Withdrawal Form – Adults and Parents: EMPOWER-1

Withdrawal Form – Adults and Parents

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

Empower®-1 Study

    This document is for consenting adults to read and complete if they wish to withdraw from the Empower®-1 study. The document can also be used to confirm withdrawal of a child from the study. If more than one child is to be withdrawn from the Empower®-1 study, a separate form needs to be completed for each child.

    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 does not have to provide any reason. Your instructions 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.

    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 have advised that the participant (i.e. yourself or your child) is withdrawn from the Empower®-1 research study.




    *The participant may either be you or your child.


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

    I 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).
    I confirm that (choose as appropriate) should be withdrawn from the Empower-1 Study based on the below selection:

    Choose ONE area only
    Option 1: No new samples collected, but medical records are updated
    Option 2: New samples collected, but medical records not updated
    Option 3: No new samples collected and medical records not updated

    By signing the below, I confirm that (choose as appropriate) should be withdrawn from the Empower®-1 Study.







    Relationship to the child (if applicable):
    Date of Birth of the (Child) Participant (DD/MM/YYYY):

    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:

    Child Participant’s NHS Number(if applicable):

    Name of NHS staff member receiving this form:

    Signature:


    Date:

    Name of Interpreter (if present/required):

    Signature:


    Date:

    Empower®1 NHS Site number

    GP Surgery Name
    Address – Street name
    City
    Post code