Ethical Considerations in Clinical Neuroscience-Reference-Cited by-同舟云学术

Ethical Considerations in Clinical Neuroscience

Published:1996-10 Issue:10 Volume:27 Page:1903-1909
ISSN:0039-2499
Container-title:Stroke
language:en
Short-container-title:Stroke

Author:

Alves Wayne A.¹,Macciocchi Stephen N.¹

Affiliation:

1. 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).

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.

Publisher

Ovid Technologies (Wolters Kluwer Health)

Subject

Advanced and Specialised Nursing,Cardiology and Cardiovascular Medicine,Clinical Neurology

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