Withdrawal Information: Parents and Adults – INVOLVE

Withdrawal Information: Parents and Adults – INVOLVE

This form documents that a consenting adult has decided to withdraw from the INVOLVE Research database. This same form may be used by parents or legal guardians to withdraw a child from the research database. Completed forms should be forwarded to Future Genetics to allow for prompt removal of the subject in accordance to the received advice.

 

Overviews

Overview of Withdrawal process

This document is for consenting adults to read and complete if they wish to withdraw from the INVOLVE research database. The document can also be used to confirm withdrawal of a child from the research database. If more than one child is to be withdrawn from the INVOLVE research database, a separate form needs to be completed for each child.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 INVOLVE research database has no impact on the level of care received by the participant.

The participant can leave the Research database 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 research database as soon as possible.

 

Withdrawal Choices

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 database.

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.

 

Future Research Options Collect New Sample Collect updates of medical records
1 x
2 x
3 x x

✓ = collected for future research

x = not collected for future research

 

In order to keep a record that you, or your child, had previously taken part and then withdrawn from the INVOLVE research database, 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.

 

Form for Withdrawal of a participant

Completion of the below form confirms that you have advised that the participant (i.e. yourself or your child) is withdrawn from the INVOLVE research database.

 

Full Name of Consenting Adult (BLOCK CAPITALS)  
Full Name of Participant* (BLOCK CAPITALS)  

*The participant may either be you or your child.

 

Confirmation:

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 research database (who work at the participating GP surgery/ NHS clinic).

I confirm that I* / *my child (*delete as appropriate) should be withdrawn from the Empower-1 Research databasebased on the below selection:

 

Options Tick 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 I* / *my child (*delete as appropriate) should be withdrawn from the INVOLVE Research database.

 

Full Name (block capitals)  
Signature  
Date (DD/MM/YYYY)  
Relationship to the child participant (if applicable)  
Date of birth (DD/MM/YYYY)

of the child participant (if applicable)

 

 

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 research database (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 research database.

The Research Team from the INVOLVE Research database.