Obtaining Informed Consent [GxP / QC / QA]

posted by ElMaestro  – Denmark, 2013-08-13 16:12 (4691 d 11:03 ago) – Posting: # 11268
Views: 5,911

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

Complete thread:

UA Flag
Activity
 Admin contact
23,654 posts in 4,992 threads, 1,571 registered users;
170 visitors (0 registered, 170 guests [including 9 identified bots]).
Forum time: 03:16 CEST (Europe/Vienna)

“Data! Data! Data!” he cried impatiently.
“I can’t make bricks without clay!”    Arthur Conan Doyle

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5