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Informed Consent Means More Than a Signature

Kate Traynor

Collecting paperwork to document compliance with regulations that protect clinical trial participants misses the point behind the rules, says a commentary in the April 9 Archives of Internal Medicine (PDF).

According to the commentators, a bioethicist and a law professor, the burden is on researchers to ensure that study participants fully understand the risks and benefits associated with clinical trials.

Of particular importance, said the authors, is that people who sign informed consent documents understand that the experimental therapy may be of less benefit to study enrollees than to future patients. Also critical is that the person explaining the possible benefits of experimental therapy not overstate them to study participants and that patients realize the therapy may not be the best treatment available. Finally, clinicians must ensure that trust is maintained among patients, hospitals, and clinicians involved in experimental research.

Protection of clinical trial participants is increasingly important now that federal policies require the recruitment of more women, children, and ethnically diverse populations in many studies, the commentators said.