Prior to 1906, when the Pure Food and Drug Act was passed, there were no regulations regarding the ethical use of human subjects in research. There were no consumer regulations, no Food and Drug Administration (FDA), no Common Rule, and no Institutional Review Board (IRB). What follows is a brief discussion of why federal rules and regulations were established and why the IRB became a necessity. Show
Nuremberg CodeA well-known chapter in the history of research with human subjects opened on December 9, 1946, when an American military tribunal opened criminal proceedings against 23 leading German physicians and administrators for their willing participation in war crimes and crimes against humanity. Among the charges were that German physicians conducted medical experiments on thousands of concentration camp prisoners without their consent. Most of the subjects of these experiments died or were permanently crippled as a result. As a direct result of the trial, the Nuremberg Code was established in 1948, stating that "The voluntary consent of the human subject is absolutely essential," making it clear that subjects should give consent and that the benefits of research must outweigh the risks. Although it did not carry the force of law, the Nuremberg Code was the first international document which advocated voluntary participation and informed consent. ThalidomideIn the late 1950s, thalidomide was approved as a sedative in Europe; it was not approved in the United States by the FDA. The drug was prescribed to control sleep and nausea throughout pregnancy, but it was soon found that taking this drug during pregnancy caused severe deformities in the fetus. Many patients did not know they were taking a drug that was not approved for use by the FDA, nor did they give informed consent. Some 12,000 babies were born with severe deformities due to thalidomide. U.S. Senate hearings followed and in 1962 the so-called "Kefauver Amendments" to the Food, Drug and Cosmetic Act were passed into law to ensure drug efficacy and greater drug safety. For the first time, drug manufacturers were required to prove to FDA the effectiveness of their products before marketing them. Tuskegee Syphilis Study (1932-1972)An equally well known chapter in history occurred during a research project conducted by the U.S. Public Health Service. Six hundred low-income African-American males, 400 of whom were infected with syphilis, were monitored for 40 years. Free medical examinations were given; however, subjects were not told about their disease. Even though a proven cure (penicillin) became available in the 1950s, the study continued until 1972 with participants being denied treatment. In some cases, when subjects were diagnosed as having syphilis by other physicians, researchers intervened to prevent treatment. Many subjects died of syphilis during the study. The study was stopped in 1973 by the U.S. Department of Health, Education, and Welfare only after its existence was publicized and it became a political embarrassment. In 1997, under mounting pressure, President Clinton apologized to the study subjects and their families. Declaration of HelsinkiIn 1964, the World Medical Association established recommendations guiding medical doctors in biomedical research involving human subjects. The Declaration governs international research ethics and defines rules for "research combined with clinical care" and "non-therapeutic research." The Declaration of Helsinki was revised in 1975, 1983, 1989 and 1996 and is the basis for Good Clinical Practices used today. Issues addressed in the Declaration of Helsinki include:
National Research Act (1974)Due to the publicity from the Tuskegee Syphilis Study, the National Research Act of 1974 was passed. The National Research Act created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, which was charged to identify the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects and to develop guidelines which should be followed to assure that such research is conducted in accordance with those principles. The Commission drafted the Belmont Report, a foundational document in for the ethics of human subjects research in the United States. In Summary:
Current RegulationsIn 1981, the Department of Health and Human Services (DHHS) and the Food and Drug Administration (FDA) issued regulations based on the Belmont Report. DHHS issued Code of Federal Regulations (CFR) Title 45 (public welfare), Part 46 (protection of human subjects). The FDA issued CFR Title 21 (food and drugs), Parts 50 (protection of human subjects) and 56 (Institutional Review Boards). In 1991, the core DHHS regulations (45 CFR Part 46, Subpart A) were formally adopted by more than a dozen other Departments and Agencies that conduct or fund research involving human subjects as the Federal Policy for the Protection of Human Subjects, or "Common Rule." In 1991, the Department of Veterans Affairs promulgated this same rule at 38 CFR Part 16. Today, the 1991 Federal Policy is shared by 17 Departments and Agencies, representing most, but not all, of the federal Departments and Agencies sponsoring human-subjects research. The main elements of the Common Rule include:
In addition, certain federally sponsored and much privately sponsored research is subject to the regulations of the Food and Drug Administration (FDA) at 21 CFR Parts 50 and 56. FDA regulations confer protections on human subjects in research when a drug, device, biologic, food additive, color additive, electronic product, or other test article subject to FDA regulation is involved. FDA regulations and the provisions of the Common Rule are largely congruent, although some significant differences exist. Both the Common Rule and the FDA regulations provide protections for human subjects in research. Hippocrates (400 BCE) and Oath: “Do no harm...“ Individual responsibility of researcher two millennia Walter Reed (1900) Consent forms in Spanish and English: malaria research Nuremberg Code (1946) Twenty-six medical researchers from holocaust tried for unethical conduct toward “vulnerable” population. Rules and principles developed. Wichita, Kansas (1950’s) Secret audio taping of jury deliberations for legal research. University of Chicago challenged in Congress by James Eastland (of Ruleville, MS). NIH Clinical Research Center at Bethesda (1960) sets up internal review committee and many other research hospitals voluntarily follow suit. Thalidomide an experimental drug in Europe was allowed for use in the United States with waiver of clinical trials by FDA (1962). Those receiving drug were not warned that it was still ‘experimental’. Sloan-Kettering conducts research using “live” cancer cells on humans (1963). Subjects were told that research was testing their resistance to cancer, but not that they would receive live cancer cells. One MD tried to stop it and took Sloan-Kettering to court where defendants were convicted of assault & battery. Malpractice was also shown. James Shannon (1964) at NIH reviews protections for all human subjects in NIH funded research. Agency begins taking a leading role in protecting human subjects. Stanley Milgram (1965) conducted famous research on ‘obedience’, using deception as part of the design. Despite debriefing, a strong outcry from other professionals. Henry K. Beecher (1966) reviewed biomedical research literature and showed that human subjects protections were violated in over 500 papers. His analysis was published in the New England Journal of Medicine and in two books (see References). PHS research on untreated syphilis (1972) was initiated in the Alabama in the 1930’s. The longitudinal project continued for years, and even after the use of penicillin, 300+ African American subjects were left untreated (and uninformed). Senator Edward Kennedy challenged this research in Congress. The National Research Act (1974) was passed by Congress. IRB’s were established and a National Commission for Protection of Human Subjects was established. The Belmont Report (1978) was published, based on the Presidentially commissioned work of MD Psychologists, Lawyers, and Biomedical and Behavioral Ethicists. This beautifully reasoned and written document proposed to go beyond “rules and regulations” to propose principles to use in judgments about protecting human subjects.
Vulnerable subject samples (1980-present) More recently, guidelines and regulations have been developed to guide researchers on protecting rights of “vulnerable” subjects including economically disadvantaged, minority, prisoners, mentally incompetent, pregnant mothers, fetuses, and even fetal tissues. While these issues are important, the volume of effort by Congress and federal agencies clearly illustrate political implications, rather than the moral or ethical considerations which are more important. What are the 4 principles of ethical research?An overview of ethics and clinical ethics is presented in this review. The 4 main ethical principles, that is beneficence, nonmaleficence, autonomy, and justice, are defined and explained. Informed consent, truth-telling, and confidentiality spring from the principle of autonomy, and each of them is discussed.
What are the 3 basic ethical principles governing research conduct?Three basic principles, among those generally accepted in our cultural tradition, are particularly relevant to the ethics of research involving human subjects: the principles of respect of persons, beneficence and justice.
What is the principle of beneficence in research?The beneficence principle includes two specific research aspects: (1) participants' right to freedom from harm and discomfort and (2) participants' rights to protection from exploitation.[8]
What are the 7 basic principles of code of ethics in research?In practice, these ethical principles mean that as a researcher, you need to: (a) obtain informed consent from potential research participants; (b) minimise the risk of harm to participants; (c) protect their anonymity and confidentiality; (d) avoid using deceptive practices; and (e) give participants the right to ...
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A subject’s right to fair selection and treatment in a study is related to which ethical principle?
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