Conducting Stroke Research With an Exception From the Requirement for Informed Consent

Author:

Bateman Brian T.1,Meyers Philip M.1,Schumacher H. Christian1,Mangla Sundeep1,Pile-Spellman John1

Affiliation:

1. From the College of Physicians and Surgeons, Columbia University (B.T.B.); Departments of Radiology (P.M.M., S.M., J.P-S.) and Neurological Surgery (P.M.M., J.P-S.), University Hospitals of Columbia and Cornell; and Doris and Stanley Tananbaum Stroke Center (H.S.C.), Neurological Institute, Columbia-Presbyterian Medical Center, New York, NY.

Abstract

Background— Obtaining viable informed consent from stroke patients for participation in clinical trials of acute stroke therapies is often problematic because of patients’ neurological deficits. Furthermore, obtaining permission from surrogates is often not possible or not legally permissible. Summary of Review— In 1996 the Food and Drug Administration and Department of Health and Human Services published regulations that allow investigators to conduct emergency research without patient consent under a narrowly defined set of circumstances. We review requirements of these regulations, paying particular attention to how they may be applied in a clinical trial of an acute stroke therapy. Conclusions— Acute stroke researchers should consider conducting clinical trials with an exception from the informed consent requirement permitted by this law.

Publisher

Ovid Technologies (Wolters Kluwer Health)

Subject

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

Reference62 articles.

1. American Heart Association. 2002 Heart and Stroke Statistical Update. Dallas Tex: American Heart Association; 2001.

2. Tissue Plasminogen Activator for Acute Ischemic Stroke

3. Connors JJ Wojak JC. Current directions in emergency stroke therapy. In: Connors JJ Wojak JC eds. Interventional Neuroradiology: Strategies and Practical Techniques. New York NY: WB Saunders Co; 1999: 629–634.

4. Intra-arterial Prourokinase for Acute Ischemic Stroke

同舟云学术

1.学者识别学者识别

2.学术分析学术分析

3.人才评估人才评估

"同舟云学术"是以全球学者为主线,采集、加工和组织学术论文而形成的新型学术文献查询和分析系统,可以对全球学者进行文献检索和人才价值评估。用户可以通过关注某些学科领域的顶尖人物而持续追踪该领域的学科进展和研究前沿。经过近期的数据扩容,当前同舟云学术共收录了国内外主流学术期刊6万余种,收集的期刊论文及会议论文总量共计约1.5亿篇,并以每天添加12000余篇中外论文的速度递增。我们也可以为用户提供个性化、定制化的学者数据。欢迎来电咨询!咨询电话:010-8811{复制后删除}0370

www.globalauthorid.com

TOP

Copyright © 2019-2024 北京同舟云网络信息技术有限公司
京公网安备11010802033243号  京ICP备18003416号-3