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Thread: MHRA produced FAQs for Investigator Sites

  1. #1

    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.

  2. #2
    2. Can a trial request tissue specimens for a patient but not specifically ask them to sign a statement to this effect on the Informed Consent Form (ICF) despite it being documented in the Patient Information Sheet (PIS)?

    As the consent form is directly linked and identifies the PIS, then this is acceptable from a GCP point of view, as the patient is consenting to all the procedures detailed in the PIS. However, the requirements of the Human Tissues Act 2004 also need to be adhered to and the enquirer may wish to contact the Human Tissue Authority to obtain additional information concerning the regulatory requirements for the collection and storage of human tissues in the UK.

    Human Tissue Authority (external link)

  3. #3
    3. For Patient Information Sheets and the Informed Consent Forms translated into languages for those patients that are non-English speaking, which consent form should the non-English speaking patient sign? Should they sign their native language version as that is what they can understand or should they sign the English language version, as this is what site staff can understand?

    Patients should sign the consent form in the language that they are able to understand to document that they are fully aware of what they have consented to. Staff working on the trial must be able to understand what consent that patient has given and work according to this consent. Therefore, there should be clear correlation by version control between the English and non-English versions of the PIS and consent form. It would also be advisable to attach the English language version in the source notes (unsigned, as a reference).
    Last edited by MHRA Super Moderator; 25th Oct 2011 at 06:55 PM.

  4. #4
    4. If there is a change of principal investigator (PI) at an investigator site, can trial activities continue uninterrupted or do they need to be halted until the necessary approvals have been obtained?

    The following position has been agreed between the MHRA GCP Inspectorate, the National Research Ethics Service (NRES) and the NIHR Clinical Research Network.

    Where a new PI is to be appointed, the preferred process is to plan ahead so that the necessary approvals can be obtained in advance of the handover, ensuring there is no gap. However, we recognise this may not always be possible, for example where a PI leaves the host organisation unexpectedly or falls ill.

    Where a gap occurs, the aim should be to enable the trial to continue uninterrupted. The sponsor is responsible for taking prompt action to identify another health professional to take on the role of PI, in consultation with the host organisation and taking into account the expertise and experience required for the trial concerned. Provided that the sponsor and host organisation are satisfied that the individual is suitable and that any risks have been assessed, there is no reason why the trial should not continue uninterrupted. Once the new PI has been identified and agreed to take on the role, new participants could be recruited.

    The sponsor should submit the necessary Notice of Substantial Amendment to the Research Ethics Committee (REC) as soon as the new PI has been appointed, so that formal approvals can be obtained to ‘ratify’ the appointment. For NHS sites, the REC will issue an approval letter promptly. For non-NHS sites, approval will follow confirmation of no objection from the site-specific assessment (SSA) REC for the site. REC approval will be subject to the host organisation confirming continued permission.

    It is of course open to the sponsor to halt new recruitment until all approvals are formally in place. However, we think it would be undesirable if recruitment of eligible participants was to be held up by administrative requirements where the sponsor is satisfied that an appropriate investigational team is in place at the site. The sponsor should of course be able to demonstrate and justify the action taken.

  5. #5
    5. Can inspectors access medical records of patients participating/who have participated in clinical trials of IMP in the UK if the consent form does not explicitly include consent for Regulators to access these records?

    The answer to this question can be found in the FAQs for Inspection process.

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