Revolution or Reform in Human Subjects Research Oversight

• Published in: The Journal of law, medicine & ethics Vol. 40; no. 4; pp. 922 - 929
• Main Author: Joffe, Steven
• Format: Journal Article
• Language: English
• Published: Oxford, UK Blackwell Publishing Ltd 22.12.2012; SAGE Publications; Sage Publications, Inc; Cambridge University Press
• Subjects: Concentration camps; Confidentiality - legislation & jurisprudence; Cost-Benefit Analysis; Efficiency, Organizational; Ethical aspects; Ethics Committees, Research - economics; Ethics Committees, Research - organization & administration; Experiments; Food service; Guideline Adherence - economics; Guideline Adherence - organization & administration; Hepatitis; Human Experimentation - ethics; Human experimentation in medicine; Human medical experimentation; Human subjects; Humans; Informed Consent - legislation & jurisprudence; Institutional review boards (Research ethics); Mental health; Models, Organizational; Oversight; Powers and duties; Public health; Self-experimentation in medicine; Syphilis; United States; United States; United States > US
• ISSN: 1073-1105; 1748-720X; 1748-720X
• DOI: 10.1111/j.1748-720X.2012.00721.x

The contemporary system of prospective oversight of human subjects research has been criticized as inefficient and ineffective. Plausible approaches to research oversight range from no prospective review, to review‐and‐comment, to the current review‐and‐approve regime. Articulating this spectrum offers an opportunity to consider systematically the strengths and disadvantages of each.