Bioequivalence and Bioavailability Forum

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.

Dear Irukulla Shravan Kumar
Please apologize but I do not understand your question.

1. informed consent must be signed before enrolment of the subject into the study
   
2. mental disorders must be excluded except that the study is in patients with mental disorders. Then losing consciousness or competence during the research period is an expected AE. Nevertheless, the subject did know that when giving his consent. A subjectś legally acceptable representative can give consent in other cases. However, I suggest to study the guideline for good clinical practice CPMP/ICH/135/95

I hope this helps.
Kind regards
Dan