Hopkins to Resume Some Human Testing

Government regulators told Johns Hopkins University on Monday that the school may resume medical research on humans, four days after the regulators halted such studies because of the death of a volunteer. Some studies will have to be reviewed first.

The federal Office for Human Research Protection approved a plan reached with the university to correct deficiencies found after the June 2 death of a healthy 24-year-old during an asthma experiment.

Research in which there is “no more than a minimal risk to the volunteers” may resume, OHRP spokesman Bill Hall said. That includes studies applying “noninvasive” means of collecting information, such as conducting surveys and taking blood, urine or saliva samples, ultrasounds and MRIs.

However, the majority of studies in which there is “greater than a minimal risk” remain suspended until they are “re-reviewed” by a Hopkins review board and approved by the federal office, Hall said.

If these studies meet OHRP requirements, they will be reinstated one at a time--a process that could “take more than a few weeks,” Hall said.

“They’re not completely back in business,” he said.

Ellen Roche, who worked for Hopkins as a lab technician, died last month after inhaling hexamethonium, which restricts airways, in a study designed to help doctors learn how healthy lungs fight asthma-like conditions.

Hopkins said it was the first time in its history that a healthy research volunteer died. The university has accepted responsibility and suspended 10 projects led by Dr. Alkis Togias, who faces no other disciplinary action.

The federal office said researchers failed to explain the risks to subjects in the asthma study, and did not promptly report another subject’s symptoms after the drug hexamethonium was administered.

Johns Hopkins receives more federal research funding than any other institution in the United States--more than $300 million last year.

The decision by the regulators affected at least 15,000 patients and volunteers.

The OHRP said Hopkins review boards often approved studies without enough information, failed to monitor ongoing experiments and tried to supervise too much research with too little staff.