Bioequivalence and Bioavailability Forum

Dear Yatish Gosai,

❝ Can Husband act as an Impartial witness for Screening and Enrolment of his wife in BABE study?

I could not find a definition of an "impartial witness" in the New Drugs and Clinical Trials Rules, 2019. ICH GCP § 1.26 defines the impartial witness as
A person, who is independent of the trial, who cannot be unfairly influenced by people involved with the trial, who attends the informed consent process if the subject or the subject’s legally acceptable representative cannot read, and who reads the informed consent form and any other written information supplied to the subject.

In a Phase 3 trial I would say yes as there is no financial benefit. In a BA/BE trial, one may object that the husband has a direct interest in having his wife participate (he will benefit from the money). The husband is not impartial as he may be influenced by the financial incentive... The wife's consent may not be freely given (particularly in the case of illiterate subjects, which is the situation where you would need an impartial witness, where wifes are used to obeying their husband).