Thank you for registering to the Genetic Links to Anxiety and Depression website!

Please note that you will need to scroll through all the information sheet here before providing consent or completing your survey, even if you have already downloaded and read the PDF version of the information sheet.

You have taken the first step to becoming a member. To join the GLAD Study, we now ask you to:

Scroll through the information sheet
Provide consent
Complete a questionnaire
Provide a saliva sample

Once you have finished reading, you can always come back later to review the information sheet from your Account Dashboard. Please don’t hesitate to contact our study team if you have any questions or concerns during the sign-up process. We would like to emphasise that you can stop taking part at any time.

To enrol in the GLAD Study, please read through this information and then complete the consent items at the end.

About the Research Resource

Eligibility

To take part in the GLAD Study you must either:

Have ever experienced or are experiencing anxiety or depressive disorders (with or without a medical diagnosis)
Have never experienced any mental health disorder.

AND you must:

Be aged 16 or over
Live in the United Kingdom

Overview page

Depression and anxiety disorders are the most common psychiatric disorders worldwide. To improve our understanding of the genetic risk factors behind anxiety and depression, we need to recruit thousands of participants. We therefore invite you to join the Genetic Links to Anxiety and Depression (GLAD) Study, currently the largest study on anxiety and depression, comprised of both individuals who have experienced or are currently experiencing depression and/or anxiety, as well as a comparison group of individuals who have never experienced a mental health disorder. The project is led by the National Institute for Health and Care Research (NIHR) BioResource Centre Maudsley (part of the NIHR BioResource) and researchers at King’s College London.

Signing up to the GLAD Study will involve providing access to your medical records (so we can find out some important clinical information), completing some questionnaires, and giving a saliva sample.

On the website you can see information on a number of research studies that are being carried out that are not just limited to anxiety and depression. If you decide to sign up to this project you will be able to choose to take part in these other studies, if you want to. You will also be offered the opportunity to complete additional, optional questionnaires relevant to mental and physical health.

You can stop taking part at any time by contacting the GLAD Study team.

1. About the Study

The GLAD Study is a project set up to explore genetic and environmental risk factors in individuals who have experienced or been diagnosed with depression and/or anxiety and will compare their data with those who have never experienced a mental health disorder. This allows us to shed light on why some people experience anxiety and depressive disorders while others do not. The GLAD Study is also a way for participants to join the NIHR Mental Health BioResource. The NIHR Mental Health BioResource is an NIHR funded project and part of the NIHR BioResource for Translational Research.

The NIHR BioResource is a national initiative where the aim is to collect genetic and clinical data from volunteers to build up a central library of information about people’s health. The NIHR BioResource is supporting studies, such as the GLAD Study, that look at how genes and other factors influence disease. Conducting research such as this allows us to better understand how disorders develop, which in turn can lead to better preventions and treatment. Participating in the GLAD Study and the NIHR BioResource offers you the chance to take part in ground-breaking research aimed at improving the lives of those not only with depression and anxiety, but other health conditions as well.

The GLAD Study aims to conduct research on mental health and treatment. We will:

➢ Collect psychological and other data (questionnaire data) and biological (saliva) samples so that we can learn more about the factors that may influence anxiety and depression.

➢ Link members’ questionnaire and biological data with their medical records.

The GLAD Study also aims to create an online research active group of individuals with anxiety or depression, as well as those with no prior experience of a mental health disorder, as part of the NIHR Mental Health BioResource. We will:

➢ Create an online resource of members interested in taking part in research.

➢ Provide members with information about research projects that they can get involved in.

➢ Regularly update members on the progress of the research and the contribution that they have made.

➢ Provide links to pages that provide detailed information on mental health difficulties, the treatments available and where to seek help if it is needed.

All data use is strictly within the terms of the Data Protection Act 2018.

2. What’s involved?

It is essential that all participants in the GLAD Study agree to take part of their own free will and indicate that they fully understand what signing up will mean. There is no obligation to sign up. Once you have provided consent you can unsubscribe at any time.

There are three steps to signing up to the GLAD Study, part of the NIHR BioResource.

Step 1: Giving consent to take part

➢ You will be asked to read and sign a consent form. The consent form includes a description of each of the types of activity you might be invited to take part in. It is up to you to decide which activity you consent to.

➢ You will be asked to provide your name, date of birth, NHS number and contact details (including email and mobile phone if available) and allow us to store this information.

➢ We will request access to your existing and future medical, health and social care records. We will also ask that you allow us to collect, store and analyse this health information about you. Your data will only be provided to the GLAD and NIHR BioResource teams and, having been de-personalised, to researchers approved by the GLAD Study, and/ or NIHR BioResource Steering Committee. De-personalised means that your identifiable, personal information is removed, including your name, date of birth, and address.

➢ We will also ask for your consent to be contacted in the future about other ongoing research studies that may be unrelated to anxiety and depression. We will use your saliva sample, and additional information, to match you to research studies that are looking for volunteers. You can decide whether to be involved at the time and are under no obligation to do so.

Step 2: Questionnaire data

➢ We will ask you to complete some questions which will ask about your demographics (e.g., age, gender, and employment situation), emotional wellbeing, health and lifestyle, personality and experiences of depression and anxiety. This will take around 30-60 minutes to complete.

Step 3: Saliva sample

➢ We will ask you to provide a saliva sample by spitting into a specially designed collection tube. This will be sent to you at home, and you can send it back to us using a freepost envelope which we will provide.

➢ We will extract, analyse and store a sample of your DNA (genetic material) from this sample.

➢ Samples will be stored without any of your personal details (e.g., name, date of birth, NHS number).

➢ If you are from England and Northern Ireland, your sample will be stored at the National Biosample Centre (NBC) in Milton Keynes or another approved laboratory. If you are from Northern Ireland, some of your sample will also be stored in secure facilities at Ulster University in Coleraine.

➢ If you are from Scotland, your sample will be stored at NBC or other approved laboratory, and some will also be stored at the Wellcome Trust Clinical Research Facility at the University of Edinburgh.

➢ If you are from Wales, your sample will be stored at NBC or other approved laboratory, and some will also be stored at National Centre for Mental Health/ MRC Centre for Neuropsychiatric Genetics and Genomics at Cardiff University.

➢ Additionally, saliva samples may be stored and processed through the NIHR BioResource Centre Maudsley (REC Ref: 22/SC/0024) at the KCL Genomics lab based in King's College London.

Confidentiality

➢ Best ethical and legal practice will be followed to ensure that all information collected about you will be handled in confidence.

➢ You will be assigned a unique ID number which is used to link your questionnaire answers and medical records to your saliva sample. This means your data is linked-anonymised; the key that links ID numbers to your personal information is stored securely in the GLAD Study and NIHR BioResource databases and can only be accessed by members of the GLAD and NIHR BioResource teams. Everyone working at King’s College London and the NIHR BioResource has a legal duty to keep personal information confidential.

➢ Information from these tests will not be used or made available for any purpose other than for research. You will not be identified personally in any report or publication.

➢ You can read the privacy notice for the NIHR BioResource on the https://bioresource.nihr.ac.uk/about-us/governance-and-ethics/privacy-notice/ website, and the King’s College London privacy notice at https://www.kcl.ac.uk/terms/privacy.

All data use is strictly within the terms of the Data Protection Act 2018.

3. Should I take part?

Benefits of taking part

➢ By joining the GLAD Study, you are also joining the NIHR BioResource. Once you are a member of the GLAD Study and the NIHR BioResource, you will be able to see information about further optional questionnaires, as well as a number of research studies that you are eligible to take part in. You may also be contacted about Patient and Public Involvement (PPI) groups or studies you may be eligible for that are not only related to anxiety and depression. We may assess your eligibility for these studies based on information you have provided (i.e., questionnaires), or information we have accessed from your medical records (i.e., diagnosis, treatment outcome) or samples (i.e., genetic information). If you choose to do so, you can sign up to be a participant in up to 8 studies per year (4 face-to-face and 4 online). You are free to accept or reject these invitations.

➢ There may be no immediate benefit to you in terms of treatment, but you will contribute to knowledge about some of the causes of depression and/or anxiety. This knowledge may lead to better treatment guidelines and improve future care for patients.

➢ The GLAD Study is an information resource for members as well as researchers. With this in mind, you will have access to pages dedicated to providing useful information to members.

➢ As a thank you, participants who return their saliva sample and/or complete the additional surveys will have a chance to be entered into corresponding prize draws, with prizes ranging from GLAD merchandise to gift vouchers and larger gifts such as a tablet computer. Before each prize draw, participants will receive an email with information on how to enter. Further, before each draw participants will be asked whether they wish to take part in the draw.

Possible disadvantages

➢ Some of the questionnaires ask about topics which some people might find sensitive, and about experiences of anxiety and/or depression. You do not have to complete any questions that you do not wish to.

➢ Providing a saliva sample is a very low risk procedure but some people find it unpleasant.

➢ Your participation is strictly confidential and the risk of identifiable information being accidentally disclosed is extremely low.

All data use is strictly within the terms of the Data Protection Act 2018.

4. Final details

What will my information be used for?

King’s College London is the sponsor for this study based in England. We will be using information from you and your medical records in order to undertake this study and will act as the data controller for the GLAD study. This means that we are responsible for looking after your information and using it properly. Cambridge University Hospitals NHS Foundation Trust is responsible for managing the NIHR BioResource and acts as the data controller for the NIHR BioResource. Your data will be stored by King’s College London and the NIHR BioResource for use in current and future ethically approved research aimed at better understanding the development and treatment of a range of health conditions. We will store your data for approved research until it is no longer useful, to enable research studies with longer term aims, such as studies looking at the long-term outcomes of depression or anxiety disorders.

If you are from outside of England, then a derived data set will also be shared with the local Principal Investigator in your country to help contribute to mental health research in your nation. Your data will also be stored securely at Queen’s University Belfast if you are from Northern Ireland, the University of Edinburgh if you are from Scotland, or the National Centre for Mental Health/MRC Centre for Neuropsychiatric Genetics and Genomics at Cardiff University if you are from Wales. Your personal information will not be shared without your permission.

King’s College London and the NIHR BioResource will use your name, NHS number and contact details to contact you about the research study, and make sure that relevant information about the study is recorded for your care, and to oversee the quality of the study. Individuals from the NIHR BioResource, the NIHR BioResource Centre Maudsley, and regulatory organisations may look at your medical and research records to check the accuracy of the research study. NHS sites will pass these details to King’s College London along with the information collected from you. The only people in King’s College London and the NIHR BioResource who will have access to information that identifies you will be people who need to contact you for follow-up questionnaires, send newsletters, invitations to open events, or to audit the data collection process. The people who analyse the information will not be able to identify you and will not be able to find out your name, NHS number or contact details.

King’s College London and the NIHR BioResource will keep identifiable information about you from this study until you choose to withdraw.

Your rights to access, change or move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. If you withdraw from the study, we will keep your de-personalised data that we have already used for analysis (e.g., we will keep scientific findings that we have obtained from your DNA sample). To safeguard your rights, we will use the minimum personally identifiable information possible.

Your information will only be used for scientific research purposes. Access to your de-personalised data and saliva sample may be made available to other scientists under strict and confidential legal data-sharing agreements. Each application to access data will require approval by the NIHR BioResource Data Access Committee or local Steering Committee. Any studies requesting contact with participants will require separate ethical approvals. Material Transfer Agreements (MTA) or contracts will govern the use of any phenotypic, clinical and biological data supplied to external organisations. Any data released to other researchers will be de-personalised using your unique ID number and will contain no personal information.

Copies of de-personalised GLAD Study data, with personal details removed, may also be stored on central, secure research databases, to enable analyses by GLAD and NIHR BioResource approved researchers. Through doing this, our data would become more widely available to researchers working on projects to find the causes of mental and physical health problems and to improve health outcomes. In this way, GLAD participants are able to make a wider contribution to science without additional effort. These centralised databases hold the highest data security certificates and often work alongside verified organisations, such as the NHS. In these cases, GLAD and the NIHR BioResource would retain control of your data, and access to use your de-personalised data would still require approval by GLAD, the NIHR Bioresource, and any other additional security panels relevant to the centralised database.

Currently, GLAD shares de-personalised data with the UK Longitudinal Linkage Collaboration (https://ukllc.ac.uk/) for the purposes of combined analyses of medical records. If we receive further proposals to merge data with other approved organisations who enable medical record linkage studies, you will be notified and given options as to how you want your data to be managed, including the option to opt-out of these arrangements if you wish.

If your de-personalised sample is used to make an invention (i.e., to develop a product to aid the diagnosis or treatment of a disease), you will not receive compensation or recognition for your contribution. We partner with companies to develop inventions that can benefit patients, service users and donors with the aim of improving healthcare in the future.

You can find out more about how we use your information by contacting us at www.gladstudy.org.uk/contact.

Will I get information about my genetic results?

The NIHR BioResource Centre Maudsley does not plan to routinely feedback any genetic results obtained from your sample. The results are for research purposes only, and thus are not for clinical diagnosis or treatment. In the extremely rare instance that we do find something that is of known clinical importance, with your consent we will write to your GP recommending further investigation.

What if I no longer want to be a member of the GLAD Study, part of the NIHR BioResource?

Volunteers are free to withdraw from the GLAD Study, part of the NIHR BioResource at any time without giving a reason. If you choose to withdraw:

• You will be asked to specify whether you would like us to destroy the sample(s) you have donated, which are stored at the central archive.

• It will not be possible to destroy samples already prepared or already distributed for testing.

• Details of your initial consent and the withdrawal process will be maintained along with your name and date of birth.

• Should you wish, no further data will be retrieved from your health-related records and no new data from laboratory measurements will be added to the research databases; pre-existing data will not be used in further analysis wherever possible.

• Pre-existing data and data that has already been distributed to other researchers cannot be destroyed.

• Once confirmation of your decision to withdraw is received, you will not be contacted again by the GLAD Study or NIHR BioResource Teams.

• If the GLAD Study, part of the NIHR BioResource is unable to confirm your decision, your sample(s) and data will be retained for future use, but you will not be contacted again.

To withdraw, please contact the GLAD Study, or NIHR BioResource team by email or phone. Please note that by withdrawing from the GLAD Study you will also be withdrawn from the NIHR BioResource and vice versa.

What if something goes wrong?

We do not anticipate that anything will go wrong but if you have a concern about any aspect of this project, please call on 0207 848 1638 (Freephone 0800 634 4504) and leave a message for the GLAD Study team who will do their best to answer your questions.

If you remain unhappy and wish to complain formally, you can do this by contacting The South London and Maudsley NHS Foundation Trust Complaints office (020 3228 2444/2499).

In the unlikely event that something does go wrong, and you are harmed during the research due to someone's negligence, then you may have grounds for a legal action for compensation against King’s College London. You may have to pay your legal costs.

Need more information before consenting?

Contact our research team here (www.gladstudy.org.uk/contact) and they will be happy to provide you with any information you need about the project and the consenting process.

All data use is strictly within the terms of the Data Protection Act 2018.

If you would like to contact us, please give us a call on 020 7848 1638, or our Freephone on 0800 634 4504, or if you would like to email us at gladstudy@kcl.ac.uk.

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