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If you are considering enrolling yourself or your child in a research program, we want you to have as much knowledge about research as possible. Here, you'll find information on medical research studies and children, learn about the rights of participants in a study and what you should know and what questions to ask before you enroll yourself or your child in a research study. Like life, information can sometimes seem complicated. We're here to help keep it as simple as possible and keep the focus on the research that matters most, yours.
The REACH program at Cook Children's Medical Center works with children and their families to prevent premature heart disease and diabetes. Treatments include changes in lifestyle and, when necessary, medications. First, each child undergoes a complete checkup, looking for medical reasons that can cause weight gain, high blood pressure, high blood fats, and other problems that may result in premature heart disease as children grow into adulthood. When appropriate, other tests may be preformed, such as checking your child's fitness level, ability to exercise and need for a special diet. Families are offered education and coaching to help make the changes necessary to improve your child's health.
Depending on your child's diagnosis, you, your child and family members will take one or more classes between each follow-up visit. Each class is one hour in length. Classes offered include:
If you are considering taking part in a research study or allowing your child to take part in a research study, you should know that you and/or your child have certain rights. Please note that the references to “you” below refer to:
These rights are summarized below:
You are likely to be presented with an informed consent form that has been approved by the Cook Children's Institutional Review Board (IRB). An IRB is made up of a group of people that work to ensure that your rights as a research participant are respected and protected. This document is intended to provide you with relevant information about the research study which should assist you in deciding whether or not you want to participate in it. Generally, informed consent will involve a he following:
Please refrain from signing the consent form and agreeing to take part in the research study until all of your questions have been answered to your satisfaction. Signing the form does not waive any of your legal rights or prevent you from withdrawing from the study at a later time. You will be given a copy of the consent form.
Participation in a research study is voluntary. You are free to decline to participate . You may also choose to participate and later decide to withdraw from the study. Withdrawing from the study may occur at any time, however in some cases stopping participation in the study will need to be done in a manner safest for you. Your decisions about participation in the study will not impact your ability to receive other treatment. For example, if you enroll in a study and later decided to stop participating in it, you will still be able to receive the same standard (regular) medical care for your health condition from Cook Children's, just as before.
If you have questions or concerns at any time during or after your participation in a research study, you may contact either the Principal Investigator (listed on page 1 of your consent form) or the Cook Children's Health Care System Human Research Protection Program (CCHCS HRPP) at 682-885-1744. The CCHCS HRPP is responsible for oversight of all research studies that are conducted under the auspices of CCHCS.
Thank you so much for your interest in participating in a research program. As a research volunteer, you have the opportunity to contribute to the health and well-being of children and even adults. In some cases, you may even be helping to find cures that will save lives in the future. To help you decide if becoming a research volunteer is the right decision for you, your child and your family, please read the following brochure from the U.S. Department of Health & Human Services which explains why research is important and what questions research participants should ask before agreeing to take part in a research study:
Becoming A Research Volunteer: It's Your Decision
If you have questions or concerns, we can help. To speak to a member of our HI team, please contact CookChildrensResearch@cookchildrens.org or call 682-885-2103.
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