Clinical Trials in Children with Impaired Mental Capacity

Provided By:

PRA Health Sciences

September 10, 2018

In the majority of clinical trials we undertake, the consent process is fairly straightforward; however, complex situations do arise. Pediatric clinical trials present unique challenges, as do those in patients who lack legal competence. In the instance of a mentally impaired child, it is important to determine the best approach for obtaining consent and assent as early as possible in the study planning process.

This whitepaper examines:
• The complex process of competency assessment
• Challenges in testing competence
• The evolution of competence (eg, the developing competence of the adolescent)
• Working with children based on their level of understanding rather than their age
• The proxy consent process for patients who are not legally competent

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