Annals of Oncology 13:1837-1838, 2002
© 2002 European Society for Medical Oncology
News |
Safety of human research participants
| The first 150 words of the full text of this article appear below. |
In Europe, the new clinical research directives of the European Union, to be implemented by 2003, are presenting a challenge that even large academic institutions such as EORTC struggle to match. Meanwhile, changes in US law also seem imminent. The US Institute of Medicine (IOM) feels that federal oversight is needed to ensure better protection of the health and well-being of people enrolled in research studies, whether publicly or privately funded.
The IOM stated that the US Congress (which was elected on 5 November 2002) should require every organization conducting research with human subjects to do so under the authority of a research participant protection program, which would be subject to federal oversight. They did, however, add that ultimate responsibility for ensuring that the essential protections are in place and followed must rest with the highest levels of the research organization’s leadership.
Daniel Federman, senior dean for alumni relations and
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