PIS – 11-15 Years: Patients

 

Introduction

 

The INVOLVE research database is trying to collect of biological and medical information for potential research purposes. This could help us carry out research studies that ask particular questions, such as how can we help people get better?

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 provide information that can help future research studies 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.

The reason we are asking you to take part in this research database is because you or someone that you are related to has been unwell or is still unwell.

Your parent or someone who looks after you will also think about whether you should take part in the Research database. However, your views are important, so we want to know whether you are happy to take part.

Whether you decide to take part or not, this will not affect your relative’s treatment or care.

Once you have read through this booklet, please ask us any questions so you can be sure about this Research database.

 

What is the purpose of this Research database?

 

This is a research database, so we are trying to collect information that can help us carry out future studies that could make new discoveries that will help us improve care of people with complicated illnesses and diseases.

This research database wants to look at your DNA, which is something that is found in almost every single cell that makes up our bodies.

Our DNA is made up of thousands of sections or bits called genes. Genes contain “instructions” that, in combination with our environment, makes us what we are. For example, some people have genes that makes them have brown eyes. Other people may have different genes that give them blue eyes.

DNA Gene for eye colour Eye Colour
DNA contains all our genes Gene for eye colour controls what colour our eyes are Eye Colour of different people

DNA also contains other genes that, in combination with our environment, influence why certain medicines work in some people but not in others. Genes can also influence why only some people develop certain illnesses but others do not. We also know that differences in DNA found between genes can also affect health for some people.

We do not know the identity of all the bits of DNA that either control or influence whether a person will stay healthy or might get ill in the future.

Scientist are now starting to understand that there are a few people in our society that take medicines that do not work for them, and this might be due to small differences in their DNA compared to other people.

In order to try and find those DNA differences, we aim to look through all the DNA of different people.

The scientists want to look at each participant’s complete DNA code and medical records, and then store this so it can be used in future research studies.

This research database could support research studies that ask specific goals such as:

  1. Designing special quick and easy tests that will tell each doctor which medicine to give to a person based on their DNA. This will hopefully mean that each person gets the right medicine for them.
  2. Making new medicines for different groups of people.

We hope this research database can support research studies aimed at helping people in the future.

 

How you can help?

 

We want to find new ways of improving the health and wellbeing of lots of different people. We can only do this if people who are healthy as well as those that are unwell join the research database.

Each person that joins the research database will be asked to give us some of their spit (scientist refer to spit as saliva). That spit contains some very small cells that contain DNA. We may ask for blood samples for additional research work, if for example, your doctor or nurse is able to collect the sample for us as part of a routine or scheduled appointment.

Scientific information from the DNA is compared to the medical records of each person. When this is done, we do not know the identity of the people. So, this scientific research database can only produce information that may help other people in the future.

 

Private Information

 

You can keep your participation private or tell anyone you want – but only you or your parents can do this.

If you or your parents do not tell anybody then nobody else apart from your Doctor, researchers and those who provide us with your patient information will know that you have agreed to take part.

Your Doctor will receive a copy of a report that is based on your medical records. This identifiable information may be used by your GP when they manage your care.

As we highlighted earlier, if this information is used in any future research study: the research scientists who will look at yours and many hundreds of other people’s medical records and samples will not know the names or identities of any of the people. Your personal details will be replaced with a unique code made up of letters and numbers, so scientists carrying out the research cannot identify anybody from that information. This data and information is sometimes called de-identified data.

The researchers will get updates of medical records from when somebody starts the Research database and also in the future. The scientists will keep your de-identified data as a reference, and also to support future medical and scientific research that has been approved by a group of people that are called an ethics committee.

A key aim of the research database is to collect and store new information that can be used in future research that helps people live better and healthier lives. One way to arrive at this goal quicker is to share research findings and results with other scientists and doctors.

We hope to share results from the de-identified data by supporting research studies that may lead to publishing reports in medical and scientific journals, and results being shared at medical/scientific conference and symposia events. The results from studies that have been supported by the INVOLVE research database will be published on the company website and social media platforms. This type of sharing can lead to other doctors and scientists to start trying to find newer ways of helping people.

The research may lead to discoveries that allow for development of new medicines, tests, and devices that can lead to better healthcare or other outcomes. However, it is also possible that we may not be able to achieve any of the above. However, without trying we will not know.

As is for all participants, there is no financial benefit or reward for you if this research database or any related research results in any advance including the development of new therapies or medical and scientific tests.

 

 

Can I choose to say YES or NO?

 

You can absolutely choose to agree to take part or not. This will be your choice.

 

If you agree to take part:

1.     You will be asked to sign a form confirming this

2.     Your parent(s) or someone looking after you will also complete a “Consent Form”

3.     You will be offered a copy of this Information Booklet & a copy of the form

4.     The Researcher will firstly ask you to provide a spit (saliva) sample and a blood sample may also be collected for the research database if it is going to be collected as part of your clinical care.

5.     We will look at your past and future medical and family history

6. Scientists will try and make new discoveries

 

Future Studies

 

This research database is called INVOLVE.

We may ask you to take part in future studies that we are setting up, but this will only be done once your parents have been informed about those Studies and they have agreed to discuss any future research with you.

As the same for this Research database, the choice will be yours to take part or not.

 

Deciding to change your mind later

 

You can change your mind anytime you wish. Please tell your parent(s) or the person who looks after you that you wish to leave the Research database. You can also tell your Doctor or Nurse. As soon as we know then we can update our records.

 

Providing saliva and blood samples

 

Saliva will be collected by the researcher. If its part of your routine clinical care, blood samples will be collected by your doctor or nurse during routine or scheduled appointments. You will be asked to provide around 3 tablespoons of each sample if this is practical for you and your doctor.

Sometimes the scientist may need additional samples, so you might be asked if you are happy to give us more sample to help with the research.

 

The Process, if you agree to take part:

 

If you are happy to take part, you will be asked to confirm that:

  1. you have given your permission for you to participate by signing an “Assent Form” or in some cases a “consent form”
  2. As soon as you provide written consent, the researchers will ask you to provide a saliva (spit) sample where you will be asked to spit in a clean tube. If you have a scheduled or routine NHS blood test appointment on that same day, then if you agree you can also have the nurse take an extra blood sample for Future Genetics.
  3. Medical records will be collected, analysed and stored for research purposes. However, your medical records will be accessed at a later date.

 

What happens when you are 16 years old?

 

When you are 16 years you will be a young adult. We will check if you would still like to continue with our Research database.

 

Questions???

 

Please ask your Researcher, Doctor, Nurse, parents any questions that you have. They will be able to answer your questions.

We are all here to make sure that you understand your role in this Research database.

 

 

Complaints Procedure

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 coo@futuregenetics.co.uk 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.

 

Finally…

 

Thank you very much for taking time to think about joining this Research database.