Re-consenting volunteers? [Off Topic]

posted by ElMaestro  – Denmark, 2016-06-21 18:42 (2837 d 00:48 ago) – Posting: # 16433
Views: 35,763

Hi all,

I am not a native French speaker but I think I sometimes understand a little bit of written French.

(and I am not too hot on Google translate)

Does the inquest into the Bial/Biotrial incident suggest that the volunteers should perhaps, possibly, maybe have been asked to re-confirm their consent after the initial SAE in their dosing group? I have no idea legally, but I am not aware of any clear clause in ICH E6 or Eudralex etc. that would require it. I think the need to re-consent is solely a matter of interpretation and that is sometimes a dangerous tool is the hands of people who look over the shoulder with little regard to the present.

Did I get the document right about re-consent? I foresee a lot of trouble if CROs in the future need to preemptively re-consent study volunteers. In the absence of firm specfic written guidance it will be very difficult to decide when a re-consent is justified and necessary.
e.g.
-When any SAE's occur? If no, which then?
-When any AE occurs? A broken toenail? Headache? Absence of info from a volunteer who has retracted her/his consent without telling why? Someone being discontioued by an investigator? Etc.

Is there a French guideline or legal document specifically discussing re-consenting?

Thanks for any input. As they say in France: Muchas gracias.

Pass or fail!
ElMaestro

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