Informed Consent
Definition
Informed consent is a process for obtaining permission before conducting a healthcare intervention on a person, or for disclosing personal information. This process originates from the legal and ethical right an individual has to decide what happens to their own body, and from the ethical duty of the person initiating the intervention to respect the autonomy of the other.
Informed consent is a foundational principle in medical ethics and international human rights law. It is built on the principle of respect for persons, which requires that individuals are treated as autonomous agents and that the choices of persons with diminished autonomy are protected.
History
The concept of informed consent has its roots in the Nuremberg Code, which was developed following the Nuremberg Trials of Nazi war criminals after World War II. The Code outlined ten principles for ethical medical research, with the first and foremost principle being the informed consent of the research subject. This was further developed in the Declaration of Helsinki, which provided additional guidance on the ethical principles of medical research involving human subjects.
Principles
The process of informed consent involves three key components: comprehension, disclosure, and voluntariness.
Comprehension
The individual must have the capacity to understand the information provided and the implications of their decision. This involves the ability to reason and weigh up the potential benefits and harms of the proposed intervention.
Disclosure
The healthcare professional must disclose all relevant information to the individual. This includes the nature of the procedure, its purpose, the risks and benefits, alternatives to the procedure, and the risks and benefits of these alternatives.
Voluntariness
The individual must be able to make the decision voluntarily, without coercion or undue influence. This means that they must have the freedom to either agree to or refuse the proposed intervention.
Legal and Ethical Considerations
Informed consent is both a legal and ethical obligation for healthcare professionals. Failure to obtain informed consent can result in legal action for battery or negligence, and can also be considered a breach of a professional's ethical duty of care.
In the legal context, the standard for what information should be disclosed to patients was traditionally what a reasonable physician would disclose. However, many jurisdictions have now adopted a patient-centered standard, which focuses on what a reasonable patient would want to know.
In the ethical context, the principle of autonomy is paramount. This means that individuals have the right to make decisions about their own bodies and medical treatment. Healthcare professionals have a duty to respect this autonomy by ensuring that patients are fully informed and able to make voluntary decisions.
Challenges
While the principle of informed consent is widely recognized, its implementation can be challenging. Some of the key challenges include:
- Ensuring that the individual truly understands the information provided. - Balancing the need for informed consent with the need for prompt treatment in emergency situations. - Respecting cultural differences and beliefs that may impact an individual's decision-making process. - Managing situations where an individual's capacity to give informed consent is impaired, such as in cases of mental illness or cognitive impairment.