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(Stroke. 1996;27:1903-1909.)
© 1996 American Heart Association, Inc.

Articles

Ethical Considerations in Clinical Neuroscience

Current Concepts in Neuroclinical Trials

Wayne A. Alves, PhD Stephen N. Macciocchi, PhD

the Department of Neurosurgery and Neuroclinical Trials Center, Virginia Neurological Institute (W.A.A.), and the Departments of Physical Medicine and Rehabilitation and of Psychiatric Medicine (S.N.M.), University of Virginia Medical School (Charlottesville).

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.

Key Words: clinical trials • ethics, medical • informed consent

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