Cameron Miranda
The concept of informed consent has evolved significantly over time, with the earliest documented evidence of informed consent being a contract used by Major Walter Reed for his experiment on the causation of yellow fever infection. The evolution of informed consent can be traced back to the 16th century, marking the start of a journey towards patient autonomy and ethical research practices. In 1914, the case law on Schloendorff v. Society of New York Hospitals gave informed consent a legal standing. However, the formalisation of informed consent principles gained momentum following World War II, with the investigation of Nazi war crimes and the Nuremberg trials in 1947. The United Nations' International Covenant on Civil and Political Rights, adopted in 1966, further emphasised free consent in medical or scientific experimentation. In the United States, informed consent was codified into law in 1981 and underwent significant modifications in 2018.
| Characteristics | Values |
|---|---|
| Earliest documented evidence of informed consent | 1914 |
| First explicit attempt to regulate the ethical conduct of research experiments with human subjects | 1947, The Nuremberg Code |
| US regulatory definition of informed consent in human subjects research | 1981 |
| Most comprehensive modifications to the Common Rule | 2018 |
| Informed consent codified in international law | 1966, The International Covenant on Civil and Political Rights |
| Early beginnings of informed consent | 16th century |
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The Nuremberg Code
The Code's 10 basic rules include requirements such as the need for voluntary consent, the avoidance of unnecessary physical and mental suffering, and the provision of animal experimentation data to demonstrate the absence of unreasonable danger to human subjects. These rules have informed numerous international ethics statements and served as the basis for the International Ethical Guidelines for Biomedical Research Involving Human Subjects proposed by the World Health Organization. The Nuremberg Code has thus become a cornerstone of clinical research and bioethics, shaping the ethical landscape of human experimentation and safeguarding the rights and welfare of research participants.
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US federal law
The history of informed consent in the United States dates back to the early 20th century, with the first explicit attempt to regulate the ethical conduct of human experiments emerging after World War II. The Nuremberg Code, established in 1947, set a precedent for the regulation of human subject research and was followed by the Declaration of Helsinki in 1964. The term "informed consent" first appeared in 1957, and serious discussions about the concept began around 1972.
In the US, the Canterbury v. Spence case in 1972 officially established the principle of informed consent in US law. This case involved a patient who underwent back surgery without being informed of the risk of paralysis and subsequently fell and became paralysed. The judgement in this case cited precedent from as early as 1914 and emphasised the importance of patients being fully informed about the risks and benefits of medical procedures.
The US federal law regarding informed consent is codified in the Code of Federal Regulations at 45 CFR 46 and 21 CFR 50. The most comprehensive set of regulations, known as the Common Rule or the Federal Policy for the Protection of Human Subjects, was adopted in 1991, with significant modifications made in 2018. These regulations outline the requirements for obtaining informed consent in human subjects research and clinical trials.
In certain circumstances, such as medical emergencies or incompetence to judge, informed consent can be waived or overridden. For example, in emergency medical situations, informed consent may not be required if a patient is incapacitated and unable to provide consent. Additionally, the Secretary of Defense can grant a waiver of advanced informed consent for research projects in the military setting, provided they adhere to relevant laws and regulations.
The evolution of informed consent in US federal law reflects a growing awareness of the importance of protecting the rights and welfare of individuals involved in research and medical procedures. The legal and ethical frameworks surrounding informed consent continue to be refined to address emerging issues and complexities.
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The Common Rule
Informed consent is an applied ethics principle that a person must have sufficient information and understanding before making decisions about accepting risk. This principle is especially pertinent in medical procedures and research involving human subjects.
The historical events that laid the groundwork for the US regulatory definition of informed consent in human subjects research include the 1964 Declaration of Helsinki, the work of medical ethicist Henry Beecher, and the 1972 revelation of the Tuskegee Study of Untreated Syphilis in the Negro Male. The latter led to the creation of the National Research Service Award Act in 1974, which included the formation of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.
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International law
The Nuremberg Code, established in 1947, set an international standard for informed consent in medical research. The code was a response to the ethical violations that occurred during the Holocaust and the trials of 23 physicians and bureaucrats charged with crimes against humanity and war crimes for medical experiments conducted on concentration camp inmates. The code includes a series of 10 basic rules for the conduct of human experiments and is recognised as the first explicit attempt to regulate the ethical conduct of research experiments with human subjects.
The Nuremberg Code is considered a source of international custom for informed consent, alongside the World Medical Association's Declaration of Helsinki, the guidelines of the Council for International Organisations of Medical Sciences, and Article 7 of the International Covenant on Civil and Political Rights. The latter, adopted by the United Nations in 1966, prohibits experiments conducted without the "free consent to medical or scientific experimentation" of the subject.
Despite the existence of guidelines and regulations to prevent exploitation, issues surrounding informed consent persist. The process of informed consent in clinical research and the lengthy consent documents that are difficult to comprehend have been criticised. Additionally, the divergent ways in which informed consent is applied in practice have resulted in moral, medical, and political confrontations.
The concept of informed consent is also influenced by cultural, social, and educational differences between countries. For example, factors such as individual autonomy, written documents requiring signatures, and experience with Western medicine and legal disclaimers may not be broadly acceptable in developing countries. As a result, strategies to improve the quality and relevance of consent in both developed and developing countries are recommended.
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Parental consent
Informed consent is a cornerstone of medicine, ensuring ethical treatment decisions and patient-centred care. It is an applied ethics principle that a person must have sufficient information and understanding before making decisions about accepting risk. In the United States, the concept of informed consent was officially established in 1972 with the Canterbury v. Spence case. However, the groundwork for informed consent in human subjects research began much earlier, with the investigation of Nazi war crimes at the end of World War II.
When it comes to parental consent, the situation can become more complex. Generally, children are presumed incompetent to provide informed consent, and it falls on parents or legal guardians to make medical decisions on their behalf. This is known as "consent by proxy". However, there are exceptions to this rule, and the legislation regarding minors and informed consent varies by jurisdiction. For example, in the US, emancipated minors may be able to provide consent for themselves in certain situations, such as decisions regarding sexually transmitted diseases, pregnancy, or financial independence. Similarly, in the UK, the General Medical Council guidelines confer the consenting age to 16 years old, although this can be overridden by a court if deemed in the child's best interest.
In some cases, an unaccompanied homeless youth who is unable to obtain parental consent may be authorised to provide informed consent for specific non-emergency, outpatient, and primary care services. This is to ensure that these youths have access to necessary healthcare even when they are not under the supervision or control of a parent or guardian.
It is important to note that the information provided to parents or guardians as part of clinical research or medical procedures can be complex and difficult to understand. This can lead to ethical dilemmas when the judgment of the parents or guardians differs from that of medical professionals regarding the best interests of the child. In such cases, an Institutional Review Board (IRB) may be involved to determine if the requirement for obtaining parental consent can be waived, especially in emergency settings or when no foreseeable harm is expected to result from the study.
While the specific laws and regulations regarding parental consent may vary by jurisdiction, the underlying principle of informed consent remains the same: to ensure that individuals have sufficient information and understanding to make voluntary decisions about accepting risk. This includes decisions regarding their own health care as well as the health care of their children.
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Frequently asked questions
The term "informed consent" was first used in 1957, in the case of Salgo v Leland Stanford Jr University Board of Trustees.
The concept of informed consent can be traced back to the 16th century, marking the start of a journey towards patient autonomy and ethical research practices.
Informed consent was codified in US law in 1981, with the passage of the Common Rule.
Informed consent became an international law in 1966, with the adoption of the International Covenant on Civil and Political Rights by the United Nations.
