Project title: Healthy Brain Initiative – Brain Health Registry
Application number: 2018-12H
(Name of) Principal investigator: Professor Cassandra Szoeke
Dear participant ,
You are invited to participate in the Healthy Brain Initiative – Brain Health Registry project.
The overall goal of this project is to improve our understanding of health across the lifespan in order to promote healthy brains and prevent disease in all Australians.
The questions you answer will give us valuable insight into the interactions of clinical, lifestyle and socioeconomic factors that may affect brain health. This information could assist in developing guidelines for modifying lifestyle factors that promote brain health.
Who is undertaking the project?
This research is being conducted by Professor Cassandra Szoeke, Dr Michael Weiner and Professor John Hopper.
What will I be asked to do?
- You will be sent a link for the HBI-BHR online questionnaire.
- You will be asked to complete online questionnaires and computerised tests about your memory, attention and thinking.
This study involves completing an online questionnaire designed to gather general health information about you. It will include topics such as demographics, general health history, family health history, mood, quality of life, physical activity, sleep, diet and alcohol intake, smoking, physical function, social relationships and negative life events.
Each task will have an approximated time to complete, and the entire questionnaire will take approximately 30 to 45 minutes to complete. In addition to the questionnaire, there will be three cognitive tasks that will take approximately 35 minutes to complete. These tasks are engaging and similar to a ‘brain game’. Your responses will provide us with valuable information about your memory, attention and thinking.
The online tool (questionnaire and cognitive tasks) are designed in the way that you can stop at any time once you’ve completed a particular section. You will get a reminder to complete unfinished section/s in your own time within the two-week timeframe.
How much time will the project take?
The entire online experience will take approximately 1 to 1.5 hours to complete. If you don’t have this amount of time, you don’t need to complete all of the tasks in one sitting. We will send you weekly reminders (no more than three) to come back and complete any unfinished tasks.
If there are any tasks that make you uncomfortable and you do not wish to complete, you can skip that task and move on to the next. While we encourage you to complete as many of the tasks as possible, any amount of information you are able to provide to us is still of great value.
We will also invite you to return to complete the survey every 12 months for as many years as you wish. If you no longer want to be contacted, you can withdraw your consent at any time.
Are there any risks associated with participating in this project?
As with the collection of any personal (private) information, there is a very slight risk of accidental disclosure of information or breach of computer security. Extensive safeguards are in place to minimise this potential risk, with hard copies of your information stored in locked cabinets within the principal investigator’s office and electronic copies stored on file with password restricted access. Data sharing between the Healthy Brain Initiative and Brain Health Registry will also occur via safe data transfer procedures.
The questionnaires may be upsetting or distressing to you and may make you feel uncomfortable. However, you are free to decline to answer any questions. Below are some Australian helplines and support services that you can contact in case of a distress, and these resources are also provided in the online questionnaire.
You are also welcome to contact the study staff at infoHBI@acu.edu.au who can provide you with the relevant information.
Phone: 13 11 14
Lifeline is a national charity providing all Australians with access to 24 hours a day, seven days a week crisis support and suicide prevention services.
Phone: 1300 224 636
Beyondblue are available 24 hours a day, 7 days a week to discuss any negative thoughts and feelings, stress or other mental health concerns. They are able to point you in the right direction for further support.
National Dementia Helpline
Phone: 1800 100 500
The National Dementia Helpline can provide information on reducing your risk of dementia, support to help manage the impact of dementia and suggest services in your area. The helpline operates nationally from 9am to 5pm Monday to Friday (excluding public holidays).
What are the benefits of the research project?
There are no direct personal benefits from participating in this project. However, there are a lot of benefits to the wider community. By participating in this project you are making a direct contribution to valuable research that has the potential to improve brain function for all Australians.
The data you provide will assist us in understanding social and behavioural determinants of brain health, and influence policies and practice towards better prevention and early detection of brain health issues that may have a long-term impact on wellbeing.
Can I withdraw from the study?
Yes, participants can withdraw from the study. Participation in this study is completely voluntary and you are not under any obligation to participate.
You may withdraw from the study at any time by logging into the study’s website and clicking ‘Withdraw consent’ on the home page. Choosing not to participate will in no way affect your current or future medical care.
The information you have provided prior to withdrawing will not be removed from the Healthy Brain Initiative – Brain Health Registry, and we will continue to use the information you provided prior to withdrawal for data linkage and research purposes.
Will anyone else know the results of the project?
This project is a collaborative partnership between the Healthy Brain Initiative at ACU and Brain Health Registry at University of California San Francisco.
All online questionnaire data will be securely stored in an encrypted portal belonging to University of California San Francisco. A secure data sharing protocol between Brain Health Registry and Healthy Brain Initiative has been established and the data will be transferred using a secure data sharing cloud platform (BOX). Only the principal investigators and approved research personnel will have access to your personal information (eg your email and name) and this information will be password protected.
All other researchers will have no access to your personal information and will have to obtain special permission to obtain access to non-identifiable data.
Research findings will be disseminated via publications, reports, media and conferences. All data used will be de-identified and reported in aggregated format. No individual or identifiable information will be used in a publication.
What is data linkage and what information will be used?
Data linkage is a valuable tool for creating a bigger picture of the health and wellbeing of the Australian population.
We want to link the information you provided in the questionnaires to information about your medical history from a variety of health care providers, such as doctors and hospitals. Your privacy and confidentiality will be strictly protected during the data linkage process.
Specifically, the information you provide to us will be sent to the Australian Institute of Health and Welfare for linkage with the Pharmaceutical Benefits Scheme, Medicare Benefits Schedule, Australian Cancer Registry, National Aged Care Database and other national registries.
Your information will also be sent to state health departments or the national Australian Department of Health to be linked with hospital administrative data.
All of this will be done using established secure data exchange processes and a linkage ID will be created. Once this ID is established and connected to your study ID, all personal information is removed from the database and stored separately from your responses.
We also request your permission to allow us to share your data with other researchers who are currently (or will be in the future) conducting research studies similar to this one.
The data that we are requesting to link to from external data sources may comprise of information related to your admission to public or private hospitals, including surgeries and use of anaesthetics; presentation to emergency departments and the reason why; what medications you were/are prescribed, by whom and how often you use them; all information related to your visits to GPs and other health professionals; and data from other similar studies you might have participated in.
By signing the attached consent form, you are authorising the release of (or access to) your past and future medical history. Any information obtained through this process will be de-identified by our research team and kept confidential, as per all other information about you collected in the study.
Access to these original records will be restricted to the study coordinator and principal investigator. A de-identified database of all relevant information will be used to communicate relevant information. Your original records will not be shared.
Will I be able to find out the results of the project?
We will keep you informed about the progress of the Healthy Brain Initiative by sending you an electronic newsletter that will outline project progress, important findings, publications and presentations, and policy changes based on the project recommendations.
What if I have a complaint or concerns?
The study has been reviewed by the Human Research Ethics Committee at Australian Catholic University (ACU) (review number 2018-12H).
If you have any complaints or concerns about the conduct of the project, you may write to the manager of the Human Research Ethics Committee, care of the Office of the Deputy Vice-Chancellor (Research).
c/o Office of the Deputy Vice-Chancellor (Research)
Australian Catholic University
North Sydney Campus, PO Box 968
North Sydney, NSW 2059
Phone: (02) 9739 2519
Fax: (02) 9739 2870
Any complaint or concern will be treated in confidence and fully investigated. You will be informed of the outcome.
Professor Cassandra Szoeke
Director of the Healthy Brain Program
Principal Investigator of the Healthy Brain Initiative
Australian Catholic University
215 Spring Street, Melbourne 3000.