US clinical-research system in need of review

Clinical Trials Sunday, June 16th, 2013

Nature – June 05, 2013

It is time for a far-reaching and comprehensive review of the way US government-backed clinical research is funded and approved. Ethical reviews of much of this work are currently inadequate and problems come to light too late.

In the most recent example, the US Department of Health and Human Services (HHS) judged that researchers carrying out a study on optimal oxygen administration in infants of low birth weight had failed to fully inform parents about the risks involved.

Clinical researchers defend such studies. But it is clear that too many institutional review boards (IRBs), which give clinical studies the green light, do not have the expertise to thoroughly review the science and ethics of complex clinical trials. Read more

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