ADOLESCENT INFORMED CONSENT INFORMATION SHEET

Title: Disease Burden and Psychosocial Impact of Hereditary Angioedema (HAE) in Pediatric Patients and Caregivers

Protocol No.: GMA-003

WCG IRB Protocol 20244649

Investigator: Nicole Garberg

777 Canal View Blvd

Suite 1400

Rochester, New York 14623

United States

STUDY-RELATED

PHONE NUMBER(S): 585-582-5145 (24 hours)

TAKING PART IS YOUR CHOICE

You can choose to join this study or not. If you start and then decide to stop, that’s okay too. Your choice won’t get you in trouble or take away any benefits you have.

If you have any questions or worries, or if you think this study has hurt you, talk to the research team. Their phone numbers are in this document.

WHO WE ARE

KJT Group is a company in the United States that does research. We are doing this study to help a medicine company learn more about what it’s like for people like you to live with HAE. We need to collect some information to make sure you can join an online discussion group. Before we start, we need you to agree to take part. This form will tell you how we will use your personal information.

WHAT YOU’LL DO

If you join, you’ll be part of an online discussion. You’ll need to do some activities for about 20 minutes each day for 5 days (about 100 minutes total). These activities could be answering questions, voting in polls, or doing creative things like telling a story. You can also talk with other people in the group and comment on their answers.

If you qualify, you will be paid for joining. You will receive $50 per day of participation (up to $250).

Your identity will be private and won’t be shared with the Sponsor. The sponsor will not know who you are.

RESEARCH RESULTS

The results of this study might be published in science magazines or talked about at medical meetings. All results will be shown in a way that no one can tell who said what.

RISKS

You might feel uncomfortable answering some questions. We will keep your information private as much as we can, but we can’t promise total secrecy.

BENEFITS

You won’t get any direct benefits from joining this study. But the information we learn might help other patients or caregivers in the future.

This study is not a treatment, and you don’t have to join if you don’t want to.

QUESTIONS OR PROBLEMS

If you have any questions or problems, or if you think this study has hurt you, you can talk to the research team at compliance@kjtgroup.com or 585-582-5045 (24 hours).

INDEPENDENT REVIEW

This research is being checked by WCG IRB, a group of people who review research studies. You can talk to them at 855-818-2289 or researchquestions@wcgirb.com if:

You have questions, worries, or complaints that the research team hasn’t answered.

You can’t reach the research team.

You want to talk to someone else about the research.

You have questions about your rights as a person in this study.

USING YOUR PERSONAL INFORMATION

By agreeing to join, you let us use your personal information for:

Research for KJT Group and the Sponsor.

Giving research results to the Sponsor.

Oversight by the IRB.

General administrative activities.

Following legal rules.

If we want to use your information for a new reason, we will ask you first.

You also agree that:

Your information will be stored on safe computers in the United States.

We might collect details like your date of birth, medical diagnoses, treatment information, dates of medical service, health insurance information, sex, household income, education level, and job status.

We might need to report any bad events mentioned in your answers. This won’t affect your payment.

We will remove your personal information 12 months after the study ends.

You can ask to see, change, limit, or erase your data anytime.

Joining is your choice, and you can stop anytime.

Our Privacy Policy explains how we protect your data.

AGREEING TO JOIN

By clicking the forward arrow, you agree that:

You have read this information and understand how KJT Group will use your personal information.
You agree to let KJT Group use your personal information. You understand that you can change your mind and withdraw your consent for future use by contacting compliance@kjtgroup.com, but this won’t affect any past use.