Consent Form – Parent

Consent Form – Parent

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

INVOLVE Research Database


    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.


    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.

    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:
    i. As the child’s parent/legal guardian, only I can decide if the child takes part in the Database
    ii. The collected samples and medical information will be de-identified before any
    research analysis is done
    iii. Regardless of whether my child takes part in the Database or not, I understand his/her medical care is not affected
    iv. My child can withdraw from the Database at any-time, without the need to give any
    reason
    v. I understand that once my child withdraws, any information or samples that have
    been de-identified will continue to be used for authorised research.
    vi. 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:
    i. 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.
    ii. The researchers can continue to review medical records of the participant for
    research study purposes, unless the participant withdraws that consent.
    iii. Samples provided by the participant can be used to carry out research studies by the Future Genetics researchers.
    iv. Researchers may contact me to request additional samples or information
    v. Researchers may contact me to invite my child to join future research studies. This will only be done if I first provide permission.

    I provide agreement to my child donating the below samples to the researchers:
    i. Saliva (spit).
    ii. If there is a need and your doctor can accommodate, other biological samples that are collected as part of routine clinical care, for example; blood samples.
    I understand that samples may be used for
    i. INVOLVE research database
    ii. Other future approved research studies by Future Genetics
    iii. Studies that will look at the whole DNA as well as other genetic and non-genetic material found in the samples
    iv. De-identified samples may be sent to specialist service providers in the UK and abroad, that produce scientific and medical data that supports the research studies carried out by Future Genetics.

    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:
    i. Only the authorised researchers will have access to my child’s data
    ii. All identifiable data held by the authorised researchers will be treated as private and confidential
    iii. All the collected data and information will be de-identified before it is used in any research analysis and experiment.
    iv. The purpose of de-identifying data is to protect the identity of the participants
    v. There is no financial incentive or benefit to me or my child by:
    a. participating in the research database;
    b. providing data;
    c. providing samples; even if the research were to result in any advance including the development of new therapies or medical and scientific tests.

    I provide agreement to the below:
    i. Authorised researchers can access and store electronic copies of the participants past and future medical records on the condition that only de-identified data is used in any subsequent research analysis
    ii. Researchers may obtain different data from organisations that hold my child’s
    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
    iii. Researchers may obtain data from the abovementioned organisations by providing
    the same organisation(s) with my child’s identifiers such as name, date of birth, and NHS number
    iv. 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
    v. 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.

    I confirm that I understand the following:
    i. 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
    ii. Once samples and data has been collected it will be de-identified
    iii. 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:
    i. As the results will be generated from de-identified data, that data cannot used to provide me with information
    ii. I accept that I nor my child will not receive any information on individual findings.


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





    *must have parental responsibility





    **optional signatory









    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.

    To help us carry out our research more effectively we request information on ethnicity and any illnesses that you have or had.

    Information on ethnicity may help us understand which medicines are best suited for different groups of people.

    Could you please let us know your child’s ethnicity?

    White

    Mixed/Multiple ethnic groups

    Asian / Asian British

    Black / African / Caribbean / Black British

    Other ethnic group

    Could you please tell if your child has or has had any of the below illnesses?

    Asthma

    Atrial Fibrillation

    Blood Pressure/Hypertension

    Cancer

    Cardiovascular Disease

    Chronic Kidney Disease

    Chronic Obstructive Pulmonary Disease (COPD)

    Coronary Heart Disease

    Dementia

    Depression

    Diabetes Mellitus

    Epilepsy

    Heart Failure

    Mental Health

    Peripheral Arterial Disease

    Rheumatoid Arthiritis

    Stroke and Transient Ischemis Attack (TIA)

    Participant’s NHS Number:
    INVOLVE NHS Site number:
    GP Surgery Name:
    Address – Street name:
    City:
    Postcode:
    Tel:
    Email: