Clinical Trials in Children with Impaired Mental Capacity

Download this resource to learn how to conduct studies with patients who lack legal competence and the 4 ethical “pillars” of medical research.

Executive Summary

In the majority of clinical trials, we undertake, the consent process is fairly straightforward; however, we do conduct studies in patients who lack legal competence. This occurs most frequently in pediatric patients; in these cases the lack of competence is status-based (age-dependent) rather than functional.

In pediatric clinical trials, challenges relating to children arise regarding information given to them and their ability to comprehend it and provide assent.

In this white paper, our PRA experts:

  • Address the complex process of competency assessment
  • Look at the evolution of competency (ie, the developing competence of the adolescent)
  • Highlight current industry challenges in testing competence
  • Explain the proxy consent process for patients who are not legally competent
  • Discuss appropriate ways of working with children based on their level of understanding rather than their chronological age



Harris Dalrymple, PhD Medicine, PhD Law, Executive Director, Global Scientific Affairs Vice Chair, Center for Pediatric Clinical Development 


Mark Sorrentino, MD, MS, Vice President, Clobal Scientific Affairs, Chair, Center for Pediatric Clinical Development


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