Participant Information Sheet
PROJECT TITLE:Surveillance of influenza using a self-test for influenza
HUMAN RESEARCH ETHICS COMMITTEE APPROVAL NUMBER:H-2019-116
Professor Nigel Stocks
You are invited to participate in the research project described below.
What is the project about?
The goal of this study is to determine if people in the community are interested, and are able to test themselves for influenza (‘the flu’) at home. This study will also compare the results from people’s self-testing with tests carried out by GPs and practice nurses to understand the effectiveness of this new approach of self-testing for flu.
Who is undertaking the project?
This project is being conducted by Professor Nigel Stocks, Monique Chilver (University of Adelaide), and colleagues, Professors Matthew Thompson, Barry Lutz, and Monica Zigman Suchsland from the University of Washington (USA). This research will form the basis for a PhD at the University of Adelaide under the supervision of Professor Nigel Stocks.
This project has received funding from Audere, a non-profit application development organisation that runs the flu@home mobile phone app. The Commonwealth’s Department of Health, Vaccine Preventable Disease Surveillance Section, funds the Australian Sentinel Practices Research Network (ASPREN) of GPs to undertake work related to monitoring levels of influenza type illness.
Why am I being invited to participate?
You are being invited to take part in this study as your GP or practice nurse has identified that you have the symptoms that are common in flu-like illnesses and you have already consented to be part of the Australian Practices Research Network (ASPREN) testing program that is run at this general practice.
In order to take part in this study, you will also need to have a smartphone that can be used to download a mobile phone application (or ‘app’).
What am I being invited to do?
You are being invited to take a swab from inside your own nose, do a test on this swab using a simple kit provided, and read the results of this test.
If you agreed to participate, you were handed a self-test kit by your GP or practice nurse and asked to download the flu@home app to your smartphone. This app will include a consent form for you to complete and provide instructions for completing the self-swab and test. You will be asked to complete the self-swab at a convenient time, preferably within 1-2 days following the in-clinic consultation.
The flu@home app will also administer a questionnaire to collect information about your age and sex, whether you have had a vaccination in previous years, your current health conditions, and some brief information about respiratory symptoms. All data collected are to be non-identifiable using only a study code assigned to your data.
Will I receive the results of my flu test in the app?
The app will communicate your flu test results. However, this app and communication of the flu test results do not constitute professional medical or healthcare advice, diagnosis, assessment or recommendation of treatment and are not intended to, nor should they be used to, replace professional medical advice. The interpretation of your result may differ from a medical test conducted in a clinical lab environment. In no circumstances should the results of the test kit be relied upon without independent consideration and confirmation by a qualified medical practitioner.
Audere makes no representations or warranties with respect to any treatment, action, suitability or application of medication or preparation by any person whether in connection with this app, the test kit or not. In no circumstances will Audere be liable for any direct, indirect, consequential, special, exemplary or other damages arising therefrom.
How much time will my involvement in the project take?
It is expected that self-testing, completing the questionnaire, and reading results should take about 20 minutes. You will be reimbursed with a $20 gift voucher for your time for participating in the project.
Are there any risks associated with participating in this project?
Some people may feel uncomfortable taking a swab test from their nose. Rarely this might cause a small nosebleed. Since the results of the self-test kit are experimental, this may make people anxious. If you are worried about flu or your health you should seek advice and care from your GP.
What are the potential benefits of the research project?
You may gain a small benefit from participating in the study by receiving instant results from the self-test kit and self-management advice related to the result. You may contribute to the development of a new way to test for flu in the future.
Can I withdraw from the project?
Participation in this project is completely voluntary. If you agree to participate by agreeing to the consent form on the next screen, anonymous data will be collected based on your interactions with the app. It will not be possible to withdraw your data once collected. Non-participation will not affect your ongoing treatment at any general practice.
What will happen to my information?
Your data will be kept confidential. You will not be identified in any report or publication about the study. All participants will be provided with their personal results of their self-swab test as part of the self-test conducted at home.
Data from the self-swab test, questionnaire, and IP address for the device using the app will be stored on Amazon Web Services, only accessible by Audere. App analytics and caching is provided by Google’s Cloud Platform (Firebase). The Amazon and Google cloud services may store data outside of Australia, such as in the United States. During data analysis these data will be transferred to the University of Washington and to the University of Adelaide. Audere will receive results of the flu test and questionnaire answers collected in the clinic via the ASPREN study. These data will only be accessible to authorized parties (e.g. the project researchers) with the University of Washington (in the United States) and the University of Adelaide for a minimum of seven years.
The overall results of this study may be presented and published in academic journals, presented at conferences, and published in a thesis paper. You will not be identified in any publications.
On the consent form, you will be given the option to agree to your information being used for future related research conducted by the University of Adelaide and/or the University of Washington.
Your information will only be used as described in this participant information sheet and it will only be disclosed according to the consent provided, except as required by law.
Whom do I contact if I have questions about the project?
If you have any questions or would like additional information, please contact:
Monique ChilverPhone: +61 8 8313 3463
Alternatively, you may contact the other members of the research team:
Professor Nigel StocksEmail: email@example.com
Dr. Matthew ThompsonEmail: firstname.lastname@example.org
Associate Professor Barry LutzEmail: email@example.com
Ms. Monica Zigman SuchslandEmail: firstname.lastname@example.org
What if I have a complaint or any concerns?
The study has been approved by the Human Research Ethics Committee at the University of Adelaide (approval number H-2019-116). This research project will be conducted according to the NHMRC National Statement on Ethical Conduct in Human Research 2007 (Updated 2018). If you have questions or problems associated with the practical aspects of your participation in the project, or wish to raise a concern or complaint about the project, then you should consult the Principal Investigator. If you wish to speak with an independent person regarding concerns or a complaint, the University’s policy on research involving human participants, or your rights as a participant, please contact the Human Research Ethics Committee’s Secretariat on:
Phone:+61 8 8313 6028
Post:Level 4, Rundle Mall Plaza, 50 Rundle Mall, ADELAIDE SA 5000
Any complaint or concern will be treated in confidence and fully investigated. You will be informed of the outcome.
Professor Nigel Stocks, Dr. Matthew Thompson, Associate Professor Barry Lutz, Ms. Monica Zigman Suchsland and Ms. Monique Chilver