Withdrawal Form – Consultees

Withdrawal Form – Consultees

Medical & Scientific Research to Help the nation and world live better

Empower®-1 Study

    This form documents that a consultee has advised that the participant should be withdrawn from the Empower®-1 Research Study. Completed forms should be forwarded to Future Genetics to allow for prompt removal of the subject in accordance to the received advice.

    A consultee is a person who informs the research team whether it is appropriate for a person who cannot reliably tell us whether they should either take part or be withdrawn from the research study.

    For purposes of this document we will refer to the person with reduced capacity as the “person” or “participant”.

    A consultee will act on behalf of a participant who is either a relative, friend, or carer of the person. You should only act on their behalf if you can best understand their views and feelings about taking part or withdrawing, and if you are also acting in their interests only.

    This document is for consultees to read and complete if they believe that the participant should be withdrawn from the Empower®-1 study. Please read through the full document before completing.

    Please be aware and assured that withdrawal from the Empower®-1 research study has no impact on the level of care received by the participant.

    The participant can leave the Study at any time, and as the consultee, you do not have to provide any reason for the decision to withdraw. Your advice will be acted upon.

    Should you wish, you can discuss withdrawal with researchers who are based at the NHS site associated with the participant (i.e. their GP surgery or clinic).

    Once researchers receive the completed form the participant will be removed from the study as soon as possible.

    The content of this form is similar to the Withdrawal form used by participants who can make their own decision to withdraw from the research study. A key difference is that this form addresses questions to you as the Consultee rather than directly to the participant.

    In order to keep a record of the withdrawal you will be asked to complete a withdrawal form and return this to your GP or clinic doctor who is involved in this research study.

    At the time of withdrawal, de-identified data may already have been used to carry out scientific and clinical research. It is not practical to discard research analyses that has already been carried out and then re-perform analyses in the absence of the withdrawing patient’s de-identified data.
    Therefore, withdrawal will only be applied to identifiable medical information and biological samples that have not been used in the research project.

    The Withdrawal form will give you three choices:
    1. No new samples will be requested by researchers. Any existing identifiable samples will be destroyed when we receive the withdrawal form. Researchers will continue to update medical records by collecting and de-identifying new information in order to support ongoing research. We will no longer contact you (neither directly or indirectly via the NHS site team).
    2. New samples may be requested if needed for research, but medical records will not be updated. We will no longer contact you (neither directly or indirectly via the NHS site team), unless there is a need to collect a sample.
    3. No new samples or updates of medical information will be collected by researchers. We will no longer contact you (neither directly or indirectly via the NHS site team). Any identifiable clinical data or samples held by Future Genetics at the time of receiving the completed withdrawal form will be deleted or destroyed.

    In order to keep a record that you, or your child, had previously taken part and then withdrawn from the Empower®-1 study, we will need to keep a record of basic information. This minimal information would include your name (and if applicable your child’s name), date of birth, and address. This is for auditing purposes and also to ensure that we do not contact you again.

    Completion of the below form confirms that you as the consultee have advised for the participant with reduced capacity to be withdrawn from the Empower®-1 research study.




    I confirm that I have read and understand the information related to withdrawal.

    Based on the views, feelings, and interests of the participant, I as the consultee understand that the participant should be withdrawn from the Empower®-1 Study.

    I, as the consultee, am aware that I have been able to ask any questions and discuss the withdrawal with NHS Doctors and Research staff that are involved in the study (who work at the participating GP surgery/ NHS clinic).

    My advice is that the participant is Withdrawn from the Empower®-1 research based on the below selection:

    Tick ONE area only

    By signing the below, I confirm that the participant should be withdrawn based on my advice, and I understand that my advice will be acted upon.








    Once this form has been completed, the original form will be kept by the researchers. Copies will be given to the NHS site taking part in the study (GP surgery or NHS clinic). You will also be given a copy of this completed form, either as a hard copy or sent to you via email.

    Thank you for your support of this project. We also appreciate you informing us of your decision for withdrawing the participant from the study.

    The Research Team from the Empower®-1 Study.

    Participant’s NHS Number:

    Name of NHS Staff Memeber receiving this form:
    Signature


    Date

    Name of Interpreter (if present):
    Signature


    Date

    Empower®-1 NHS Site number:
    GP Surgery Name:
    Address – Street name:
    City:
    Postcode:
    Tel:
    Email: