Consent Form – Parents

Consent Form – Parents

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

EMPOWER-1 Research Study


    Generally, in order for children under the age of 16 to participate in a research study 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 study’s aims and design are summarised in the Patient Information sheet that is relevant to your child’s age.
    In summary, the aim of the project is to compare DNA and medical records of lots of healthy and unwell people to try and discover parts of human DNA that can either help people stay healthy or, in some cases, increase the risk of other people developing illnesses or diseases. The information gathered from this research study may help us improve healthcare of the UK population and beyond.

    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 study, 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 “Empower®-1 Information for parents and legal guardians of children who are eligible for participation” (version: EMPOWER-1_PIS_Parent_20191219_v3). I acknowledge that if my child is aged between 11-15 years that he/she has viewed the “Empower®-1 Study Information for people aged between 11-15 years” EMPOWER-1_PIS_11-15yrs_20191022_v2).

    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 Empower®-1 Research Study.

    I confirm the following:
    i. As the child’s parent/legal guardian, only I can decide if the child takes part in the Study
    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 Study or not, I understand his/her medical care is not affected
    iv. My child can withdraw from the Study 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 that are relevant to the research study, 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 child’s doctor can accommodate blood samples that are collected as part of routine clinical care.

    I understand that samples may be used for
    i. Empower®-1 research study
    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 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.


    I understand that the Empower®-1 study 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 study;
    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 that are relevant to the research study on the condition that only de-identified data is used in any subsequent research analysis
    ii. Researchers may obtain different data that is relevant to the study 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 that is relevant to the study 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.
    vi. 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.


    I confirm that I understand the following:
    i. The purpose of this research study 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 be used to provide me with information
    ii. I accept that I nor my child will not receive any information on individual findings.


    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 Study.















    This original completed form will be stored by the researcher as part of the Empower®-1 Research Study 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 Empower®-1 Study.

    To help us carry out our research more effectively we request information on ethnicity and any illnesses that your child 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 childs 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:
    EMPOWER-1 NHS Site number:
    GP Surgery Name:
    Address – Street name:
    City:
    Postcode: