Wednesday, February 8, 2012

"Informed Consent Is 20 Pages of Nothing"

Nature reporter Daniel Cressy writes that

Informing clinical-trial participants of the risks they face is a cornerstone of modern medical research, and it is enshrined as a human right in international codes of ethics. But an influential group of ethicists and medical researchers warned at a meeting in Brussels last week that the process has become a box-ticking exercise focused more on offering legal protection to a trial’s organizer than actually protecting patients.

[Daniel Cressey, "Informed Consent on Trial," Nature 482, 16 (2 February 2012) doi:10.1038/482016a]

Ethicists are particularly alarmed by the steady growth in the length of consent forms.

In many cases “the informed consent is 20 pages of nothing,” says Harry Bleiberg, an oncologist formerly at the Jules Bordet Institute in Brussels who is now a medical consultant for the pharmaceutical industry.

While consent forms have grown longer, it is not clear that they were ever anything other than "a box-ticking exercise focused more on offering legal protection to a trial’s organizer than actually protecting patients." Perhaps Cressey wrote "has become a box-ticking exercise" when he meant "remains a box-ticking exercise."

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