Children’s Health Queensland and our research partners are committed to finding new ways to prevent, diagnose, treat or manage childhood diseases and conditions so we can make a real and enduring difference to the care and health outcomes of all children and families.
You can help us achieve our vision by taking part in our studies at the Queensland Children’s Hospital, the Centre for Children’s Health Research and in the community.
What is clinical research?
Clinical research and studies play a vital part in telling us more about a disease or health issue, so we can come up with new and better ways to care for sick and injured children. A study is often the only way we can test a new medication, approach to care or treatment to see if it helps solve a problem. Clinical research contributes to the advancement medical knowledge and the findings from a study can change the way children and young people are cared for across Australia and the world.
Involvement in clinical research can range from something as simple as an interview or questionnaire or giving researchers permission to look at your child’s medical history, to providing blood or urine tests, or testing a new medicine or medical treatment (this called a clinical trial – see below). The level of involvement depends on what the researchers are investigating. Sometimes researchers may also ask permission to use leftover tissue or blood that is collected from your child as part of their routine medical care.
All research must be approved by the Children’s Health Queensland Human Research Ethics Committee which is responsible for assessing the ethical principles of research and to protect the welfare and rights of participants in research.
A clinical trial is a research study where human volunteers receive a new medical intervention in a hospital, research centre or other clinical environment to test if it is safe and effective. Clinical trials can involve research into:
- New medicines
- New drugs/medicines
- Medical treatments and procedures
- Surgical procedures
- Medical devices
- Educational interventions
- Psychological or behavioural counselling
Clinical trials are conducted only after the drug or intervention has been tested for safety in a non-clinical setting (e.g. a laboratory), and an ethics committee has approved the trial.
Before agreeing to your child participating in a clinical trial, it is important for you to know all important facts and details about the trial so you can decide if it is right for your child. For example, you will want to know the study’s purpose, duration, required procedures and appointments, and the key contacts. Potential known risks and the benefits to your child and family must be clearly explained to you before you agree to participate. This is called informed consent.
The information you need is usually given to you in a clear, easy-to-read, Patient Information Statement provided by the people conducting the trial.
You will be given the opportunity to ask your doctor or other clinician any questions about the trial. You should ask about anything that is not clear to you. Before being enrolled in a clinical trial, you will be asked to sign an informed consent form.
Participation in a clinical trial is voluntary. Only you can decide what is best for your child. No matter what you decide, your child will continue to receive the same high-quality medical care from his or her doctors and nurses. There is no right or wrong decision when it comes to enrolling in a clinical trial.
You also have the right to change your mind at any time. Should you decide to withdraw your child from a clinical trial, he or she will continue to be treated by his or her doctor, without prejudice.
Frequently asked questions
By taking part in a clinical research trial, your child is helping to improve medical knowledge about their disease or condition and how it is treated, and in some cases, it may improve their health and that of other children with the same disease or condition.
There may be some risks associated with your child’s participation in a clinical trial. New drug, device or procedures are always tested first in a non-clinical setting, and may have been tested on animals to determine how much risk might be involved. Some side effects may be known, while others are not. Each child may react differently to a medication or procedure.
Your child may also have to come off his or her usual medication to test the effectiveness of the new medication being tested and there could be risks associated with that.
All known risks will be described in a document called an ‘informed consent’ form. Researchers will provide this to you before you decide to take part in a clinical trial and answer any questions you have about the risks.
Clinical trials are generally sponsored by government agencies, universities, medical centres, pharmaceutical companies and device manufacturers. There should be no cost to your family.
Yes – clinical trials are carefully regulated and are governed by clearly defined legal and ethical codes.