W A Alves1, S N Macciocchi. 1. Department of Neurosurgery and Neuroclinical Trials Center, Virginia Neurological Institute, USA.
Abstract
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.
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.
Authors: J Hofmeijer; G J Amelink; H M den Hertog; A Algra; L J Kappelle; H B van der Worp Journal: J Neurol Neurosurg Psychiatry Date: 2007-03-30 Impact factor: 10.154