Informed Consent to Participate in a Research Survey

External Flow Prototype

You are invited to participate in the External Flow prototype study. The goal of this study is to obtain your thoughts regarding a prototype with individual features to direct distribution decisions.

The purpose of your participation in this research is to help the manufacturer understand your thoughts on the prototype features. You were selected as a possible participant in this study because you have been using an intermittent catheter for longer than 3 months and have a history of urinary tract infections.

Participation in this study is voluntary. If you agree to participate in this study, you will be interviewed for about 45-60 minutes. The interview may include questions about your catheterizing process and what features are important to you when it comes to selecting an intermittent catheter. We will ask for a summary of your background as it relates to intermittent catheters, your first impressions of the samples, usability observations, and finally, a wrap-up. The interview will take place via a Zoom call.

Participating in this study may not benefit you directly, but it will help us learn. You may find answering some of the questions uncomfortable, embarrassing, and/or inconvenient. You may skip any questions you don’t want to answer, and you may end the interview at any time.

The records from this study will be kept confidential.  No individual identities (names or images) will be used in any reports or publications resulting from the study. The anonymized recording will be stored on a secure server and deleted after 7 days. Research material will be kept in locked files at all times. Only research personnel (Morgan Ledford) will have access to the files to provide the report.

Materials may include:

• Video – (Zoom recording)
• Written feedback

Your decision whether to participate in this study is voluntary and will not affect your relationship with 180 Medical. If you choose not to participate in this study, you can withdraw your consent and discontinue participation at any time without prejudice.

If you have any questions about the study, please contact Morgan Ledford by emailing MorganLedford@180Medical.com

I have read and I understand the provided information, and have received answers to any questions I asked. I understand that my participation is voluntary and that I am free to withdraw at any time, without giving a reason and without cost. I understand that I will be given a copy of this consent form. I am at least 18 years old, and voluntarily agree to take part in this study.