G2a NCMH Participant Information Sheet (UK MINDS) Cohort 1 (v1.0) 24 November 2023

You are being invited to take part in a research study. Before you decide whether or not to take part, you should understand why the research is being done and what it will involve. Please take time to read the following information. Contact us if anything is not clear or if you would like more information. Take as much time as you need to decide whether or not you wish to take part. 

What is the purpose of the research?                                                                                    

We are trying to understand why some people experience problems with their mental and/or cognitive health. The purpose of this study is to collect information and samples for genetic, biological, psychological and clinical research. This will allow us to look for genes and other factors which make some people more likely than others to become ill. We hope that our study will improve understanding of these conditions and help find better treatments in the future. 

Who is being asked to take part?

You have been invited because you have experienced a mental illness such as depression, schizophrenia and/or psychosis, and bipolar disorder.

We will compare information from people who have experienced a mental illness or cognitive disorder with information from people who have not experienced such problems, and compare people with the same or different disorders, in order to learn more about the factors that may make some people more susceptible to these conditions.

We may offer you the opportunity to take part in additional studies based on the information you have already provided. 

We aim to invite many thousands of people to take part and we would be very grateful if you would be kind enough to help with this study. 

What does taking part involve?

Taking part involves a meeting with a member of the research team in person (at a local health clinic, in your own or family member’s home, at a university site or a voluntary organisation site) or over the telephone or videocall. You will: 

1. Discuss the details of the study and have the chance to ask questions 

2. Sign a consent form stating that you agree to take part in the study. If this is over the telephone or video call, the statements will be read aloud and the researcher will complete the form on your behalf. 

3. Be given a copy of your completed consent form to keep along with this information sheet.

4. Complete a 15-60 minute assessment with the researcher including some general questions about you, your diagnosis, your symptoms, and any treatment.

5. Be asked to provide blood sample(s) (maximum 50ml of blood) and/or saliva (spit) sample(s). This may be done at the same time as the assessment or separately depending on whether the assessment is completed over the phone/video call. On rare occasions, if there are problems with your original samples, for example delivery delays, then it may be necessary to take additional samples at another time and if you agree to this we will arrange this with you.

6. You may be asked to provide samples for extended biomarkers analysis. This will typically involve visiting a health clinic or university site. This will not be greater than that stated in point 5.

7. Be asked to complete some additional questionnaires in your own time. They take approximately 30 minutes to complete.

How long will the research take?

• Talking about the research and completing the consent form with a research assistant: 15-minutes (estimated)
• An informal interview: 15-minutes - 1-hour (estimated)
• Donating a sample of blood: 10-15-minutes (estimated)
• Complete additional questionnaire in your own time: 30 minutes (estimated)

You will receive £25 on completion of the study as a thank you for taking part and to reimburse you for your time, usually as a gift voucher or via a bank transfer. If you are invited to provide samples for extended biomarker analysis you will be reimbursed for this. Reasonable travel expenses will be paid by Cardiff University. To allow us to process your travel expenses, your details will be provided to Cardiff University’s Finance Department. 

We may ask you if any other members of your family would like to take part as this enables us to acquire a wide base of family genetic information. However, we would only contact your relatives with your full agreement.

What will my samples and data be used for?

Our research uses the samples and information you have provided to help understand these disorders better. We study the huge number of genetic differences found between one person and another.  We hope to find out if these genetic variations are related in any way to mental health and/or cognitive problems. Technical terms for the methods we use are ‘association’ and ‘gene sequencing’ studies. In recent years, these kinds of studies have led to major advances in understanding many health conditions. For example, asthma, several types of cancer, diabetes and heart disease. Your sample(s) may be used in studies in which the entire length of the genetic code is examined. This is called genome-wide sequencing. Your sample may also be used for investigating how genes are expressed, and to examine how other biological markers and proteins may be involved. These will be used for a range of research purposes aimed at increasing our understanding of the biological mechanisms underlying neurodevelopmental, neuropsychiatric and cognitive disorders.

With your permission, the information you provide for this study, including clinical and genetic data, will be linked in an anonymous format (this will not include any of your personal details, such as your name and address) to routinely collected, anonymised datasets. These existing datasets, and data that may be collected in the future, contain anonymous health, administrative and social record information (for example, general practice records, hospital records and other Healthcare Organisations clinical record systems). For example, in Wales a databank that we will link to is the Secure Anonymised Information Linkage (SAIL) dataset at Swansea University, and across the UK where available. Another dataset we will link with is the Akrivia Health Platform, which forms part of the UK MINDS study. Akrivia Health is a commercial organisation established as a spin out from the University of Oxford, with more than a decade long history with the NHS and Academia.

Linking clinical and genetic data with the Akrivia Health platform is required if you would like to take part in this study. Linkage with other datasets is optional. 

For more information on Akrivia Health please visit https://akriviahealth.com/about/terms-privacy-cookies/

All data linkage is undertaken in line with the UK General Data Protection Regulation (UK GDPR) 2018, the Data Protection Act (2018) and University governance. 

With your permission, we may look at your medical records in strict confidence. This is to gain further details about the kinds of symptoms and treatments you have had. With your permission, we may also like to look at your records in the future to see if there has been any change in your health.

These data and samples will be available for use by other researchers under a system that strictly protects your confidentiality. To make best use of resources we will share data (including genetic data), tissue samples and DNA (after removing any personal details such as name and address) with different groups of researchers from the NHS, universities and commercial companies, both within the UK and abroad. A linked genetic and electronic health data resource that can be accessed by researchers across the aforementioned groups. Samples will only ever be used in research that has the ultimate goal of helping patients or the general public. 

What are the possible benefits of taking part?

There have been recent important discoveries of genetic factors in several common disorders, including mental and/or cognitive disorders and developmental problems.  We hope that these findings will lead to new ways of diagnosing, treating or even preventing these disorders. However, these remain long-term aims and you will not benefit directly from taking part in this study. 

What are the possible disadvantages and risks of taking part?

This study does not include any treatment changes or invasive techniques. Some people feel mild discomfort when giving a blood sample. Sometimes there is mild bruising afterwards. 

Some people can find it difficult or upsetting to answer questions about their mental health, cognitive problems, and unpleasant experiences they have had. If you do get upset, the person doing the interview will be sympathetic and supportive. You can take a break or stop the interview altogether. 

Will my taking part in this research project be kept confidential?

All information collected from (or about) you during the research project will be kept confidential and any personal information you provide will be managed in accordance with data protection legislation. Please see ‘What will happen to my Personal Data?’ (below) for further information.

We will not routinely inform your GP or care team that you are taking part. However, if you have been invited to take part through an NHS service, a note may be added to your medical records by an NHS member of staff indicating your participation in the study. We will not pass on any of the information we collect unless we have serious concerns about your mental or physical health, or any concerns regarding the safety or wellbeing of others.

To make best use of resources we will share data with different groups of researchers from the NHS, universities and commercial companies, both within the UK and abroad. These organisations will use the data for their own research, which may involve genetic analysis and research using the linked genetic and clinical data. However, we would stress that they will never obtain access to personal/ identifying information (for example, your name, address, date of birth).

What will happen to my Personal Data?

All information and samples collected during the course of the research will be kept strictly confidential. There are strict laws that safeguard your privacy at every stage. In accordance with GDPR and the Data Protection Act, your personal information will be kept confidential by assigning a unique study code to your sample and data.  

We will need to use information from you, from your medical records and from your GP (with your permission) for this research project. 

This information will include your name, initials, NHS number, contact details and information about your health and any medication you might be taking.  People will use this information to do the research or to check your records to make sure that the research is being done properly.

People who do not need to know who you are will not be able to see your name or contact details. Your data will have a code number instead. 

We will keep all information about you safe and secure. 

Once we have finished the study, we will keep some of the data so we can check the results. We will write our reports in a way that no-one can work out that you took part in the study.

Cardiff University is the Data Controller and is committed to respecting and protecting your personal data in accordance with your expectations and Data Protection legislation. Further information about Data Protection, including:

• your rights
• the legal basis under which Cardiff University processes your personal data for research
• Cardiff University’s Data Protection Policy
• how to contact the Cardiff University Data Protection Officer
• how to contact the Information Commissioner’s Office

may be found at https://www.cardiff.ac.uk/public-information/policies-and-procedures/data-protection and at https://www.hra.nhs.uk/information-about-patients/

If you require printed copies of the above-mentioned documentation and privacy notice, please contact the study team using the details below.

For data that is linked with the Akrivia Health Platform, Akrivia Health and Cardiff University are joint data controllers. This means that we are jointly responsible for looking after your information and using it properly. However, only anonymised data will be shared with Akrivia Health. Akrivia Health will not have access to personal/identifying information (for example, your name, address, date of birth).

We will keep your personal data for 15 years following the end of the research project.

After 15 years, the research team will anonymise all the personal data it has collected from, or about, you in connection with this research project. Anonymised information may be published in support of the research project and/or retained indefinitely, where it is likely to have continuing value for research purposes.

Declining and withdrawing from the study

You do not have to take part in this study. If you do decide to take part, you are still free to withdraw or to stop taking part at any time without giving a reason. A decision to withdraw at any time, or a decision not to take part, will not alter the care you receive. 

If you decide to stop taking part in the study, you will be asked if you give permission for us to retain and use the data/samples that you have provided before your decision to stop taking part. If you agree, we will keep your information and samples for use in future research and analysis, however, we will no longer contact you with any follow-up questionnaires or invite you to take part in other research.

If you decide to withdraw from this study, research data and samples you have provided will be destroyed. We will keep minimal information such as your name and study ID to prevent you from being contacted about future research. The data/samples will not be used further in the research.

It is not possible to remove your data from research datasets which have already been published, however you would not have been personally identifiable at any stage. In addition, when linking your research data to other databanks such as the Akrivia Health Platform and/or SAIL, additional safeguards for preventing reidentification are used, meaning neither ourselves, nor the databanks could personally identify you after linkage. This means we cannot remove your data from these linked datasets. 

In the unlikely event that you lose capacity, the research team will retain your identifiable sample and data and continue to use it in the research.

What happens when the study is finished?

This is a long-term study that will allow us to learn a lot about the causes and triggers of mental health and/or cognitive problems. 

You will not receive specific results or feedback from your participation in the NCMH study. You will not have any claim to any future commercial use of results from the study in which your data/ sample has been used. 

With your permission, your biological sample will be passed to an approved biobank when it is no longer required for this study. You can withdraw your sample from the biobank at any point without giving a reason. To do this, please contact the original study team. If you do withdraw your consent any sample that has not already been used for research will be destroyed according to local practices.

In order to maximise the potential of your sample, information collected through this study might also be passed to the biobank, such as your NHS number and information from your medical records (both now and in the future). The biobank might also access your data through the Secure Anonymised Information Linkage databank or the Akrivia Health linked genetic and clinical dataset. Neither your name nor any other identifying information from any of these sources will be shared with researchers and your identity will always be protected.

Researchers in the UK and abroad, including certain commercial companies, may request permission to use your sample for their own research. This research may involve genetic analysis and research using the linked genetic and clinical data. Samples will only ever be used in research that has the ultimate goal of helping patients or the general public.

The biobank may seek to recover costs involved in the project. By signing the biobanking statement on the consent form you are agreeing for your sample to be used for these purposes. 

What will happen to the results of the study?

It is our intention to publish the results of this study in academic journals and present findings at conferences. Participants will not be identified in any report, publication or presentation. 

We will keep in touch with you via our website and by sending an annual newsletter to let you know how the research is going and to ask you to let us know if your contact details change.

Who is organising the research and why?

This study is a collaboration between the National Centre for Mental Health (NCMH), which is led by Cardiff, Swansea and Bangor Universities, and Akrivia Health. This project is funded by Health and Care Research Wales, Welsh Government and Akrivia Health. The Director of the NCMH is Professor Ian Jones. 

Future research opportunities

We may contact you again about other related research. We very much hope that many of the individuals who join NCMH will also take part in these future research opportunities. You will be free to decline if you do not want to take part in these other research opportunities – just as you are free to withdraw from this study at any time. 

Who has reviewed this study?

The study has been given a favourable ethical opinion by Wales Research Ethics Committee (REC) 2 and NHS (Research and Development) permission has also been obtained.

If you have further questions about the study please contact the study team: 

National Centre for Mental Health
Hadyn Ellis Building
Maindy Road
Cathays
Cardiff    
CF24 4HQ

Phone: 029 206 88401

Fax: 029 20687100

Email: info@ncmh.info

If you would like to discuss this study with someone independent of the study please contact:

Vanessa Davies

Institute Manager

Neuroscience and Mental Health Research Institute 

3rd Floor, Hadyn Ellis Building

Maindy Road 

Cardiff

CF24 4HQ

Phone: 029 206 88340 

Email: daviesvj@cardiff.ac.uk

National Centre for Mental Health, Cardiff University, Hadyn Ellis Building, Maindy Road, Cardiff, 

CF24 4HQ

Tel: +44(0) 29 206 88401    Fax: +44(0) 29 206 87100    Email: info@ncmh.info