Taking Part in Clinical Research

What is clinical research? 

Clinical research is scientific research that includes people. Scientists do it to learn more about diseases. They also test new medical treatments or combinations of treatments that doctors already use. The goal is to find new and better treatments that help patients.

Clinical research is also called a clinical trial, a research study, or just a study. 

Clinical research volunteers

All the people taking part in clinical research are volunteers. If your child is eligible, they can take part in clinical research studies if you agree.

Some reasons for taking part in clinical research include: 

• Helping learn about disease
• Helping find new treatments
• Getting a treatment that is not available to the public yet
• Getting a new treatment because the usual treatment is not working well

Differences between clinical research and regular medical treatment

Clinical research often includes medical treatment. But it is not the same as regular medical treatment for your child’s illness.

Every clinical research study has a plan that scientists must follow closely. The plan is sometimes called a protocol.

Researchers cannot change the treatment for each volunteer. This is one way that clinical research is different from other types of treatment. Medical treatment is the specific treatment a doctor recommends for your child. Doctors know the benefits of the treatment. And they can change the treatment plan just for your child. 

Your child might have both medical treatment and clinical research treatment. The medical treatment is known, but the clinical research treatment is new. It is not fully tested or approved yet.

You can also choose for your child to have just medical treatment or just clinical research treatment. 

Clinical research oversight

Many people work together to make sure scientists do clinical research safely and correctly. A group called an Institutional Review Board reviews every new clinical research study at a hospital or medical school before the study starts.

The Institutional Review Board, or IRB, includes:

• Scientists
• Doctors
• Other health care professionals
• People from the community

They consider the benefits and risks of the research study. They can approve the study or ask scientists to make changes. The IRB helps make sure the patients who volunteer to be in a clinical research study are protected. 

How to take part in clinical research

If you are interested in having your child take part in clinical research, your first step is to meet with someone from the clinical research team. They will explain the study before you decide. They will use words you and your child can understand.

The research team member will also encourage you to ask questions, so you and your child know exactly what to expect. 

Here are the main things the research team will explain: 

• Why scientists are doing the study
• What will happen in the study:
  • New tests
  • Treatments
  • Procedures
• How long the study will last
• The possible benefits of taking part in the study
• Possible risks, side effects, or expected discomforts
• Your child's other treatment options
• How the study will protect your privacy. 
• Who to contact with questions

The research team member will also explain that taking part in the study is your choice.

You do not lose any rights to treatment if your child does not take part. You may also take your child out of the study at any time. If you do, you can ask for regular medical treatment. 

Learn more about questions to ask the research team.

Consent for clinical research

The process of understanding the research study and choosing to take part is called informed consent. Depending on where you live, where the study takes place, and your child’s age, you or your child may be asked to sign a consent form for the study.

If you want your child to stop taking part in clinical research, they can do so. You can take your child out of a research study at any time, for any reason.

If your child is older than 18, they can stop taking part on their own.

If you want to stop taking part in clinical research, talk to your child's doctor first about other options or treatments.