Clinical Trials in Children with Impaired Mental Capacity
PRA has written a new white paper on conducting clinical trials with adolescents, specifically children with impaired mental capacity.
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.
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
You’ll also learn about the 4 ethical “Pillars” that support medical research:
• Respect for autonomy – the patient has the right to refuse or accept treatment.
• Beneficence – a practitioner should act in the best interest of the patient.
• Non-maleficence – “First, do no harm.”
• Justice – the distribution of scarce health resources and decisions about who receives treatment must be fair.