The Ethical Problems of the Open Label Extension Study
Micetich, Kenneth Craig
Cambridge Quarterly of Healthcare Ethics. 1996 Summer; 5(3): 410-414.
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. The problems can, in part, be solved by informing the patient prior to OLES participation of RDBS treatment identity and whether the RDBS participants objectively benefitted from the treatment. This peek and tell procedure would be consistent with the principle of beneficence and sound medicine. There are also concerns that prior knowledge of possible participation in an OLES may entice participants into enrolling in the RDBS and that OLES serves the interests of the sponsor and not those of the participants. IRBs should carefully consider the wisdom of approving OLES as they are currently structured.
Alternatives; Autonomy; Beneficence; Consent; Disclosure; Drugs; Ethics; Ethics Committees; Human Experimentation; Incentives; Informed Consent; Investigators; Knowledge; Medicine; Research; Research Design; Research Ethics; Research Ethics Committees; Research Subjects; Risks and Benefits; Selection of Subjects; Therapeutic Research;
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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 ...