Human Research Reinstated at Johns Hopkins, with Conditions
Bren, Linda, FDA Consumer
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. …