- The Washington Times - Friday, August 31, 2001

BALTIMORE (AP) — Johns Hopkins University researchers used "possible subtle coercion" to solicit participants and viewed regulatory safeguards as barriers to research, according to an external report on the death of a healthy volunteer.
However, report authors said they were "very pleased and gratified" with corrective steps taken by the university since federal regulators last month temporarily shut down most of Hopkins' studies using human subjects.
The report, issued Wednesday, portrayed an academic dynamic where safety took a back seat to research and there was a general misconception of regulation.
"Our interviews suggest that many people at Hopkins believe that oversight and regulatory processes are a barrier to research and are to be reduced to the minimum rather than their serving as an important safeguard," the report said.
The external committee also detected an "adversarial relationship" between researchers and the federal Office of Human Research Protections.
The report from the five-member committee chaired by Dr. Samuel Hellman, dean emeritus of the University of Chicago School of Medicine, in many ways echoed observations made by an internal Hopkins investigation and the OHRP.
But the Hellman panel, appointed by Hopkins President William R. Brody in July, drew some significant distinctions.
For example, Hopkins' internal committee reported last month there was no coercion in lab worker Ellen Roche's participation in an asthma study. Miss Roche, 24, died June 2 after taking a drug to induce asthmatic symptoms.
Yet the external report said, "There appears to be possible subtle coercion in the solicitation and recruitment of volunteers to the Asthma Center Studies."
That coercion included posting signs around the center recruiting volunteers and allowing center staff to participate in center studies during work hours.
Like the OHRP and internal committee, the external committee criticized Hopkins' oversight process, calling it "grossly inadequate" to handle the thousands of studies at the university.
It also commended the university's plans to expand the number of internal review boards — which oversee and approve research on human subjects — from three to four. A year ago, there were two.
In a written statement, Mr. Brody pledged to provide enough oversight for the university's growing body of research.
The external committee's report also faulted the lead researcher in the asthma study, Dr. Alkis Togias, for not properly sterilizing the inhalant, hexamethonium, and for not seeking approval to use it from the Food and Drug Administration.
Dr. Togias also prepared a participant consent form that was "misleading" about risks and failed to report adverse symptoms developed by another study participant, the report said.
Previous investigations made similar observations about Dr. Togias.
The university has accepted full responsibility for Miss Roche's death and suspended projects led by Dr. Togias, who remains on the staff.
In July, the OHRP temporarily shut down most of the university's 2,400 federally funded studies on human subjects. After five days, the studies were allowed to continue, but they must be approved again, one by one, in an additional review.
That process is ongoing.
Mr. Brody said he was "grateful" for the reports by the external and internal committees.
"These reports, together with suggestions by the OHRP and the FDA, offer valuable guides for improving our institutional processes," Mr. Brody said.


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