Big toe arthritis study
It is possible that results from this study will be displayed in a postgraduate research thesis, presented at a conference, or published in a peer reviewed journal.
A number of measurements will be compared between the initial appointment and the follow-up appointment. This will include measurements of pain in the big-toe joint, use of pain relieving medications and amount of unpleasant effects. It should be noted, however, that participant information will be expressed anonymously (e.g. participant 1, participant 2, etc), with no mention of your name or personal details. Furthermore, results of the study and your individual results will be made available to you upon request. This may entail mailing of results to your home residence, emailing to your preferred email address, or if you prefer, a discussion with Dr Shannon Munteanu in person.
The results obtained from this study may also be used in future research projects. Such projects may include studies investigating how factors (such as x-ray or MRI features) may contribute to pain in big-toe joint osteoarthritis, or what tests can predict favourable outcomes of treatment in people with big-toe joint osteoarthritis.
The investigators listed at the beginning of this participant information statement will have access to your data. In instances where other researchers need to access your data for future research projects, the University Human Ethics Committee will be advised and requested to grant permission to do so.
Participation in this project is entirely voluntary. You are free to deny consent before or during the study. In the latter case, such withdrawal of consent should be performed at any time you specify, and not at the end of a particular trial. Your participation and / or withdrawal of consent will not influence your present or future involvement at La Trobe University. In the case that you are a student at La Trobe University, it will not influence your grades or progress in your course of study. Your consent form will be stored in a locked filing cabinet in the Chief Investigator’s office. No one apart from the investigators listed at the beginning of this participant information statement will have access to the computer records and written records. The raw data and consent forms will be destroyed in fifteen years’ time after collection using secure methods.
You have the right to withdraw from active participation in this project at any time and, further, to demand that data arising from your participation are not used in the research project provided that this right is exercised within four (4) weeks of the completion of your participation in the project. You are asked to complete the “Withdrawal of Consent Form” or to notify the investigator by email or telephone that you wish to withdraw your consent for your data to be used in this research project.