Informed Consent

Excerpt

Informed consent is a process in which a healthcare professional educates a patient about the risks, benefits, and alternatives of a given procedure or intervention. The history of informed consent in medicine is rooted in a broader evolution of ethical practices and legal standards surrounding patient autonomy. In the early 20th century, medical practice was largely paternalistic, with clinicians making decisions on behalf of patients without necessarily informing them of the details. The concept of informed consent began to emerge in response to several landmark legal cases, such as 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 a 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, including the Tuskegee Study of Untreated Syphilis in the Negro Male and the Nazi human experiments during World War II, further underscored the need for stringent consent standards. These events, along with the establishment of the Nuremberg Code and the Declaration of Helsinki, cemented informed consent as a fundamental ethical standard in research and clinical practice. Informed consent has evolved from simply obtaining a patient's signature to a process centered on clear communication. This approach ensures that patients understand the risks, benefits, and alternatives of medical interventions, establishing it as a cornerstone of patient-centered care and medical ethics.

The patient must be competent to make a voluntary decision regarding whether to undergo a procedure or intervention. Providing informed consent requires assessing the patient's understanding, making a clear recommendation with supporting reasoning, and documenting the process. Healthcare professionals must emphasize the patient's active participation in decision-making and avoid creating any sense of coercion to agree with the clinician's recommendation.