QA
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Hi all,
We have recently had a REC insist that consent could not be taken by the treating clinician, and that the person recruiting could not be the same person taking consent. The REC’s reason for this is to avoid coercion and they referenced the recent HRA Proportionate Consent guidance (section 2.3) as justification.
Has anyone else had similar REC requirements?
Thanks,
Katie Neville
CTRC QA Manager (University of Liverpool)
Katie Neville
Head of QA & Regulatory Affairs
Liverpool Clinical Trials Centre (LCTC), University of Liverpool
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