What does your participation in this data cooperative mean?

For the purpose of this data cooperative, “member” refers to the person diagnosed with Congenital Heart Defects (CHD). “You” refers to the person completing the survey or form. “You” may be the member or a family-member, caregiver, or legal guardian of the member.

When joining The Co-Op @ HeartWorks, you will be asked to provide the contact information, medical survey information, electronic health record, and possibly other information about the member. Participation is voluntary, and you may withdraw at any time.

Below we offer more details about what information we are collecting, why we are collecting the information, how it might be used, the possible benefits and risks of joining the data cooperative and more. If you have any questions, please contact Clinton Hagen / TheCoOp@WeBuildHearts.org .

What is a data cooperative?

A data cooperative is a database that stores the names, medical information, contact information and some additional information (e.g., age, sex, race/ethnicity) about people living Congenital Heart Defects. It also provides the members with an active voice in the research important to their care if they choose.

What a data cooperative is not?

A data cooperative is not a business (i.e. cooperative association), it is a research study where members share in the benefits of research. There is no ownership or expected financial return to anyone who becomes a member in The Co-Op @ HeartWorks.

What is the purpose of a data cooperative?

A data cooperative provides a mechanism for members and researchers to collaborate, where both have prospect of benefit. Members can donate their data to help researchers learn more about CHD. Members can also inform researchers about the topics important to their health. Researchers can quickly identify people living with CHD who are willing to participate in research studies. Researchers who are interested in recruiting people with CHD can contact our data cooperative. We will contact the members about the study.

What are the benefits of joining a data cooperative?

The benefit of joining a data cooperative is to give members an active voice in the research intended to affect them. Data donated by data cooperative members will increase knowledge about signs and symptoms, progression (natural history) of CHD, learn more about quality of life, and potentially discover treatment options and a cure.

Who can join the data cooperative?

People diagnosed at any time in their life with CHD can contribute information for the data cooperative.

Patients with CHD and over the age of 18 (who are fully competent to enter into a legal agreement) are eligible to join the data cooperative. Otherwise, the parent or legal guardian must answer the data cooperative questions for the patient to join.

Family members of deceased CHD individuals will be allowed to create accounts within The Co-Op @ HeartWorks and enter data of the deceased individual. These members will have the opportunity to donate all the same data as other members. However, will not need to update their information after the initial data donation.

Will I be expected to update the information or provide additional information in the future?

The Co-Op @ HeartWorks is most valuable for scientific research when it is kept up to date and you will be asked to update your profile and information. We will send out notifications annually to remind you. You can also update the information whenever there is a change in contact information. We may also reach out to you if additional information or clarification is needed.

Where will the data be stored?

We value and respect your privacy. All the information you provide to The Co-Op @ HeartWorks will be stored in The Matrix database, which is rigorously controlled for physical and electronic threats.

Who will have access to the information in data cooperative?

The designated data cooperative staff will have access to the information provided in the data cooperative. HeartWorks Inc. may collaborate with other researchers but will only provide de-identified data in those cases. Meaning, fields such as your name and date or birth (along with other identifying information) will not be provided to anyone without your prior written consent, unless otherwise required by law.

What are the risks of registering?

There is minimal risk in taking part in The Co-Op @ HeartWorks. The Co-Op @ HeartWorks includes questions that can be sensitive. You do not have to share any information you do not wish to. Another unlikely risk is potential breaches in the computer system. In the event of a breach, all data cooperative participants will be notified.

I want to participate in a clinical trial. If I register, is this guaranteed?

Although one of the main goals of The Co-Op @ HeartWorks is to make it easier for members to participate in research, there is no guarantee that any member will be eligible and/or selected for a trial. When we learn about clinical trials for CHD, we will contact you if you are eligible, based on the information you have provided in The Co-Op @ HeartWorks. Please note that research protocols determine eligibility criteria, and not everyone is able to participate in research studies.

Should I join the data cooperative if I am not interested in participating in a clinical trial?

Even though you may not be interested in participating in a clinical trial, you may still want to join The Co-Op @ HeartWorks. We can send you information about new treatment or other disease-related updates.

Can I withdraw if I change my mind?

Because your participation with The Co-Op @ HeartWorks is completely voluntary, you can withdraw at any time. Should you decide to withdraw, you can simply contact our registry coordinator by emailing Matrix Support at matrixsupport@acrossmatrix.com. When you contact us, you can choose to just stop participating or to also remove your data from the data cooperative.

Will it cost me to join or be part of the Co-Op @ HeartWorks?

No. There are no costs associated with joining or being part of The Co-Op @ HeartWorks.

Who should I contact if I have any questions?

If you have any questions, please contact The Co-Op @ HeartWorks at TheCoOp@WeBuildHearts.org .

If you have questions about the joining The Co-Op @ HeartWorks or about participation in the Co-Op @ HeartWorks, please contact the registry at TheCoOp@WeBuildHearts.org