Draft guidelines on the ethics of clinical trials involving children have been put out for public consultation by the European Commission and the European Medicines Agency.
The guidelines have been drawn up in line with EU legislation on the conduct of good clinical practice in trials of medicinal products for human use. This legislation specifically called for criteria to be agreed to protect children.
The guidelines are directed at sponsors of clinical trials, ethics committees, and investigators of clinical trials involving children of all ages (from birth to 18 years of age). They emphasise that trials should be carried out under conditions that provide the best possible protection for this vulnerable population, while recognising that children have the right to benefit from research.
The guidelines set out the criteria that those conducting trials must follow when seeking the informed consent of parents or legal representatives and, depending on their maturity, the assent of children themselves. Consent should always be obtained before potential participants in a trial are approached, the guidelines say, and separate forms for children should be used that provide age appropriate information.
Undue pressure is prohibited, and financial inducements to enter a trial are banned, although adults can be compensated for their time and expenses.
The guidelines advise that consent or assent is a dynamic, continuous process. “It must be sought at the beginning and must be maintained during the trial.”
In long term trials particular attention should be paid to checking that assent is still being given by children as they mature. And children should not incur any disadvantages in medical care if consent is withdrawn during the trial.
The guidelines note that the use of placebo is more restricted in children than in adults, because children cannot give their consent. “Placebo must not be used when it means withholding effective treatment, particularly for serious and life threatening conditions.” However, if those conducting a trial want a placebo to be used, it must be given in addition to standard care.
Where issues emerge during a trial that could present a potential conflict between the interests of the child and research, the welfare of the child should always prevail.
Unnecessary replication of trials is considered unethical. To prevent similar initiatives with similar aims the guidelines call for systematic registration of all paediatric clinical trials. All information and results gained during a study, even if unfavourable, should be made available to researchers and the public.
An annex sets out a checklist of the 24 issues that trials involving children must take into consideration. These range from the justification for the trial and an assessment of the balance between potential risks and benefits to statistical methods and insurance cover for participants.
The consultation period runs until January.
The draft guidelines will be available soon at http://emea.europa.eu.