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Lina20
3 months ago
11

A healthy volunteer is considering participating in a research study testing a new vaccine for Ebola. He has left his glasses at

home and he is unable to read the informed consent form. According to ICH E6, who must be present during the discussion of informed consent?
Health
1 answer:
Leni [1.5K]3 months ago
6 0

Answer:

An unbiased witness

Explanation:

As per ICH E6 4.8.9, if a participant cannot read the informed consent, an unbiased witness must be present for the entire discussion. The informed consent is provided to the participant and read aloud to ensure comprehension. Once the participant signs, the witness also needs to sign and date the document. This signature indicates that the witness confirms the information was adequately explained and the participant has provided consent.

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