Protections for clinical trials in low and middle income countries need strengthening not weakening

被引：18

作者：

Dal-Re, Rafael ^{[1
]}

Ndebele, Paul ^{[2
]}

Higgs, Elizabeth ^{[3
]}

Sewankambo, Nelson ^{[4
]}

Wendler, David ^{[5
]}

机构：

[1] Univ Autonoma Madrid, BUC Biosci UAM CSIC Program, E-28049 Madrid, Spain

[2] Med Res Council Zimbabwe, Harare, Zimbabwe

[3] NIAID, Div Clin Res, Off Director, NIH, Bethesda, MD 20892 USA

[4] Makerere Univ, Coll Hlth Sci, Makerere, Uganda

[5] NIH, Unit Vulnerable Populat, Dept Bioeth, Ctr Clin, Bethesda, MD 20892 USA

来源：

BMJ-BRITISH MEDICAL JOURNAL | 2014年 / 349卷

关键词：

OBLIGATIONS; PROVISION; BENEFITS; WORLD;

D O I：

10.1136/bmj.g4254

中图分类号：

R5 [内科学];

学科分类号：

100201 [内科学];

摘要：

[No abstract available]

引用

页数：5

共 33 条

[1]

[Anonymous], 2000, Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects

[2]

[Anonymous], 2002, INT ETH GUID BIOM RE

[3]

[Anonymous], 1979, Federal Register, V44, P23192

[4]

[Anonymous], 2008, DECL HELS ETH PRINC

[5]

[Anonymous], 2013, DECL HELS ETH PRINC

[6]

Phase II and Phase III attrition rates 2011-2012 [J].

Arrowsmith, John ;

Miller, Philip .

NATURE REVIEWS DRUG DISCOVERY, 2013, 12 (08) :568-568

[7]

A decade of change [J].

Arrowsmith, John .

NATURE REVIEWS DRUG DISCOVERY, 2012, 11 (01) :17-18

[8]

Ballantyne AJ, 2010, AM J BIOETHICS, V10, P26, DOI 10.1080/15265161.2010.482629

[9]

Casarett D, 2001, IRB, V23, P1, DOI 10.2307/3563676

[10]

REPORTING OF INFORMED CONSENT, STANDARD OF CARE AND POST-TRIAL OBLIGATIONS IN GLOBAL RANDOMIZED INTERVENTION TRIALS: A SYSTEMATIC SURVEY OF REGISTERED TRIALS [J].

Cohen, Emma R. M. ;

O'Neill, Jennifer M. ;

Joffres, Michel ;

Upshur, Ross E. G. ;

Mills, Edward .

DEVELOPING WORLD BIOETHICS, 2009, 9 (02) :74-80

← 1 2 3 4 →