Ethical considerations in clinical neuroscience. Current concepts in neuroclinical trials.

Abstract

Ethical decision making in clinical trials has become increasingly emphasized at many levels of the review process. 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. Investigators proposing neuroclinical trials face increasing ethical scrutiny by institutional review boards. Attention to ethical issues early in the trial planning process is recommended.