Consultee Declaration Form Information – INVOLVE

Consultee Declaration Form Information – INVOLVE Research Database

 

This form documents that that a person has agreed to act as a Consultee and provided advice on whether a person lacking capacity may participate in the INVOLVE Research Database.

 

Introduction

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, and a blood 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 Research Database.

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. 

 

Consultee Declaration Form

 

Section 1. Research Database Participation

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

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:

  1. I am able to provide advice on whether the above-named person should take part in this Research Database.
  2. 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.
  • 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.
  1. I understand that once the person withdraws, any information or samples that have been de-identified will continue to be used for authorised research.
  2. 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:

  1. The researchers can inform the person’s GPs and healthcare professionals that they are taking part in the INVOLVE Research Database.
  2. 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.
  • The researchers can continue to review medical records of the participant that are relevant to the Research Database, unless the participant withdraws.
  1. Samples provided by the participant can be used to carry out research studies.
  2. Researchers may contact me for advice on collecting additional samples or different information.
  3. Researchers may contact me for advice on whether the person can join future research studies.

 

Section 2. Biological Samples

I can advise that it would be okay for the person to donate the below samples to the researchers:

  1. Saliva (spit)
  2. If there is a need and the patient’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. Other 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 the person’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 subsequent research analysis and experiments.
  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 the person by them:
    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 advise that:

  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 participant’s personal and medical data, such as 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 participant’s 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 or the participant with information
  2. I accept that the participant or me will not receive any information on individual findings that may support research that used data from this database.

 

Section 5. Declaration by Consultee

Before proceeding to provide the below Informed Consent, the consultee agrees that they have read, understood, and agree with sections 1, 2, 3, and 4 of this declaration form. 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.

 

Person lacking capacity

Full Name (BLOCK CAPITALS)

 
Date of Birth (DD/MM/YYYY)  

 

 

 

Declaration

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

Full Name (BLOCK CAPITALS)

 

 
Signature

 

 
Date (DD/MM/YYYY)  
*Relationship of the personal consultee to the person lacking capacity  

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

 

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 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.