Health research in children: What parents need to know
Health research is the study of what makes us healthy or unhealthy. It can help us understand why some children become sick, and help to improve their health.
Research gives health care providers the best information possible to prevent illness and to treat children who are sick.
How do people get asked to take part in research?
Your child may be asked to take part in research in a number of ways:
A researcher may contact you directly because of a specific condition that your child has. To respect your privacy, this request will almost always come from someone who already knows you.
You may learn of research opportunities through newsletters, bulletin boards, phone calls or other media.
No matter how you are asked, it is always your child’s or a family’s choice whether to take part in health research.
Who sets the rules about research?
All researchers in Canada must follow Canadian rules on human research. Most human research in Canada must be approved by a research ethics board. Their job is to make sure the research is done in a way that respects and protects the rights of the children and youth involved in the study.
The research ethics board is made up of doctors, scientists, lawyers, ethicists (people trained in ethics) and members of the public. All hospitals and universities use research ethics boards.
What are my child’s rights in health research?
You and your child do not have to take part in health research. It is your choice.
You will be told about all the possible benefits and risks of taking part in the research. This will help you decide whether to take part.
You will be asked for permission (consent) for your child to take part, if your child cannot give his own consent.
Your child will be asked for her permission (assent) if she is old enough to understand parts of the research.
Your child’s health care will not be affected if you decide not to take part.
You can decide to stop taking part in the research at any time.
Your child has a right to confidentiality. The researcher will keep your child’s personal research information private.
You and your child have a right to know about new information that may change your mind about taking part in the research.
You and your child have a right to be offered a summary of the results of the research.
You will be provided with a copy of a consent form or information letter for your records.
What does ‘consent’ and ‘assent’ mean?
Consent is the permission a participant gives to take part in research. Older children or youth may give their own consent if they are mature enough to fully understand the research. In the case of younger children or those who cannot fully understand the research, the parent or guardian may give consent. Local laws may require children to reach a minimum age before they can provide consent. There are 3 things needed for consent to be valid:
You must make the decision freely. It is entirely your choice.
You must have enough information to make a choice.
You must understand the information.
Assent is an agreement to take part in research when your child cannot give full consent. Children often understand some, but not all parts of a research study. Assent is how they can say they agree to take part, as much as they understand.
What should I do if I have questions?
You or your child may have questions about the research you are being asked to take part in. You should ask the research team to explain any issues.
If you have more questions, speak with a health care provider you trust, such as your doctor, or someone from the research ethics board that approved the study. Most hospitals have information about their research ethics board on their website, or you can contact your hospital’s general inquiry line for more information.