NIH OFFICE SANCTIONS U.VA. RESEARCH OVERSIGHT COMMITTEE
Inadequate Staffing a Concern

	CHARLOTTESVILLE, Va., April 11 -- Citing "serious
noncompliance" with recordkeeping and other procedural regulations,
a National Institutes of Health office has restricted the operation
of one of the University of Virginia's two boards that review
research projects involving human subjects. 
	The March 24 report from the NIH Office for Protection from
Research Risks (OPRR) followed an extensive review, including an
on-site visit in December, of the University's approval processes
for projects in medicine, psychology, education and other behavioral
sciences. In October, the University had self- reported several
instances of noncompliance with procedural requirements.
	"The treatment of patients and other participants in
research studies here was not an issue," said U.Va. vice provost for
research Gene D. Block. "There were no findings about individual
researchers or the way they are conducting their studies." 
	Block acknowledged that both of the University's
Institutional Review Boards (IRBs), one in medicine and another for
projects in other disciplines, had administrative deficiencies.
Among the likely causes, the report said, was a shortage of staff
assistance.
	As a result, 35 research projects were temporarily suspended
in mid-December until the most serious problems were corrected.
	For example, "each IRB must have at least one member who is
primarily not a scientist," Block said. "Unfortunately, the person
we had thought met that requirement for one committee had too much
scientific involvement to qualify." Eleven of the 12 projects
suspended for that reason have now been re-approved by a newly
constituted board; the remaining researcher decided to reapply later.
	Other problems cited by OPRR for the behavioral and
educational sciences IRB include failure to maintain detailed
meeting minutes and other records, failure to review continuing
research at appropriate intervals, and failure in some cases to
obtain sufficient information for making decisions.
	These issues are now being corrected, Block said, in part by
setting up a computer tracking system in his office.
	For at least the next year, that IRB must submit its reviews
of Health and Human Services-funded studies to OPRR for approval on
a project-by-project basis. That restriction does not apply to the
University's medical review board, which may continue to approve
research projects under an agreement known as multiple project
assurance.
	In the medical area, OPRR found that the IRB had "failed to
ensure timely and substantive continuing review of research as
required under HHS regulations."
	Dr. John A. Owen Jr., chair of the medical IRB, said the
committee has changed its procedures for renewing approval of
ongoing research projects. About two dozen medical projects were
restricted from adding new subjects until they were re-reviewed in
January.
In discussing staffing levels, the report said "OPRR has serious
concerns about the lack of adequate staff support . . . [The medical
IRB] is currently responsible for approximately 1200 active
protocols, including more than $20 million in HHS- supported human
subjects research. OPRR's experience suggests that such volume would
generate more administrative demands than a single . . . analyst
could reasonably be expected to handle." 
	The University's formal response, an attachment to the OPRR
document, notes various changes that already have been made to
provide additional administrative support and to assure overall
compliance with the regulations.
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April 10, 1995