Which document was created to protect the Public from exploitation in human research
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The Nuremberg Code is one of the most influential documents in the history of clinical research.Natalie Jarmusik, Clinical Research Associate, IMARC Research The Nuremberg Code is one of the most influential documents in the history of clinical research. Created more than 70 years ago following the notorious World War II experiments, this written document established 10 ethical principles for protecting human subjects. We’ll take a closer look at its origins, its guidelines and its enduring impact. What Is the Nuremberg Code?When World War II ended in 1945, the victorious Allied powers enacted the International Military Tribunal on November 19th, 1945. As part of the Tribunal, a series of trials were held against major war criminals and Nazi sympathizers holding leadership positions in political, military, and economic areas. The first trial conducted under the Nuremberg Military Tribunals in 1947 became known as The Doctors’ Trial, in which 23 physicians from the German Nazi Party were tried for crimes against humanity for the atrocious experiments they carried out on unwilling prisoners of war. Many of the grotesque medical experiments took place at the Auschwitz concentration camp, where Jewish prisoners were tattooed with dehumanizing numbers onto their arms; numbers that would later be used to identify their bodies after death. The Doctors’ Trial is officially titled “The United States of America v. Karl Brandt, et al.,” and it was conducted at the Palace of Justice in Nuremberg, Bavaria, Germany. The trial was conducted here because this was one of the few largely undamaged buildings that remained intact from extensive Allied bombing during the war. It is also said to have been symbolically chosen because it was the ceremonial birthplace of the Nazi Party. Of the 23 defendants, 16 were found guilty, of which seven received death sentences and nine received prison sentences ranging from 10 years to life imprisonment. The other 7 defendants were acquitted. The verdict also resulted in the creation of the Nuremberg Code, a set of ten ethical principles for human experimentation. What Are The Nuremberg Code’s Ethical Guidelines For Research?The Nuremberg Code aimed to protect human subjects from enduring the kind of cruelty and exploitation the prisoners endured at concentration camps. The 10 elements of the code are:
Want to learn more about the history of clinical research? Take a minute to watch the video and explore our History of Clinical Research timeline for more detail. The Significance Of The Nuremberg CodeThe Nuremberg Code is one of several foundational documents that influenced the principles of Good Clinical Practice (GCP). Good Clinical Practice is an attitude of excellence in research that provides a standard for study design, implementation, conduct and analysis. More than a single document, it is a compilation of many thoughts, ideas and lessons learned throughout the history of clinical research worldwide. Several other documents further expanded upon the principles outlined in the Nuremberg Code, including the Declaration of Helsinki, the Belmont Report and the Common Rule. Although there has been updated guidance to Good Clinical Practice to reflect new trends and technologies, such as electronic signatures, these basic principles remain the same. The goal has always been—and always will be—to conduct ethical clinical trials and protect human subjects. The opinions expressed in this post are the author’s only and do not necessarily reflect those of MedicalDesignandOutsourcing.com or its employees. After the U.S Public Health Service’s (USPHS) Syphilis Study at Tuskegee, the government changed its research practices. In 1974, the National Research Act was signed into law, creating the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Researchexternal icon. The group identified basic principles of research conduct and suggested ways to ensure those principles were followed. In addition to the Commission’s recommendations, regulations were passed in 1974 that required researchers to get voluntary informed consent from all persons taking part in studies done or funded by the Department of Health, Education, and Welfare (DHEW). They also required that all DHEW-supported studies using human subjects be reviewed by Institutional Review Boards, which decide whether research protocols meet ethical standards. The rules and policies for human subjects research have been reviewed and revised many times since they were first approved and efforts to promote the highest ethical standards in research are ongoing. An Ethics Advisory Board was formed in the late-1970s to review ethical issues of biomedical research. As a result of their work, the 1979 publication commonly known as The Belmont Reportexternal icon summarized the three ethical principles that should guide human research: respect for persons; beneficence; justice. From 1980-1983, the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Researchexternal icon reported “every two years on the adequacy and uniformity of the Federal rules and policies, and their implementation, for the protection of human subjects in biomedical and behavioral research.” In 1991, federal departments and agencies (16 total) adopted the Federal Policy for the Protection of Human Subjectsexternal icon. In October 1995, President Bill Clinton created a National Bioethics Advisory Commissionexternal icon, funded and led by the Department of Health and Human Services. The commission’s task was to review current regulations, policies, and procedures to ensure all possible safeguards are in place to protect research volunteers. It was succeeded by the President’s Council on Bioethicsexternal icon, which was established in 2001, and then the Presidential Commission for the Study of Bioethical Issuesexternal icon established in 2009. Which document was created to protect the public from exploitation and human research?The Belmont Report was written by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.
Why is it called the Belmont Report?It was named the Belmont Report, for the Belmont Conference Center, where the National Commission met when first drafting the report. The Belmont Report is one of the leading works concerning ethics and health care research.
How can we protect human subjects in research?One of the key aspects of protecting individuals participating in research is making assurances to those participants regarding how their personal information will be protected. This includes protecting participants' privacy, keeping information confidential, and/or allowing the participant to remain anonymous.
What document was the first to summarize ethical principles and establish guidelines for human subject research?The Belmont Report identifies basic ethical principles for conducting research that involve human subjects. It also sets forth guidelines to assure these principles are followed throughout the research process.
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