Hopes for Helsinki: reconsidering "vulnerability''
Hopes for Helsinki: reconsidering "vulnerability''
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DOI：
10.1136/jme.2007.023481
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发表时间：
2008-10-01
影响因子：
4.1
通讯作者：
Schonfeld, Toby
中科院分区：
文献类型：
--
作者：
Eckenwiler, Lisa A.;Ells, Carolyn;Schonfeld, Toby
The Declaration of Helsinki is recognised worldwide as a cornerstone of research ethics. Working in the wake of the Nazi doctors’ trials at Nuremberg, drafters of the Declaration set out to codify the obligations of physician-researchers to research participants. Its significance cannot be overstated. Indeed, it is cited in most major guidelines on research involving humans and in the regulations of over a dozen countries. Although it has undergone five revisions, 1 and most recently incorporated (albeit controversial) language aimed at addressing concerns over research carried out in resource-poor countries, 2–5 theDeclaration could go much farther in addressing the profoundly altered landscape of research with humans. Research involving humans is now a global enterprise and often involves participants from resource-poor countries. Rather than being carried out at single institutions by veteran researchers, many studies are now conducted at many locations—including sites that are not academic medical centres—by new and relatively inexperienced investigators. A growing number of projects involve novel agents, based on innovative work in genomics and proteomics. Increasingly, research is sponsored by the for-profit sector. National governments and professional organisations around the globe provide laws, regulations and standards for the conduct of research involving humans. Considerable scholarship also critiques and guides this endeavour. In light of the current effort of the World Medical Association (WMA) to revise the Declaration, we offer ideas on
