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Previous Volume 346:1425-1430 May 2, 2002 Number 18

	Since this article has no abstract, we have provided an extract of the first 100 words of the full text and any section headings.

	Full Text PDF PDA Full Text Purchase this article Editorial by Slater, E. E. Letters Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited Related Article Related Article by Christian, M. C. PubMed Citation

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 . . . [Full Text of this Article]

Background

Federal Regulations

Problems with the System

The Office for Human Research Protections

The FDA's Office for Good Clinical Practice

Accreditation

Institutional Review Boards

Fines

Ongoing Review of Research

Conclusions

References

Related Letters:

Institutional Review Board Reform
Emanuel E. J., Kornfeld D. S., Mann H., Paasche-Orlow M. K., Taggart J. C.
Extract | Full Text | PDF  
N Engl J Med 2002; 347:1285-1286, Oct 17, 2002. Correspondence

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