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Ethical considerations in clinical neuroscience. Current concepts in neuroclinical trials
1Department of Neurosurgery and Neuroclinical Trials Center, Virginia Neurological Institute, USA.
Background:
Ethical decision making in clinical trials has become increasingly emphasized at many levels of the review process.
Summary Of Review:
Ethical concepts applicable to neuroclinical trials are reviewed. The discussion is directed toward ethical concerns that investigators must consider and justify prior to institutional review board submission. Risk-benefit analysis, methodology (randomization, placebo, design), and consent (informed, deferred, waived) are reviewed and guidelines of the Office for Protection From Research Risk are described.
Conclusions:
Investigators proposing neuroclinical trials face increasing ethical scrutiny by institutional review boards. Attention to ethical issues early in the trial planning process is recommended.