A federal agency lifted a suspension of human medical research at the Johns Hopkins University yesterday but frustrated school officials by imposing severe restrictions that will likely delay full resumption of research for months.
While regulators accepted Hopkins' plan to improve safeguards for research volunteers, they are requiring that internal review boards reconsider most of the 2,400 federally funded studies on humans.
Many sick patients will be allowed to continue receiving experimental treatments that are deemed in their "best interests." In contrast, studies that hold no immediate benefit for patients remain suspended until Hopkins completes its review.
Voicing a mixture of relief and exasperation, doctors said it could take four months to complete the required reviews and free all trials from constraints.
"If you're my patient, you shouldn't expect to get a hold of me," said Dr. David Cornblath, a neurologist who heads one of three institutional review boards at Hopkins. "This means rescheduling of patient appointments because we're not available. It means dropping whatever we're doing to get this research back up and running."
On its face, the decision was a victory for Hopkins. But as officials sifted through the new requirements imposed by the agency, many expressed disappointment that the institution must clear many bureaucratic hurdles.
"Frankly, we remain concerned that the conditions imposed on the resumption of research by the regulators will create an enormous paperwork burden," said Gary Stephenson, a Hopkins spokesman.
The conditions, he said, "will delay the start of new studies and prevent some patients from entering valuable clinical studies that could be their only hope."
The decision late Sunday by the federal Office for Human Research Protections to approve the university's "action plan" came three days after the agency suspended most of Hopkins' studies. The suspension affected Johns Hopkins Hospital and medical school, Bayview medical center, the nursing school, Kennedy Krieger Institute and Applied Physics Laboratory.
Yesterday, the agency lifted the suspension for an estimated 600 studies that are considered of minimal risk - analyses of blood samples or patient surveys, for example - and qualify for expedited review under federal law.
But the remaining studies will have to be sent back to the Hopkins review boards for reconsideration, the agency said. The boards, composed largely of physicians from a variety of specialties, must discuss and vote on each project.
"They have a tremendous number of studies that need to be re-reviewed, and this may take some time," said Bill Hall, spokesman for the federal agency. "The pace of it will depend on Hopkins."
Hall said the full suspension, although limited in duration, served an important purpose.
"The point of the suspension was that we found systemic problems in the protection of human subjects," Hall said. "We wanted to make sure that no other volunteers were placed at potential risk of severe adverse events."
The agency suspended the studies after finding widespread deficiencies in Hopkins' system of protecting people in medical experiments.
Though regulators had expressed concerns about Hopkins' safeguards in October, their scrutiny intensified when Ellen Roche, a previously healthy lab technician from Reisterstown, died June 2 after inhaling a chemical in an asthma experiment.
In that case, the agency faulted scientists for not discovering and warning research volunteers about severe lung toxicity among patients exposed to the drug in the 1950s. It also criticized the Bayview review board for approving a consent form that disclosed only mild side effects.
Yesterday, review boards began what promised to be weeks of meetings, taking up studies in order of medical necessity, Cornblath said. Each project could take from 10 minutes to a half-hour to review, he said. The boards are also fielding thousands of requests from doctors wanting to continue treating patients.
"Based on the experience at other centers, it will take about four months to get back to where we were a week ago," Cornblath said. "We've calculated that the review process alone ... will take thousands of physician-hours just in the meeting process."
Dr. George Dover, director of the Johns Hopkins Children's Center, said he was relieved that Hopkins was again on course to make its own decisions.
"They've given us our [internal review board] privileges back, but we're starting over again," he said.
In its action plan, Hopkins said it would create a fourth review board to handle the large volume of cases, and planned to begin audits of human experiments that are in progress.
It also promised to develop a standard to determine whether scientists have fully assessed risks.
And though it took issue with the government's criticism that review boards didn't individually discuss each proposal, Hopkins promised that all proposals would be "presented individually, discussed individually."
