ETHICAL CONSIDERATIONS IN NEUROCLINICAL TRIALS

Ethical decision making in clinical trials has become increasingly emp hasized at many levels of the review process. Ethical concepts applica ble to Neuroclinical Trials (NCT) are reviewed. The discussion is dire cted towards ethical concerns that investigators must consider and jus tify prior to Institutional Review Board (IRB) submission. Risk-benefi t analysis, methodology (randomization; placebo; design) and consent ( informed; deferred; waived) are reviewed and Office for Protection fro m Research Risk (OPRR) guidelines are described. Our conclusions: Inve stigators proposing NCT face increasing ethical scrutiny by IRBs. Atte ntion to ethical issues early in trial planning process is recommended .