Requirements in latest revision of Declaration of Helsinki but absent in GCP:
Investigators to disclose funding, sponsors, and other potential conflicts of interest to both research ethics committees and study participants
Study design to be disclosed publicly (eg, in clinical trial registries)
Research, notably that in developing countries, to benefit and be responsive to health needs of populations in which it is done.
Restricted use of placebo controls in approval process for new drugs and in research done in developing countrie
Post-trial access to treatment
Authors to report results accurately, and publish or make public negative findings
The article calls for an immediate return to the old rule while the matter be reconsidered.
[Daly's comment:] I agree with the authors that the new rule should be suspended until the Obama administration can reconsider the matter. The change, made by a Bush administration more interested in pandering to its (industrial) constituencies than in protecting the public, creates undue risks for people in developing nations. It will also result in foreign policy problems for the United States.
Posted by
Peter Suber at 1/07/2009 12:02:00 PM.
The open access movement:
Putting peer-reviewed scientific and scholarly literature
on the internet. Making it available free of charge and
free of most copyright and licensing restrictions.
Removing the barriers to serious research.
