Research Study Participants
Research plays a very important role in medicine around not only the world, but also right here at Cook Children's. We are making great strides in improving the lives of children now and for future generations.
If you are thinking about enrolling yourself or your child in a research study, we want you to have as much information about research as possible.
Here, you will find information about:
- Clinical research studies and children
- Protection for research participants
- The rights of participants in a study
- 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 are here to help keep it as simple as possible and keep the focus on the research that matters most, YOURS.
Children are not little adults. There is a lot of proof that children's growing brains and bodies can respond to medicines and treatments differently than adults respond. The way to get the best treatments for children is through research meant specifically for them.
Research studies contribute to improving children's health outcomes. Vaccines, treatments for children with cancer and other illnesses, and improving care for premature babies are a few examples of how research is helpful.
What is research?
"Clinical research allows me to provide the healthcare of tomorrow for my patients today." -Donald Beam, MD, Medical Director, Hematology/Oncology
Research is the careful study and investigation for the purpose of finding and explaining new information. Research also includes the collecting of data about a topic such as a disease or illness.
Volunteers in research are participants.
Researchers, usually a doctor or a nurse, reach out to possible participants. The researcher gives the participant a consent form, which shares key facts about the research study. You will find out about the consent form in the Participating in Research: Your Rights section below.
Protecting you and your child
The Institutional Review Board (IRB) reviews research done at Cook Children's. An IRB is a group of people tasked with protecting your rights and your child's rights as a research participant. The Cook Children's IRB membership includes, doctors, nurses, chaplains, and community members. The Cook Children's IRB follows all rules and regulations set out by multiple government agencies.
- The U.S. Department of Health and Human Services' (HHS') Office for Human Research Protections (OHRP)
The OHRP helps protect the rights, welfare, and well-being of research participants. They provide direction and supervision to the IRBs, develop educational programs and materials, and offer advice on research-related issues.
- The Food and Drug Administration (FDA)
In the US, the Food and Drug Administration (FDA) provides supervision for research studies that are testing new medicines or medical devices. They check to make sure that the planned studies provide proper informed consent and protection for participants.
Some research studies have a separate group of people to review safety. This group reviews records from the research looking for problems or differences in results among different groups or participants. These results may show that the study causes unknown risks or that the study is showing early benefit to the participants.
Participating in research: your rights
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 word "you" used below means the following:
- Yourself (if you are an adult) and are able to understand and sign the consent form for yourself in order to take part in a research study, or
- Your child (that is younger than 18) and you (as the parent or caregiver) will be providing permission (by signing the consent form) for your child to take part in the research, or
- You are the court appointed legal guardian that may make medical consent decisions for an adult patient that does not have the ability to understand and sign the consent form for him/herself.
A summary of your rights are below.
Informed consent is the process of giving a research study participant all of the facts about a trial. This happens before you agree to take part and during the course of the trial. Informed consent includes details about the treatments and tests you may receive and the benefits and risks they may have. The consent form supplies this information in writing.
Generally, informed consent will include the following:
- Information explaining the purpose of the research
- A description of what you will be asked to do in the study
- How long you will be in the study
- An explanation of any risks involved in the study
- An explanation of any benefits to you or to the general public as a whole
- An explanation of any choices other than participating in the study
- A statement saying if you will be paid for your time for taking part in the study
- The plan for protecting your personal information
- A statement that you may chose not to take part in the research, and you may stop the research at any time
- A statement that if you decide not to take part or stop taking part, you can still get standard, non-research health care from CCHCS
- Contact information is provided if you have any questions about the research study
Get answers to all your questions before agreeing to take part in the research study.
Signing the consent form does not take away any of your legal rights or prevent you from stopping the study later. It is your right to receive a copy of the signed consent form.
Research at Cook Children's
Cook Children's is conducting many different research studies. For more about our research, please click here. For more information about our active studies, click here.
We know that you have many questions when thinking about enrolling a child in a research study. Children and adolescents have questions too. Consider these helpful links for more information: