ELSI ORIGIN-FH-UW Health Patient and Person Affected By FH Consent

University of Wisconsin-Madison
Consent to Participate in Research
and
Authorization to Use Protected Health Information for Research

Study Title for Participants: “Ethical, Legal, and Social Issues in the Opportunity to Research Individuals with Genetic dyslipidemia during Infancy and the Newborn period to find Familial Hypercholesterolemia” (ELSI ORIGIN-FH)

Formal Study Title: “Ethical, Legal, and Social Issues in the Opportunity to Research Individuals with Genetic dyslipidemia during Infancy and the Newborn period to find Familial Hypercholesterolemia” (ELSI ORIGIN-FH)

Lead Researcher: Krisjon Olson, (608) 265-2236, H6/516b UW Health 600 Highland Avenue, Madison WI 53792-4108

Institution: University of Wisconsin–Madison

Key Information

The information in this section is to help you decide whether or not to be a part of this study. You can find more detailed information later on in this form.

Why are researchers doing this study?

Drs. Amy Peterson and Krisjon Olson at UW-Madison are conducting a research study sponsored by the Wisconsin Alumni Research Foundation. We are looking at the ethical, legal, and social acceptability of familial hypercholesterolemia (FH) screening and diagnosis in early childhood. We also aim to characterize the natural history of cholesterol care during the first five years of life in a population of children in Wisconsin who have undergone FH testing.

We invite you to take part in this research study because we hope to talk with at least 20-80 people, including:

1. People of reproductive age (18-50)
   1. Including pregnant people and their partners
2. People being screened for FH and their family members
   1. Children 3 years old or older who are being tested for or have been tested for FH and their parent/guardian

The purpose of this study is to improve screening practices for FH. To do that, we would like to include a broad range of participants. If you are a parent of a child who is being or has been tested for FH, the “you” in this consent form should be understood to mean “you and your child”, as you will both be participants in our study.

What will I need to do in this study?

The research team will ask you to complete the following:

1. You will complete a 30-90 minute interview
2. Pregnant participants will complete an approximately 10-minute follow-up interview approximately 3 months after their first interview

Interviews will be held over a phone call or secure Zoom. Any participants in the Madison area also have the option to participate in interviews in-person. You may invite a support person to participate with you.

We expect that this research will take 60 to 90 minutes of interview time.

You can find detailed information about the study procedures in the section called If I take part in the study, what will I do?

What are some reasons I might – or might not – want to be in this study?

Do I have to be in the study?

No, you do not have to be in this study. Taking part in research is voluntary. If you decide not to be in this study, your choice will not affect your healthcare or any services you receive. There will be no penalty to you. You will not lose medical care or any legal rights. You can ask all the questions you want before you decide.
Your healthcare will not be impacted.

Detailed Information

The following is more detailed information about this study in addition to the information listed above.

How is research different from health care?

When you take part in a research study, you are helping to answer a research question. Study tests and procedures are not for your health care.

Who can I talk to about this study?

If you have questions, concerns, or complaints, or think that participating in the research has hurt you, talk to the research team at the following addresses: Dr. Krisjon Olson (608-262-5024) or elsioriginfh@pediatrics.wisc.edu

If you have concerns about your rights as a research participant or have complaints about the research study or study team, call the confidential research compliance line at 1-833-652-2506. UW Staff not part of the study team will work with you to address concerns and assist in resolving any complaints.

If I take part in the study, what will I do?

1. You will complete a 30-90 minute interview
   1. We would like to learn how you think about FH. We will ask you to tell us your story of FH screening. Interviews will be held over a phone call or secure Zoom. Any participants in the Madison area also have the option to participate in interviews in-person. And you may invite a support person to participate with you. You can choose not to answer any of the questions you are asked and can stop the interview at any time. Your answers will be kept confidential. We will ask you and anyone you choose to have participate in the interview to use only their first names and not to share any information from the interview with people outside the study team. Study participants in the interviews are allowed to talk about information shared as much or as little as they want.
2. Pregnant participants will complete an approximately 10 minute follow-up interview approximately 3 months after their first interview.
   1. This is an unstructured follow-up interview.

As part of the study we will collect audio recordings will be made of the interview with your permission. You can also choose to have us take notes instead of a recording. If you choose a recording, only the researchers will have access to these recordings. The researchers or someone hired by the researchers will listen to the recording and write down what people said during the interview. The written copy is called a transcription. The transcription will be saved but the recording will be destroyed. No information that could identify you will be included in the transcription. Your name and personal information will be replaced with your unique study ID that will match clinical information we collect on all our patients. Recordings will not be used for purposes outside of the study or in any papers or publications.

Protected health information (PHI) used in this study

Protected health information, also called PHI, is information about your physical or mental health that includes your name or other information that can identify you, like your date of birth or medical record number. To do this study, we will use the following kinds of PHI:

• Things you tell the researchers about your health

If you choose to have a support person in your interview (for example, you are a person with FH and have a pregnant partner you would like to participate in the interview with) your FH diagnosis may come up in the discussion. You should only choose to participate in the interview with someone you are comfortable with knowing your FH diagnosis.

What happens if I say yes, but I change my mind later?

You can leave the research at any time. If you choose to leave the study, your choice will not affect your healthcare or any services you receive. No matter what decision you make, and even if your decision changes, there will be no penalty to you. You will not lose medical care or any legal rights.

Your authorization for researchers to use your protected health information (PHI) will last until the research study is done. However:

• You can choose to take back your authorization for researchers to use your health information. You can do this at any time before or during your participation in the research.
• If you take back your authorization, information that was already collected may still be used and shared with others, but the researchers will no longer be able to collect NEW information about you.
• If you take back your authorization, you will not be able to take part in the research study.
• To take back your authorization, you will need to tell the researchers by writing to the Lead Researcher, Krisjon Olson, at H6/516 600 Highland Avenue, Madison, WI 53792-4108

Will being in this study help me in any way?

Being in this study will not help you directly. Your participation in the study may benefit other people in the future by helping us understand attitudes towards screening for FH.

What are the study risks?

• Psychological risks- you may become upset or experience emotional distress when recounting your experience with screening and diagnosis of FH
• Privacy risks- it is possible that your information could be revealed and your confidentiality is breached.

What happens to the information collected for the research?

We have strict rules to protect your personal information and protected health information (PHI). We will limit the use and disclosure of your personal information, including research study and medical records, to people who have a need to review this information. The study will be protected by a Certificate of Confidentiality from the National Institutes of Health. This means we will not share any information that would identify you as a participant in the study, even if the police or courts ask to look at the data we have collected. issued, the Certificate will retroactively cover information collected since the beginning of the study.

However, we cannot promise complete confidentiality. We will share information with individuals or organizations identified in this consent form. Federal or state laws may permit or require us to show information to university or government officials responsible for carrying out or monitoring this study. This includes University of Wisconsin and its representatives and affiliates, including those responsible for ensuring compliance, such as the Human Research Protection Program.

We may also have to tell appropriate authorities, such as child protective services or health care providers, if we learn during the study that you or others are at risk of harm (for example, due to child or elder abuse, or suicidal thoughts).

Authorizing the research team to use your PHI means that we can release it to the people or groups listed in this form for the purposes described in this form. Once we share your identifiable health information outside UW-Madison, the HIPAA Privacy Rule may no longer protect it. However, we try to make sure that everyone who sees your health information keeps it confidential.

Also, with appropriate confidentiality protections, we might use information that we collect during this study for other research, or share it with other researchers without additional consent from you.

We may publish the results of this research. However, we will keep your name and other identifying information confidential but may share parts of our interview with any information that identifies you removed, we may also share summaries of our findings with community collaborators and in published research.

Will information from this study go in my medical record?

None of the information we collect for this study will go in your medical record.

Can I be removed from the research without my agreement?

The person in charge of the research study or the sponsor can remove you from the research study without your approval. Possible reasons for removal include:

• Death of patient participant under age 18

What else do I need to know?

Permission to communicate about the study by email

We are requesting your email address so we can make it easier for you to participate. Email is generally not a way to about your health as there are many ways for
unauthorized users to email. You should avoid sending sensitive, detailed personal information by email. Email should also not be used to convey information of an urgent nature. If you need to talk to someone immediately, please contact Krisjon Olson, Principal Investigator, (608) 262-5024. You do not have to provide your email address to participate in this study.

How many people will be in this study?

We expect about 20-80 people will be in this research study.

Who is funding this study?

This research is being funded by the Wisconsin Alumni Research Foundation.

Will my data be used for future research?

This study is collecting interview and medical record data from you. We will save your data for other research studies that may be done in the future. The research may be about similar diseases or conditions to this study.

Qualitative data from interviews will not be shared outside of the research team. We will be summarized and deidentified findings with our community collaborators and in publications.

Data will be collected in the form of audio recordings, transcriptions of these recordings, physical notes taken during interviews, and any documents (e.g., email correspondences, scanned copies of letters or photographs) that respondents voluntarily choose to share with the researchers. Data, particularly interview transcripts, records, and notes, will not be shared with the other study participants or made available to the wider scientific community.

Your name and identifying information will be removed from any data you provide before they are shared with other researchers. Researchers cannot easily link your identifying information to the data.

We will do our best to protect your data during storage and when they are shared. However, there remains a possibility that someone could identify you. There is also the possibility that people who are not supposed to might access your data. In either case, we cannot reduce the risk to zero.

Participating in this study means you agree to for your data to be stored and later used. You can change your mind later, but researchers might still use your data if they have already been shared. If you do not want your data stored and used for other research studies, you should not participate in this study.

Agreement to participate in the research study

You do not have to agree to participate. If you do not agree, however, you cannot take part in this research study. If you agree, it means that:

• You have read this consent and authorization form.
• You have had a chance to ask questions about the research study, and the researchers have answered your questions.
• You want to be in this study.
• You give authorization for your protected health information to be used and shared as described in this form.