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    MHRA produced FAQs for Investigator Sites

    1. Is it acceptable for a non-medic to take consent from clinical trial patients?

    The Clinical Trial Regulations (UK SI 2004/1031, as amended) refers to the process of informed consent in parts 3(1), 4(1) and 5(1) of Schedule 1. The text in each part of the schedule states:
    "...has had an interview with the investigator, or another member of the investigating team, in which he has been given the opportunity to understand the objectives, risks and inconveniences of the trial and the conditions under which it is to be conducted".

    The Clinical Trial Regulations (UK SI 2004/1031, as amended), Regulation 15 (5) (g) requires:
    ?the ethics committee to consider the adequacy and completeness of the written information to be given, and the procedure to be followed, for the purpose of obtaining informed consent to the subjects? participation in the trial.?

    Therefore, the consenting procedures and personnel (ie which members of the investigator team will be performing consent) should be clearly described in the Research Ethics Committee application, and a favourable opinion given. Any proposed changes to the consenting procedure following a favourable opinion, should be notified to the Ethics Committee and approval granted.
    Last edited by MHRA Super Moderator; 25th Oct 2011 at 06:53 PM.

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