Ill-informed consent: EU meeting lays into clinical trials small print for patients

European Union
Image by erjkprunczyk via Flickr

Daniel Cressey at Nature has written this report from last week’s meeting of the European Forum for Good Clinical Practice which took place in Brussels.

The basic thrust of the discussion at the meeting was that information given to patients prior to them signing up for a clinical trial: is often vague, too long, doesn’t communicate clearly about the risks, and is full of jargon.  The upshot of the evidence is that we are all failing in our duties under the EU Clinical Trials Directive to ensure that patients are fully-informed about the risks.  This is what is known in the trade as ‘informed consent.’

Interestingly the meeting heard evidence from countries outside the EU as well, including the US.

EFGCP is planning to produce a template ‘form’ for all.  Their webiste is here but it is probably too early for a report and the presentations from the conference to appear on their site just yet.

Good ( in a roundabout way) to have affirmation of the first of my suggested ‘bill of rights’ for those taking part in medical research (see post from earlier this year).

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