The ethics and regulatory landscape of including vulnerable populations in pragmatic clinical trials.

摘要: Policies have been developed to protect vulnerable populations in clinical research, including the US federal research regulations (45 Code of Federal Regulations 46 Subparts B, C, and D). These policies generally recognize include pregnant women, fetuses, neonates, children, prisoners, persons with physical handicaps or mental disabilities, disadvantaged persons. The aim has these from harm, often by creating regulatory ethical checks that may limit their participation many trials. recent increase pragmatic trials raises at least two questions about this approach. First, is exclusion itself a harm populations, as groups be denied access understanding how health interventions work for them settings? Second, are considered traditional also trials? We argue first excluding subjects can harmful preventing acquisition data meaningfully inform decision-making future. we protections trial settings not translatable, feasible, even apply conclude offering specific recommendations appropriately protecting trials, focusing on