Institutional Review Boards as Arbiters of Expanded Access to Unapproved Drugs: Time for a Change?

被引：2

作者：

Redman, Barbara K. ^{[1
]}

Bateman-House, Alison Shea ^{[1
]}

机构：

[1] NYU, Sch Med, 227 E 30th St,754A, New York, NY 10016 USA

来源：

THERAPEUTIC INNOVATION & REGULATORY SCIENCE | 2016年 / 50卷 / 04期

关键词：

institutional review boards (IRBs); regulation; compassionate use; preapproval access; ethics;

D O I：

10.1177/2168479016628918

中图分类号：

R-058 [];

学科分类号：

摘要：

Institutional review boards (IRBs) are one of the bodies charged with prospectively reviewing compassionate use, the hopefully therapeutic use of an unapproved drug in a seriously ill or dying patient who has no other treatment options. However, there are ethical issues in assigning this role to a body whose primary purpose is to review research proposals. The role of IRBs with regard to compassionate use must be examined and potentially revised.

引用

页码：515 / 516

页数：2

共 15 条

[1] Institutional Review Boards as Arbiters of Expanded Access to Unapproved Drugs: Time for a Change?
Barbara K. Redman
Alison Shea Bateman-House
Therapeutic Innovation & Regulatory Science, 2016, 50 : 515 - 516
[2] It Is Time to Professionalize Institutional Review Boards
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ARCHIVES OF PEDIATRICS & ADOLESCENT MEDICINE, 2009, 163 (12): : 1163 - 1164
[3] Institutional review boards under stress: Will they explode or change?
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[6] Is it time to rethink institutional review boards for the era of big data?
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[7] Improving Expanded Access in the United States: The Role of the Institutional Review Board
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[8] Improving Expanded Access in the United States: The Role of the Institutional Review Board
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Bateman-House, Alison
THERAPEUTIC INNOVATION & REGULATORY SCIENCE, 2018, 52 (03) : 285 - 293
[9] Time required to review research protocols at 10 Veterans Affairs Institutional Review Boards
Varley, Patrick R.
Feske, Ulrike
Gao, Shasha
Stone, Roslyn A.
Zhang, Sijian
Monte, Robert
Arnold, Robert M.
Hall, Daniel E.
JOURNAL OF SURGICAL RESEARCH, 2016, 204 (02) : 481 - 489
[10] Time, place, and consciousness: Three dimensions of meaning for US institutional review boards
Putney, SB
Gruskin, S
AMERICAN JOURNAL OF PUBLIC HEALTH, 2002, 92 (07) : 1067 - 1070

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