Husband ≠ impartial [GxP / QC / QA]

posted by Helmut Homepage – Vienna, Austria, 2019-05-22 10:52  – Posting: # 20291
Views: 1,132

Hi Yatish,

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

Look up impartial in a dictionary. A married couple is a paradigm of not being impartial. 
See the definition of impartial witness in the ‘Ethical Guidelines for Biomedical Research on Human Subjects’ of the Indian Council of Medical Research:

A literate person, who is independent of the research and would not be unfairly influenced by people involved with the study, who attends the informed consent process if the participant […] cannot read, and understand the informed consent form and any other written information supplied to the participant.


Cheers,
Helmut Schütz
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