HLHS

The Todd and Karen Wanek Family Program for Hypoplastic Left Heart Syndrome (HLHS) is a research program with the goal of delaying or preventing heart failure for individuals with HLHS.

To learn more or to participate, please visit our website or contact HLHS@mayo.edu.

Follow the program on Facebook at Mayo Clinic HLHS, on Twitter @MayoClinicHLHS, and on Instagram at MayoClinicHLHS.

PUBLIC PAGE
Dec 9, 2019

Your Guide to Children in Research

By Brianna N. Tranby, @briannatranby

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Demystifying Clinical Trials Series – Part 4
The research world can seem confusing or overwhelming at times. Our ongoing series is designed to give you the information you need and help answer common questions. Part 4 in this series focuses on research involving children, and the special regulations that are in place to protect them. You can find our previous posts here: (Part 1, Part 2, Part 3).

 

The Importance of Children in Research

Clinical research is the formal process through which doctors and scientists study diseases and develop better treatments. However, most diseases that get studied – and most drugs and doses that get developed – are only tested using adults.

But children aren’t just little adults. Their bodies grow and change in ways that are very different from adults. For example, new research is showing that infants’ heart cells have a much greater potential for regeneration than adults’ hearts. So it’s vital that researchers design studies specifically for children.

“Children need clinical trials that focus on them, as medical treatments and approaches often differ for children. For example, children may need lower doses of certain medicines or smaller medical devices. A child’s stage of development also can affect how safe a treatment is or how well it works.” - National Heart, Lung, and Blood Institute (2019)

 

Protections for Children

Children aren’t just little adult, and the Department of Health & Human Services has special legal regulations to ensure that children (and pregnant women) are kept safe. For example, these rules require an Institutional Review Board (IRB), the impartial group that reviews and approves research studies, to look more closely at research involving kids and evaluate the potential risks and benefits more closely. There are also special requirements for both parents and children to agree to participate. This is called giving “consent” and “assent”.

Consent: The process that gives a research participant all the information s/he needs to make an informed decision about whether to participate in a study.

Assent: An additional process for children ages 7-17 to make sure s/he understands the study and is comfortable participating. Most institutions have a separate document that explains the study in kid-friendly language, and the research team and parents will work together to ensure the child understands.

In most cases, a child under the age of 18 cannot sign a legal consent form agreeing to participate in a research study. However, they can participate in research with their parents’ permission.

 

The Rights of Patients and Parents

It’s important to note that while “assent” is not a legal requirement, most IRBs require it for research involving children. If assent is required for participation in a study, the parents must give legal consent and the child must give assent. If a child declines to give assent, they are not allowed to participate in the study even if the parents give legal consent.

In all research, at least one parent must give consent for their child to participate. In some studies, both parents must give consent. Parents have the same rights as the child to understand the study completely, ask questions, get results of the study – and say “no”.

Some good questions to ask before considering participating in research include:

Why am I (or my child) eligible for this study? Does my doctor recommend this study for me?
What are the possible risks? When will we be told about the results?
What are the potential benefits? Will the tests hurt?
How does this study compare to the normal standard of care? Am I eligible for other studies?
Are there extra tests or visits needed for this study? Can we talk to a doctor who is not a part of this study?

Connecting with Other Parents

Some studies now have websites or social media pages to provide more information and allow participants to connect with each other and share their experiences. For example, the Mayo Clinic HLHS Program has a private Facebook group for families who have joined our stem cell trial. The National Institutes of Health has a Facebook page “to increase understanding of research in kids and help families make informed decisions about participating in a pediatric study.” In addition, most physician researchers keep a list of previous study participants who are willing to share their experiences with new patients, and you can ask to talk to them.

“We felt very passionate about getting involved with the study right away because there was someone before our son who paved the way to get him to where he was. So we felt very connected to that, and it was important for us to make sure that he was a part of this study.” – Staci Strand, 2019 Feel the Beat Panel Guest

We are grateful to the families who are involved in our research work! This year’s Feel the Beat event featured a panel discussion with three families whose children participated in our Phase I stem cell delivery clinical trial. You can watch their conversation – and hear Dr. Tim Nelson discuss our current and future research – on our Facebook page.

 


Meet other people talking about HLHS or CHD on Mayo Clinic Connect – an online community designed to help patients and families connect with each other.  Our community is a safe space to share experiences, ask questions, find answers, and exchange support.  The discussion groups and topic pages are moderated to ensure that all posts are respectful, and Mayo Clinic Connect never sells or shares posted information to third parties.  Here are some you might like to follow:


The Todd and Karen Wanek Family Program for Hypoplastic Left Heart Syndrome (HLHS) is a collaborative network of specialists bonded by the vision of finding solutions for individuals affected by congenital heart defects including HLHS. Our specialized team is addressing the various aspects of these defects by using research and clinical strategies ranging from basic science to diagnostic imaging to regenerative therapies. Email us at HLHS@mayo.edu to learn more.

 

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