When Did Informed Consent Become Law

While some flexibility is important given the scope of human research, overall flexibility can lead to such volatility that in practice, the new section containing key information in the consent document may not serve the original purpose of facilitating understanding. On the other hand, many versions of the key information section implemented in various institutions and by researchers contain an almost literal list of the 5 elements listed in the preamble and ask subjects to read the entire consent document for more details. While this form of the key information section may not be of optimal use to participants, it may prevail as the most common version due to limited advice from official sources in terms of content. The history of informed consent in research and clinical medicine has largely evolved as separate parts in a broader mosaic of biomedical ethics, and these parts have never been well integrated, even though they have evolved side by side. Research ethics before World War II had no more impact on research practice than the parallel history of clinical and medical ethics on clinical practice. But one event that undoubtedly influenced thinking about informed consent was the Nuremberg trials. In their examination of "crimes against humanity", the Nuremberg military tribunals unequivocally condemned the sinister political motivation of the Nazi experiments. A list of ten principles formed the Nuremberg Codex. The first principle of the Code states unreservedly that the primary consideration in research is the voluntary consent of the subject, which is "absolutely necessary" (Germany [Territory under Allied Occupation], 1947). Remarkably, these founding cases, which set the legal precedent for patient autonomy, all had plaintiffs at a time when women in the United States did not have the right to vote, which indelibly combined the patient`s right to autonomy with a woman`s right to consent to a procedure on her own body. Informed consent should begin with a concise and focused presentation of the key information most likely to help a potential subject or legally authorized representative understand why one may or may not want to participate in the research.

This part of informed consent must be organized and presented in a way that facilitates understanding.27 The legal history of patients` disclosure obligations and self-determination rights has gradually evolved. It is in the nature of precedent that any decision based on previous judicial opinions is linked to a chain of authority that understands the relevant language and reasoning of the cases cited. In this way, some cases of early consent have relied on each other to arrive at a legal doctrine. The best known and ultimately most influential of these early cases is Schloendorff v. New York Hospital (1914). Schloendorff used the right to self-determination to justify the imposition of an obligation to obtain a patient`s consent. Subsequent cases, which followed Schloendorff and relied on Schloendorff, implicitly adopted their justifactory justification. In this way, self-determination has become the main justification or justification for the legal requirements that the patient`s consent must be obtained. This indifference to consent procedures seems to have changed in the late 1960s, when most physicians seem to have recognized a moral and legal obligation to obtain consent for certain procedures and to make some sort of disclosure. However, there is also evidence that physicians` views on appropriate consent practices, even in the late 1960s, differed significantly from today`s consensus of opinion and convention. For example, in one study, half of the doctors surveyed considered it medically correct and 30% ethically correct for a doctor to perform a mastectomy without the patient`s permission other than their signature on the general consent form required for admission to hospital; More than half of the doctors considered it ethically appropriate for a doctor not to tell a cancer patient that she had participated in a double-blind clinical trial of an experimental cancer drug.

The first documented evidence of consent was a contract that Major Walter Reed asked his volunteers in Spain to sign for his experiment in causing yellow fever infection. [6] Interestingly, it also had a translated Spanish version, a concept that existed in the same geographical area in India today due to different local languages. Surgical records at Massachusetts General Hospital from the 1840s to the 1860s, the New York Hospital from the 1840s to the 1850s, and Pennsylvania Hospital fracture books from the 1850s to the 1860s shed light on cases in which patients opposed surgery. At the same time, however, benevolent decisions were made on behalf of the patient, without involving him. 1914 in the United States for the first time the schloendorff v. The Society of New York Hospitals gave the term "informed consent" a legal position when the court made a decision in favor of a competent woman. Schioendorff, who had accepted an abdominal examination under anesthesia but had not been informed of the tumor, which was removed by the surgeon without informing him of the possible adverse outcome. [7] Much later, the infamous Tuskegee syphilis study conducted by the U.S.

Government Department of Public Health Services from 1932 to 1972, when the Nuremberg Code had been in effect since 1947, led to the publication of the Belmont Report by the United States in 1979. The report highlighted three main ethical principles during the course of research, namely respect for people, charity and justice. [8] Respect for people refers to autonomous decisions made by a "prudent" patient (reasonable or average) to volunteer for research after understanding the risks and benefits involved. The prerequisite for informed consent is that the patient or research participant is competent and that the disclosed facts are understood before consent is freely given. Courts rely on a "prudent patient test" to see if adequate information has been provided to the patient or participant. However, cultural differences can influence the decision to full disclosure. For example, the Navajo tribe in the United States does not want to know negative information because they believe it could lead to harmful effects. They believe that thoughts and language could be powerful in making events positive. Methods: We examine the history of informed consent as a legal and regulatory concept and the expected impact of the new section on key information, a requirement introduced in the 2017 revisions to the common rule. Among the most important publications of the medical literature published during this period was a 1981 statement from the Judicial Council of the American Medical Association. For the first time, WADA has recognized informed consent as "a basic social policy" needed to enable patients to make their own decisions, even if the physician disagrees.

WADA`s statement is evidence of the impact of the Informed Consent Act on medical ethics: WADA`s position closely followed the wording of Canterbury v. Spence (Judicial Council, 1981). In some U.S. states, informed consent laws (sometimes referred to as "right to know" laws) require a woman who requests an elective abortion to provide information from the abortion provider about her legal rights, alternatives to abortion (e.B. Adoption), receive the available public and private support, and other information set forth in the law before the abortion is performed. Other countries with such laws (for example. B, Germany) require that the information provider be duly certified to ensure that no abortion is performed for the financial benefit of the abortion provider and to ensure that the decision to abort is not influenced by any form of inducement. [32] [33] The ability to give informed consent is subject to a general competency requirement. Common law jurisdictions assume that adults have a right to consent.

This presumption can be rebutted, for example, in the circumstances of mental illness or other incompetence. This may be required by law or based on a common law standard of inability to understand the nature of the proceeding. In the case of incompetent adults, a representative of the health care system makes medical decisions. In the absence of a power of attorney, the physician is expected to act in the best interests of the patient until a power of attorney can be found. When the American Medical Association was founded, it produced a book in 1847 that was called the first edition of the American Medical Association`s Code of Medical Ethics. [11]:69 Many sections of this book are literal copies of passages from Perceval`s medical ethics. [11]:69 A new concept in this book was the idea that doctors should honestly disclose all patient data when talking to other doctors, but the text does not also apply this idea to the disclosure of information to patients. [11]:70 Thanks to this text, Perceval`s ideas became ubiquitous guidelines in the United States, as other texts were derived from them. [11]:70 Research on children has helped society in many ways. .

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