Part 1: What does my participation involve?

1. Introduction

You are invited to take part in this research project, which is called ‘REACH-MS – Regional Education Access Collaboration Healthcare for people with Multiple Sclerosis. A digital health program providing accessible education for regional Australians with Multiple Sclerosis.’ You are invited because you have multiple sclerosis and live in a regional or remote area. Your neurologist provided us with your contact details.

This Participant Information Sheet/Consent Form tells you about the research project. It explains the processes involved with taking part. 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 local health worker.

Participation in this research is voluntary. If you don’t wish to take part, you don’t have to.

2. What is the purpose of this research?

This research has been initiated by the researcher, Professor Simon Hawke. The aim is to improve your understanding of multiple sclerosis and your management of it, using monthly emails and online meetings.

This research has been funded by Central West Neurology and Neurosurgery.

3. What does participation in this research involve?

If you join the study, you’ll need to provide your email address and complete two surveys: one before and one after the program.

The program will run for 12 months. The program will consist of:

• receiving monthly email newsletters
• attending webinars (online meetings) with health professionals every 4 months
• an optional face-to-face regional meeting (at a location to be confirmed)

The content covered will include: MS research updates, how to manage MS symptoms such as fatigue, heat sensitivity, mental health issues, bladder and bowel management, diet and exercise, accessing allied health, and strategies on living well with MS.

If you decide to take part in the research project, you will first be given a questionnaire asking about your age, diagnosis with MS, and your postcode; this will determine if you are eligible to take part. Completing the questionnaire will take approximately 2 minutes.

If the screening questionnaire shows that you meet the requirements, then you will be able to start the research project. If the screening questionnaire shows that you cannot be in the research project, the research coordinator will discuss other options with you.

This research project has been designed to make sure the researchers interpret the results in a fair and appropriate way and avoids study doctors or participants jumping to conclusions.  

There are no costs associated with participating in this research project, nor will you be paid.

4. Other relevant information about the research project

This study will be recruiting people with MS from regional and rural areas in NSW, Queensland and Victoria. 

5. 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 can check the box giving consent on this form and you will be emailed a copy to keep.

Your decision whether to take part or not to take part, or to take part and then withdraw, will not affect your routine care, your relationship with professional staff or your relationship with your neurologist.

6. What are the possible benefits of taking part?

We cannot guarantee or promise that you will receive any benefits from this research; however, possible benefits may include increased understanding of your disease, treatments available and management of symptoms.

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

Some questions might be stressful or upsetting. You can skip any questions you don’t want to answer or stop the survey at any time. If you become upset or distressed as a result of your participation in the research project, the research team will be able to arrange for counselling or other appropriate support.

8. 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. A member of the research team will inform you if there are any special requirements linked to withdrawing.  If you do withdraw, you will be asked to complete and sign a ‘Withdrawal of Consent’ form; this will be provided to you by the research team.

If you decide to leave the research project, the researchers will not collect additional personal information from you, although personal information already collected will be retained to ensure that the results of the research project can be measured properly and to comply with law. You should be aware that data collected up to the time you withdraw will form part of the research project results.  If you do not want your data to be included, you must tell the researchers when you withdraw from the research project. There is a withdrawal form that you will be able to submit to withdraw from the research project.

10. What happens when the research project ends?

If you would like to receive a summary report at the conclusion of the study, please select the box that indicates this on the online survey.

Part 2  How is the research project being conducted?

11. What will happen to information about me?

By signing the consent form 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.

Data collected will remain individually identifiable, for the purpose of data comparison. Your identifiable data will be used solely for the purpose of comparing your survey responses before and after the educational program. All data will be handled in strict accordance with privacy regulations, and after the analysis is complete, we will remove any identifying information from the dataset. Only the study coordinator and investigators will have access to the information collected.  

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 personal information that the research team collect and use is information from the questionnaire.

All data will be recorded to an electronic database. Access to electronic data will only be granted after appropriate training and username/password has been allocated to specified study staff.

Data collected from the survey will be stored on SurveyMonkey servers located in USA, Ireland and Canada. This company is ISO 27001 certified, meaning that it is internationally recognised for using the highest level of information security management.

Data will be stored for 5 years according to the data retention laws.

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. All information will be de-identified after analysis.

In accordance with relevant Australian and/or Qld, NSW, VIC 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 your information.

Once responses are submitted, the data analysis workflow is initiated. Participants will not be able to edit their responses before analysis or publication as this can disrupt the data process stage, and delay analysis.

Changes will also not be allowed to minimise bias that may occur. 

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.

12. Complaints and compensation

If you suffer any distress 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.

13. Who is organising and funding the research?

This research is being conducted by Central West Neurology and Neurosurgery, Orange NSW.

This research is funded in Australia by Central West Neurology and Neurosurgery, Orange NSW, Novartis Pharmaceuticals Australia, and Roche Products Pty Limited.

No member of the research team will receive a personal financial benefit from your involvement in this research project (other than their ordinary wages).

14. 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 Townsville University Hospital.

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.

Research contact person