The Hepatitis C Treatment Outcome Study
Dr Mark Edwards
Associate Professor and Research Project Supervisor
Head and Chair of Psychology
Dr Christina Samios
Dr Mike Lyvers
Mr Simon A. Langston
PhD Student Researcher
Department of Psychology
Gold Coast, Qld, 4229
Â Ph;Â +61 7Â 55 95 1111
You are invited to take part in a study designed to determine some of the physical, psychological, and social factors associated with Hepatitis C treatment outcomes. Previous research has indicated that certain physical and psychological profiles predict better treatment outcomes across a range of medical conditions. However, little is known of how these factors predict treatment outcomes in Hepatitis C.Â The primary objective of this research is to increase understanding of individualÂ profiles that are associated with better Hepatitis CÂ treatment outcomes.
We are inviting individuals who are over the age of 18 years, who have a current diagnosis of Hepatitis C, who have access to the internet and a current email address, and who are planning to commenceÂ Hepatitis C treatment, to complete two confidential online surveys. Specifically, we require your email address so that we can send you a link to the second survey at the appropriate time. The first survey must be completed prior to the commencement of treatment. A link to the second survey will be sent out to participants 14 weeks after commencing treatment. The first survey should take 35-40 minutes to complete, whilst the second survey can be completed in 5-10 minutes.
Participation in this research is voluntary and any information you provide is completely confidential. Your email address and responses to the survey are not linked to any information that could personally identify you. Only the principal investigators will have access to your email address. You have the right to withdraw from the research at any time, and without penalty.
Prior to commencing the surveyÂ you willÂ be asked to read the ‘participant consent acknowledgment’ section below. If you then agree to participate, you will be asked to check an acknowledgement box confirming your consent to voluntarily participate in the study. Clicking on a link directly below this acknowledgement box will lead you into the first survey.
Questions included in the online surveys will cover some of the following areas:
- Demographic information (For example, your gender, age and employment status)
- Medical information (For example, your Hepatitis C genotype, the general condition of your liver, and questions related to your general overall health)
- Psychological (For example, questions assessing how much Hepatitis C has impacted individuals lives, and further questions related to individual coping styles and general mental health)
Benefits to Participants
At regular intervals, result summaries and other relevant Hepatitis C based education and information will be posted on our website blog page. This information may be useful for individuals preparing for and undergoing treatment for Hepatitis C. Further, in recognition for the time and effort involved in participating in this research, participants who meet the eligibility criteria for participating in this study (decision at the discretion of the PhD student researcher), will be sent a AUSÂ $20 Amazon gift voucher after completing both the online surveys.
Storage of Collected Information
We value your privacy and right to have your information treated in the strictest confidence. All collected information will be stored electronically in a password secured file at the Bond University and only the principal investigators will have access to this information.
Potential Risks to Participants
If participating in this study results in any level of distress beyond the normal experience of everyday life, we would recommend that you consider contacting either or both of the following services:
- Lifeline 24 hour counselling on 13 11 14.
- A general medical practitioner (GP).
This research project has been granted ethics approval by the following Human Research Ethics Committees:
- Bond University Human Research Ethics Committee (HREC Reference Number: RO1359).
- Gold Coast Health Service District Human Research Ethics Committee (HREC Reference Number: HREC/11/QGC/39).
If You Have Any Questions or Concerns About This Researchâ¦â¦..
Any Questions regarding this study can be directed to the principal investigator and PhD student researcher, Mr Simon Langston at: 9365538259
If you have any concerns related to the manner in which this research is conducted, please contact either of the Human Research Ethics Committees listed below quoting the relevant research ethics approval reference details listed above:
Bond University Human Research Ethics Committee
Gold CoastÂ QLD 4229
Phone: (07) 7Â 55 95 4194
Chair of the Ethics Committee,
Gold Coast Hospital and Health Service
Southport, Qld, 4215
Patient Liaison Services
Gold Coast Hospital and Health Service
Phone:Â 1300 744 284
Participant Consent Acknowledgement
Â By ticking the box below I confirm that I have read and understood the information contained in both the âParticipant Informationâ and âParticipant Consent Acknowledgementâ sections on this website and in particular that:
- I agree to participate in the study, and I am aware that I can withdraw from the study at anytime. Further, I reserve the right not to provide any piece of information that I do not wish to provide.
- Whilst understanding that I may withdraw from this study at anytime, I also understand that if I do decide to withdraw that I will not be able to remove information that I may have provided earlier.
- I understand that my involvement in the research project will involve completing online surveys both prior to and after commencing treatment for Hepatitis C.
- I understand that my participation in this study will contribute to an increased understanding of why individuals experience differences in Hepatitis C treatment outcomes, and that the findings from this study will primarily benefit individuals undergoing Hepatitis C treatment in the future.
- I understand the potential risks involved in participating in this study and I am also aware of the contact options should I experience any distress or discomfort related to participating in this study.
- I understand that if I have any additional questions related to this study I can contact a member of the research team.
- I understand that if I have any concerns related to the ethical conduct of this study I can contact either TheÂ Bond University Human Research Ethics CommitteeÂ on (07)Â 55 95 4194 (quoting the following research project details: RO1359) or either the Chair of the Human Research Ethics Committee or the Patient Liaison Service at the Gold Coast Hospital onÂ 1300 744 284Â (quoting the following research project details: HREC/11/QGC/39).
- I agree that de-identified research information collected from me can be included in future research related activities, including the publishing of findings in thesis papers, presentation of results in relevant conferences and other public forums and may also be published in peer reviewed journals.