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FDA regulations
Clinical investigators required to certify informed consent as required by the Kefauver-Harris amendments. -
Food and Drug Act
Requires that drugs be shown to be safe before marketing. This leads to the need for human trials -
Helsinki Declaration signed by U.S.
Clinical research should be based on animal and laboratory experiments.
Clinical research should be conducted and supervised only by qualified medical workers.
Clinical research should be preceded by a careful assessment of risks and benefits to the patient.
Human beings should be fully informed and must freely consent to the research.
Responsibility for the human subject must always rest with a medically qualified person, and never with the subject.
Results of experiments that do not compl -
U.S. Surgeon General policy statement
All human subject research requires independent prior review. Origin of Institutional Review Boards (IRBs). -
National Research Act
Regulations to be codified.
All research funded by DHEW to be reviewed by IRBs -
President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research
Recommended that all federal agencies adopt the human subject regulations of the Department of Health and Human Services -
Final report of Advisory Committee on Human Radiation Experiments
Further means required to ensure highest ethical standards.
Special care to be taken where research must be kept secret. -
National Bioethics Advisory Commission (NBAC)
Series of ethical and policy reports -
World Health Organization Operational guidelines for ethics committees that review biomedical research
Intended to facilitate and support ethical review in all countries around the world. Suggests role, constituents and requirements for ethics committees -
Best Pharmaceuticals for Children Act
Provides six-month patent extension for manufacturers who conduct voluntary pediatric trials. -
Suspension of rule requiring pediatric studies of medicines for children.
Two-year suspension of 1997 rule. Safety concerns considered addressed by incentive under Best Pharmaceutical for Children Act, above.