Ethical considerations in clinical neuroscience - Current concepts in neuroclinical trials

被引：9

作者：

Alves, WA

Macciocchi, SN

机构：

[1] UNIV VIRGINIA, DEPT PHYS MED & REHABIL, CTR HLTH SCI, CHARLOTTESVILLE, VA 22901 USA

[2] UNIV VIRGINIA, DEPT PSYCHIAT MED, CTR HLTH SCI, CHARLOTTESVILLE, VA 22901 USA

[3] VIRGINIA NEUROL INST, DEPT NEUROSURG, CHARLOTTESVILLE, VA 22901 USA

[4] VIRGINIA NEUROL INST, NEUROCLIN TRIALS CTR, CHARLOTTESVILLE, VA 22901 USA

来源：

STROKE | 1996年 / 27卷 / 10期

关键词：

clinical trials; ethics; medical; informed consent;

D O I：

10.1161/01.STR.27.10.1903

中图分类号：

R74 [神经病学与精神病学];

学科分类号：

摘要：

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.

引用

页码：1903 / 1909

页数：7

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