US reviews human trial participant protections

• Published in: The Lancet (British edition) Vol. 376; no. 9757; pp. 1975 - 1976
• Main Author: Bristol, Nellie
• Format: Journal Article
• Language: English
• Published: Kidlington Elsevier Ltd 11.12.2010; Elsevier; Elsevier Limited
• Subjects: Biological and medical sciences; Clinical trial. Drug monitoring; Clinical trials; Clinical Trials as Topic - ethics; Clinical Trials as Topic - history; Clinical Trials as Topic - methods; Clinical Trials as Topic - standards; Clinical Trials as Topic - trends; Codes of Ethics; Developing Countries; Drug Industry; Ethics; Ethics, Research - history; Federal regulation; Financing, Government - ethics; Financing, Government - standards; Financing, Government - trends; General pharmacology; Guatemala; Helsinki Declaration; History, 20th Century; Humans; Informed Consent; Internal Medicine; International Cooperation; International standards; LDCs; Medical research; Medical sciences; Mentally Ill Persons - history; National Institutes of Health (U.S.); Pharmacology. Drug treatments; Poverty; Prisoners - history; Research Subjects; Research Support as Topic - ethics; Research Support as Topic - standards; Research Support as Topic - trends; Sexually Transmitted Diseases - transmission; Social Justice; Studies; United States; United States Food and Drug Administration; United States Public Health Service; Vulnerable Populations - legislation & jurisprudence; Guatemala; Central America; United States; North America; America; United States > US; Human; Ethics; Participation; Person protection; Clinical trial; Review; Case history; Bibliographic review
• ISSN: 0140-6736; 1474-547X; 1474-547X
• DOI: 10.1016/S0140-6736(10)62247-7

On Nov 24, President Obama asked the Presidential Commission for the Study of Bioethical Issues to undertake a "thorough review of human subjects' protection to determine if Federal regulations and international standards adequately guard the health and well being of participants in scientific studies supported by the Federal government." The concerns cited by medical ethicists include the ability of local regulatory bodies and institutional review boards to adequately monitor clinical trials to protect the rights and welfare of subjects and to ensure data integrity.