Informed Consent is a process to make sure that potential participants in clinical trials:
- can ask questions and get answers before, during and after the trial;
- fully understand the nature and purpose of the trial;
- fully understand what the trial will involve;
- are informed about potential benefits to health, risks and inconveniences;
- only agree to take part willingly; and
- remain informed throughout their period of participation.
This process starts when your CF doctor or researcher introduces details of the clinical trial to you. Following initial discussions, you will be given information to take home to read and consider further with family or friends, who may also attend meetings with you. You should feel confident that you have enough information to help you decide whether you want to take part in the trial, and that you have been given enough time to consider all the information and what the trial will mean to you in practical terms, such as extra appointments and tests.
You can’t be entered into a trial without giving your written consent. Where clinical trials involve children the consent process is also different and will be fully explained by the CF doctor or researcher you talk to about the trial, however you can also find out more in the section below, ‘Informed Consent in trials involving babies and children’.
If you decide to take part, you will be given a consent form to sign to say that you understand the information and give your consent willingly – you should retain a copy of this form for your own records.
Informed Consent is an ongoing process throughout your period of participation in a trial. Researchers should continue to provide information, answer your questions and advise if any new relevant information comes to light during the trial. You can reconsider your participation at any point, or even withdraw without the need to give a reason. Your decision must be respected and will not affect your ongoing CF treatment plan.
Trials involving babies and children
Clinical trials are not just for adults. Cystic fibrosis, as you know, affects children from birth and treatment is vital to maintain good health and slow the deterioration. Clinical trials therefore often need to include children or even babies. Children are not just small adults and may react differently to the same medication; it’s not sufficient or effective to simply adapt the dose. As with clinical trials involving adults, trials involving children are very carefully regulated, and approval to include children will only be given if the potential benefits can be shown to outweigh any possible risks.
Some parents can struggle with the decision of whether to enroll their child in a clinical trial, and it is understandable to have concerns. Talking to your child/children openly about research and trials from an early age can make it easier to reach decisions about taking part in research when opportunities arise.
Informed Consent in trials involving babies and children
Obviously, babies and younger children are not able to give Informed Consent, and special consideration is given to the fact that children are less likely than adults (or completely unable) to be able to communicate their experiences of participating in a trial. Talk to your healthcare professional or CF research team about the consent process for including children and babies in research, or look at the detailed information on consent in children from the NHS Health Research Authority.
Older children and teenagers can be asked to provide their agreement to participate. This is called “assent”.