U.S. Food and Drug Administration
FDA Consumer magazine
September-October 2001
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Human Research Reinstated at Johns Hopkins, With Conditions

by Linda Bren

Human medical research at Johns Hopkins University in Baltimore resumed in July under strict conditions and federal monitoring following the June 2 death of a healthy 24-year-old woman who was part of an asthma study at the school.

Federal investigators uncovered multiple violations of federal research requirements and suspended nearly all federally funded human research studies at the university except for those that were determined to be "in the best interests of individual subjects." These included studies that had potential benefit for participants being treated for fatal diseases. Hopkins also agreed to suspend all studies not federally funded but regulated by the Food and Drug Administration, and the institution took full responsibility for the death of Ellen Roche, a healthy lab technician and study participant.

The Department of Health and Human Services' Office for Human Research Protections (OHRP) reinstated most human research studies three days after the July 19 suspension. The OHRP oversees all federally funded research studies; the Hopkins study was funded by the National Institutes of Health.

Roche's death occurred about a month after she inhaled the drug hexamethonium. The experimental drug is a lung irritant and is not approved by the FDA. Hopkins researchers used the drug to test the way healthy lungs work to fight restricted airways occurring in people with asthma or other impaired breathing conditions.

Based on a coordinated investigation by the FDA and OHRP, violations were found involving both the study investigators and the Institutional Review Boards (IRBs), which serve to conduct ethical reviews of studies involving human research participants. The IRBs were cited for inadequate review of study design and failure to provide continuing oversight of the asthma study. The FDA also identified violations involving the lead researcher at Hopkins, Alkis Togias, M.D., including inadequacies in the consent forms given to study participants, failure to report side effects of the hexamethonium used in an earlier patient, and use of a drug unapproved for humans.

"The researchers should have consulted us on their intent to use the drug," says David Lepay, M.D., senior adviser for clinical science at the FDA. "We would have reviewed toxicity data and required that the consent form notify participants that this was a research study of an unapproved drug used in a way where there might be unknown risks."

The OHRP required a corrective action plan from Hopkins telling how it will address the violations and restructure its system for protecting human subjects. In its plan, Hopkins said it would create additional IRBs, educate IRB members and researchers in human subject protection, and provide study participants with a detailed and easy-to-understand consent form that lists all potential study risks.

With more than 2,000 experiments underway, Johns Hopkins is the largest recipient of federal research funding in the United States.

"Human studies play a vital role in drug development," says Lepay. "We must strive to promote continued advances in medicine through high-quality studies conducted safely and with the highest ethical standards."

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