Consent Form-Parents – INVOLVE

Consent Form-Parents – INVOLVE

This form documents that Consent has been given by an adult that has parental responsibility for allowing a child to participate in the INVOLVE Research Database.

 

Overviews

Overview of Parental Consent

Generally, in order for children under the age of 16 to participate in a Research Database consent from an adult that has parental responsibility is required.

Adults with parental responsibility tend to be the biological parents or those that are legal guardians of the child. If you are not clear on this, please seek clarification from your Doctor.

 

Overview of the INVOLVE Research Database

The Research Database’s aims and design are summarised in the Patient Information sheet that is relevant to your child’s age.

Regardless of whether a person decides to take part or not, the treatment and care that persons receives will not be affected.

Please read the sheet and discuss the content with your child. In addition to this, a Researcher will go through the information with your child when you are present.

If your child is happy to take part in the Research Database, then this will be confirmed by the completion of an “assent form”, coupled with the signing of this form.

Once your child reaches the age of 16, they will then be legally able to give consent themselves. Therefore, the researcher will seek Consent from the participant.

 

Consent Form – Parental Consent

Section 1. Research Database Participation

I can confirm that I have parental responsibility for my child …………………………

I have read and understood the participants information sheet that has the title “INVOLVE Information for parents and legal guardians of children who are eligible for participation” (version: INVOLVE_PIS_Parent_20191205_v1). I acknowledge that if my child is aged between 11-15 years that he/she has viewed the “INVOLVE Research Database Information for people aged between 11-15 years” INVOLVE_PIS_11-15yrs_20191205_v1).

The researchers have provided opportunity for me to ask any questions, and these have been answered by them.

I give authority so that my child, named above, can join and participate in the INVOLVE Research Database.

I confirm the following:

  1. As the child’s parent/legal guardian, only I can decide if the child takes part in the Research Database
  2. The collected samples and medical information will be de-identified before any research analysis is done
  3. Regardless of whether my child takes part in the Research Database or not, I understand his/her medical care is not affected
  4. My child can withdraw from the Research Database at any-time, without the need to give any reason
  5. I understand that once my child withdraws, any information or samples that have been de-identified will continue to be used for authorised research.
  6. I understand that if my child dies, de-identified information and samples will be used for continued authorised research.

I provide agreement to the below:

  1. The researchers will keep the participant’s identity private, except where researchers have to contact organisations to request data, as set out in Section 3 herein.
  2. The researchers can continue to review my medical records and store them on the Research Database, unless I withdraw that specific consent.
  3. Samples provided by the participant can be used to carry out research studies by the Future Genetics researchers.
  4. Researchers may contact me to request additional samples or information
  5. Researchers may contact me to invite my child to join future research studies. This will only be done if I first provide permission.

 

Section 2. Biological Samples

I provide agreement to my child donating the below samples to the researchers:

  1. Saliva (spit).
  2. If there is a need and your child’s doctor can accommodate blood samples that are collected as part of routine clinical care.

I understand that samples may be used for

  1. INVOLVE Research Database
  2. Future approved research studies by Future Genetics
  3. Studies that will look at the whole DNA as well as other genetic and non-genetic material found in the samples
  4. De-identified samples are classified as personal data. These may be sent to collaborators and specialist service providers in the UK and abroad, that produce scientific and medical data that supports the research studies carried out by Future Genetics.

 

Section 3. Participant Data

I understand that the INVOLVE Research Database requires the comparison of de-identified medical records and samples to carry out the research.

I confirm that I understand the following:

  1. Only the authorised researchers will have access to my child’s data
  2. All identifiable data held by the authorised researchers will be treated as private and confidential
  3. All the collected data and information will be de-identified before it is used in any research analysis and experiment.
  4. The purpose of de-identifying data is to protect the identity of the participants
  5. There is no financial incentive or benefit to me or my child by:
    1. participating in the Research Database;
    2. providing data;
    3. providing samples;

even if the research database supports future research that results in any advance including the development of new therapies or medical and scientific tests.

 

I provide agreement to the below:

  1. Authorised researchers can access and store electronic copies of the participants past and future medical records to the Research Database on the condition that only de-identified data is used in any subsequent research analysis
  2. Researchers may obtain different data to store on the Research Database from organisations that hold the participants personal and medical data, such as my GP Practice, hospital, clinics, social care, and medical or scientific data stored on any local or national databases or registries
  3. Researchers may obtain and store data to the Research Database from the abovementioned organisations by providing the same organisation(s) with the participants identifiers such as name, date of birth, and NHS number
  4. Researchers will attempt to derive maximum benefit from the data they have so will look at as many medical and scientific areas of interest as possible
  5. Data will be collected at different time points by approved persons, in order to allow the research to continue, unless the participant is withdrawn from the project.
  6. De-identified data is classified as personal data. This may be sent to collaborators and specialist service providers in the UK and abroad, that produce scientific and medical data that supports the research studies carried out by Future Genetics.

 

Section 4. Research Results

I confirm that I understand the following:

  1. The purpose of this Research Database is to support continued research efforts that may lead to improved healthcare and wellbeing of the UK population and beyond
  2. Once samples and data has been collected it will be de-identified
  3. Scientists carrying out the research will not be able to link any findings to individual participants. Therefore, it is not practically possible to share “individual” findings with any of the participants.

 

I provide agreement to the below:

  1. As the data is de-identified, it cannot be used to provide me with information
  2. I accept that my child or I will not receive any information on individual findings that may support research that used data from this database.

 

 

Section 5. Provision of Consent

Before proceeding to provide the below Informed Consent, the participant agree that they have read and understood sections 1, 2, 3, and 4 of this consent form, and completion and signing of this document by the participant will confirm their agreement.

Completion of the below form confirms the provision of Informed Consent for the named participant to join the Research Database.

 

Participant Child’s

Full Name (BLOCK CAPITALS)

 
Date of Birth (DD/MM/YYYY)  

 

*Parent’s/ legal guardian’s

Full Name (BLOCK CAPITALS)

 
Signature

 

 
Date (DD/MM/YYYY)  

*must have parental responsibility

 

**Other Parents

Full Name (BLOCK CAPITALS)

 
Signature

 

 
Date (DD/MM/YYYY)  

** optional signatory

Name of Future Genetics Researcher witnessing Consent

(BLOCK CAPITALS)

 
Signature

 

 
Date (DD/MM/YYYY)  

 

Name of interpreter (if present)

(BLOCK CAPITALS)

 
Signature

 

 
Date (DD/MM/YYYY)  

 

This original completed form will be stored by the researcher as part of the INVOLVE Research Database Records. Copies will be provided to you as the parent(s)/ legal guardian, and your child’s Doctor.

You can either have a hard copy of the form or receive a copy via email. Please let the researcher know your preference.

 

Thank you again,

The Research Team from the INVOLVE Research Database.