PSY-B - Psychology PSY-B 311 Lecture Notes - Lecture 9: United States Public Health Service, Institutional Review Board, National Research Act
11 Oct 2016
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Historical events that contributed to regulation of research with human participants: Incl. physicians who conducted medical experiments on concentration camp prisoners. 1950s thalidomide approved as sedative drug in europe (not approved by fda in usa) Widely prescribed in europe and us to pregnant women as sleep aid and to reduce nausea but later found to cause severe deformities of fetus (e. g. , babies born without limbs) > public outcry, us senate hearings, tightening of laws. Drug manufacturers required to prove to fda the effectiveness and safety of products. Now that government mandated research, bears some responsibility to regulate how it is done. 400 low income african-american males infected with syphilis; monitored for 40 years but not offered treatment or even informed that they had the disease. Created national commission for protection of human subjects of biomedical and. > current regulations including requirements for institutional review boards (irb) Decides whether proposed research may be conducted based on safety of ps.
