Ethical considerations in neuroclinical trials.

Ethical decision making in clinical trials has become increasingly emphasized at many levels of the review process. Ethical concepts applicable to Neuroclinical Trials (NCT) are reviewed. The discussion is directed towards ethical concerns that investigators must consider and justify prior to Institutional Review Board (IRB) submission. Risk-benefit analysis, methodology (randomization: placebo; design) and consent (informed; deferred; waived) are reviewed and Office for Protection from Research Risk (OPRR) guidelines are described. Our conclusions: Investigators proposing NCT face increasing ethical scrutiny by IRBs. Attention to ethical issues early in trial planning process is recommended.