The Ethical Problems of the Open Label Extension Study
Micetich, Kenneth Craig
Cambridge Quarterly of Healthcare Ethics 1996 Summer; 5(3): 410-414
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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. ...
Wainwright, P. (2002-12)A frequent feature of pharmaceutical research is the open label extension study, in which patients participating in double blind placebo controlled trials of new medications are invited, on completion of the initial trial, ...
Micetich, Kenneth Craig (1994)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 ...