Good Clinical Practice (GCP) Practice Exam

When a subject cannot read the informed consent form, it is essential to ensure that the consent process remains ethical and that the subject understands what they are consenting to. The involvement of an impartial witness is important in this scenario for several reasons.

An impartial witness can provide assistance by explaining the information contained in the informed consent form in a way that is clear and understandable to the subject. This ensures that the subject's autonomy is respected and that they are making an informed decision regarding their participation in the trial. The presence of an impartial witness also adds an additional layer of protection, ensuring that the consent process is transparent and not influenced by anyone involved in the trial who might have a vested interest.

This approach aligns with good clinical practice guidelines, which emphasize the importance of obtaining informed consent in a manner that is ethical and respectful of participants' rights. Thus, involving an impartial witness is a necessary step to uphold the integrity of the informed consent process when a subject cannot read the form themselves.