Historical Events, Evolution of Regulations, and Phases & Types of Studies Flashcards
The Nuremberg Code
Year : 1947
a set of standards that were part of a judgment made in “The Nazi Doctors Trial”.
>informed consent of volunteers must be obtained without coercion in any form and able to terminate participation anytime
>human experiments should be based upon prior animal studies
>anticipated scientific results should justify the experiment
>only qualified scientists should conduct medical research
>physical and mental suffering or injury should be avoided
>there should be no expectation of death or disabling injury from the experiment
National Research Act
Year : 1974
passed by Congress authorized federal agencies to develop human research regulations (45 CFR 46, 21 CFRs). IRB’s were established and a National Commission for Protection of Human Subjects was established. It required that all human subject research be reviewed by an IRB/IEC to ensure human subject protections. 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.
The Belmont Report
Year : 1978
> > the three basic principles are respect for persons, beneficence, and justice
respect for persons: manifested by the informal consent process, as well as in safeguards for the vulnerable populations, such as children, pregnant women, mentally disabled adults and prisoners. other important concerns of respect for persons are privacy and confidentiality
beneficence: do no harm and maximize benefit while minimizing risk. beneficence is manifested in the use of good research design, competent investigators and a favorable risk/benefit ratio
justice: implies fairness and is manifested in the equitable selection of subjects for research, ensuring that no group of people is “selected in” or “selected out” unfairly based on factors unrelated to the research.
Kefauver-Harris Drug Amendment
Year : 1962
was a result of US Senate hearing following the use of the Thalidomide Drug. Manufacturers were required to provide proof of effectiveness of their drugs prior to approval. This amendment also required that side effects were to be reported.
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.
The Declaration of Helsinki (DoH)
Year : 1964
governs international research ethics and defines
rules for “research combined with clinical care” and “non-therapeutic research.” The Declaration is the
basis for Good Clinical Practices used today. The Declaration of Helsinki addresses the following: (1)
Research with humans should be based on the results from laboratory and animal experimentation, (2)
Research protocols should be reviewed by an independent committee prior to initiation, (3) Informed
consent from research participants is necessary,(4) Research should be conducted by
medically/scientifically qualified individuals and (5) Risks should not exceed benefits
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it repeats the Nuremberg Code requirements for consent for non-therapeutic research but emphasizes the importance of consent when enrolling patients in therapeutic research. the DoH also added that legal guardians need to grant permission to enroll subjects in research, both therapeutic and non-therapeutic, and recommends written consent – an important issue not addressed in the Nuremburg Code. in addition, the DoH requires review and prior approval of a protocol by an ethics committee `
FDA Regulations Title 21
Year : 1981
Department of Health and Human Services (DHHS)
Issued the Code of Federal Regulations (CFR)
»_space; Title 45 (public welfare)
»_space; Part 46 (protection of human subjects)
Food and Drug Administration (FDA)
Issued the Code of Federal Regulations (CFR)
»_space; Title 21 (food and drugs)
»_space; Part 50 (protection of human subjects)
»_space; Part 56 (Institutional Review Boards)
Common Rule
Year : 1991
CFR 45 part 46
Set of ethics involving the protection of human subjects was
adopted by 17 Federal agencies. The main elements of the Common Rule include: (1) requirements for
assuring compliance by research institutions, (2) requirements for researchers obtaining and
documenting informed consent, (3) requirements for Institutional Review Board (IRB) membership,
function, operations, review of research, and record keeping, (4) additional protections for certain
vulnerable research subjects– pregnant women, prisoners, and children