Consent Form – Consultee

Consent Form – Consultee

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

INVOLVE Research Database

    When an adult (in this case either your relative, friend, or a person you take care of) cannot make an informed decision to take part in this research database because of their physical or mental disability they are referred to as lacking capacity. Given that you may be someone who knows and understand this person, you are being approached to consider whether you can advise us on them taking part in the research database.
    This document refers to the person lacking capacity as the “person”.

    If you agree to help in this matter, you will be asked to give the Researcher involved in the research database advice on whether the person should or should not take part, and other key matters. As you will be the individual who is formally consulted and asked for advice, you will be referred to as the Consultee.

    The choice to accept or decline the role of the Consultee is only yours, and you do not have to give any reason for your decision.
    Should you accept the role as a Consultee, you can change you mind at any time, and you do not have to provide a reason for your decision.

    Please refer to the document tilted “Participants Information Document – Consultees” before making any decision. You are asked to consider the:
    1. persons interest and views and what they may want
    2. aims of the research database
    3. practical aspect of the person providing a saliva or other biological sample
    You can also discuss acting as Consultee with the NHS healthcare professional at the GP surgery or clinic that is taking part in this study.
    If you agree to act as a Consultee and you believe that the person lacking capacity would wish to sign-up to this research database, please complete the below form.

    I can confirm that I am a (relative/ friend/ unpaid carer) for the person lacking capacity, named (“person”).

    I have read and understood the Participants Information sheet that has the title “INVOLVE
    Research Database Information for Consultees” (version: EMPOWER-1_PIS_Consultee_20191205_v1).

    The Researcher has provided opportunity for me to ask any questions, and these have been answered by them.
    I advise that the person named above can join and participate in the INVOLVE Research Database.

    I confirm the following:
    i. I am able to provide advice on whether the above-named person should take part in this research database.
    ii. I am aware that regardless of whether the person takes part or not, their medical care or legal rights are not affected in any way.
    iii. I can advise that the person should be withdrawn from the research database, without the need to give any reason and this advice will be acted upon by the Researcher.
    iv. I understand that once the person withdraws, any information or samples that have been de-identified will continue to be used for authorised research.
    v. I understand that if the person dies, de-identified information and samples will be used for continued authorised research.

    I provide agreement to the below:
    i. The researchers can inform the person’s GPs and healthcare professionals that they are taking part in the INVOLVE research database.
    ii. The researchers will keep the participant’s identity private, except where researchers have to contact organisation to request data, as set out in Section 3 herein.
    iii. The researchers can continue to review medical records of the participant for research database purposes, unless the participant withdraws.
    iv. Samples provided by the participant can be used to carry out research studies.
    v. Researchers may contact me for advice on collecting additional samples or different information.
    vi. Researchers may contact me for advice on whether the person can join future research studies.

    I can advise that it would be okay for the person to donate 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 collaborators and specialist service providers 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 the person’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 subsequent research analysis and experiments.
    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 the person by them:
    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 advise that:
    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 the person’s personal and medical data, such as their 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 above mentioned organisations by providing the same organisation(s) with the person’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 me or the person lacking will not receive any information on individual findings.

    Completion of the below form confirms the advice provided by the Consultee for the named participant (person) who lacks capacity to join the Research Database.




    I understand that the person would want to participate. I confirm that I agree to act as a Consultee for the person lacking capacity.






    * relative/ friend/ unpaid carer for the person lacking capacity






    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 consultee and the person’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 the person lacking capacity ethnicity?

    White

    Mixed/Multiple ethnic groups

    Asian / Asian British

    Black / African / Caribbean / Black British

    Other ethnic group

    Could you please tell if the person lacking capacity 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: