When and how to include vulnerable subjects in clinical trials

• Published in: Clinical trials (London, England) Vol. 17; no. 6; p. 696
• Main Author: Wendler, David
• Format: Journal Article
• Language: English
• Published: England 01.12.2020
• Subjects: Biomedical Research - legislation & jurisprudence; Child; Clinical Trials as Topic - ethics; Clinical Trials as Topic - legislation & jurisprudence; Decision Making; Ethics Committees, Research - ethics; Ethics Committees, Research - legislation & jurisprudence; Female; Fetus; Humans; Male; Pragmatic Clinical Trials as Topic - ethics; Pragmatic Clinical Trials as Topic - legislation & jurisprudence; Pregnancy; Pregnant People; Prisoners; Research Subjects - legislation & jurisprudence; United States; Vulnerable Populations - legislation & jurisprudence; United States; Vulnerable subjects; clinical trials; pragmatic trials; regulations

There has been a good deal of discussion in the literature regarding which subjects are vulnerable in the context of clinical trials. There has been significantly less discussion regarding when and how to include vulnerable subjects in clinical trials. This lack of guidance is a particular problem f...