Reflections of an IRB Chair
Micetich, Kenneth Craig
Cambridge Quarterly of Healthcare Ethics. 1994 Fall; 3(4): 506-509.
In summary, the local IRB is now and probably always will be the sole protection afforded the research participant. It is incorrect to perceive local IRBs as having jurisdiction only over the consent process. Multiple levels of review of a cooperative group- or company-sponsored protocol prior to IRB submission do not guarantee that there are no serious design flaws in the study that would render the results invalid or not statistically credible. The most serious error an IRB can make (on a par with failing to obtain proper consent) is to approve a study that cannot possibly test the hypothesis in a credible fashion.
Cancer; Compensation; Conflict of Interest; Consent Forms; Consent; Drug Industry; Drugs; Economics; Ethical Review; Ethics; Ethics Committees; Federal Government; Financial Support; Food; Forms; Government; Human Experimentation; Industry; Informed Consent; Injuries; Investigational Drugs; IRB; Medical Devices; Random Selection; Regulation; Research; Research Design; Research Ethics; Research Ethics Committees; Research Subjects; Review; Risks and Benefits;
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Micetich, Kenneth Craig (1996)In summary, the relationship between RDBS [randomized double-blind study] and OLES [open label extension study] violates the principles of beneficence and autonomy and is not consistent with the sound practice of medicine. ...