School of Psychology
Deakin University
PLAIN LANGUAGE STATEMENT

Your Consent
You are invited to take part in this research project titled above.  This Plain Language Statement contains detailed information about the research project. Its purpose is to explain to you as openly and clearly as possible all the procedures involved in this project so that you can make a fully informed decision whether you are going to participate. Please read this Plain Language Statement carefully. Feel free to ask questions about any information in the document.  You may also wish to discuss the project with a relative or friend or your local health worker. Feel free to do this.

Once you understand what the project is about and if you agree to take part in it, you will be asked to follow a link to an online questionnaire. By completing and submitting the online questionnaire, you indicate that you understand the information and that you give your consent to participate in the research project. You may print a copy of this Plain Language Statement to keep as a record.


Purpose and Background
There is continuing debate about which tests should be used to evaluate and diagnose myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and fibromyalgia syndrome (FMS). In particular, symptoms need to be assessed in terms of how they change over time and whether they can be predicted by other symptoms.  Additionally, a test battery that is sensitive enough to differentiate between chronic illnesses (that often share the same symptoms) is also required.  This study will seek to develop a test battery that differs between ME/CFS, FMS, rheumatoid arthritis (RA) and healthy populations, and is sensitive to real change within individuals. 

The purpose of this project is to validate an instrument that will assist in the diagnosis of chronic illness sufferers and assess symptom improvement in these groups.  You are invited to participate in this research project because you either do or do not have a chronic illness and were recruited via posters around Deakin University or word of mouth. The results of this research may be used to help researchers Briony Pattinson, Emma Abeyaratne, Emma Trifiletti, and Simone Gindidis to obtain a Graduate Diploma of Psychological Studies degree and researcher Hannah Bereznicki obtain a Doctorate degree.

A total of 400 people aged 18-80 years will participate in this project. Currently we seek to recruit volunteers who have ME/CFS, FMS or RA and also people who do not have any of the conditions so we can compare data from healthy people to people with a chronic illness. This questionnaire aims to assess what symptoms (if any) you experience, the severity of these symptoms, and how they impact on you. The following are some examples of questions you will be asked to complete: “Do you have problems with tiredness?”, Over the past week, were you able to walk several blocks?”, Over the past week, how nervous or anxious have you felt?”.

Funding
This research is totally funded by Deakin University.

Procedures
Participation in this project will involve completing a 20-minute online questionnaire once a month for three months. You will be emailed with a reminder to complete the survey over the three time points.

        
Possible Benefits
This research may add further knowledge toward a diagnosis and symptom course for ME/CFS and FMS.  This understanding may help inform identification of the illnesses and be used to assess treatment effectiveness.  We cannot guarantee or promise that you personally will receive any benefits from this project.

        
Possible Risks
It is possible that some participants may feel mild discomfort in answering certain questions - if you do not feel comfortable completing the survey you can suspend or end your participation at any time by simply not completing the survey.  If you feel distress resulting from completion of this survey it is advised you contact your GP or other relevant health professional.  You may also call Lifeline on 13 11 14 for 24-hour phone counselling in Australia or the Pain Link helpline on 1300 340 357. If the pattern of your answers indicates that you may be at risk of, or suffering from, an undiagnosed psychological condition such as major depression or an anxiety disorder, the principal researcher (a registered clinical psychologist) will contact you to let you know about this and offer suggestions about how to find an appropriate assessment agency.

        
Privacy, Confidentiality and Disclosure of Information
If you give us your permission by completing and submitting the survey, your data will form part of the group data to be analysed and reported in scientific papers and/or conferences. Only group data will be reported. The data obtained from this research will be re-identifiable (coded so your data can only be linked to your personal information by the principal researcher).  The re-identifiable information will be stored in password protected files, and paper copies will be stored in a locked cabinet. Only the principal and associate researchers will have access to the files. Your data will contribute to an existing databank. Data from this databank may be used for another purpose such as future research into chronic illnesses led by the principal researcher, for which ethics approval will be sought. Under NO circumstances will your personal data be revealed or passed on to any partner or organisation other than the researchers All data collected in Australia will be securely stored for six years at Deakin University as set out in the University regulations, after which all data will be destroyed. These data will be stored securely at Deakin University regardless of researchers’ future affiliation with the University. Deakin University will be responsible for disposing of information after six years, and this will be done according to Victorian privacy laws, which requires the University to "take reasonable steps to destroy or permanently de-identify personal information if it is no longer needed for any purpose". (IPP4.2, Information Privacy Act 2000 Vic.) To protect your confidentiality, any doctors or organisations that referred you to the weblink will not know whether or not you completed the study, nor will any individual results be released to them.

Results of Project
You will be asked to indicate if you would like information on the outcomes of group data in the questionnaire. If you indicate yes, a copy of the group data will be emailed to you in September.

Participation is Voluntary
Participation in any research project is voluntary. If you do not wish to take part you are not obliged to. If you decide to take part and later change your mind, you are free to withdraw from the project at any stage. Your decision whether to take part or not to take part, or to take part and then withdraw, will not affect yourrelationship with Deakin University. Before you make your decision, a member of the research team will be available to answer any questions you have about the research project. You can ask for any information you want.  Complete and submit the survey only after you have had a chance to ask your questions and have received satisfactory answers. If you decide to withdraw from this project, please do not complete and submit the survey.

Ethical Guidelines
This project will be carried out according to the National Statement on Ethical Conduct in Human Research (2007) produced by the National Health and Medical Research Council of Australia. This statement has been developed to protect the interests of people who agree to participate in human research studies. The ethics aspects of this research project have been approved by the Human Research Ethics Committee of Deakin University.

Complaints
If you have any complaints about any aspect of the project, the way it is being conducted or any questions about your rights as a research participant, then you may contact: The Manager, Office of Research Integrity, Deakin University, 221 Burwood Highway, Burwood Victoria 3125, Telephone: 9251 7129, Facsimile: 9244 6581; research-ethics@deakin.edu.au.

Please quote project number EC 2011-098.

Reimbursement for your costs
You will not be paid for your participation in this project.

Further Information, Queries or Any Problems
If you require further information, or if you have any problems concerning this project, you can contact the below researchers from the School of Psychology at Deakin University:

Professor Gregory Tooley:  gregory.tooley@deakin.edu.au

Hannah Bereznicki: hannah.bereznicki@deakin.edu.au

If you would like to participate in this project, please click the following button to indicate that you have read and understand the terms of the plain language statement and agree to give your consent to participate in the study: