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