BME 314 Lecture 23 2012


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Unformatted text preview: y be obtained; An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research­related injury to the subject; and A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled. What do you need in an informed consent? Whenever appropriate, one or more of the following elements of information shall also be provided to each subject: A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable ; Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent/authorization; Any additional costs to the subject that may result from participation in the research; The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject; A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject; and The approximate number of subjects involved in the study. Before performing research with Before performing research with human subjects here at UT Go to: If you are not sure whether you need informed consent or not, check with the IRB first EVEN if you are sure you do not need informed consent check with the IRB History of Research on Humans History of Research on Humans Atrocities and ethical disasters give rise to ethical codes and laws Nazi atrocities Nuremberg code Thalidomide disaster Kefauver Amendments Tuskegee Syphilis Study Belmont Report Source: “History of Research Ethics.” Office for the Protection of Research Subjects. Nuremberg Code Nuremberg Code The trials were conducted in 1946­7 by an American military tribunal Criminal proceedings against 23 German doctors who conducted horrible experiments on concentration camp prisoners Nuremberg Code established in 1948: “The voluntary consent of the human subject is absolutely essential.” Thalidomide caused 12,000 babies Thalidomide caused 12,000 babies to be born severely deformed Prescription drug prescribed in late 1950s Not approved by FDA, but FDA approval not yet required. U.S. Senate hearings followed 1962 Kefauver Amendments to FDA required drug manufacturers to prove safety Tuskegee Syphilis Study, Tuskegee Syphilis Study, 1932­1...
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This note was uploaded on 03/17/2014 for the course BME 314 taught by Professor Frey during the Spring '08 term at University of Texas.

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