The INVOLVE research database is a structured collection of biological and clinical data stored for potential research purposes, which allows analysis of data to answer research questions for multiple projects, for example, EMPOWER-2, EMPOWER-3 etc.
This research database aims to build data and information that can be used in research studies to help us better understand how the body works, develop ways of preventing illnesses, and find new ways to treat people when they are ill.
The INVOLVE research database has the ultimate aim of laying the foundations that may lead to improved healthcare for the broad range of people that make up our society.
A potential key success factor for this research database is whether it can recruit large numbers of people who are healthy and those that are unwell due to specific illnesses or diseases.
This is why we are inviting:
- People that are unwell or whose relative(s) are unwell with particular illnesses or diseases.
- Healthy people of different ages
The definition and role of the consultee is discussed on the next page.
Please read through this booklet and also engage with the person with reduced capacity before advising us further.
Please take time to consider the decision to act as a consultee, and ask the research team at the participating GP surgery or NHS clinic.
A Definition of a Personal Consultee
A consultee is a person who reasonably understands the views and feelings of a person that lacks capacity. The consultee will only provide advice related to taking part in this research database that is in the interest of the person lacking capacity.
As a personal consultee, you will either be a next-of-kin, relative, friend, unpaid carer, unpaid former carer, or a carer appointed by the Courts.
There is no obligation on you to act as a consultee, and you should only agree to take this role if you are happy to do so.
From a legal position, your role is to advise on whether a person with reduced mental capacity would wish to be enrolled or withdraw from the research database.
We will refer to the person with reduced capacity as the “person” or “participant” in this document.
Role of the Personal Consultee
Based on your relationship with the person, you can advise on whether they would wish to take part in the INVOLVE research database.
As you are acting as the advisor, please think about the purpose and aims of the project and whether taking part is something that the person would like to contribute and take part in. You will also need to think about issues such as them providing samples such as saliva, and blood if it is being taken as part of routine care. You should discuss this with the NHS research staff members at the participating GP surgery/ clinic.
If you advise the Research team member that the person would wish to take part, then the research team at the GP surgery/clinic will see if it is practical to move forward. If the person can be signed up to take part, you will be asked to sign a “consultee confirmation form”.
Once the participant enrols to the research database we will collect biological samples such as saliva. If additional samples are needed by the researchers, we will contact you to make sure this is okay with the participant.
Leaving the research database:
You can also let the NHS research team know at any time that you advise that the participant should be withdrawn from the research database.
Your instructions to withdraw the participant from the research database will be followed.
Ending the role as a Consultee
You can stop acting as a consultee any time you wish, and do not have to provide reason for your decision.
If for any reason you wish to stop acting as a consultee, please contact the research team at the participating GP surgery/ clinic. Your decision will be acted upon and you will no longer be a consultee for the participant. The researchers will then try to identify another suitable personal consultee. If none can be identified, then the participant will be withdrawn from the research database.
Considerations before deciding to act as a consultee
There are five key matters that you may wish to consider before signing up as a consultee:
- Read and understand this document (Consultee Information Document)
- Read and understand the Patient Information Document
- Read and understand the Consultee Confirmation Form
- Ask the NHS GP or researchers any questions you have about the research database
- Seek independent advice about the purpose of a consultee.
There is additional information available on the Future Genetics website (https://futuregenetics.co.uk/welcome/empower).
If you agree to act as a consultee then a research team member at the NHS site (GP surgery or the clinic) will ask you to complete the Consultee Confirmation Form.
In the unfortunate event that you feel you are unhappy or dissatisfied with any aspect of the INVOLVE research database or the Future Genetics researchers, please contact our Chief Operating Officer at firstname.lastname@example.org or call 0121 667 3007.
We take your complaints seriously, and this why the first person to formally address your complaint is a senior person in our organisation. They will take responsibility to resolve the matter.