Health Sciences 2610F/G Chapter Notes - Chapter 3: Randomized Controlled Trial, Institutional Review Board, World Medical Association
27 Feb 2013
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Document Summary
Belmont report 1979- identified respect for persons as autonomous agents, beneficence, and justice as necessary principles for any research to be justified: to be ethical, all medical research on humans must conform to these requirements. Institutional review boards (irbs) have authority and responsibility to monitor research protocols to ensure that these 5 conditions are met. Clinical trials designed to test the safety and efficacy of a drug/surgical procedure before it is used on patients in a clinical setting. Administration (fda) and has been marketed, trials used to monitor a drugs side effects and to collect more info for possible additional uses. Design of trial becomes esp. imp in phase ii- control group is introduced as a point of comparison with the intervention group receiving the experimental treatment. Placebo response: physiological changes in our bodies that occur because we expect them to occur.
