Participant Information Sheet

1. Introduction

You are invited to participate in this research project, which is called the ‘Australian ASD and ADHD Study’. We are seeking individuals 18 or over who have been diagnosed with or treated for Autism Spectrum Disorder (ASD) and/or Attention Deficit Hyperactivity Disorder (ADHD).

This Participant Information Sheet/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. Why are we studying ASD and ADHD in the same research project?

In 2013 the criteria used to diagnose ASD and ADHD were updated. Autism spectrum disorder replaced the diagnoses of autistic disorder, Asperger’s disorder and pervasive developmental disorder and changes were made to the age criteria for ADHD. The new criteria also make it possible for a person to be diagnosed with both ASD and ADHD.

We’re interested in the way these changes might have influenced the support, impacts and treatment experiences of individuals who are living with ASD and/or ADHD and their families. We're also interested in finding out if the updates to the diagnostic criteria might help us find new genetic factors that influence these traits. To look at this we plan to compare the data provided by individuals diagnosed before and after these changes were made.

3. What is the purpose of this study?

The purpose of the study is to try and improve our understanding of the financial, emotional and educational impacts on individuals and their families who are living with ASD and ADHD and the genetic factors that influence these traits.

The aim of the study is to collect information to help improve treatment as well as access to and delivery of health and education services for Australian families.

To do this we are interested in finding out what your experiences are with accessing health care and education. What has worked for you and what hasn’t?

An aim of this research project is to identify environmental and genetic factors that may influence the response to treatment. We hope that this research will help us learn more about ASD and ADHD and the factors influencing why some treatments are successful for some people and not for others.

For this study we hope to recruit at least 5,000 individuals who have been diagnosed with or treated for ASD and/or ADHD. This research has been funded by the National Health and Medical Research Council (NHMRC). There is no drug company funding involved in this 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.

4. What does participation in this research 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 30 minute online questionnaire.

• Depending on your responses to the online questionnaire, you may 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.

• Some details of your medical history that would be helpful to the project investigators (like how many prescriptions you may have had for various medications) would be hard for many people to remember.
  
  So we will ask for your permission to access your Medicare Benefits Schedule (MBS) and Pharmaceutical Benefits Scheme (PBS) claims information from the last five (5) years.
  
  Medicare collects information on medical visits and procedures, and the associated costs, while the PBS collects information on the prescriptions that have been filled at pharmacies. Once you complete the online questionnaire we will post you a consent form for you to fill out, authorising the study access to your Medicare and PBS data as outlined in this information sheet.
  
  Once you return this consent form to us, it will be sent securely to Services Australia which holds Medicare and PBS information confidentially.
  
  Consent to access your Medicare and/or PBS claims information is completely separate from consent for the rest of the study (online questionnaire and biological sample). You can participate in the other parts of this study without consenting to the Medicare and PBS component.

We appreciate the time and effort you will give in this study.  For participants who came into the study before 31st January 2024, we will provide you with an e-gift card to the value of $25 at the end of your participation in the study [you will still be reimbursed for your time in participating even if you do not provide consent to access your Medicare and PBS information]. Please note that we are not be able to reimburse participants who participate after 31st January 2024; only those who have participated before this date are able to be reimbursed by the study. 

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, you will be able to choose whether the study will destroy or retain the information it has collected about you. You should only choose one of these options. Where both boxes are ticked in error or neither box is ticked, the study will destroy all information it has collected about you. 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. Your privacy will continue to be protected at all times.

6. 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. These may help improve the available treatments and outcomes for people living with ASD and/or ADHD.

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

Risks are minimal for involvement in this study. 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 may 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 contact:

• the researchers (The researchers can be contacted using our free call number 1800-257-179, or via email aaastudy@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).

8. What will happen to information about you?

All personal, questionnaire 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 research team. All information provided by you will be stored securely, with access restricted to members of the research team.

Any Medicare and PBS data you consent to provide (including the consent form itself) will be used for the purposes of this study only. It cannot be shared with anyone outside the research team for this project without specific Commonwealth Government approval. The original records supplied to the research team, and any copies, will be deleted from our computer systems 5 years from the publication of the final project report, or after 10 years from the date of supply (whichever is sooner). However, any research findings associated with your Medicare or PBS data will not be able to be destroyed or recalled.

The researchers will store personal, questionnaire and genetic information indefinitely (but not your Medicare or PBS data) 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, Medicare or PBS data) 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.

9. What will happen to my biological sample?

We will use your biological 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 a treatment while others do not.

Your biological 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 biological sample or DNA using the barcode is restricted to specific members of the QIMR Berghofer research team.

We may wish to 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.

We would like to store your biological and/or DNA samples for use in any 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 biological and/or DNA samples. In the future, other doctors and scientists at this and other medical and research centres may use your samples to learn about many different 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.

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

No. 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.

11. 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.

12. What if we don't want to participate or what if we change our minds 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 Coordinator by phone 1800 257 179 (freecall) or email aaastudy@qimrberghofer.edu.au. These contact details will be listed on your correspondence with the project team.

13. Further information and who to contact

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:

If you have a privacy complaint in relation to the use of your MBS/PBS data you should contact the Office of the Australian Information Commissioner. You will be able to lodge a complaint with them.

Website: www.oaic.gov.au

Telephone: 1300 363 992

Email: enquiries@oaic.gov.au

Mail: GPO Box 5218, Sydney NSW 2001

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