Who will take informed consent? {26a}
ICH
EVENT
A study counselor will review the study information sheets (screen consent and when applicable enrolment consent) with all potential participants and discuss emerging questions with the individual. In the event that informed consent is being discussed with a couple rather than an individual, each partner will be asked to provide separate independent informed consent for study participation. If the participant is illiterate, a witness will be present when informed consent is verbally administered and a checkmark is obtained. If electronic consent is unavailable due to technical challenges, then paper back consents will be used. Separate electronic informed consents complying to ICH guidelines E6 4.8. will be completed for screening and for enrolment of eligible participants.