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A correction has been published: N Engl J Med 2002;346(21):1678.

Health Policy Report
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Volume 346:716-720 February 28, 2002 Number 9

Protecting Research Subjects — The Crisis at Johns Hopkins
Robert Steinbrook, M.D.

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Ellen Roche, a 24-year-old technician at the Johns Hopkins Asthma and Allergy Center and a healthy volunteer in a study of asthma funded by the National Institutes of Health, died on June 2, 2001. Prompted by Roche's death, the federal Office for Human Research Protections reviewed the system at the Johns Hopkins Medical Institutions for protecting research subjects and found widespread deficiencies.

On July 19, 2001, the office suspended all federally supported research projects at Johns Hopkins and several affiliated institutions — not because of Roche's death but because of the additional problems that had been identified.1 Johns Hopkins quickly . . . [Full Text of this Article]

Background

The Asthma Study

The Death of Ellen Roche

The Internal Investigation

The FDA Review

The Suspension of Federally Supported Research

The External Investigation

Johns Hopkins's Response

The Ongoing Review

The Future

References


Related Letters:

Protecting Research Subjects
Kaufman J. L., Ross L. F., Robertson W. O., Steinbrook R.
Extract | Full Text | PDF  
N Engl J Med 2002; 346:2093-2095, Jun 27, 2002. Correspondence

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