Improving Protection for Research Subjects

• Published in: The New England journal of medicine Vol. 346; no. 18; pp. 1425 - 1430
• Main Author: Steinbrook, Robert
• Format: Journal Article
• Language: English
• Published: Boston, MA Massachusetts Medical Society 02.05.2002
• Subjects: Accreditation; Biological and medical sciences; Biomedical research; Clinical Trials as Topic - legislation & jurisprudence; Clinical Trials as Topic - standards; Ethics; Ethics Committees, Research - organization & administration; Ethics Committees, Research - standards; Gene therapy; Government Regulation; Health Care Reform - legislation & jurisprudence; Health Care Reform - organization & administration; Human Experimentation - legislation & jurisprudence; Humans; Medical sciences; Multicenter Studies as Topic; Research - legislation & jurisprudence; Research - organization & administration; Research - standards; Research Subjects; Review boards; United States; United States Dept. of Health and Human Services - organization & administration; United States Food and Drug Administration; United States; North America; America; Human; Ethics; Clinical trial; Regulation; Public health; Legal Approach; Biomedical and Behavioral Research
• ISSN: 0028-4793; 1533-4406; 1533-4406
• DOI: 10.1056/NEJM200205023461828

In March 1996, Hoiyan Wan, a 19-year-old nursing student and a healthy volunteer in a study at the University of Rochester, died two days after undergoing bronchoscopy as part of the study. During the procedure, she received a fatal dose of lidocaine. A report that followed a state investigation criticized the researchers, the institutional review board (IRB), and the university. 1 Wan's death led to many changes at the University of Rochester, including the establishment of training programs for investigators and an overhaul and expansion of the university's IRBs. The university's response is sometimes cited as a model for other institutions . . .