Patient Perceptions of Healthcare Specialists’ Knowledge of Hypermobile Ehlers-Danlos Syndrome Pre-Diagnosis

Investigator: Brittany Galante MS, GC, Chief Interdepartmental Communication Advisor at Rare Advocacy Movement (RAM), Department of Health Equity Diagnostic Infrastructure (HEDI) initiative, Brittany.galante7@gmail.com

RESEARCH PARTICIPANT INFORMED CONSENT FORM

You are being asked to join a research study. Participation in this study is voluntary. Even if you decide to join now, you can change your mind later.

Research Summary (Key Information):
The information in this section is intended to be an introduction to the study only.  Complete details of the study are listed in the sections below. If you are considering participation in the study, the entire document should be discussed with you before you make your final decision.  You can ask questions about the study now and at any time in the future.

• This study’s purpose is to investigate patient perceptions on healthcare specialists' knowledge of hypermobile Ehlers-Danlos syndrome.
• Your participation in this study is entirely voluntary. You choose whether to participate.
• To participate in this study, you must be 18 years of age or older, have a clinical diagnosis of hypermobile Ehlers-Danlos syndrome, have discussed hEDS with a provider before you were diagnosed with hEDS, be able read and write the English language at an 8th grade level or above, and be a resident of the United States of America.
• Participation in this study involves completing a survey that will take approximately 10-20 minutes.
• There are no costs associated with participation.
• The risks associated with participation in this study are no greater than those encountered in daily life.
• You may or may not benefit from being in this study. This study may benefit society if the results lead to a better understanding of patient perceptions of health care specialists’ knowledge of hypermobile Ehlers-Danlos syndrome.

Why is this research being done?

• This research is being done to investigate patient perceptions on healthcare specialists' knowledge of hypermobile Ehlers-Danlos syndrome. Better understanding the perceived knowledge of commonly seen health care specialists by patients with hypermobile Ehlers-Danlos syndrome may assist in targeted education to those specific specialties.

• People that meet the following requirements may participate in this study: have a clinical diagnosis of hypermobile Ehlers-Danlos syndrome, have discussed hEDS with a provider before you were diagnosed with hEDS, are 18 or older, are able to read and write the English language at an 8th grade level or above, and are a resident of the United States of America.

What will happen if you join this study?

If you agree to be in this study, we will ask you to do the following things:

• If you decide to participate in this study, you will be asked to complete a survey.
• This survey will be made available immediately following this consent form if you agree to participate.
• This survey will consist of multiple choice and several written response questions.
• This survey will be completed electronically and should take between 10-20 minutes to complete.

Will research test results be shared with you?

• At the time that the results of this study are published, they will be posted on the landing page on the Rare Advocacy Movement website. This was the webpage where you clicked on the link that took you to the survey.

How long will you be in the study?

• Participation in the study will take approximately 10-20 minutes.

What are the risks or discomforts of the study?

• The risks associated with participation in this study are no greater than those encountered in daily life.
• You may get tired or bored when we are asking you questions, or you are completing questionnaires. You do not have to answer any question you do not want to answer.
• Although your IP Address will not be stored in the survey results, there is always the possibility of tampering from an outside source when using the Internet for collecting information. While the confidentiality of your responses will be protected once the data is downloaded from the Internet, there is always the possibility of hacking or other security breaches that could threaten the confidentiality of your responses.
• There is the risk that information about you may become known to people outside this study.
• Even if identifiers are removed, the information will not be used or distributed for future research studies.

Are there benefits to being in the study?

• You may or may not benefit from being in this study.
• This study may benefit society if the results lead to a better understanding of patient perceptions of healthcare specialists’ knowledge of hypermobile Ehlers-Danlos syndrome.

What are your options if you do not want to be in the study?

• Your participation in this study is entirely voluntary. You choose whether to participate.
• You can choose not to participate in this survey by not continuing.
• If you decide not to participate, there are no penalties, and you will not lose any benefits to which you would otherwise be entitled.

Will it cost you anything to be in this study?

• No.

Will you be paid if you join this study?

• No.

Can you leave the study early?

• You can agree to be in the study now and change your mind later, without any penalty or loss of benefits. If you want to withdraw from the study, please know that you may exit the survey at any time.

How will the confidentiality of your biospecimens and/or data be protected?

• Any study records that identify you will be kept confidential to the extent possible by law. The records from your participation may be reviewed by people responsible for making sure that research is conducted properly, including members of the Univo Institutional Review Board and officials from government agencies such as the National Institutes of Health and the Office for Human Research Protections. (All of these parties are required to keep your identity confidential.) Otherwise, records that identify you will be available only to people working on the study, unless you give permission for other people to see the records.

What other things should you know about this research study? What is the Institutional Review Board (IRB) and how does it protect you?

• This study has been reviewed by an Institutional Review Board (IRB), a group of people that review human research studies. The IRB can help you if you have questions about your rights as a research participant or if you have other questions, concerns, or complaints about this research study.  You may contact the IRB with the following link: https://www.univo-group.com/contact-us/.

What should you do if you have questions about the study?

• Contact the investigator (Brittany Galante at Brittany.galante7@gmail.com). If you cannot reach the investigator or wish to talk to someone else, contact the IRB with the following link: https://www.univo-group.com/contact-us/.

You can ask questions about this research study now or at any time during the study. If you have questions about your rights as a research participant or feel that you have not been treated fairly, please contact the UNIVO Institutional Review Board with the following link: https://www.univo-group.com/contact-us/.