AGDS_CellO Participant Information

Thank you for your interest in participating in this project. We will now begin the formalities of actively recruiting you into the project by collecting your personal details and obtaining your formal consent. The instructions below will walk you through the process for this formal consent.

Instructions:

1. Click on the title of each section to read the information required to participate.
2. Sections that are marked with ✅ must be read and agreed to by clicking the checkbox at the bottom of each.
3. Click on "I Agree and Wish to proceed" at the bottom of the page to consent to participate.
*Note: You will not be able to provide your consent unless you indicate your agreement to the sections marked.

Title	Australian Genetics Depression Study: Anti-depressant Cell-omics Study
Short Title	AGDS-CellO
Protocol Number	2023/HE000050
Project Sponsor	The University of Queensland
Coordinating Principal Investigator	Professor Naomi Wray
Associate Investigator(s)	Professor Ian Hickie Professor Nick Martin Dr Sonia Shah Professor Sarah Medland Dr Enda Byrne Dr Jacob Crouse Dr Brittany Mitchell
Location	The University of Queensland

Part 1. What does participation involve?

1. Introduction

You are invited to take part in the research project, Australian Genetics Depression Study –Cell-omics study (AGDS-CellO). This study is being supported by the Human Studies Unit (HSU), a dedicated genomics research facility at the University of Queensland.

Please read this information carefully. Ask questions about anything that you don’t understand or want to know more about. Before deciding whether or not to take part, you might want to talk about it with a relative, friend or your doctor.

Participation in this research is voluntary. If you don’t wish to take part, you don’t have to. You will receive the best possible care whether or not you take part.

If you decide you want to participate in the research project, you will be asked to sign the consent section. By signing, you are telling us that you:

Understand what you have read.
Consent to taking part in the research project.
Consent to having the tests that are described.
Consent to the use of your personal and health information as described.

You will be given a copy of this Participant Information and Consent Form to keep.

2. What is the purpose of this research? ✅

The purpose of this study is to understand depression from an individual experience. Understanding the reasons for these differences and how and why people respond differently to treatments will help understand this complex disorder. In the long-term, we hope this understanding will help more personalised prescription of anti-depressants medication.

A goal for personalised medicine is to know which drug to choose for each individual. Personalised drug choices are advancing in other branches of medicine, but much more research is needed to make progress for drug choices in depression. Research needs to build on the experiences of those who have had depression and who have responded well or poorly to specific antidepressants. As well as your questionnaire responses we can use your prescription history to understand your personal journey with antidepressants. In this study we will use cells derived from blood to investigate biological differences between people who report to respond particularly well, or poorly, to specific antidepressant classes. Cells derived from blood can be transformed into neuronal brain cells for these studies.

FS2 tickbox *

I have read and understood.

3. What does participation in this research involve? ✅

Consent

If you agree to participate, you will be asked to sign the consent form prior to any data and blood collection.

By signing the consent, you agree to:

Complete a personal journey questionnaire.
Provide a blood sample to collect viable cells for cell biology and systems genomics with and for viable cells to be transformed into LCLs with an option to extend your consent to generate iPSc lines.
Linkage of information you have previously provided as part of your participation in the Australian Genetics of Depression Study (QIMRB). This may include information you provided about your depression, treatment, and lifestyle behaviours from the QIMRB questionnaire.

Questionnaire

Personal Journey Questionnaire
You will be asked a series of questions about what depression looks like to you. The questions relate to your lifetime story/journey and the medications, therapies, and other treatments that you have tried to manage your depression. We will also ask you about your general health, and for women, girls, and those who are gender diverse specific questions relating to menstruation, pregnancy and menopause.

You will receive a unique research participant number and an electronic link from the Human Studies Unit (HSU) to complete the questionnaire online. This will take approximately 30 minutes to complete. Should you wish to complete a paper copy, we can provide this to you, or a member of the research team can administer this over the phone.

You will only need to complete the questionnaire one time.

You are not obliged to answer any questions that make you feel uncomfortable or questions you do not wish to answer. You can skip over them.

Biological Sample

If you consent to participate in this study, we will ask you to donate 30mls of blood. Your blood sample will be used in three different ways, and you are able to choose how your sample will be used.

1. Genetic research, which may include sequencing your genome.

Genetic research by collecting the DNA from your sample and DNA collection for genetic analysis including whole genome DNA methylation or whole genome sequencing or measurement of biomarkers, such as antibodies or lipidomic, immune, and other metabolomic biomarkers.

DNA will be obtained from the blood sample to look for DNA differences which could be involved in how the body responds to anti-depressant medication. Other parts of your plasma and serum will also be collected and stored for use in biomarker studies.
DNA methylation analysis provides information how our genetics code responds to the environment in which we live.

Whole genome sequencing means recording the DNA sequence of our genes on each of your chromosomes. This can reveal up to three to four million variations in your unique code compared to others. Most of these variations are not disease-causing but make you unique.

2. Generate lymphoblastoid cell lines (LCLs) by collecting peripheral blood mononuclear cells (PBMCs)

Generating LCLs means to store your blood cells in a way that they last forever (this is called immortalisation of cell lines). An immortalised cell line is a group of cells that can live and divide indefinitely outside of the body. Having an LCL provides an unlimited supply of cells without needing to take more blood samples. This would make it possible for researchers to study the DNA in your blood cells in the future. DNA forms a set of instructions, and in the future researchers could look at these instructions in more detail. Technology is always progressing and having LCLs available allow researchers to undertake new work in the future that could lead to new information and treatments for depression.

3. Collect and store additional peripheral blood mononuclear cells (PBMCs) under specific conditions to generate induced pluripotent stem cells (iPS cells)

Induced pluripotent stem cells (iPSCs) are cells that are able to self-renew by dividing so they can potentially produce any cell or tissue the body needs to repair itself. These cells can also make excellent laboratory models for studying how a disease unfolds as they are able to develop multiple cell types and functions mimicking real organs found within the body. When these cells group together and are able to form more complex organ-like structures they are called organoids.

The iPSCs can be stored for long periods without compromising the cells making it a useful tool for researchers to use to study how a disease develops, how it responds to treatment and how the disease differs across people. The PSCs this project will collect come from blood, but they can be derived from different kinds of biological samples including, skin, hair, and tissue. It is important to note this method is different from embryonic stem cells, which can only be derived from embryos.

With your consent, we will create iPSC cell lines from your blood sample using the PBMC cells contained within it. Using laboratory techniques these iPSC lines will be re-programmed to become neural networks that mimic the brain to support this research in understanding depression and how best to deliver a more personalised approach to treatment.

FS3 tickbox *

I have read and understood.

4. How will I give my blood sample?

You will be provided with a blood sample kit, along with instructions on how to collect and handle your sample. This will be sent to your nominated address. You will be asked to attend a pathology collection centre near you for the collection of blood sample. Return your blood sample using the prepaid lab mailer kit provided, to the Institute for Molecular Biosciences, University of Queensland, via Australia Post.

5. What will happen to my biological sample? ✅

Genetic information derived from these biological samples will be held at IMB on secure servers behind UQ firewall and under the direct supervision of the IMB IT Manager and Prof. Naomi Wray (lead investigator).

The blood samples will be assigned a unique research code and the laboratory team who process your sample do not have access to any confidential information provided in questionnaires or medical information. Similarly, individuals of the research team who may be involved in your recruitment do not have access to your genetic information. The separation of information helps to maintain your confidentiality and privacy. These samples will be re identifiable only by the Principal Investigator or authorised member of the laboratory research team.

Your biological sample and cell lines will be stored and used into the future with your consent.

If you do not wish to have your biological samples and genetic material available for further use in ethically approved studies you can indicate this on the consent form and the material will be disposed of after mandated time of retention of samples and data has passed, which is currently 7 years after the close of the project.

You may want to discuss your participation in this project with your family and other trusted individual before agreeing to participate in the project.

FS5 tickbox *

I have read and understood.

6. Additional costs & reimbursement

There are no costs associated with participating in this research project. On completion of the questionnaire and once we have received your blood sample you will be given the option of receiving an electronic gift card to the value of $50 to your nominated email address for reimbursement of your time, and other expenses that you may have incurred as a result of participating. Or to donate all or some of the reimbursement back to the research should you wish to.

7. Data storage, retrieval, and destruction

Responses to the questionnaire will be stored on the secure AGDS-CellO research portal developed by HSU at IMB on secure servers behind UQ firewall and under the direct supervision of the IMB IT Manager and PI. Data collected is held independently within the portal with investigator approving access to research staff.

We know that research progresses faster if other researchers can also access your de identified data and samples. Other researchers may obtain access to and use your de-identified health information, genetic information, and biological samples for mental health research. Your data can only be obtained and used by researchers who have obtained relevant clearance from a Human Research Ethics Committee and with approval from principal investigators of this project. Any researchers who wish to use your data must also agree to protect your privacy.

In all cases, only approved research personnel will have access to the biological sample and its derivatives or health related data collected during this project.

8. What do I have to do?

There are no restrictions in lifestyle, dietary or types of treatment you receive throughout the study. If you are involved in another research study, we ask you to advise the research coordinator.

9. Other relevant information about the research project

The study will primarily be conducted by the Human Studies Unit, University of QLD on behalf of Prof. Naomi Wray. We are seeking 480 individuals who have a diagnosis of depression and received or receiving treatment.

10. Do I have to take part in this research project? ✅

Participation in any research project is voluntary. If you do not wish to take part, you do not have to. If you decide to take part and later change your mind, you are free to withdraw at any stage without consequences.

Your decision whether to take part or not take part, or take part and then be withdrawn, will not affect your routine treatment, or your relationship with those treating you, or your relationship with University of Queensland or QIMRB.

If you do decide to take part, you will be given this Participant Information and Consent Form to sign and you will be given a copy to keep.

FS10 tickbox *

I have read and understood.

11. What are the possible benefits of taking part?

There will be no clear benefit to you from your participation in this research. However, we hope that the results generated from this work may benefit community by the discovery of information on biological and genetic markers for the selection of anti-depressant medication to enable better treatment options.

The University of Queensland, QIMR Berghofer or another company may benefit financially from the outcomes of research projects that have used your health information in approved research projects.

12. What are the possible risks and disadvantages of taking part? ✅

There are risks and discomforts associated with every research project. They deserve careful thought and consideration.

Blood sample
Having a blood sample taken may cause you some discomfort or bruising. Sometimes, the blood vessel may swell, or blood may clot in the blood vessel, or the spot from which the blood is taken could become inflamed. Rarely, there could be a minor infection or bleeding. If this happens, it can be easily treated.

Discomfort
The online questionnaire will ask questions that you may find sensitive, or make you feel uncomfortable depending on your personal experience. Should you experience distress please contact Lifeline 131114 or Beyond Blue https://www.beyondblue.org.au/get-support.
You can contact the research team via email: cello@imb.uq.edu.au or by leaving a message on the dedicated HSU participants hotline number 07 33462089 and a member of the research team will respond.

Genetic Information
Someone could trace the coded information in a scientific database back you and your participation in this study. Even without your name or other identifiers, your genetic information is unique to you (like a fingerprint). We think the risk of this happening is very low.

Generating genetic information using the DNA obtained from your sample raises some important issues. Standard practice for genomic research is not to return individual research findings to participants. We will not be communicating the results of the genetic analysis on your sample to you as these results will be combined with data from many other individuals and reported as aggregate data.

Although the genetic analysis planned in this study will not identify any variants of medical significance, it is possible that in rare or future cases health related information that could be of significance to you (such as expanded white cell compartment in your blood) but not directly related to the research project could be observed. If such incidental findings occur, this information will be relayed back to you treating physician who can make a clinical decision on whether to pursue this information using accredited laboratories.

In the unlikely case we identify a genetic variant that could be of clinical significance or potentially clinically significant to you and your family, you will have the tests repeated and the results verified. This will involve a blood sample being taken and having it tested in an accredited laboratory. You will be given an option on consent page whether to be notified or not. To assist you in deciding whether to receive this information and the potential risks associated, we suggest you discuss this with a health professional, family members or a trusted person. A member of the research team is a certified and practicing genetic counsellor and is available for you to speak to. At any stage you wish to change your mind about whether to receive these findings please contact the research team.

If you consent to receiving this information and before a repeat blood sample is collected, you will be contacted by the research genetic counsellor to discuss the possible issues that might arise, and the risks involved for you and potentially your family. With your consent, we will share this information with a health professional of your choosing who will discuss the clinical significance of this information and the process for further genetic testing. There may be a cost for further genetic testing. This is especially important for individuals who are found to have a genetic mutation that is associated with an increased risk of developing a particular medical condition. If you agree to providing a new sample for the purpose of clinical genetic testing, this will be performed as part of the clinical care being provided by a health professional.

Statutory or contractual duties may require you to disclose results of genetic test or analysis to third parties (for example, insurance companies, employers, financial and educational institutions), particularly where results provide information about health prospects. If the genetic results are not available to you or you choose not to have the results given to, then future requests for insurance will not be affected by participating in this research.

If you do obtain the results of your genetic tests, you may then be obliged to disclose this on any future requests for insurance or employment should it be requested.

For more information, please see attached documents:

Life Insurance products and genetic testing in Australia
Genetic tests and applying for life insurance – Key Facts (Financial Services council)

Participants in this or any related studies cannot claim ownership rights to any medical or scientific product that results from research with their samples. Research results about you as an individual will not be available to you, your health professional nor will it be recorded in your health records.

FS12 tickbox *

I have read and understood.

13. What if I withdraw from this research project?

If you decide to withdraw during the research project, we ask you to contact us via email: cello@uq.edu.au. Withdrawal from the study at any time will not affect your primary care delivered to you, in any way, or your relationship with the University of Queensland or QIMRB.

The research team will not collect additional personal information and your genetic data will be removed and your biospecimens will be destroyed. Information already collected and included in analysis, will be retained to ensure research results are measured correctly and comply with law.

Part 2. How is the research project being conducted?

14. What will happen to information about the participant?

University of QLD and research staff are bound to undertake research in accordance with the Australian Privacy Principles (2014), the Australian Code of the Responsible Conduct of Research and NHMRC National Guidelines for the Ethical Conduct of Human Research (2007) updated 2018.

By signing the consent form, you consent to the principal investigator and relevant research staff collecting and using personal information about you for this research project.

Your de identified personal health information, questionnaires responses and biological samples maybe given to authorised researchers for HREC approved projects. The information will always be disclosed to them in a de-identified form, that is without your name, initials, date of birth, address or contact details being attached to it. Any information obtained in connection with this research project that can identify you will remain confidential.

Your information will only be used for the purpose of this research project, and it will only be disclosed with your permission, except as required by law.

Your information obtained during the research project are subject to inspection (for the purpose of verifying the data) by the relevant authorities, the institution relevant to this Participant Information Sheet, University of Queensland or as required by law.

By signing the Consent Form, you authorise release of, or access to, this confidential information to the relevant study personnel and regulatory authorities as noted above.

We will also seek your permission to access your Medicare and Pharmaceutical Benefits Scheme (PBS) claims information. Medicare collects information on your medical visits and procedures, and the associated costs, while the PBS collects information on the prescription medications you have had filled at pharmacies. If you agree, you will be asked to fill out a consent for authorising the study access to your Medicare and or Pharmaceutical Benefits scheme data as outlined on the consent form.

Consent to access your Medicare and/or PBS claims information is separate from consent for the rest of the study (online questionnaire and biological sample). You can participate in other parts of this study without consenting to Medicare and PBS component.

It is anticipated that the results of this research project will be published and or presented in a variety of forums. In any publication and/or presentation, information will be provided in such a way that the participant cannot be identified, except with your permission.

15. Who is organising and funding the research?

This research is conducted by Professor Naomi Wray and is funded by PI Wray’s NHMRC Investigator Grant: “Quantitative Genomics of Common Diseases” awarded in 2020.

You will not benefit financially from your involvement in this research project. In addition, if knowledge acquired through this research leads to discoveries that are of commercial value to The University of Queensland, there will be no financial benefit to you or your family.

16. Who has reviewed the research project?

All research in Australia involving humans is reviewed by an independent group of people called a Human Research Ethics Committee (HREC). The ethical aspects of this research project have been approved by University of Queensland HREC (protocol number 2023/HE000050) and of Queensland Institute of Medical Research Berghofer HREC (protocol number P2118).

This project will be carried out according to the National Statement on Ethical Conduct in Human Research (2007) updated 2018. This statement has been developed to protect the interests of people who agree to participate in human research studies.

17. Further information and who to contact

The person you may need to contact will depend on the nature of your query. If you want further information concerning this project or if you have any medical problems which may be related to your involvement in the project, you can contact:

Research Project Manager contact

Name	Ms Anjali Henders
Position	Study Manager
Telephone	07 3346 2089
Email	a.henders@uq.edu.au

Research Genetic Counsellor

Name	Ms Leanne Wallace
Qualification	Master of Genetic Counselling
Email	cello@uq.edu.au

Reviewing HREC approving this research and HREC Executive Officer details

For matters relating to the online questionnaire troubleshooting or queries on biological samples, you can contact the HSU (Human Studies Unit) research staff:

Research staff contact

Name	HSU research staff
Telephone	07 3346 2089
Email	hsu-projects@uq.edu.auu

If you have any complaints about any aspect of the project, the way it is being conducted or any questions about being a research participant in general, then you may contact:

Reviewing HREC name	University of Queensland Human Research Ethics Committee
HREC Executive Officer	HREC Executive Officer
Telephone	07 3365 3924 / 07 34431656
Email	humanethics@research.uq.edu.au

Reviewing HREC approving this research and HREC Executive Officer details

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