Hopkins' Funding Renewed

Tony Parker and Eva Longoria leave their hotel to attend a cruise on the Seine river with friends on July 5, 2007, in Paris.
GETTY IMAGES/Pascal Le Segretain
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.

The federal Office of 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.

Hopkins said the federal office has also "imposed certain conditions on the resumption of research." The OHRP said in a letter to the university, posted to its Web site, that the conditions include the continued suspension of certain projects that were not properly reviewed by a local review board.

"OHRP recognizes the extraordinary efforts that your faculty and staff have made to develop these corrective action plan and to begin the initial steps to improve your system for protecting human subjects," the federal agency said in the letter to Hopkins.

Ellen Roche, 24, 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 full responsibility and suspended 10 projects led by Dr. Alkis Togias, who remains on staff and faces no other disciplinary action.

In its letter to the school Thursday, the year-old federal office put almost all of Hopkins' federally funded research involving human subjects on hold.

The Rules
"Research investigators have a fundamental responsibility to safeguard the rights and welfare of the people participating in their research activities."

Click here to read the rest of the "Guidelines for the Conduct of Research Involving Human Subjects at the
National Institutes of Health."

The 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.

Roche was one of three subjects who inhaled hexamethonium. The first developed a cough lasting a week. The third showed no symptoms.

Roche also began coughing and died a month later while hospitalized.

Ainternal review board was mixed on whether Togias should have stopped the experiment after the first subject developed symptoms. Earlier this month, a preliminary federal report said researchers should have sought that FDA approval for experimental use of hexamethonium.

Johns Hopkins receives more federal research funding than any other institution in the United States — more than $300 million last year, making it No. 1 for the ninth straight 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.

The hospital had called the government's action draconian, and the suspension of funding, "unwarranted, unnecessary, paralyzing and precipitous."

"We strongly believe that this action was taken in utter disregard of patients' health and potentially of life," Hopkins Medical School spokeswoman Joann Rodgers said last week.

CBS News Medical Correspondent Elizabeth Kaledin reports the suspension came at a time of intense public and federal scrutiny of human research projects, perhaps sparked by the death of Jesse Gelsinger, an 18-year-old who died during a gene therapy experiment at the University of Pennsylvania. Eight gene therapy trials at Penn were also suspended.

The OHRP replaced the Office for Protection from Research Risks, which had been criticized for not doing enough to protect patients in clinical trials.

The OHRP was born shortly after Gelsinger's 1999 death.

©MMI, CBS Worldwide Inc. All Rights Reserved. This material may not be published, broadcast, rewritten, or redistributed. The Associated Press contributed to this report