Participant Information Sheet/Consent Form:
GAMBLINGLESS RCT
|
Title |
Development and evaluation of an online gambling self-help program |
|
Protocol Number |
E07-2015 |
|
Project Sponsor |
Victorian Responsible Gambling Foundation |
|
Coordinating Principal Investigator/ Principal Investigators |
Nicki Dowling/ Simone Rodda, Stephanie Merkouris, Dan Lubman, Peter Harvey, Malcolm Battersby, John Cunningham, Bryan Rodgers, David Austin, Tiffany Lavis, David Smith |
|
Location |
Deakin University, 221 Burwood Highway, Burwood, Victoria, 3125. Turning Point, 54-62 Gertrude St, Fitzroy, Victoria 3065. Statewide Gambling Therapy Service. Victorian Responsible Gambling Foundation. |
Part 1 What does my participation involve?
1 Introduction
You are invited to take part in this research project, which is called Development and evaluation of an online gambling self-help program. You have been invited because you have indicated that you are experiencing problems with your gambling. The research project is testing a new online self-help program for gambling, called GamblingLess.
This Participant Information Sheet/Consent Form tells you about the research project. It explains the processes involved in taking part, including a brief description of the self-help program and the questionnaires involved. Knowing what is involved will help you decide if you want to take part in the research.
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 local doctor.
Participation in this research is voluntary. If you don’t wish to take part, you don’t have to.
If you decide you want to take part in the research project, you will be asked to check the box during the registration process, which indicates that you agree to the terms and conditions. By checking this box you are telling us that you:
• Understand what you have read
• Consent to take part in the research project
• Consent to be involved in the treatment program and associated data collection that is described
• Consent to the use of your personal and health information as described.
You will be emailed a copy of this Participant Information and Consent Form to keep.
2 What is the purpose of this research?
The aim of this project is to evaluate the effectiveness of a new online self-help program for people who are having difficulties controlling their gambling. Previous research has examined the effectiveness of face-to-face psychological interventions in the treatment of problem gambling. However, limited research has examined the effectiveness of an online self-help program for the treatment of problem gambling. The current project aims to do just that.
The aim of this program is to help you manage your gambling related problems by reducing your gambling activities and increasing your well-being. The GamblingLess program has been designed to be interactive and easy to use. It is also flexible and can be tailored to suit your needs. The GamblingLess program contains four core modules:
· Module 1 – Getting ready to gamble less: This module will help you to get ready for changing your gambling by helping you to understand your gambling, increase your motivation to change your gambling, and define your goals.
· Module 2 – Taking action to gamble less This module involves learning many new skills to help you achieve your goals. These strategies are designed to reduce and stabilise your gambling. Learning these coping skills will help you to gain and maintain control over your gambling.
· Module 3 – Thinking differently to gamble less: This module is all about learning how gambling works and some of the tricks that are used to keep you gambling. In this module, we will help you to understand which thinking traps you are using and to adjust those beliefs so you don’t keep gambling because of them.
· Module 4 – Gambling less for good: This module will help you increase your awareness of the chain of events and behaviours leading up to a relapse, so that you can be more prepared to maintain your goals in the future. You will learn how you can adapt some your existing skills and learn some new skills to deal with high risk situations and gambling urges so you don’t slip back into your old ways.
This research has been initiated by the Coordinating Principal Investigator, Associate Professor Nicki Dowling.
This research has been funded by the Victorian Responsible Gambling Foundation.
This research is being conducted by researchers at Deakin University, Turning Point, Flinders University and the Australian National University.
3 What does participation in this research involve?
If you agree to participate you will be asked to do the following:
3.1 Take part in the GamblingLessonline program:
The GamblingLessprogram for gambling problems includes four modules. The program will be open for 14 weeks, and it is recommended that you complete one module a fortnight. Each module takes approximately 1 to 2 hours to complete and you do not have to do it all in one go.
You will be participating in a pragmatic randomised trial. Sometimes we do not know which treatment is best for treating a condition. To find out we need to compare different treatments. We put people into groups and give each group a different treatment. The results are compared to see if one is better. To try to make sure the groups are the same, each participant is put into a group by chance (random). For this project, we would like to know if it is better for people to work through the program by themselves in their own time or if having a bit of support helps. Everyone will get access to the GamblingLessprogram and a randomly allocated group of people will also receive support from a trained professional via email. If you are allocated additional support, you will be notified of this immediately after completion of the initial questionnaire. The support will be provided weekly and will take a maximum of 20 minutes per contact.
At the end of the program, the emails between you and the trained professional will be collected by the research team and safely stored at Deakin University, in password-protected files. Any identifiable information will be removed. These emails may be checked by the research team to make sure that the support provided to you is delivered properly.
Everyone has a one in two chance of being allocated to the additional support group. This research project has been designed to make sure the researchers interpret the results in a fair and appropriate way and avoids researchers or participants jumping to conclusions.
3.2 Complete brief online questionnaires:
The purpose of this study is to evaluate the GamblingLessprogram. In order to do this, we will ask you some questions about your gambling behaviours, emotional health, alcohol use, wellbeing, other supports you have used, general demographic information and contact information.
Once you have signed up to the GamblingLessprogram, you will be asked to complete a brief online questionnaire, which will take around 10 to 15 minutes to complete. You will also be asked to complete similar online questionnaires at 2, 3, 12 and 24 months after starting the program. You will also be asked to answer a small number of the same questions at the end of every module that will take approximately 5 minutes to complete.
Your answers to these questions will help us to determine if the program has been helpful to you. Some of these questions will allow you to track your own progress as you work your way through the program.
In recognition of your contribution, you will receive a $30 gift voucher for the completion of the 2-month questionnaire, a $30 gift voucher for the completion of the 3-month questionnaire, a $30 gift voucher for the completion of the 12-month questionnaire and a $30 gift voucher for the completion of the 24-month questionnaire. An address will need to be provided to receive these gift vouchers.
3.3 Telephone interview (optional)
A small number of people will be asked to take part in an additional telephone interview, which is entirely optional. In this interview we will ask you about what you thought of the program, such as what you found most or least helpful about the program. The interview will take around 60 minutes. In recognition of your contribution, you will receive a$50 gift voucher at the completion of this telephone interview.
There are no additional costs associated with participating in this research project, nor will you be paid. You will be recognised for your contribution at the completion of the follow-up questionnaires as outlined above.
4 What do I have to do?
You can take part in this program if you:
· Are concerned about your own gambling
· Are 18 years of age or older
· Are currently living in Australia
· Have internet access
· Are willing to commit to completing the program modules in the 14 week period
· Are willing to complete the questionnaires before starting the program, at 2, 3, 12 and 24 months and at the end of the modules
· Have good knowledge of the English language
You can still take part in this research project if you are receiving other treatment for your gambling. It is in fact encouraged for you to do so, if it is something you wish to do.
5 Other relevant information about the research project
It is anticipated that up to 156 participants will take part in this project. Participants will be recruited in various ways, including from Gambling Help Online, Gambling Helpline, Gamblers Help, Statewide Gambling Therapy Service and various advertisement online and in public forums.
The project involves researchers from Deakin University, Turning Point, Flinders University and the Australian National University.
6 Do I have to take part in this research project?
Participation in any research project is voluntary. If you do not wish to take part, you do not have to. If you decide to take part and later change your mind, you are free to withdraw from the project at any stage.
If you do decide to take part, you will be emailed a copy of this Participant Information and Consent Form to keep.
Your decision whether to take part or not to take part, or to take part and then withdraw, will not affect your relationship with the organisations involved in the study.
7 What are the alternatives to participation?
You do not have to take part in this research project to receive treatment from the participating organisations. Other options are available; these include Gambling Help Online, Gambling Helpline, Gamblers Help and Statewide Gambling Therapy Service. Please note that participating in this study does not mean that you cannot seek other treatment or assistance for your gambling problems. In fact it is encouraged that you seek as much help as you need.
8 What are the possible benefits of taking part?
We cannot guarantee or promise that you will receive any benefits from this research; however, the GamblingLessprogram is designed to help people reduce gambling and improve psychological well-being. The content of the program is based on the best available research evidence for the treatment of gambling problems. You should be aware, however, that this is a new program and its efficacy is still to be established. By participating in this program you are helping us to refine the program for people who are experiencing gambling problems in the future. The results will also be used to help improve the services that are offered for people who are having difficulties with their gambling.
9 What are the possible risks and disadvantages of taking part?
If you become upset or distressed as a result of your participation in the research, we encourage you to contact the free 24 hour service, Gambler’s Helpline on 1800 858 858 or speak to a counselor online at www.gamblinghelponline.org.au.
If you experience extreme distress or have concerns for your safety, we encourage you to contact the appropriate emergency services for assistance. A list of emergency, crisis and other support services can be found on the program’s website at all times.
10 What if new information arises during this research project?
It is not expected that any new information that arises during this research project will influence the treatment program being provided, but you are encouraged to seek other help where required.
11 Can I have other treatments during this research project?
Whilst you are participating in this research project, you may take part in other treatments for gambling problems or any other problems that may arise. It is in fact encouraged for you to do so. Information on other treatment and support services will be easily available from the program’s website at all times.
12 What if I withdraw from this research project?
If you do consent to participate, you may withdraw at any time. If you decide to withdraw from the project, please notify a member of the research team before you withdraw. This notice will allow that researcher to inform you if there are any implications for your welfare in terms of withdrawing.
If you do withdraw your consent during the research project, the research team will not collect additional personal information from you. If you wish to remove your data you will need to contact the Research Contact person (Section 19).
13 Could this research project be stopped unexpectedly?
It is not expected that this research project could be stopped unexpectedly.
14 What happens when the research project ends?
The online self-help program will be available to you for 14 weeks from the time you complete the first questionnaire. Once you have completed the program you will be able to save and keep a copy of the program, including your responses to the activities you completed. This means that you can look over the program any time you like.
When the research project ends, the findings will be submitted for publication in a research journal, presented at conferences and will be made publically available on the Victorian Responsible Gambling Foundation website http://www.responsiblegambling.vic.gov.au/what-we-do/research/published-research-reports
Part 2 How is the research project being conducted?
15 What will happen to information about me?
By providing consent, you consent to the research team collecting and using personal information about you for the research project. Any information obtained in connection with this research project that can identify you will remain confidential. Your information will only be used for the purpose of this research project and it will only be disclosed with your permission, except as required by law.
The information that the research team collects and uses is collected from the questionnaires, and from the self-help program activities. The data collected will remain anonymous. To further protect anonymity, you can sign up for this program using your real name or a pseudonym, if you prefer. The data will be stored without any identifiable information at Deakin University, for seven years, in password-protected files. Your contact details will never be shared with anyone outside the research team. If you are allocated to the additional support group, the trained professional will have access to your contact information, basic demographic details and your progress through the program.
It is anticipated that the results of this research project will be published and/or presented in a variety of forums. In any publication and/or presentation, information will be provided in such a way that you cannot be identified, except with your permission. The results from this study will be published in a summarised format without identifying individuals.
In accordance with relevant Australian and/or Victorian privacy and other relevant laws, you have the right to request access to your information collected and stored by the research team. You also have the right to request that any information with which you disagree be corrected. Please contact the study team member named at the end of this document if you would like to access your information.
Any information obtained for the purpose of this research project that can identify you will be treated as confidential and securely stored. It will be disclosed only with your permission, or as required by law.
16 Complaints and compensation
If you suffer any distress or psychological injuries as a result of this research project, you should contact the research team as soon as possible. You will be assisted with arranging appropriate treatment and support. For those individuals that are randomly allocated to the additional support group, you may also inform your trained professional. They will also be able to assist you with arranging appropriate treatment and support. They will inform the research team of any such arrangements.
In the event of injury, the parties involved in this research project are covered by Deakin University’s public liability insurance.
17 Who is organising and funding the research?
This research project is being conducted by Associate Professor Nicki Dowling, from Deakin University, and her research team.
Deakin University may benefit financially from this research project if, for example, the project assists Deakin University to obtain approval for a new evaluation grant.
You will not benefit financially from your involvement in this research project even if, for example, your samples (or knowledge acquired from analysis of your samples) prove to be of commercial value to Deakin University.
In addition, if knowledge acquired through this research leads to discoveries that are of commercial value to Deakin University, the researchers or their institutions, there will be no financial benefit to you or your family from these discoveries.
Deakin University will receive a payment from the Victorian Responsible Gambling Foundation for undertaking this research project.
No member of the research team will receive a personal financial benefit from your involvement in this research project (other than their ordinary wages).
18 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 Deakin University, Eastern Health and Southern Adelaide.
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.
19 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 or if you have any problems, which may be related to your involvement in the project, you can contact any of the following people:
Research contact person
|
Name |
Stephanie Merkouris |
|
Position |
Research Fellow |
|
Telephone |
03 9244 3068 |
|
|
stephanie.merkouris@deakin.edu.au |
For matters relating to research at the site at which you are participating, the details of the local site complaints person are:
Complaints contact person
|
Name |
Nicki Dowling |
|
Position |
Associate Professor |
|
Telephone |
03 9244 5610 |
|
|
nicki.dowling@deakin.edu.au |
For 24-hour assistance
|
Organisation |
Gambler’s Helpline |
|
Telephone |
1800 858 858 |
|
Website |
www.gamblinghelponline.org.au |
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:
Reviewing HREC approving this researchand HREC Executive Officer details
|
Reviewing HREC name |
Deakin University Human Research Ethics Committee |
|
HREC Executive Officer |
The Manager, Research Integrity |
|
Telephone |
03 9251 7129 |
|
|
Research-ethics@deakin.edu.au |
|
Project number |
2014-123 |
|
Reviewing HREC name |
Eastern Health Human Research Ethics Committee |
|
HREC Executive Officer |
Chair Person |
|
Telephone |
03 9895 3398 |
|
|
ethics@easternhealth.org.au |
Consent Form: RCT
|
Title |
Development and evaluation of an online gambling self-help program |
|
Protocol Number |
E07-2015 |
|
Project Sponsor |
Victorian Responsible Gambling Foundation |
|
Coordinating Principal Investigator/ Principal Investigator |
Nicki Dowling/ Simone Rodda, Stephanie Merkouris, Dan Lubman, Peter Harvey, Malcolm Battersby, John Cunningham, Bryan Rodgers, David Austin, Tiffany Lavis, David Smith |
|
Location |
Deakin University, 221 Burwood Highway, Burwood, Victoria, 3125. Turning Point, 54-62 Gertrude St, Fitzroy, Victoria 3065. Statewide Gambling Therapy Service. Victorian Responsible Gambling Foundation. |
Declaration by Participant
I have read the Participant Information Sheet.
I understand the purposes, procedures and risks of the research described in the project.
I have had an opportunity to ask questions and I am satisfied with the answers I have received.
I freely agree to participate in this research project as described and understand that I am free to withdraw at any time during the study without affecting my future health care, or my relationships with the researchers, or any of the organisations/institutions.
I understand that I will be emailed a copy of this document to keep.
Participant Information Sheet/Consent Form:
GAMBLINGLESS RCT
|
Title |
Development and evaluation of an online gambling self-help program |
|
Protocol Number |
E07-2015 |
|
Project Sponsor |
Victorian Responsible Gambling Foundation |
|
Coordinating Principal Investigator/ Principal Investigators |
Nicki Dowling/ Simone Rodda, Stephanie Merkouris, Dan Lubman, Peter Harvey, Malcolm Battersby, John Cunningham, Bryan Rodgers, David Austin, Tiffany Lavis, David Smith |
|
Location |
Deakin University, 221 Burwood Highway, Burwood, Victoria, 3125. Turning Point, 54-62 Gertrude St, Fitzroy, Victoria 3065. Statewide Gambling Therapy Service. Victorian Responsible Gambling Foundation. |
Part 1 What does my participation involve?
1 Introduction
You are invited to take part in this research project, which is called Development and evaluation of an online gambling self-help program. You have been invited because you have indicated that you are experiencing problems with your gambling. The research project is testing a new online self-help program for gambling, called GamblingLess.
This Participant Information Sheet/Consent Form tells you about the research project. It explains the processes involved in taking part, including a brief description of the self-help program and the questionnaires involved. Knowing what is involved will help you decide if you want to take part in the research.
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 local doctor.
Participation in this research is voluntary. If you don’t wish to take part, you don’t have to.
If you decide you want to take part in the research project, you will be asked to check the box during the registration process, which indicates that you agree to the terms and conditions. By checking this box you are telling us that you:
• Understand what you have read
• Consent to take part in the research project
• Consent to be involved in the treatment program and associated data collection that is described
• Consent to the use of your personal and health information as described.
You will be emailed a copy of this Participant Information and Consent Form to keep.
2 What is the purpose of this research?
The aim of this project is to evaluate the effectiveness of a new online self-help program for people who are having difficulties controlling their gambling. Previous research has examined the effectiveness of face-to-face psychological interventions in the treatment of problem gambling. However, limited research has examined the effectiveness of an online self-help program for the treatment of problem gambling. The current project aims to do just that.
The aim of this program is to help you manage your gambling related problems by reducing your gambling activities and increasing your well-being. The GamblingLess program has been designed to be interactive and easy to use. It is also flexible and can be tailored to suit your needs. The GamblingLess program contains four core modules:
· Module 1 – Getting ready to gamble less: This module will help you to get ready for changing your gambling by helping you to understand your gambling, increase your motivation to change your gambling, and define your goals.
· Module 2 – Taking action to gamble less This module involves learning many new skills to help you achieve your goals. These strategies are designed to reduce and stabilise your gambling. Learning these coping skills will help you to gain and maintain control over your gambling.
· Module 3 – Thinking differently to gamble less: This module is all about learning how gambling works and some of the tricks that are used to keep you gambling. In this module, we will help you to understand which thinking traps you are using and to adjust those beliefs so you don’t keep gambling because of them.
· Module 4 – Gambling less for good: This module will help you increase your awareness of the chain of events and behaviours leading up to a relapse, so that you can be more prepared to maintain your goals in the future. You will learn how you can adapt some your existing skills and learn some new skills to deal with high risk situations and gambling urges so you don’t slip back into your old ways.
This research has been initiated by the Coordinating Principal Investigator, Associate Professor Nicki Dowling.
This research has been funded by the Victorian Responsible Gambling Foundation.
This research is being conducted by researchers at Deakin University, Turning Point, Flinders University and the Australian National University.
3 What does participation in this research involve?
If you agree to participate you will be asked to do the following:
3.1 Take part in the GamblingLessonline program:
The GamblingLessprogram for gambling problems includes four modules. The program will be open for 14 weeks, and it is recommended that you complete one module a fortnight. Each module takes approximately 1 to 2 hours to complete and you do not have to do it all in one go.
You will be participating in a pragmatic randomised trial. Sometimes we do not know which treatment is best for treating a condition. To find out we need to compare different treatments. We put people into groups and give each group a different treatment. The results are compared to see if one is better. To try to make sure the groups are the same, each participant is put into a group by chance (random). For this project, we would like to know if it is better for people to work through the program by themselves in their own time or if having a bit of support helps. Everyone will get access to the GamblingLessprogram and a randomly allocated group of people will also receive support from a trained professional via email. If you are allocated additional support, you will be notified of this immediately after completion of the initial questionnaire. The support will be provided weekly and will take a maximum of 20 minutes per contact.
At the end of the program, the emails between you and the trained professional will be collected by the research team and safely stored at Deakin University, in password-protected files. Any identifiable information will be removed. These emails may be checked by the research team to make sure that the support provided to you is delivered properly.
Everyone has a one in two chance of being allocated to the additional support group. This research project has been designed to make sure the researchers interpret the results in a fair and appropriate way and avoids researchers or participants jumping to conclusions.
3.2 Complete brief online questionnaires:
The purpose of this study is to evaluate the GamblingLessprogram. In order to do this, we will ask you some questions about your gambling behaviours, emotional health, alcohol use, wellbeing, other supports you have used, general demographic information and contact information.
Once you have signed up to the GamblingLessprogram, you will be asked to complete a brief online questionnaire, which will take around 10 to 15 minutes to complete. You will also be asked to complete similar online questionnaires at 2, 3, 12 and 24 months after starting the program. You will also be asked to answer a small number of the same questions at the end of every module that will take approximately 5 minutes to complete.
Your answers to these questions will help us to determine if the program has been helpful to you. Some of these questions will allow you to track your own progress as you work your way through the program.
In recognition of your contribution, you will receive a $30 gift voucher for the completion of the 2-month questionnaire, a $30 gift voucher for the completion of the 3-month questionnaire, a $30 gift voucher for the completion of the 12-month questionnaire and a $30 gift voucher for the completion of the 24-month questionnaire. An address will need to be provided to receive these gift vouchers.
3.3 Telephone interview (optional)
A small number of people will be asked to take part in an additional telephone interview, which is entirely optional. In this interview we will ask you about what you thought of the program, such as what you found most or least helpful about the program. The interview will take around 60 minutes. In recognition of your contribution, you will receive a$50 gift voucher at the completion of this telephone interview.
There are no additional costs associated with participating in this research project, nor will you be paid. You will be recognised for your contribution at the completion of the follow-up questionnaires as outlined above.
4 What do I have to do?
You can take part in this program if you:
· Are concerned about your own gambling
· Are 18 years of age or older
· Are currently living in Australia
· Have internet access
· Are willing to commit to completing the program modules in the 14 week period
· Are willing to complete the questionnaires before starting the program, at 2, 3, 12 and 24 months and at the end of the modules
· Have good knowledge of the English language
You can still take part in this research project if you are receiving other treatment for your gambling. It is in fact encouraged for you to do so, if it is something you wish to do.
5 Other relevant information about the research project
It is anticipated that up to 156 participants will take part in this project. Participants will be recruited in various ways, including from Gambling Help Online, Gambling Helpline, Gamblers Help, Statewide Gambling Therapy Service and various advertisement online and in public forums.
The project involves researchers from Deakin University, Turning Point, Flinders University and the Australian National University.
6 Do I have to take part in this research project?
Participation in any research project is voluntary. If you do not wish to take part, you do not have to. If you decide to take part and later change your mind, you are free to withdraw from the project at any stage.
If you do decide to take part, you will be emailed a copy of this Participant Information and Consent Form to keep.
Your decision whether to take part or not to take part, or to take part and then withdraw, will not affect your relationship with the organisations involved in the study.
7 What are the alternatives to participation?
You do not have to take part in this research project to receive treatment from the participating organisations. Other options are available; these include Gambling Help Online, Gambling Helpline, Gamblers Help and Statewide Gambling Therapy Service. Please note that participating in this study does not mean that you cannot seek other treatment or assistance for your gambling problems. In fact it is encouraged that you seek as much help as you need.
8 What are the possible benefits of taking part?
We cannot guarantee or promise that you will receive any benefits from this research; however, the GamblingLessprogram is designed to help people reduce gambling and improve psychological well-being. The content of the program is based on the best available research evidence for the treatment of gambling problems. You should be aware, however, that this is a new program and its efficacy is still to be established. By participating in this program you are helping us to refine the program for people who are experiencing gambling problems in the future. The results will also be used to help improve the services that are offered for people who are having difficulties with their gambling.
9 What are the possible risks and disadvantages of taking part?
If you become upset or distressed as a result of your participation in the research, we encourage you to contact the free 24 hour service, Gambler’s Helpline on 1800 858 858 or speak to a counselor online at www.gamblinghelponline.org.au.
If you experience extreme distress or have concerns for your safety, we encourage you to contact the appropriate emergency services for assistance. A list of emergency, crisis and other support services can be found on the program’s website at all times.
10 What if new information arises during this research project?
It is not expected that any new information that arises during this research project will influence the treatment program being provided, but you are encouraged to seek other help where required.
11 Can I have other treatments during this research project?
Whilst you are participating in this research project, you may take part in other treatments for gambling problems or any other problems that may arise. It is in fact encouraged for you to do so. Information on other treatment and support services will be easily available from the program’s website at all times.
12 What if I withdraw from this research project?
If you do consent to participate, you may withdraw at any time. If you decide to withdraw from the project, please notify a member of the research team before you withdraw. This notice will allow that researcher to inform you if there are any implications for your welfare in terms of withdrawing.
If you do withdraw your consent during the research project, the research team will not collect additional personal information from you. If you wish to remove your data you will need to contact the Research Contact person (Section 19).
13 Could this research project be stopped unexpectedly?
It is not expected that this research project could be stopped unexpectedly.
14 What happens when the research project ends?
The online self-help program will be available to you for 14 weeks from the time you complete the first questionnaire. Once you have completed the program you will be able to save and keep a copy of the program, including your responses to the activities you completed. This means that you can look over the program any time you like.
When the research project ends, the findings will be submitted for publication in a research journal, presented at conferences and will be made publically available on the Victorian Responsible Gambling Foundation website http://www.responsiblegambling.vic.gov.au/what-we-do/research/published-research-reports
Part 2 How is the research project being conducted?
15 What will happen to information about me?
By providing consent, you consent to the research team collecting and using personal information about you for the research project. Any information obtained in connection with this research project that can identify you will remain confidential. Your information will only be used for the purpose of this research project and it will only be disclosed with your permission, except as required by law.
The information that the research team collects and uses is collected from the questionnaires, and from the self-help program activities. The data collected will remain anonymous. To further protect anonymity, you can sign up for this program using your real name or a pseudonym, if you prefer. The data will be stored without any identifiable information at Deakin University, for seven years, in password-protected files. Your contact details will never be shared with anyone outside the research team. If you are allocated to the additional support group, the trained professional will have access to your contact information, basic demographic details and your progress through the program.
It is anticipated that the results of this research project will be published and/or presented in a variety of forums. In any publication and/or presentation, information will be provided in such a way that you cannot be identified, except with your permission. The results from this study will be published in a summarised format without identifying individuals.
In accordance with relevant Australian and/or Victorian privacy and other relevant laws, you have the right to request access to your information collected and stored by the research team. You also have the right to request that any information with which you disagree be corrected. Please contact the study team member named at the end of this document if you would like to access your information.
Any information obtained for the purpose of this research project that can identify you will be treated as confidential and securely stored. It will be disclosed only with your permission, or as required by law.
16 Complaints and compensation
If you suffer any distress or psychological injuries as a result of this research project, you should contact the research team as soon as possible. You will be assisted with arranging appropriate treatment and support. For those individuals that are randomly allocated to the additional support group, you may also inform your trained professional. They will also be able to assist you with arranging appropriate treatment and support. They will inform the research team of any such arrangements.
In the event of injury, the parties involved in this research project are covered by Deakin University’s public liability insurance.
17 Who is organising and funding the research?
This research project is being conducted by Associate Professor Nicki Dowling, from Deakin University, and her research team.
Deakin University may benefit financially from this research project if, for example, the project assists Deakin University to obtain approval for a new evaluation grant.
You will not benefit financially from your involvement in this research project even if, for example, your samples (or knowledge acquired from analysis of your samples) prove to be of commercial value to Deakin University.
In addition, if knowledge acquired through this research leads to discoveries that are of commercial value to Deakin University, the researchers or their institutions, there will be no financial benefit to you or your family from these discoveries.
Deakin University will receive a payment from the Victorian Responsible Gambling Foundation for undertaking this research project.
No member of the research team will receive a personal financial benefit from your involvement in this research project (other than their ordinary wages).
18 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 Deakin University, Eastern Health and Southern Adelaide.
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.
19 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 or if you have any problems, which may be related to your involvement in the project, you can contact any of the following people:
Research contact person
|
Name |
Stephanie Merkouris |
|
Position |
Research Fellow |
|
Telephone |
03 9244 3068 |
|
|
stephanie.merkouris@deakin.edu.au |
For matters relating to research at the site at which you are participating, the details of the local site complaints person are:
Complaints contact person
|
Name |
Nicki Dowling |
|
Position |
Associate Professor |
|
Telephone |
03 9244 5610 |
|
|
nicki.dowling@deakin.edu.au |
For 24-hour assistance
|
Organisation |
Gambler’s Helpline |
|
Telephone |
1800 858 858 |
|
Website |
www.gamblinghelponline.org.au |
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:
Reviewing HREC approving this researchand HREC Executive Officer details
|
Reviewing HREC name |
Deakin University Human Research Ethics Committee |
|
HREC Executive Officer |
The Manager, Research Integrity |
|
Telephone |
03 9251 7129 |
|
|
Research-ethics@deakin.edu.au |
|
Project number |
2014-123 |
|
Reviewing HREC name |
Eastern Health Human Research Ethics Committee |
|
HREC Executive Officer |
Chair Person |
|
Telephone |
03 9895 3398 |
|
|
ethics@easternhealth.org.au |
Consent Form: RCT
|
Title |
Development and evaluation of an online gambling self-help program |
|
Protocol Number |
E07-2015 |
|
Project Sponsor |
Victorian Responsible Gambling Foundation |
|
Coordinating Principal Investigator/ Principal Investigator |
Nicki Dowling/ Simone Rodda, Stephanie Merkouris, Dan Lubman, Peter Harvey, Malcolm Battersby, John Cunningham, Bryan Rodgers, David Austin, Tiffany Lavis, David Smith |
|
Location |
Deakin University, 221 Burwood Highway, Burwood, Victoria, 3125. Turning Point, 54-62 Gertrude St, Fitzroy, Victoria 3065. Statewide Gambling Therapy Service. Victorian Responsible Gambling Foundation. |
Declaration by Participant
I have read the Participant Information Sheet.
I understand the purposes, procedures and risks of the research described in the project.
I have had an opportunity to ask questions and I am satisfied with the answers I have received.
I freely agree to participate in this research project as described and understand that I am free to withdraw at any time during the study without affecting my future health care, or my relationships with the researchers, or any of the organisations/institutions.
I understand that I will be emailed a copy of this document to keep.
