Participant Information Sheet

1. Introduction

You are invited to participate in this research project, which is called the ‘ClozaGene Study’. We are seeking individuals 18 or over who have taken the medication Clozapine.

This Participant Information Sheet and Consent Form tells you about the research project. It explains what is involved in the study to help you decide if you want to take part.

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.

If you decide you want to take part in the research project, you will be asked to provide your consent online. You will be able to save an electronic copy of this Participant Information Sheet and Consent Form to keep.

If you do not wish to take part in this study, you do not have to. The project investigators do not have your name or contact details unless you provide them, so if you do not wish to take part you do not have to do anything further.

2. What is the purpose of the study?

The aim of the ClozaGene Study is to try to identify environmental and genetic factors that may influence how well Clozapine works. Clozapine can also be called Clopine or Clozaril. Clozapine can be used to treat Schizophrenia but may be prescribed for other reasons. We are also trying to find out why some people experience side-effects. This research is important because Clozapine does not work for all people and can have unpleasant side-effects.

We are also interested in understanding what the symptoms or conditions are for which Clozapine is prescribed, including Schizophrenia. We would also like to find out if the genetic factors that influence these symptoms or conditions also influence response to Clozapine.

You have been contacted by Services Australia because you may have been prescribed Clozapine sometime in the last five years.

We hope that you will choose to participate in the study.

Your participation is voluntary

Your participation in this study is completely voluntary and there will be no cost to you. If you do not want to take part in this study you do not have to. You should feel under no obligation to participate in this study. Choosing not to take part in this study will not affect your current and future medical care in any way.

3. Who are invited to participate?

For this study we need to recruit both men and women who have been prescribed Clozapine.

4. What does participation involve?

There are 3 parts to this study:

• Before providing any of your personal information, you will be asked to complete an online consent form. After giving your consent, you will be asked to complete a brief 20-minute online questionnaire.
• We will also ask permission to access your pathology records relating to tests you may have had because you were taking Clozapine, such as your Clozapine levels or blood cell counts.
• You will be asked to donate a saliva sample.

To collect the saliva sample, we will send you a specialised collection container. The collection kit is easy to use and the sample can be collected in your own home.

You will be asked to return this sample via Australia Post to our laboratory, at no cost to you.

We will extract DNA from your saliva sample to investigate genetic risk factors.

Participation also involves consenting to storage of your questionnaire and genetic information for future use.  This information may be stored indefinitely and pooled together with similar data from other participants.  To see how your privacy is protected, please read Section 10 - ‘Is it confidential?’

We appreciate the time and effort given by participants in this study.  To compensate you for your time, we will provide each participant a gift card to the value of $30 after you have participated.

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

Participation in this research project is voluntary. If you do not wish to take part, you do not have to.

The project investigators do not have your name or contact details unless you provide them, so if you do not wish to take part you do not have to do anything. If you decide to take part and later change your mind, you are free to withdraw from the project at any stage.

You are under no obligation to continue with the research study. People withdraw from studies for various reasons and you do not need to provide a reason.  You can withdraw from the study at any time by contacting the research team and requesting a withdrawal of consent form for you to complete and sign.

If you withdraw from the study, your information that has already been analysed and/or included in a publication may not be able to be withdrawn or destroyed. In such circumstances, your personal information will continue to form part of the project/research study records and results. If you have provided a saliva sample and subsequently withdraw from the study, completing the withdrawal of consent form will initiate destruction of any remaining saliva or DNA sample.

Your privacy will continue to be protected at all times.

6. Do I have to give a DNA sample?

Participation in this study involves providing a saliva sample.  Providing a sample can be done in your own home.

7. What are the possible benefits of taking part?

This study is unlikely to be of any immediate and specific benefit to you. Extensive research is required to find answers to the questions we are studying. However, future medical or scientific discoveries may come from the research in which you participate, and, in turn, help improve the outcomes for people taking Clozapine.  

Due to the design of the study, we will not be able to provide any individualised feedback to participants about their health condition, saliva sample, or DNA.  However, researchers will be providing everyone who participates with study updates.

Our research team greatly value the time and effort that you give to research.

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

Researchers acknowledge that being invited into this study may be a sensitive issue for you and may, therefore, cause you some discomfort.  Please note that we do not have any information about who the study letters were sent to by Services Australia.

You may feel that some of the questions we ask in the questionnaire are stressful or upsetting.  If you do not wish to answer a question, you can skip it and go to the next question, or you may stop immediately.

If you find that you are becoming uncomfortable or distressed and wish to speak to someone about this, you can also contact:

• the researchers (The researchers can be contacted using our free call number 1800-257-179, email ClozaGene@qimrberghofer.edu.au)
• Lifeline (who provide free confidential psychological support, 13 11 14), or
• Beyond Blue (who provide free confidential psychological support, 1300 22 4636).

9. Will I be contacted again about this study?

If you choose to participate, we may contact you to clarify some of your responses or invite you to be part of future studies.

Choosing to participate in the current study does not mean that you will be re-contacted.  If we do contact you about a follow-up study, you can choose not to participate and it will not impact your participation in the current study in any way.

10. Is it confidential?

Yes. All personal, questionnaire, pathology and genetic information collected for the study remains confidential in accordance with the National Health and Medical Research Council (NHMRC) ethical guidelines and the Privacy Act. Personal details, questionnaire data and genetic data will all be stored separately. The only link between personal details and other data is a participant identification number. Linking personal details and other data using this number is restricted to selected members of the QIMR Berghofer Medical Research Institute research team. All information provided by you will be stored securely, with access restricted to members of the research team.

The researchers will store personal, questionnaire, pathology and genetic information indefinitely at QIMR Berghofer Medical Research Institute. This information may continue to be valuable to researchers many years into the future, and may be considered for use in future, related projects. Before any future work proceeds it will be subject to approval by the relevant ethics committees.

Your genetic information and some of the questionnaire information (but no names, other personal details) may eventually be contributed to an international genetics data repository. Information in the database would only be available to researchers who are approved to study how genes influence health conditions. These scientists will never know your name or any other personal information.

Results of this research project may be presented in scientific papers in medical literature, or in public talks, but your identity will not be revealed. The data collected as part of this study will be combined at analysis with the data from many other people, and as such there will be no way of identifying individual participants.

In accordance with relevant Australian privacy and other relevant laws, you have the right to request access to the information about you that is collected and stored by the research team. You also have the right to request that any information with which you disagree be corrected. Please inform the research team member named at the end of this document if you would like to access the information you provided.

By confirming your consent online you consent to the research team collecting and using personal, questionnaire and genetic information about you as described for the research project.

11. What will happen to my saliva sample?

This Study: We will use your saliva sample to extract DNA. The research team will then look for differences and similarities between participants’ DNA samples. This information can help us understand why some people respond to Clozapine while others do not.

Your saliva sample and samples of DNA will be stored securely at QIMR Berghofer Medical Research Institute along with samples from many other people. They will be re-identifiable, which means that they will be stored with a barcode label, and can be identified as yours even though your personal details will be stored separately. Linking your personal details with your saliva sample or DNA using the barcode is restricted to specific members of the QIMR Berghofer research team.

We may send part of your saliva sample or DNA to another laboratory (which may be overseas) for processing or analysis. If this occurs, that sample would only be labelled with a number, and would be transported along with samples from many other people. No information about you will be sent to or accessible by the other laboratory. Any sample remaining after processing or analysis by another laboratory would be destroyed.

Future Studies: We would like to store your saliva and/or DNA samples for use in future research studies that may or may not be related to the original research project. There is no direct benefit to you from the storage of your saliva and/or DNA samples. In the future, researchers at this and other medical and research centres may use your samples to learn about other diseases and conditions. Their goal is to improve health outcomes and develop new treatments. The purpose of storing these types of samples is to answer questions in the future, so we expect to keep your samples indefinitely.

12. Will I be given the results of the research project?

The information collected in this study will not be analysed at an individual level and there will be no results specifically about you.

We will be sending updates about our research findings, which will include group level results.

Your information will be used for research purposes and you will not be given any clinical results from this study.

This research is not intended for the purpose of treating any health problems you may have. Participation in this research study does not take the place of visits to a doctor or other health professionals.

Please note that genotype results are for research purposes only. They are not intended and validated for clinical purposes and will not be returned to participants.

13. 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 the HREC of the QIMR Berghofer Medical Research Institute (QIMRB-HREC).

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

14. What if I don't want to participate or what if I change my mind later and want to withdraw from the study?

Participation is voluntary and you can choose not to participate. If you do choose to participate, you can withdraw from the study at any time, at any stage, or for any reason for some, part, or all of the research.  You can withdraw your consent by contacting the Project Co-Coordinator by phone 1800 257 179 (freecall) or email clozagene@qimrberghofer.edu.au. These contact details will be listed on your correspondence with the project team.  If you do withdraw, you will be asked to complete and sign a ‘Withdrawal of Consent’ form; the research team will provide this to you.

You can also choose to remove yourself from the Services Australia mailing list by emailing data.requests@humanservices.gov.au. You will need to provide your full name, address, Medicare care number and a contact phone number.

15. What if I have questions?

The person you may need to contact will depend on the nature of your query.

If you want any further information concerning this project, you can contact the project coordinator:

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: