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Howlers in Human Research Protections

Informed Consent on Trial Daniel Cressey Nature News 2012-01-30: http://www.nature.com/news/informed-consent-on-trial-1.9933

The US Department of Health and Human Services is currently consulting about revising clinical-trial regulations, and looks likely to demand shorter, more understandable consent forms, although there is no specific deadline for a decision. Our effort is to enable a patient who is contemplating enrolling in a clinical trial to have clear and full information to use in making a decision, says Ann Bradley, a spokeswoman for the department's Office for Human Research Protections. A number of US medical groups are backing the effort: the American Society of Hematology in Washington DC, for example, says that in addition to making the process less burdensome for researchers, shorter forms could help to increase the number of patients recruited to clinical trials.


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