Australian Genetics of Parkinson’s Disease Research Study

Information Sheet

1. What is the purpose of the study?

A person’s risk of Parkinson’s disease (PD) has a hereditary component. Genes also influence disease prognosis and a patient’s treatment response. Large scale studies investigating genetic risk factors increase our understanding of the disease process and may help identify novel and more effective treatments. However, these studies need the participation of large numbers of people who have been diagnosed with the condition. So far, studies on PD genetics have lagged behind those on other common conditions (such as heart disease and cancers). Therefore, we are trying new ways to contact as many people as possible who have or have had treatment for PD, and one way of doing this is to approach people who have been prescribed medications. In the past, we have taken this approach for other medical conditions and had a good response.

Dopaminergic agents (e.g. medications such as Duodopa, Sinemet, Stalevo, Madopar, Movapo, Apomine, Cabaser, APO-Pramipexole ER, Pramipexole XR GP, Simipex XR, Sifrol, Simpral, Neupro, Eldepryl, Azilect) and anticholinergic agents (e.g. medications such as Symmetrel, Artane, Benztrop or Benztropine) are medications used to treat symptoms of PD. You have been contacted by Services Australia (formerly the Australian Government Department of Human Services) because you may have recently been prescribed one of these medications.

We hope that you will participate in the study. Our aim is to find new ways to improve treatment for PD, and also to improve the lives of patients and their families.

2. Who can participate?

For this study we need to recruit both men and women who have been prescribed dopaminergic and/or anticholinergic agent medications.

3. What does participation involve?

Participation involves consenting to participate in the project, providing your contact details and answering a questionnaire about their disease diagnosis. Based on your answers to the questionnaire, you may be asked to donate a saliva sample and invited to answer a follow-up questionnaire.

Participation involves consenting to the storage of your questionnaire and genetic information in a secure data repository 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 8 - ‘Is it confidential?’

Some details of your medical history that would be helpful to the project investigators (like how many prescriptions you may have had for various medication) would be hard for many people to remember.  Therefore, we will ask for your permission to access your Pharmaceutical Benefits Scheme (PBS) claims information from the last five (5) years.  Medicare collects information on your medical visits and procedures, and the associated costs, while the PBS collects information on the prescription medications you have filled at pharmacies.  If you agree, you will be asked to fill out a consent form authorising the study access to your complete Pharmaceutical Benefits Scheme (PBS) data.  The consent form will be sent securely to Services Australia who holds your 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 is not necessary to participate in the other parts of this study.

The questionnaire component will consist of a handful of modules, each about a different dimension of PD, such as symptoms, medical history, treatment effectiveness, lifestyle and environmental factors, etc. Altogether the questionnaire should take about 15 minutes.

If you are asked to provide a saliva sample, we will send you a collection pack including a specialised collection container to collect the sample. You will be asked to return this sample via Australia Post to our laboratory, at no cost to you.

If you donate a sample, we will extract DNA from your saliva to investigate genetic factors that increase PD risk and/or influence disease prognosis and treatment response. For instance, we will compare DNA from people with PD against a control group who do not have this condition, or compare DNA of PD patients who experience a particular side effect against those who do not.

4. Do I have to give a DNA sample?

To participate in this study, you may be asked to provide a saliva sample, as explained in the paragraph above. Providing a sample can be done in your own home.

5. What is in it for me?

While 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 investigating. Future medical or scientific discoveries may come from the research in which you participate, and, in turn, help improve the available treatments and outcomes for people with PD. Many participants value the unique contribution that they can make to research.

Due to the specific sample design of the study, we will not be able to provide any individualised analytical feedback to participants about their health condition, biological sample, or DNA. However, researchers will be providing everyone who participates with a newsletter. In this newsletter we will give you information about the progress and outcomes of this study, as well as that of several other studies. Our research team values the time and effort that you give to research.

6. Are there any risks?

Researchers acknowledge that being invited into this research study may be a sensitive issue for you and may, therefore, cause you some discomfort. We would like to restate that we currently do not have any information about you.

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 have any questions or concerns about this research study, you may telephone the Project Coordinator, Richard Parker on 07-3362-0297. You may also use our free call number: 1800-257-179. If you have any concerns or complaints regarding the conduct of this study, you may contact the Chairperson of the QIMR Berghofer Medical Research Institute Human Research Ethics Committee (QIMRB HREC) via the Secretary on Tel: 07-3362-0117 and quote reference number P1218.

7. Will I be contacted again about this study?

We plan to extend this study and may seek to re-contact some of the participants in the current study.

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

8. Is it confidential?

Yes. All information and data collected for the study remains confidential in accordance with The Australian National Health and Medical Research Council (NHMRC) Human Research guidelines and the Australian Privacy Act.

Your personal details, questionnaire data, biological sample and genetic data will all be stored separately. Your individual questionnaire, biological sample and genetic data files will have a number assigned to it, not your name. Your name and personal details will continue to be stored on file at QIMR Berghofer but will be stored separately from, and not linked with, your questionnaire information, biological sample and genetic data. The only link between your data and your personal details is your participant identification number (meaning your sample is potentially re-identifiable). Linking both your personal details and data file using this number is severely restricted to members of the QIMR Berghofer research team.

Any Medicare and Pharmaceutical Benefits Scheme (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 7 years after the publication of the final project report.  However, any research findings associated with your Medicare or PBS data will not be able to be destroyed or recalled.

Results of this research study 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 you as a participant.

In accordance with relevant Australian privacy and other 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 your information.

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 study.

9. What will happen to information about me?

The researchers will store your personal, questionnaire and genetic information indefinitely at QIMR Berghofer Medical Research Institute. The reason why we need to store this information indefinitely is that it will 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 your questionnaire information (but not your name, other personal details, Medicare or PBS data) may eventually be put into an international genetic data repository.  Information in the database will be available only to researchers from around the world who are approved to study how genes cause a variety of health conditions. These scientists will not know your name or other personal information we learn about you.

10. What will happen to my biological and DNA samples?

This Study: We will use your biological (saliva) sample to extract one or more samples of DNA. The research team will then look for differences and similarities between participants’ DNA samples. This information can help us understand why some people have a certain condition such as Dementia and some people do not. The research team will also investigate why some people have differing caregiver experiences.

Your biological sample and samples of your 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 are stored separately. Linking your personal details with your biological sample or DNA using the barcode is restricted only to members of the QIMR Berghofer research team.

We may decide to send part of your biological sample and/or a sample of your DNA to another laboratory (which may be overseas) for processing or analysis. If this occurs, your part sample will only be labelled with a number and transported along with samples from many other people. No information identifying you will be sent to or accessible by the other laboratory. Any sample remaining after processing or analysis by the other laboratory will be returned to QIMR Berghofer Medical Research Institute for indefinite storage.

Future Studies: We would like to store your biological and/or DNA samples for a long time for use in future research studies that may or may not be related to this study. 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 for a long time.

11. Who are the researchers?

This study is being conducted by the following researchers:

  • Dr Miguel Renteria, QIMR Berghofer Medical Research Institute.
  • Dr Penelope Lind, QIMR Berghofer Medical Research Institute.
  • Prof Nick Martin, QIMR Berghofer Medical Research Institute.

12. 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 Coordinator by phone 1800 257 179 (free call) or email pd.genetics@qimrberghofer.edu.au.

13. What if I have questions?

You can call or email us. Our Free call number is 1800 257 179. Our email address is pd.genetics@qimrberghofer.edu.au. We are happy to answer any questions you have before you agree to participate and also at any time throughout the study.