Obtaining Informed Consent [GxP / QC / QA]

posted by ElMaestro  – Denmark, 2013-08-13 16:12 (4687 d 01:19 ago) – Posting: # 11268
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Hello ISK,

❝ What is the process of obtaining a consent from a participant who losses consciousness or competence during the research period due to mental disorder???


You obtain the consent before the trial and not during it. If one of your subjects looses competence during the study I'd suggest you to discontinue her/him immediately and care for the subject rather than for the study.
Loss of competence implies different aspects, one of them being that she/he may not be able to give an informed consent. Another important aspect is that the subject may not be able to execute a voluntary withdrawal.

Pass or fail!
ElMaestro

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