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RegisterICH-GCP Informed Consent Procedure [Regulatives / Guidelines]
Dear All,
I want help from GCP experts to understand following clause of ICH-GCP.
4.8.13 Except as described in 4.8.14, a non-therapeutic trial (i.e. a trial in which there is no anticipated direct clinical benefit to the subject), should be conducted in subjects who personally give consent and who sign and date the written informed consent form.
4.8.14 Non-therapeutic trials may be conducted in subjects with consent of a legally acceptable representative provided the following conditions are fulfilled:
a) The objectives of the trial can not be met by means of a trial in subjects who can give informed consent personally.
b) The foreseeable risks to the subjects are low.
c) The negative impact on the subjectís well-being is minimized and low.
d) The trial is not prohibited by law.
e) The approval/favourable opinion of the IRB/IEC is expressly sought on the inclusion of such subjects, and the written approval/ favourable opinion covers this aspect.
As Bioequivalence is non-therapeutic trial can we use LAR for taking consent?
If yes,Can bioequivalence study satisfy all the conditions mentioned in 4.8.14?
Regards,
Swapnil D. Kuche
I want help from GCP experts to understand following clause of ICH-GCP.
4.8.13 Except as described in 4.8.14, a non-therapeutic trial (i.e. a trial in which there is no anticipated direct clinical benefit to the subject), should be conducted in subjects who personally give consent and who sign and date the written informed consent form.
4.8.14 Non-therapeutic trials may be conducted in subjects with consent of a legally acceptable representative provided the following conditions are fulfilled:
a) The objectives of the trial can not be met by means of a trial in subjects who can give informed consent personally.
b) The foreseeable risks to the subjects are low.
c) The negative impact on the subjectís well-being is minimized and low.
d) The trial is not prohibited by law.
e) The approval/favourable opinion of the IRB/IEC is expressly sought on the inclusion of such subjects, and the written approval/ favourable opinion covers this aspect.
As Bioequivalence is non-therapeutic trial can we use LAR for taking consent?
If yes,Can bioequivalence study satisfy all the conditions mentioned in 4.8.14?
Regards,
Swapnil D. Kuche
Complete thread:
- ICH-GCP Informed Consent Procedureswapnil.kuche 2011-03-17 08:15
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- ICH-GCP Informed Consent Procedure Ohlbe 2011-03-17 10:14
Ing. Helmut Schütz