On July 19, 2001, the U.S. Office for Human Research Protections (OHRP) ordered a suspension of all federally funded human research studies at Hopkins that were approved either by the Joint Committee on Clinical Investigation (JCCI) at the John Hopkins School of Medicine or by the Bayview Internal Review Board (BIRB). The suspension covered about 2,400 federally funded human experiments at Johns Hopkins and involved at least 15,000 patients and volunteers.

The extensive review of the procedures of the JCCI and BIRB by OHRP was prompted by the tragic death of a healthy volunteer, Ellen Roche, a 24-year-old lab technician at the Bayview Research Campus, who died June 2 from the effects of a drug administered to her during an NIH-funded research study. On May 4, she had inhaled two doses of a chemical, hexamethonium, to help doctors find out how healthy lungs protect against asthma attacks. By May 7 Roche was reporting a cough and fever and, two days later, tests revealed lung inflammation and a 101-degree fever. She was admitted to the Johns Hopkins Bayview Medical Center but her condition worsened and she died.

Most human research studies at the Johns Hopkins Bloomberg School of Public Health were unaffected, since the School has its own assurance with the OHRP and two independent Institutional Review Boards (IRBs) of its own. About 110 human research studies of School faculty members, however, which had been approved either by the School of Medicine's JCCI or by Bayview's IRB, were halted.

According to Sharon S. Krag, PhD, associate dean for graduate education and research, and professor, Biochemistry and Molecular Biology, although the federal agency accepted Johns Hopkins' corrective action plan on July 22, thereby technically allowing human subject research to resume, months will pass before all studies are up and running again.

"Although the suspension has been lifted," said Krag, "the affected researchers cannot resume their studies until each protocol has been re-reviewed-a fairly long process."

Krag went on to say that because of the time needed for the re-review process, some research staffers at the School could potentially be laid off, some students will not finish their research in time to graduate when they expected to, and some investigators have begun to miss deadlines (for such things as progress reports and patient enrollment totals) dictated by their research contracts.

The School, with OHRP's approval, has formed a special IRB-the institution's third-to handle the re-reviews of the research protocols of the School's faculty so that the two existing IRBs can continue to perform their regular duties.

"We do not know how long this process will take," said Krag. "The re-reviews will be deliberate and thorough. We will try to carry them out as rapidly as is feasible. The School's Office of Research Subjects staff and the faculty on the School's IRBs are working hard and diligently and deserve special recognition."

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