Clinical research trial subjects, or parents and children who agree to take part in a clinical trial, are protected by
- ethical and legal codes
- federal regulations
- built in safeguards
You must give your written consent before your child’s participation in the clinical trial can begin. In some cases, your child will also have to give his or her own separate consent, or assent, as well.
The process of informed consent lets you and your child know exactly what is going to happen during the trial including information like how long the trial will last, how many visits will be involved, what kind of procedures and testing will take place. The study team will answer any questions before you give your consent and begin the clinical trial.
As a parent, you must be comfortable with what your child will be doing in a study. Even with efforts to make your child safe, remember there may still be risks. Make sure you understand the possible risks and benefits and understand how they apply to your child.
PROCESS OF INFORMED CONSENT AND ASSENT
Deciding to allow your child to participate in a clinical trial is completely up to you. No one can force you to or make you feel bad if you decide not to participate.
The informed consent process is about making your own decision, whether yes or no. Every parent has to make the individual decision and consider what is right for their child and their family. Your child’s medical care and treatment will not change should you decide that you do not want your child to participate in the clinical trial.
The informed consent form is not a contract. If you give your consent and your child is enrolled in a clinical trial and you feel you need to leave, you have every right to do so. You may leave the study at any time, for any reason. And again, your child’s medical care and treatment will not change because you choose to withdraw your child from the clinical trial.
Informed consent is the process of:
- learning the important facts about a clinical trial
- deciding whether or not your child will participate
This process continues throughout the clinical trial, providing ongoing information about the trial to you and your child.
The Informed Consent Form lets you know:
- what the researcher is trying to find out in the clinical trial
- what you and your child will be asked to do during the trial
- how long the trial will last
- possible risks to your child
- possible benefits to your child
- who to contact from the clinical trial team if you have questions
Remember to read the entire form, even though some can be very long. Take your time. Write down questions you have, note parts that you would like more information about and discuss these issues with your clinical trial team before deciding whether on not to participate in the clinical trial.
ASSENT
In most states, children over a certain age must be part of the decision of whether or not they will participate in a clinical trial. As part of the informed consent process, the child is given an informed assent form that functions much like the parent informed consent form.
The assent form gives the child basic information about the clinical trial, what they will be asked to do, how long it will go on, what the possible risks and benefits to them are. The child will also be given the opportunity to discuss any questions or concerns with the clinical trial team (PDF) before making his or her decision.
THE CLINICAL TRIAL TEAM
Parents should be familiar and comfortable with the clinical trial team. The team is prepared to answer any and all questions throughout the clinical trial and not just at the beginning. It is important to know who to call for general questions related to the trial and who to call in an emergency:
- Principal Investigator (PI): is a medical doctor and is responsible for the entire study at that location. He or she oversees the care of all the participants while they are in the study. The PI can sometimes be your child’s regular doctor.
- Research Nurse(s): can be responsible for recruiting people to participate in the clinical trial. They also help to determine whether or not your child is eligible to participate and can sometimes provide treatment. Research nurses can also collect trial information or data and follow up with participants.
- Research Coordinator(s): make sure the study runs smoothly. Coordinators understand all parts of the study and make sure the clinical trial staff has the right equipment, medication or devices needed to run the study.
The clinical trial study team must follow a study protocol, or plan, which lists exactly what researchers will do in the trial. An Institutional Review Board or IRB that monitors the safety of the clinical trial approves the protocol and informed consent/assent forms.
INSTITUTIONAL REVIEW BOARD (IRB)
An Institutional Review Board or IRB is an independent group of health care providers, experts in the field of the clinical trial, and community members who help to ensure that clinical trials are fair and safe. Before a clinical trial can begin, it must have the approval of an IRB.
The IRB is responsible for
- approving and reviewing the detailed study plan, or protocol
- monitoring the trial as long as it continues
- reviewing and approving study subject informed consent/assent forms
Many larger hospitals and universities have their own in-house IRBs that approve and monitor all studies that take place within the hospital. Smaller hospitals and private doctor’s offices or outpatient clinics can use the services of a regional IRB. Both types of IRBs are qualified to oversee the safety of clinical trial subject safety.