History and Ethical Principles – SBE Latest Update 100% Verified

History and Ethical Principles – SBE Latest Update 100% Verified Introduction Research with human subjects has a long and often troubled history in the United States (U.S.) and throughout the world. Chances are you already have heard of some of the most egregious and well-known examples of unethical research in the biomedical sciences, such as the experiments conducted by Nazi doctors and scientists on concentration camp prisoners during World War II, and the U.S. Public Health Service (PHS) study titled "Tuskegee Study of Untreated Syphilis in the Negro Male" (Tuskegee Study). These abuses led to the creation of codes of research ethics in Europe and the U.S. In the wake of the Second World War, the subsequent Nuremberg Trials on war crimes produced the Nuremberg Code, which outlined ten points for conducting ethical research with human subjects. Nearly two decades later, the World Medical Association (WMA) developed a code of research ethics known as the Declaration of Helsinki, published in 1964 and subsequently revised. This document is built on both the Nuremberg Code and the physician's code of ethics known as the Declaration of Geneva. In the U.S., news that researchers deceived and withheld treatment from subjects who suffered from syphilis in the Tuskegee Study led to the creation of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (National Commission or "the Commission"). The Commission was charged with establishing a code of research ethics for U.S. research involving human subjects. In 1979, the Commission issued the Belmont Report, the foundational document of the current system of U.S. human subjects protections. The Belmont Report outlines three key ethical principles for conducting research with human subjects: respect for persons, beneficence, and justice. The Belmont Report, in turn, informed the U.S. Department of Health and Human Services (HHS) Code of Federal Regulations (45 CFR 46), which was created in 1974 and later revised. In 1991, Subpart A of these regulations "Basic HHS Policy for the Protection of Human Research Subjects" was adopted by 15 federal agencies and became known as the Common Rule. Landmark social sciences studies such as Milgram's Obedience to Authority study, Zimbardo's Stanford Prison Experiment, and Humphreys's Tearoom Trade study , made it clear that social and behavioral research may carry risks of harm related to psychological well-being , violations of autonomy and privacy, and reputational damage. Despite good intentions and best efforts, researchers are not always able to anticipate risks of harm. This module aims to bring human subjects protections into focus for researchers in the social and behavioral sciences, education, and the humanities, by examining the complex issues raised by research with human subjects and how these issues may be addressed using the ethical principles outlined in the Belmont Report. Respect for Persons Respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection. The principle of respect for persons thus divides into two separate moral requirements: the requirement to acknowledge the autonomy and the requirement to protect those with diminished autonomy (The National Commission 1979). Autonomy Autonomy means that people must be empowered to make decisions concerning their own actions and well-being. According to the principle of respect for persons, researchers must acknowledge the "considered opinions and choices" of research subjects. In other words, individuals must be given the choice whether to participate in research, and they must be provided sufficient information and possess the mental competence to make that choice. Respect for persons also recognizes that some individuals may not be capable of making decisions or choices that are in their best interest. Individuals with "diminished decision-making capacity" may lack the ability to comprehend study procedures or how participating in a study might adversely affect them. Special care should be taken to protect those with diminished capacity to the point of excluding individuals who are not able