Overseeing Innovative Therapy without Mistaking It for Research: A Function-Based Model Based on Old Truths, New Capacities, and Lessons from Stem Cells

被引：34

作者：

Taylor, Patrick L. ^{[1
,2
]}

机构：

[1] Childrens Hosp Boston, Boston, MA USA

[2] Harvard Univ, Sch Med, Cambridge, MA 02138 USA

来源：

JOURNAL OF LAW MEDICINE & ETHICS | 2010年 / 38卷 / 02期

关键词：

MEDICINE; ETHICS;

D O I：

10.1111/j.1748-720X.2010.00489.x

中图分类号：

B82 [伦理学（道德学）];

学科分类号：

摘要：

Should innovative therapy occur only within a research paradigm and under institutional review board oversight? The health risks from current human embryonic stem cell clinical applications have raised again a fundamental question addressed first in papers submitted to inform the writing of the Belmont Report. Revisiting the thinking underlying the Belmont Report, together with examining changed circumstances since then, leads to a new model for overseeing innovative therapy based on its unique risks and context, important changes since the Belmont Report, and new opportunities for addressing risks through safety and quality systems in health care.

引用

页码：286 / +

页数：18

共 40 条

[1] Is academic medicine for sale? [J].

Angell, M .

NEW ENGLAND JOURNAL OF MEDICINE, 2000, 342 (20) :1516-1518

[2]

ANGELL M, 1987, HASTINGS CENT REP, V17, pS12

[3]

[Anonymous], Medicare Clinical Trial Policies

[4]

[Anonymous], DHEW PUBLICATION

[5]

[Anonymous], CROSS QUAL CHASM

[6]

ARMSTRONG D, 2005, WALL STREET J 1212, pA1

[7]

*ASS ACCR HUM RES, ACCR STAND PRINC

[8] Standards for gene therapy clinical trials based on pro-active risk assessment in a London NHS Teaching Hospital Trust [J].

Bamford, KB ;

Wood, S ;

Shaw, RJ .

QJM-AN INTERNATIONAL JOURNAL OF MEDICINE, 2005, 98 (02) :75-86

[9]

Bankert E, 2000, IRB, V22, P9, DOI 10.2307/3563586

[10]

Beauchamp T L., 2001, Principles of Biomedical Ethics. 5ed, P322

← 1 2 3 4 →