Safeguarding Vulnerable Participants: Operational Guidance for Pediatric, Cognitively Impaired, and Prisoner-Involved Trials
Safeguarding Vulnerable Participants: Operational Guidance for Pediatric, Cognitively Impaired, and Prisoner-Involved Trials Ethical Operations for Children, Adults with Impaired Capacity, and Incarcerated Participants Defining Vulnerability and Translating It into Practical Protections “Vulnerable populations” is a regulatory shorthand for participants who—because of age, cognitive status, environment, or constrained liberty—may face elevated risks of misunderstanding, coercion, or…