Students inResearchRutgers- The State University of New Jersey (AllCampuses) - Social / Behavioral / EpidemiologicResearch InvestigatorsQuiz ResultsYou correctly answered4 of 5quiz questions.Question 1 Show QuestionYour informed consent form must describe_______. Question 2ResultCorrectCommentPer the federal regulations, the informedconsent form must describe all foreseeablerisks and discomforts. QuestionWhich of the following studies would need IRBapproval? Question 3ResultCorrectCommentIf a study intends to collect identifiable orinformation about a living individual, you wouldneed IRB review and approval. QuestionIn the U.S., the first federal regulations forhuman subjects research began in 1981 withthe codification of the ________. CommentThe first federal regulations for human subjects Nuremberg CodeA well-known chapter in the history of research with human subjects opened on Dec. 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. 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 the 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 the “Declaration of Helsinki,” which provides 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 effective clinical practices used today.
National Research Act (1974)Because of 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. This commission was tasked with identifying the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects. It was also tasked with developing guidelines that should be followed to assure that such research is conducted in accordance with these ethical principles. The commission drafted the Belmont Report, a foundational document in for the ethics of human subjects research in the United States. The Belmont Report
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. The DHHS issued the 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
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. Sources
When was the first IRB created?On July 12, 1974, the National Research Act established the existence of IRBs to review biomedical and behavioral research involving human subjects.
Why did the IRB start?The recognition of the need for guidelines dealing with human subjects in research emerged following the Nuremberg trials, where the medical experimentation abuses of World War II Nazi doctors came to public attention.
What are human subjects according to federal regulations?A human subject is defined by Federal Regulations as “a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.”
What is the IRB charged with under the HHS and FDA?An IRB is a committee charged with protecting the rights and welfare of human subjects in research. An IRB reviews and monitors research plans, including protocols and instruments, for risks to human participants.
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