The ethics and regulatory landscape of including vulnerable populations in pragmatic clinical trials - Welch, Mary Jane; Lally, Rachel; Miller, Jennifer E; Pittman, Stephanie; Brodsky, Lynda; Caplan, Arthur L; Uhlenbrauck, Gina; Louzao, Darcy M; Fischer, James H; Wilfond, Benjamin (Clinical trials (London, England), 2015)
Keywords: Biomedical Research - ethics; Biomedical Research - legislation & jurisprudence; Biomedical Research - standards; Child; Child, Preschool; Children & youth; Clinical trials; Clinical Trials as Topic - ethics; Clinical Trials as Topic - legislation & jurisprudence; Clinical Trials as Topic - standards; Disabled Persons; Federal regulation; Female; Fetus; Humans; Infant; Infant, Newborn; Informed Consent - ethics; Informed Consent - legislation & jurisprudence; Informed Consent - standards; Male; Medical ethics; Medical research; Pregnancy; Prisoners - legislation & jurisprudence; Research Subjects - legislation & jurisprudence; Vulnerable Populations - legislation & jurisprudence; Vulnerable subjects; research with children; research with disadvantaged populations; regulation; research with persons with diminished capacity; cluster randomized trials; pragmatic clinical trials; research with prisoners; research ethics; research with pregnant women