PARTICIPANT INFORMATION SHEET
Swinburne University of Technology, Royal Melbourne Hospital
& St Vincent’s Hospital (Melbourne)
FULL PROJECT TITLE:
Exploration of the psychosocial issues associated with gastroparesis: A quantitative investigation.
NAME/S OF INVESTIGATORS:
Dr Simon Knowles (Swinburne University), Associate Professor Geoff Hebbard (Royal Melbourne Hospital), Professor David Castle (St Vincent’s Hospital Melbourne) and Ms Sally Woodhouse (Swinburne University).
You are invited to take part in this research project. This is because you currently experience gastroparesis. We are aware that having gastroparesis can have a significant impact on your health, both physiologically as well as psychologically. It is well recognised that individuals undergoing treatment for a medical condition also report anxiety, stress, and even depression.
We are looking to gain a better understanding as to the psychosocial impact of having gastroparesis.
This Participant Information and Consent Form tells you about the research project. It explains the procedures 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 healthcare worker.
Participation in this research is voluntary. If you don’t wish to take part, you don’t have to. You will receive the best possible care whether you take part or not.
If you decide you want to take part in the research project, you will be asked to complete an online questionnaire (further details are provided under ‘What does participation in this research project involve?’).
Clicking CONTINUE and completing the questionnaire will be signalling that you are telling us that you:
- understand what you have read;
- consent to take part in the research project; and,
- consent to participate in the research processes that are described.
2. What is the purpose of this research project?
The purpose of this study is to explore how you experience your gastroparesis and how it impacts on your life. Questions will explore gastroparesis symptoms (e.g., How often do you experience nausea, pain?), illness perceptions (e.g., How much control do you feel you have over your illness?), coping (e.g., I've been turning to work or other activities to take my mind off things), psychological distress (e.g., I found it difficult to workup the initiative to do things), personality (e.g., I am extraverted, enthusiastic), and quality of life (e.g., have you restricted eating at restaurants or at someone's home?).
Under the supervision of the primary investigator, data from this study will also be used by Ms Sally Woodhouse as part of her PhD research. We aim to recruit a total of 200 participants. This research involves the collaboration between the Royal Melbourne Hospital, St Vincent’s Hospital, and Swinburne University.
3. What does participation in this research project involve?
If you wish to join the study, please click CONTINUE and complete the questionnaire. The questionnaire will take between 45-60 minutes to complete.
4. Participant inclusion/exclusion criteria
- Aged 18 years or older
- Having been diagnosed with Gastroparesis
- English as a first language or able to read English
- Not currently experiencing severe mental illness
- Not currently seeking support from a mental health expert (i.e., psychologist or psychiatrist)
5. What are the possible risks?
It is recommended that you discuss your participation in this research with your gastroenterologist or health professional. If you become upset or distressed as a result of your participation in the research, the researcher is able to arrange a referral for counselling and/or other appropriate support. Any counselling or support will be provided by individuals who are not members of the research team.
6. Do I have to take part in this research project?
Participation in this 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 a later stage. If you do decide to leave this project, the researchers would like to keep the personal and health information about you that has been collected. This is to help them make sure that the results of the research can be measured properly. If you do not want them to do this, you must tell them before you withdraw from the study.
If you are completing this questionnaire from outside of Australia, please be alert to any local restrictions in your home country on participating in foreign research activity.
7. How will I be informed of the results of this research project?
The research group conducting the study plan to write a report, which will be made available to anyone who is interested. The report will be available via www.gastroparesisclinic.org. The results will also be written for publication in a scientific medical journal.
8. What will happen to information about me?
Any information obtained in connection with this project and that can identify you will remain confidential. It will only be disclosed with your permission, except as required by law. No information used in future presentations or written publications like articles or books will identify any participant. This is done through coding all participants using numbers and keeping all documents involved with individuals in a locked cabinet, accessible only to people involved in the project. All information will be kept at Swinburne University of Technology, in a locked filing cabinet (or secured computer) for a period of 7 years and subsequently shredded (or deleted).
9. Can I access research information kept about me?
In accordance with relevant Australian and /or Victorian privacy and other relevant laws, you have the right to access the information collected and stored by the researchers about you. You also have the right to request that any information, with which you disagree, be corrected. Please contact one of the researchers named at the end of this document if you would like to access your information.
10. Is this research project approved?
The ethical aspects of this research project have been approved by the Swinburne University Human Research Ethics Committee (SUHREC).
This project will be carried out according to the National Statement on Ethical Conduct in Human Research (2007 – updated May 2013) 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.
11. Who can I contact?
If you want further information concerning this project or if you have any problems which may be related to your involvement in the project, you can contact the Principal Researcher, Dr Simon Knowles, on +61 3 9214 8206 or firstname.lastname@example.org.
If you have any complaints about any aspect of the study or the way in which it is being conducted you may contact the Research Ethics Officer, Swinburne Research (H68), Swinburne University of Technology, PO BOX 218, HAWTHORN VIC 3122. Tel +61 3 9214 5218 or email@example.com.
I have read this document and I understand the purposes, procedures and risks of this research project as described within it.
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.
I understand that I can print off or contact the principal researcher to attain a copy of the information and consent form.
If you have read this information and consent form and agree to participate, please click on the CONTINUE button.