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RideAnS [48]
3 years 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:
deff fn [24]3 years ago
6 0

Answer:

an impartial witness

Explanation:

According to ICH E6 4.8.9, in case a volunteer is not able to read informed consent form, an impartial witness has to be present during the entire discussion. The consent form is given to the volunteer and it is also read out loud for the volunteer to understand. After the volunteer signs the consent form, the witness also has to sign and date it. This signature means that the witness agrees that the information in consent form was explained properly to the volunteer and he or she has consented to it.

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