INVOLVE  Research Database – Information for Parents

INVOLVE  Research Database – Information for Parents

Introduction

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.

Children that are unwell or whose relative(s) are unwell with particular illnesses or diseases are invited to take part.

From a legal position, as a parent or legal guardian you can ultimately decide whether your child takes part in this study. However, the study rules are clear that any child not wanting to take part should not be enrolled.

Please read through this booklet and also the Participants Information sheet that has been written for your child (titled Information for People Aged Between 11-15yrs).

Please read through this booklet and also the Participants Information sheet that has been written for your child (titled ‘Information for Parents and Legal Guardians of Children who are Eligible for Participation’).

Please take time to consider the invitation and ask us any questions.

 

What is the purpose of this Research database?

This research database focuses on “complex” diseases and illnesses that affect large numbers of people in the UK.

Different groups of people in our society are more likely to develop certain illnesses than others. It is thought that the reasons for this may be influenced by differences between people’s DNA.

The research programme consists of building a research database and also conducting a series of planned studies, where the ultimate goal is to improve care and outcomes of people with complicated illnesses and diseases.

This research database will form a resource for us to carry out research studies in the future that are designed to improve patient health and wellbeing.

 

What will the Research database do?

The medical information and DNA from different participants will be collected by authorised research personnel who understand that personal data must be kept private and confidential.

One of the methods used to protect a participant’s identity is by de-identification. This involves removal of personal information such as names, address, NHS number, and date of birth.

The collected medical information and records will be de-identified, as well as all biological samples, such as the saliva (spit). Once this is done, the de-identified information will be reviewed alongside information produced from analysing de-identified samples.

Scientists will try and find links between large groups (100’s-1000’s) of participants that have a particular illness or disease. DNA that is unique to a particular group will be compared to equally large groups of healthy participants. This will then allow scientists to carry out future studies to find ways of improving human health and wellbeing for people in the UK and beyond.

Given that only de-identified data will be used to produce research findings or results, it is not practical to link any finding or results back to any individual that participates in the research database. Therefore, there is no personal benefit to participants taking part. Instead, by joining the research database, each participant can help researchers try and find ways of helping others.

 

Enrolment and Participation Process

If you are happy for your child to participate, you will be asked to confirm that:

  1. you have given your permission for your child to participate by signing a “consent form”.
  2. As soon as you provide written consent and your child has given assent, the researchers will ask your child to provide a saliva (spit) sample where they will be asked to spit in a clean tube. If your child has a scheduled or routine NHS phlebotomy appointment on that same day, then if you agree and your child agrees, 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.

 

Collection and Use of Samples

Once samples have been collected from a participant, all samples will be de-identified prior to further analysis by researchers. Therefore, the identity of individual participants is unknown to researchers who carry out research using the de-identified samples and data.

DNA and other materials will be recovered from de-identified samples and then analysed.

Samples will be only used for research purposes.

All samples will be stored at the Future Genetics research laboratories that is a secure facility. The samples may be stored for a period of time that spans several years, so researchers can continue their work.

 

Extent of DNA and biological analysis

The DNA of a person contains different sections called genes that are often separated by long sections sometimes called “non-coding DNA”. We know that our genes contain the information that either decides or influences the characteristics of a person. For example, eye colour is controlled by our genes. There is also evidence that there are genes that influence characteristics such as the ability of a person to respond to medicines at certain doses. The DNA of a person contains private information about that person. This is why researchers have a responsibility to ensure the privacy of a person taking part in a trial is maintained in line with what has been agreed with the patient.

As already highlighted above in this Patient Information Sheet, Future Genetics will collect biological material in the form of DNA from saliva. If your child also provide blood then we can recover something called RNA and Proteins. RNA is produced from genes that are switched on in the body to produce proteins. Proteins are used by cells and body to grow and carry out bodily functions such as walking and talking.

Given that DNA, RNA and protein essentially contains all of the persons private biological information, our research database is designed to separate all identifying information linked to your child’s saliva (and potentially blood) samples. When this is done the samples are classed as being “de-identified”. It is only at that stage the samples are forwarded to researchers that carry out something called “hypothesis driven research”, which in this research database means research that is primarily designed to find out why some medicines work in some patients but not others. As already highlighted above, the researchers who carry out the studies cannot link any findings to a person taking part because they do not have personal details of any participant. In this way we protect the identity and privacy of patients.

De-identified samples provide DNA (and possibly RNA and protein). These purified biological samples may be used in a variety of analysis that may or may not include something called whole genome sequencing (WGS). This involves documenting all the information (the genes and the sections between them). That information may be used to help understand why certain medicines may only be effective or safe in some but not other groups of patients, and show all the biological characteristics of a person that are based on DNA. This de-identified information cannot be directly linked back to you, but may help us to improve health outcomes for the general patient population that has a particular illness.

Future Genetics may not carry out WGS for all DNA samples, and instead use some of the DNA samples in other types of studies where a small section of the DNA corresponding to part of a gene is examined to look for certain “DNA codes”. These types of research database complement our planned WGS studies.

Where we have RNA and protein (from blood samples), we examine those biological materials to further check reasons for treatments not working on some patients.

The biological materials taken from cells found inside the de-identified saliva (and potentially blood) samples may be used in other scientific techniques and procedures to address questions that this research database is aiming to answer, which may in the future include using techniques that have not yet been developed.

Once the INVOLVE research database is completed, Future Genetics may continue to use de-identified information and samples in authorised research.

 

Collection and Use of Data

As explained above, Future Genetics will collect a saliva sample (and blood should you agree and your child has a scheduled for a phlebotomy appointment) and also access your child’s medical records. In order to protect your child’s identity and privacy both their samples and medical records will be de-identified before any research analysis. Therefore, as already explained all of the studies research-findings are based on de-identified data.

However, when we collect your child’s medical records (clinical reports), a copy of that information is left with your GP. The Clinical reports may be used by your GP when they manage your child’s care

The research involves comparing de-identified medical information and records of a participant to the information that was obtained from the de-identified biological samples.

Once researchers have the results of any research database, they usually interpret those results and make a statement of what they mean (conclusion). This can then lead to them taking the next step to try and improve the healthcare of people.

Continued access to medical information will allow researchers to monitor and check the certainty of any conclusions made by researchers. The access to information may also help researcher make new discoveries in the future.

Each person’s medical records and history develops overtime. The researchers will therefore collect all previous and future medical records, unless the participant withdraws from the research database.

The type of information used in the research will include GP, clinic, hospital, social care, and dedicated databases that hold personal scientific or clinical data. This access is based on the need to confirm any link between the results seen from samples with different types of social or health information.

Information will be requested from the NHS (including your child’s GP and hospitals that may have treated you) and other organisations that hold medical information. The information collected will include the treatments received as well as test results such as images, X-rays, or MRI scan results.

In order to receive copies of medical and health information from organisations holding the information, the researchers will need to provide a minimum level of information, such as the NHS number and date of birth, to obtain the correct records. The authorised researchers will only receive a copy of the information, and the original data will always be kept by the NHS or other organisation.

Similar to the collected samples, all medical information that is collected will be de-identified before any further analysis.

The data is kept safe and protected by Future Genetics, and they are responsible for ensuring that only authorised people can access it.

All the data from this project is owned by Future Genetics.

 

 

Privacy

If you decide and give consent that your child may enrol, we will notify your child’s GP/health professional.

The purpose of the research database is to collect and analyse data and samples from lots of different people.

Future Genetics is a research organisation that is committed to working closely with the NHS, British Universities, UK charities, partnerships, third party collaborators and organisations that provide technical services, both in the UK and abroad.

As already explained in this information sheet, only de-identified data will be used to carry out research after it has been collected. This applies to both our researchers and any person(s) from other organisations that are working with us to find solutions for better healthcare. We will be responsible for ensuring that only de-identified information can be accessed by our partners and collaborators.

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 or your child if this research database or any related research results in any advance including the development of new therapies or medical and scientific tests.

 

Sample and Data Management

The processing of biological and clinical data will be carried out by Future Genetics Limited, which is a UK based medical research organisation committed to improving health outcomes.

The samples and data will be securely stored at their business premises site. The research facilities have controlled access, are alarmed, with CCTV, and security patrols.

Electronic data will be encrypted and password protected at a level that is meets NHS standards.

All personnel handling data will be bound by robust confidentiality agreements and UK law that prevents unauthorised disclosure. All authorised staff handling sensitive information are made aware that any breach may be a criminal offence and can lead to a prosecution under UK Law. Further, the organisation(s) associated with a breach may also be held responsible. Therefore, the risk of any individual participant being identified has been notably reduced.

De-identified data and results will be used by authorised people from collaborating and partner organisations from the NHS, universities, UK charities, and other third-party organisations both in the UK and overseas.

Only selected de-identified information will be shared with our collaborators. Therefore, in the absence of personal information the identity of each participant can remain protected.

 

Access to Data

Medical and health data that is collected will be de-identified at the earliest opportunity. Once that has been done, your child’s original data file collected and held by Future Genetics will be destroyed. However, where clinical audits are performed at NHS sites as part of collaborative research such as at your child’s GP surgery or specialist NHS clinic, we will offer a copy of the original information to them.

Any research database results related to a particular person cannot be practically shared with that person or their doctor because the results are produced by looking at only de-identified data.

 

Life or health Insurance

This is a research database so it will not produce any diagnostic information for individual participants.

Once data has been collected it is de-identified at an early stage. The research database only uses de-identified data in further studies, and all reported data will always remain de-identified.

There is no relevant information available that can be shared with insurance companies because all the research finding will be based on de-identified data and information.

No insurance company will have any access to your child’s personal information or data from this research database.

 

Future Engagement

We may contact your child’s GP, clinic, or you to:

  1. Ask for further information or support
  2. Ask for feedback from you and your child
  3. Invite your child to take part in future studies

As is the case in all instances, it will be your decision if or how you respond.

 

 

Withdrawal

Your child can leave the Research database at any time, and you or they do not have to provide any reason for the decision.

In order to keep a record of the withdrawal you will be asked to complete a withdrawal form and return this to your child’s GP or clinic doctor who is involved in this research database.

At the time of withdrawal, de-identified data may already have been used to carry out scientific and clinical research. It is not practical to discard research analyses that has already been carried out and then re-perform analyses in the absence of the withdrawing patient’s de-identified data. Therefore, withdrawal will only be applied to identifiable medical information and biological samples that have not been used in the research database.

The Withdrawal form will give you three choices:

  1. No new samples will be requested by researchers. Researchers will continue to update medical records by collecting and de-identifying new information in order to support ongoing research.
  2. New samples may be requested if needed for research, but medical records will not be used to updated for research purposes.
  3. No new samples or updates of medical information will be collected by researchers.

 

Future Research Options Collect New Sample Collect updates of medical records
1 x
2 x
3 x x

✓ = collected for future research

x = not collected for future research

 

Once we receive the completed withdrawal form, your child will be withdrawn from the research database as soon as possible.

 

Complaints Procedure

In the unfortunate event that you or your child feels that you or they 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 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 considering whether your child should take part in the research database.