Participate in a Clinical Research Study
Research studies are one of the best ways to help find cures and better treatments for diseases and other conditions. Treating children is different from treating adults, and has its own set of challenges, research, and results. Research studies test new medicines, treatments, or devices and equipment specifically with pediatric patients in mind. Clinical research leads to developments which help doctors all over the world provide cutting-edge care and treatments for children.
View this video from the National Heart, Lung, and Blood Institute to learn more about the critical importance of participating in clinical research studies.
Other Names for Research Studies:
- Clinical Experiments
- Clinical Research
- Clinical Research Trials
- Clinical Studies
- Clinical Tests
- Clinical Trials
- Experimental Studies
- Experimental Tests
- Experimental Trials
- Experiments
- Medical research
- Research
- Research Experiments
- Research Tests
- Test Studies
- Trials
There is a lot to think about when deciding whether to participate in a research study, and you should ask a lot of questions before making your decision. Below are some of the questions you may want to ask.
Frequently Asked Questions about Clinical Research
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Will your health insurance pay for the cost of the research study?
Will your health insurance pay for the cost of the research study?
Not always. Ask the doctor or researcher and your insurance company if you will need to pay for any of the research study costs.
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What happens during research studies of new medicines?
What happens during research studies of new medicines?
First, a few volunteers test the safety of the medicine and how much should be taken. This is called a Phase 1 study. In Phase 2 and 3 studies, larger groups of people test the long term safety of the medicine and how well it works. Ask the doctor or researcher which Phase the study is in.
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Will the study help you if you get a placebo or substitute?
Will the study help you if you get a placebo or substitute?
Probably not, but your participation can result in information that will help others.
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Can the research study make your child’s condition worse?
Can the research study make your child’s condition worse?
Your child’s safety is our main concern at Children’s Hospital of San Antonio. The researcher or doctor will be monitoring your child throughout the research study. Ask the doctor or researcher what could happen during the study and if there are any risks involved. Ask when and how you will be told if your child’s condition worsens. Ask for a copy of the study “protocol” or plan. Ask about what is known about side effects of the medicine, treatment, device or equipment. Look for side effects while you are in the study. Taking part in research is always voluntary, even after the study has started, and your child can withdraw at any time.
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What is "informed consent?"
What is "informed consent?"
This means that the doctor or researcher explained to you about the research study and its risks. It also means that you understand what you were told. You will be asked to sign an informed consent form, which explains all of the benefits and risks of the study. Take the form home and read it with your family before you decide if you want to sign it.
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What should you do if you don't understand the informed consent form or study protocol?
What should you do if you don't understand the informed consent form or study protocol?
Ask your doctor or the researcher to explain. Don’t sign the informed consent form until you fully understand the study and all of your questions are answered. If English is not your primary language, or hearing impaired, Children’s Hospital of San Antonio can provide interpreters or sign language professionals to assist in this process. You can also ask your doctor or the researcher to recommend a patient “advocate.” This person helps patients understand their treatment and their choices in treatment.
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Who can you call if you have concerns about the research study?
Who can you call if you have concerns about the research study?
Many research studies are reviewed by an Institutional Review Board. This board makes sure that the study is safe and ethical. It can also stop a study if there is a concern about safety. If the study is paid for by the federal government it must be registered with the Office of Human Research Protections and listed on the www.clinicaltrials.gov website. The contact number for the Researcher, or Principal Investigator, is always included in the Informed Consent form.
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Other questions to ask the doctor or researcher
Other questions to ask the doctor or researcher
- What is the purpose of the research study?
- What tests or treatments will be used in the study?
- How long will the study last?
- Will the new treatment help your child more than the regular treatment?
- Will you be able to continue seeing your own doctor?
- Will the study cost you any money?
- Will you be paid to participate in the study?
- Does anyone else receive money when you participate in the study?
- Who pays for the research study to be carried out?
- What happens if you decide not to take part in the study?
- Could your child get a “placebo” or a substitute?
- Has anyone reported any bad effects?
- How serious were they?
- Who pays for your care if your child is injured during the study?
- Can your child stop participating in the study if you change your mind?
- Is there any danger to your child if you stop participating?
- What will happen to your child after the study?
- Will you be told the results of the study?
- Who could benefit financially from the results of the study?
- Does the doctor or researcher personally benefit if you participate?
- Are there any patient advocates you can talk to? The advocate should not be employed by the clinic or laboratory that is doing the research study.