Key Considerations for Consent and Assent in Pediatric Clinical Trials

Posted by Paddy Wall on Jul 6, 2020 9:22:59 AM

It was not always the case that society believed patients should know and understand the risks of any treatment they received before taking that treatment. In fact, in 500 BCE, the Hippocratic Oath explicitly stated that physicians should conceal information from patients in order to shelter them from fear.  

Denying information about risk to patients remained the norm until the twentieth century, when the US Army Yellow Fever Commission used consent forms with Spanish volunteers in 1900. Since that time, the practice of attaining informed consent has evolved. In order to provide informed consent, adults in clinical trials must acknowledge that they understand what taking part in the trial involves, that participating in a clinical trial is different from seeing their regular healthcare provider, that they may potentially be exposed to risk, and that they may receive a placebo instead of an active study drug and thus gain no clinical benefit from taking part in the trial. 

What about children in clinical trials? They cannot legally give informed consent because they have not reached the official age of maturityYet, without testing on children, a drug can be used only in an off-label capacity, a practice that gives rise to a host of unknowns, including:  

  • Is the dosing accurate for a child? 
  • Will the drug interfere developmentally with a still-growing child? 
  • Will an acceptable side-effect profile in adults be similarly acceptable in children? 

 Investigators and sponsors must balance the risks with the benefits in terms of clinical trials that include minors.  

Consent vs. Assent: What It Means to Patients and Investigators 

Children can give assent, meaning they can agree to take part in a clinical trial, which is very different than consent. In the United States, pediatric assent requires 

  • Both parents giving permission, unless one parent is deceased, unknown, or mentally incapable of providing such permission.  
  • The team clearly explaining the trial to the child, using language the child understands 
  • Encouraging the child to ask and talk about the trial with their family and the researchers 

 It may take several sessions before the child is informed enough to assent to taking part in the trial.  

Different European countries have different standards for pediatric consent, with varied ages of when a child can assent, whether both parents must give consent or not, and other factors. 


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Considerations for Sponsors and Investigators 

What do investigators and sponsors need to keep in mind when enrolling children in a trial? Ensuring that the parents and the child understand what will happen in the study is very important. Using developmentally appropriate language to communicate with the child should be top of mind. A 2016 paper in the journal Pediatrics breaks down key aspects of assent: 

  • Helping the child achieve appropriate awareness of his or her condition 
  • Clearly explaining what the trial will involve, including tests, procedures, and drug administration  
  • Clinically assessing the child’s level of comprehension 
  • Asking for and receiving the child’s informed assent 

It’s also vitally important that investigators recognize children’s autonomy. Respectful, compassionate consideration of the child’s judgment in reference to his or her own health does a valuable service to both research and the children themselves. Dr. William Bartholome, who presented the first draft of pediatric decision-making protocols to the American Academy of Pediatrics in 1985noted that children are in the process of becoming "intelligent, observant, capable, and responsible persons." 

Investigators continually strive to communicate difficult medical information to patients, and they must work even harder to communicate to children. A patient-centric approach has been found to be key. This includes adaptable, simplified material that engages young patients, and time enough for them to discuss and come to understand the material.  

Although pediatric patients cannot grant informed consent directly, they are patients and as such extremely important active participants in their own healthcare. 

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Topics: Informed Consent, Clinial trial sites, Clinical Operations, Clinical Studies, pediatric trials

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