Protecting research subjects--the crisis at Johns Hopkins.

LLEN 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 took corrective action, and the suspension was lifted.2 Nonetheless, the suspension was “a gigantic shock” to an institution that “has always prided itself on excellence in care and excellence in research,” according to Dr. Edward D. Miller, dean of the Johns Hopkins University School of Medicine. Along with the 1999 death of 18-year-old Jesse Gelsinger in a gene-transfer trial at the University of Pennsylvania and the suspension of federally supported research at other prominent institutions (Table 1), the shutdown at Johns Hopkins has focused attention on the safety of medical research, particularly when the subjects are healthy volunteers or are employed at the institution where the research takes place. The shutdown has also spurred efforts to improve the effectiveness of the various groups that have a role in protecting research subjects, including investigators, institutional review boards (IRBs), sponsors, and the institutions where the research is conducted. In this report, I examine the crisis at Johns Hopkins and the ongoing response.