Informed Consent Form

For Participants

Q: Are there any risks or benefits to me if I complete the survey?

A: You will not be exposed to any risks to your health by participating in this study. Some people feel uncomfortable when answering questions about the quality of their life. Though it is always better to have fully completed questionnaires, you do not need to answer any questions that make you feel uncomfortable or that you do not wish to answer.

There may be risks that are unknown.

This study is to support access to wipes used during your everyday stoma care. The potential benefit to you is potentially ease of access and a reduction in cost of accessing wipes.

Q: Are there any risks or benefits to me if I complete the survey?

A: You will not be exposed to any risks to your health by participating in this study. Some people feel uncomfortable when answering questions about the quality of their life. Though it is always better to have fully completed questionnaires, you do not need to answer any questions that make you feel uncomfortable or that you do not wish to answer.

There may be risks that are unknown.

This study is to support access to wipes used during your everyday stoma care. The potential benefit to you is potentially ease of access and a reduction in cost of accessing wipes.

Q: What personal information of mine will the survey collect?

A: The only personal information we will collect from you during this survey will be your Internet protocol (IP) address, email address (if you wish to participate in a follow-up survey), age, gender and type of stoma. 

Q: How will my results be used?

A: Your responses, including any personal information you share, will be anonymised and analysed by KMC Health Care*. The results of the analysis will be shared with Coloplast. All responses to this survey will be combined and analysed to help with accessing wipes. The results of this research study may be presented to the Department of Health, at scientific meetings or in publications, but your identity will not be disclosed.

Q: Are there any risks or benefits to me if I complete the survey?

A: You will not be exposed to any risks to your health by participating in this study. Some people feel uncomfortable when answering questions about the quality of their life. Though it is always better to have fully completed questionnaires, you do not need to answer any questions that make you feel uncomfortable or that you do not wish to answer.

There may be risks that are unknown.

This study is to support access to wipes used during your everyday stoma care. The potential benefit to you is potentially ease of access and a reduction in cost of accessing wipes.

* KMC Health Care is an independent, global consultancy in health economics and outcomes research. KMC Health Care has been commissioned by a medical devices company to conduct this survey.

Q: Will my personal information and my responses be safe?

A: Yes. Your electronic data will be stored on a secure server, and all personally identifiable information will be destroyed 2 years following study completion or study publication, whichever comes first. 

Q: Do I have to take part in this study?

A: No. Your decision to participate in this study is voluntary. You may choose to not participate or you may withdraw from the study for any reason without penalty or loss of benefits to which you are otherwise entitled and without any effect on your future medical care. However, please note that any information collected up to the point of your withdrawal cannot be removed from the study.

Q: Whom to contact about this study?

A: During the study, if you have questions, concerns or complaints about the study, please contact Coloplast at +61 3 95411111

Adverse events (side effect) reporting

Although what you mention during the survey will be treated in confidence, should you mention a side effect, product complaint or special reporting situation when you or someone utilized Brava wipes, we will need to follow appropriate reporting procedures. The details of these will be reported anonymously unless you agree to share your personal details at the end of the survey for the purpose of follow-up by the company’s device safety team. Everything else you mention in this survey will remain confidential except where disclosure is required by law.