Background There is increasing international recognition that populations included in trials
should adequately represent the population treated in clinical practice; however, adults who …

Background Around two million adults in the UK have significantly impaired decision-making
capacity. However, there are concerns that this population is under-represented in research …

Background Trials involving adults who lack capacity to consent encounter a range of ethical
and methodological challenges, resulting in these populations frequently being excluded …

Background Society is failing in its moral obligation to improve the standard of healthcare
provided to vulnerable populations, such as people who lack decision making capacity, by a …

When children and incapacitated adults are enrolled in research that cannot directly benefit
them, they can be exposed to no more than “minimal” risks, according to guidelines …

This article presents an overview for clinician investigators on the concepts of decision-
making capacity and vulnerability as related to human subjects research. Tools for capacity …

Although the importance of including vulnerable populations in medical research is widely
accepted, identifying how to achieve such inclusion remains a challenge. Ensuring that the …

Objective: Adults with mental retardation have histories of cognitive and adaptive deficits
posing unique ethical challenges for research consent assessment. This study examined the …

Background: Novel rationales for randomizing clusters rather than individuals appear to be
emerging from the push for more pragmatic trials, for example, to facilitate trial recruitment …

Progress in diagnosing, treating, and preventing medical conditions that impair decision-
making abilities depends on clinical research involving individuals who may be either …