicians are liable for failing to disclose information that a patient would need to make an informed decision.

Informed consent is codified in both national and international law. In the US, it was formalised in the requirement for decision-making capacity and professional determinations in these contexts have legal authority. To qualify as possessing decision-making capacity, an individual must meet four conditions: choice, understanding, appreciation, and reasoning.

Obtaining informed consent is not always required. If an individual is considered unable to give informed consent, another person is generally authorised to give consent on their behalf, such as the parents or legal guardians of a child. Alternatively, the doctrine of implied consent permits treatment in limited cases, for example, when an unconscious person will die without immediate intervention.

Informed consent can be overridden in emergency medical situations pursuant to 21CFR50.24. Additionally, the 21st Century Cures Act enacted in 2016 allows researchers to waive the requirement for informed consent when clinical testing "poses no more than minimal risk" and "includes appropriate safeguards to protect the rights, safety, and welfare of the human subject."

Informed consent in international law

Informed consent is a principle in medical ethics and law that requires a person to have sufficient information and understanding before making decisions about accepting risk, such as medical care. In most systems, healthcare providers have a legal and ethical responsibility to ensure that a patient's consent is informed.

The principle of informed consent is codified in both national and international law. The term "free consent" is used in the International Covenant on Civil and Political Rights, which was adopted in 1966 by the United Nations and came into force in 1976. Article 7 of the covenant prohibits experiments conducted without the "free consent to medical or scientific experimentation" of the subject.

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 the principle of patient autonomy. The Nuremberg Code, established after World War II, represents the first explicit attempt to regulate the ethical conduct of human experiments and emphasises the importance of voluntary consent. The Belmont Report, published in 1979, further identified three critical concepts for informed consent: information, comprehension, and voluntariness.

Informed consent procedures vary across different countries and cultural contexts. In developed countries, informed consent is typically based on the autonomy of the individual and is documented through written forms and signatures. However, in developing countries, decision-making for informed consent is often vested in the community rather than the individual, and illiteracy can limit the effectiveness of written documents.

International law recognises the unique challenges of obtaining informed consent in certain contexts, such as in emergency situations or when conducting research involving children. For example, the Oviedo Convention of the Council of Europe states that interventions on children who cannot consent require the authorisation of their representative and must consider the child's opinion based on their age and maturity.

The process of obtaining informed consent has evolved over time, and regulations continue to be revised to improve the protection of individuals involved in research. The key information section, introduced in the 2017 revisions to the Common Rule, aims to facilitate comprehension by presenting essential information at the beginning of the informed consent document.

Overall, informed consent in international law recognises the importance of ensuring that individuals have the necessary information and understanding to make autonomous decisions about their health and participation in research.

Informed consent in the social sciences

Informed consent is a critical procedure in scientific research in the social sciences, as it fulfils the ethical dimension. It is not a one-time procedure but rather something that should be continuously considered and assessed throughout the research process.

Informed consent in social sciences research involves prospective participants being informed so that they understand their involvement as a subject, providing consent, and making a personal decision to get involved that is voluntary, without physical or psychological pressure.

Informed consent is not always required in the social sciences, as research often involves low or no risk for participants, unlike in many medical experiments. The mere knowledge that they are participating in a study can cause people to alter their behaviour, as in the Hawthorne Effect. In such cases, seeking informed consent directly interferes with the ability to conduct the research.

The birth of new online media, such as social media, has complicated the idea of informed consent. In an online environment, people pay little attention to Terms of Use agreements and can subject themselves to research without thorough knowledge.

Informed consent is codified in both national and international law. In the US, definitions of informed consent vary and the standard required is generally determined by the state.

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.

Informed consent in the 21st century

The concept of informed consent has evolved significantly over the years, with the term "informed consent" first appearing in 1957 and serious discussions on the topic beginning around 1972. Informed consent is a principle in medical ethics and law that requires individuals to have sufficient information and understanding before making decisions about accepting risks, such as medical care. While the specific regulations vary across different countries and states, the core principle of informed consent remains the same.

In the 21st century, informed consent continues to be a crucial aspect of medical practice and research. With advancements in medicine and technology, the process of obtaining informed consent has become more complex. Patients now have access to a wealth of information, and ensuring they understand the risks and benefits of treatments can be challenging. The use of digital consent forms and electronic consent methods has increased, providing patients with more accessible and lay-friendly information. However, evaluating informed consent remains complex, as expressions of consent do not always indicate full comprehension or true consent.

In the United States, the 21st Century Cures Act, enacted in 2016, allows researchers to waive the requirement for informed consent in certain low-risk clinical trials. This act highlights the ongoing evolution of informed consent regulations to adapt to modern research needs.

In the field of medical research, the birth of new online media, such as social media, has complicated the idea of informed consent. The Facebook emotional contagion experiment in 2014 sparked outrage among researchers and users, as it involved altering users' news feeds without their explicit consent. This incident brought to light the ethical dilemmas of conducting research in an online environment, where users often pay little attention to terms of use agreements.

In the 21st century, there is a growing recognition of the importance of patient autonomy and shared decision-making. The shift towards a more patient-centric approach to informed consent, as seen in the UK's Montgomery v Lanarkshire Health Board ruling, emphasizes the need to provide patients with information relevant to their specific circumstances. This includes not only the risks and benefits of treatments but also alternative treatments and the patient's role in their care.

In conclusion, informed consent in the 21st century is marked by a continued evolution of regulations, the integration of digital technologies, and a stronger focus on patient autonomy. While the basic principles remain unchanged, the complexities and ethical considerations of obtaining informed consent continue to evolve with advancements in medicine and technology.

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