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37-495: Though it was articulated as part of the court's verdict in the trial, the Code would later become significant beyond its original context; in a review written on the 50th anniversary of the Brandt verdict, Jay Katz writes that "a careful reading of the judgment suggests that [the authors] wrote the Code for the practice of human experimentation whenever it is being conducted." The origin of

74-422: A formula to guide decision-making for this situation. They also argued that, for healthcare professionals and other types of professionals subject to moral codes, in general beneficence takes priority over non-maleficence (“first, do good,” not “first, do no harm”) both historically and philosophically. Researchers should apply the concept of beneficence to individuals within the patient/physician relationship or

111-597: A practice that opposes the welfare of any research participant. According to the Belmont Report , researchers are required to follow two moral requirements in line with the principle of beneficence: do not harm and maximize possible benefits for research while minimizing any potential harm on others. The concept that medical professionals and researchers would always practice beneficence seems natural to most patients and research participants, but in fact, every health intervention or research intervention has potential to harm

148-410: A prohibition on doing harm to others as in #1 is more compelling than any duty to benefit others as in #2–4. This makes the concept of "first do no harm" different from the other aspects of beneficence. One example illustrating this concept is the trolley problem . Morality and ethical theory allows for judging relative costs, so in the case when a harm to be inflicted in violating #1 is negligible and

185-739: The Common Rule , which is now codified in Part 46 of Title 45 of the Code of Federal Regulations . These regulations are enforced by Institutional Review Boards (IRBs). In 1966, the International Covenant on Civil and Political Rights was adopted by the United Nations , and after enough nations had ratified the Covenant, it came into force on 23 March 1976. Article Seven prohibits experiments conducted without

222-481: The Nuremberg trials . In the trial of USA v. Brandt, which became known as the " Doctors' Trial ", German physicians responsible for conducting unethical medical procedures on humans during the war were tried. They focused on physicians who conducted inhumane and unethical human experiments in concentration camps , in addition to those who were involved in over 3.5 million sterilizations of German citizens. Several of

259-808: The United States Air Force . He served as a First Lieutenant and Captain at the Air Force Hospital at Maxwell Air Force Base in Montgomery, Alabama . Katz began his four-decades-long affiliation with Yale University in 1953 when he became Chief Resident at the Yale School of Medicine 's outpatient clinic. He started teaching psychiatry in 1955 and became an assistant professor of psychiatry and law at Yale University in 1958, teaching psychiatry and law. He continued to teach as an emeritus professor after his retirement from Yale in 1993. He served on

296-691: The World Health Organization . Another notable symposium review was published by the Medical University of Vienna in 2017: "Medical Ethics in the 70 Years after the Nuremberg Code, 1947 to the Present". President and Rector Markus Muller writes in his introduction that the Code "constitutes one of the most important milestones in the history of medicine, providing for the first time a proper framework for research on human subjects. This milestone

333-478: The " free consent to medical or scientific experimentation" of the subject. As of September 2019, the Covenant has 173 states parties. In his 2014 review, Gaw observes that the Code "not only entered the legal landscape, but also became the prototype for all future codes of ethical practice across the globe." The idea of free or informed consent also served as the basis for International Ethical Guidelines for Biomedical Research Involving Human Subjects proposed by

370-550: The "dubious experiments have no therapeutic purpose", and Fredrich von Muller, physician and the president of the Deutsche Akademie , joined the criticism. In response to the criticism of unethical human experimentation, the Weimar Republic (Germany's government from 1919 to 1933) issued "Guidelines for New Therapy and Human Experimentation". The guidelines were based on beneficence and non-maleficence , but also stressed

407-486: The Code began in pre– World War II German politics, particularly during the 1930s and 1940s. Starting in the mid-1920s, German physicians, usually proponents of racial hygiene , were accused by the public and the medical society of unethical medical practices. The use of racial hygiene was supported by the German government in order to promote an Aryan race . Racial hygiene extremists merged with National Socialism to promote

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444-640: The Code created an image that it was designed for singularly egregious transgressions. However, the Code is considered by some to be the most important document in the history of clinical research ethics , because of its massive influence on global human rights. In the United States, the Code and the related Declaration of Helsinki influenced the drafting of regulations promulgated by the United States Department of Health and Human Services to ensure ethical treatment of human research subjects, known as

481-508: The Code known as the Memorandum, which stated explicit voluntary consent from patients is required for human experimentation, was drafted on 9 August 1947. On 20 August 1947, the judges delivered their verdict against Karl Brandt and 22 others. The verdict reiterated the Memorandum's points and, in response to expert medical advisers for the prosecution, revised the original six points of the Memorandum to ten points. The ten points became known as

518-513: The Code, which includes such principles as informed consent and absence of coercion ; properly formulated scientific experimentation; and beneficence towards experiment participants. It is thought to have been mainly based on the Hippocratic Oath , which was interpreted as endorsing the experimental approach to medicine while protecting the patient. The Code was initially ignored, but gained much greater significance about 20 years after it

555-643: The Nazi party included more than 38,000 German physicians, who helped carry out medical programs such as the Sterilization Law . After World War II, a series of trials were held to hold members of the Nazi party responsible for a multitude of war crimes . The trials were approved by President Harry Truman on 2 May 1945, and were led by the United States, Great Britain, and the Soviet Union. They began on 20 November 1945, in Nuremberg , Germany, in what became known as

592-466: The Western world initially dismissed the Nuremberg Code as a "code for barbarians, but unnecessary (or superfluous) for ordinary physicians." Additionally, the final judgment did not specify whether the Code should be applied to cases such as political prisoners , convicted felons, and healthy volunteers. The lack of clarity, the brutality of the unethical medical experiments, and the uncompromising language of

629-503: The accused argued that their experiments differed little from those used before the war, and that there was no law that differentiated between legal and illegal experiments. This worried Andrew Ivy and Leo Alexander , who worked with the prosecution during the trial. In April 1947, Alexander submitted a memorandum to the United States Counsel for War Crimes outlining six points for legitimate medical research. An early version of

666-467: The author of the 1967 book Human Guinea Pigs , Andrew Ivy claimed sole authorship of the code. Leo Alexander, approximately 30 years after the trial, also claimed sole authorship. However, after careful reading of the transcript of the Doctors' trial, background documents, and the final judgements, it is more accepted that the authorship was shared and the code grew out of the trial itself. The ten points of

703-514: The award was renamed. Dr. Katz wrote extensively on subjects of medicine, law and their interconnections. His books included The Family and the Law (1964, with Joseph Goldstein), Psychoanalysis, Psychiatry and Law (1967, with Alan Dershowitz and Joseph Goldstein), Experimentation with Human Beings (1972), Catastrophic Diseases: Who Decides What? (1975, with Alexander M. Capron ) and The Silent World of Doctor and Patient (1984). He also wrote on

740-489: The code were given in the section of the judges' verdict entitled "Permissible Medical Experiments": The Code has not been officially accepted as law by any nation or as official ethics guidelines by any association. In fact, the Code's reference to Hippocratic duty to the individual patient and the need to provide information was not initially favored by the American Medical Association . Katz observes that

777-877: The committee which established the terms of patient privilege in Connecticut for psychotherapists and their patients. Enacted in 1961, it was used to establish comparable terms in the Federal Rules of Evidence that apply across the United States . Katz was named to serve on a federal inquiry into the Tuskegee Syphilis Study , an experiment started in 1932 by the United States Public Health Service in which about 400 black men in Alabama infected with syphilis were left untreated, with at least 28 of

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814-542: The community has been notified about the experiment and where the FDA has reviewed the plans in advance and approved of the protocol. Katz insisted that these changes violated the Nuremberg Code enacted in response to Nazi human experimentation conducted on unwilling prisoners during World War II , noting that "here we are making exceptions" to the first sentence of the Code's first point, which states that "The voluntary consent of

851-440: The data from the way they were obtained". He was appointed to serve on the 1994 Advisory Committee on Human Radiation Experiments , established by President Bill Clinton to investigate some 30 experiments in which individuals were unwittingly exposed to radiation. Katz issued a statement as part of the committee's report, stating that his "most serious reservations" were about the issue of protections to study subjects, and that

888-429: The discussions about ethics should happen. Some outstanding problems in discussing beneficence occur repeatedly. Researchers often describe these problems in the following categories: Many people share the view that when it is trivial to do so, people should help each other. The situation becomes more complicated when one person can help another by making various degrees of personal sacrifice. Young and Wagner provided

925-462: The existing informed consent process invites "repetitions of the dignitary insults which unconsenting citizen-patients suffered during the Cold War". In 1996, the U.S. Food and Drug Administration implemented changes that allowed doctors to perform medical studies on patients without their consent in certain situations where the patient has a life-threatening condition and cannot offer consent, where

962-569: The family of their German citizenship. His father obtained a Czechoslovakian passport, which he used to leave Germany and travel to Prague as a 16-year-old. He made it to New York City through Italy and England, with his parents and brother joining him in the United States in 1940. He graduated from The University of Vermont in 1944 and was awarded his Doctor of Medicine degree in 1949 from Harvard Medical School . He completed internship and residency programs in New York, and then enlisted in

999-406: The harm prevented or benefit gained in #2–4 is substantial, then it may be acceptable to cause one harm to gain another benefit. Academic literature discusses different variations of such scenarios. There is no objective evidence which dictates the best course of action when health professionals and researchers disagree about the best course of action for participants except that most people agree that

1036-575: The human subject is absolutely essential". Katz was involved in renaming the Cornelius P. Rhoads award given for cancer research from the American Association for Cancer Research , in 2002. He determined that although Rhoads' racist and inflammatory letter was reprehensible, Rhoads did not actually murder or inject cancer into anyone, or participate in medical misconduct. Nonetheless, due to Rhoads' racism, which denigrated Puerto Ricans and Italians,

1073-514: The importance of physicians collaborating with patients to obtain informed consent. Katz died at age 86 on November 17, 2008, at his home in New Haven, Connecticut of heart failure . Beneficence (ethics) Beneficence is a concept in research ethics that states that researchers should have the welfare of the research participant as a goal of any clinical trial or other research study. The antonym of this term, maleficence , describes

1110-417: The legal doctrine of informed consent . The guidelines clearly distinguished the difference between therapeutic and non-therapeutic research. For therapeutic purposes, the guidelines allowed administration without consent only in dire situations, but for non-therapeutic purposes any administration without consent was strictly forbidden. However, the guidelines from Weimar were negated by Adolf Hitler . By 1942,

1147-416: The question of when "can human beings be used for purposes of acquisition of knowledge" must be answered and that the disadvantaged and disempowered are often deliberately chosen as subjects. After efforts were made by scientists to make use of data from Nazi human experimentation , conducted on concentration camp inmates against their will, Katz emphasized that "however hard we might try, we cannot separate

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1184-629: The recipient. There are many different precedents in medicine and research for conducting a cost–benefit analysis and judging whether a certain action would be a sufficient practice of beneficence, and the extent to which treatments are acceptable or unacceptable is under debate. Despite differences in opinion, there are many concepts on which there is wide agreement. One is that there should be community consensus when determining best practices for dealing with ethical problems. These four concepts often arise in discussions about beneficence: Ordinary moral discourse and most philosophical systems state that

1221-463: The study subjects dying from the untreated disease and many more suffering severe injury. The group concluded that the research was "ethically unjustified", that the participants should have been given penicillin and called for greater federal oversight and protection of subjects in medical studies. Katz protested that the group should have issued a stronger response, noting that the subjects were "exploited, manipulated and deceived". Dr. Katz noted that

1258-596: The use of biology to accomplish their goals of racial purity, a core concept in the Nationalist ideology. Physicians were attracted to the scientific ideology and aided in the establishment of the National Socialist Physicians' League in 1929 to "purify the German medical community of ' Jewish Bolshevism '." Criticism was becoming prevalent; Alfons Stauder, member of the Reich Health Office, claimed that

1295-464: Was an American physician and Yale Law School professor whose career was devoted to addressing complex issues of medical ethics and other ethical problems involving the overlaps of ethics, law, medicine and psychology. Katz was born in Zwickau , Germany on October 20, 1922, where his father owned a department store. After Adolf Hitler came to power in 1933, Nazi Germany implemented rules stripping

1332-557: Was not a voluntary, precautionary measure, but only came into existence in the aftermath of Nazi atrocities. The Nuremberg Code became a cornerstone of clinical research and bioethics." In 1995, Judge Sandra Beckwith ruled in the case In Re Cincinnati Radiation Litigation (874 F. Supp 1995) that the Nuremberg Code may be applied in criminal and civil litigation in the Federal Courts of the United States . Jay Katz Jacob "Jay" Katz (October 20, 1922 – November 17, 2008)

1369-460: Was written. As a result, there were substantial rival claims for the creation of the Code. Some claimed that Harold Sebring , one of the three U.S. judges who presided over the Doctors' trial , was the author. Leo Alexander , MD and Andrew Ivy , MD, the prosecution's chief medical expert witnesses, were also each identified as authors. In his letter to Maurice Henry Pappworth , an English physician and

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