http://www.nytimes.com/2001/08/31/health/policy/31RESE.html
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August 31, 2001 Report on Research Death Says Review Board Is Overworked
By THE ASSOCIATED PRESS
The report, by an external panel appointed by the university's president,
also said researchers may have used "subtle coercion" to solicit
participants in medical studies, which are overseen by the federal Office for
Human Research Protections. "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," said the report, which was issued on Wednesday. However, the authors praised corrective steps taken by the university
after the volunteer, Ellen Roche, 24, died in June after inhaling a chemical
to induce asthmatic symptoms. The government shut down most of Hopkins's 2,400 federally financed
experiments for five days, an action the university called unwarranted.
Regulators are allowing the studies to resume one at a time. The report, by a five-person committee led by Dr. Samuel Hellman, dean
emeritus of the University of Chicago School of Medicine, in many ways echoed
observations by an internal Hopkins study and the federal office for research
protection. But the Hellman panel, appointed by the university's president, William R.
Brody, in July, drew some significant distinctions. For example, the university's internal committee reported last month that
there was no coercion in Ms. Roche's participation in an asthma study. But
the external report found the possibility of subtle coercion, including signs
around the asthma studies center recruiting volunteers and saying staff
members could participate in work hours. Ms. Roche worked at the center. The external committee also echoed criticisms from the federal office that
the university's review board was "grossly inadequate" to handle the
thousands of studies at the university. But the committee commended the
university's plans to expand the number of internal review boards to four
from three. The committee's report faulted the asthma study's lead researcher, Dr.
Alkis Togias, for not properly sterilizing the chemical Ms. Roche inhaled,
hexamethonium, and for not seeking approval from Food and Drug Administration
to use it. Dr. Togias also prepared a participant consent form that was misleading
about risks and did not report adverse symptoms in another participant, the
report said. Previous studies made similar observations. The university posted "selected comments" from Dr. Togias on its
Web site, www.hopkinsmedicine.org.
In his comments, Dr. Togias agreed
with some of the criticisms, but disputed others as "unduly
dismissive" of his research methods. The university has accepted responsibility for Ms. Roche's death and suspended projects led by Dr. Togias, who remains on the staff. ALL
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