Roanoke Times
Copyright (c) 1995, Landmark Communications, Inc.
DATE: SUNDAY, April 16, 1995 TAG: 9504180081
SECTION: VIRGINIA PAGE: B-5 EDITION: METRO
SOURCE: The New York Times
DATELINE: CHARLOTTESVILLE LENGTH: Long
University officials said no one was hurt and no crucial data were lost. All but a handful of the studies have been resumed, but some professors said the restrictions could have disrupted careers.
Some researchers viewed the unusually broad sanction imposed by the Federal agency as a sign of increased vigilance.
Dr. J. Thomas Puglisi, a compliance official for the agency, said, ``It may be perceived that we are being more aggressive, but it is simply that we have gotten many more complaints, and we pursue them all.''
The university's spokeswoman, Louise M. Dudley, said the violations were ``procedural and record-keeping matters'' that had been overlooked as the university's research enterprise grew at the same time that budgets were being cut.
In a report last month, the agency cited ``serious noncompliance'' with Department of Health and Human Services regulations and ``substantial confusion'' among those involved in the university's research about some rules.
Puglisi said the investigation began after the university reported errors in obtaining the informed consent of research subjects.
Federal regulation require such errors be reported. An agency inspection uncovered violations that included failure to review continuing research regularly, failure to include a nonscientist on all oversight committees and inadequate meeting minutes.
Dr. Gary B. Ellis, the director of the agency's Office for Protection from Research Risks, said: ``What we found was a systemic problem, and we are very pleased that the university took immediate steps to correct it. It is, fortunately, unusual that it is necessary to restrict activities at a research institution.''
Puglisi said his agency conducted investigations at eight to 12 institutions each year and restricted research in about half the cases. But he said the UVa investigation was unusual because a large category of research was involved.
The projects included tests of experimental drugs and treatments, a study of language acquisition by infants, and an investigation of how humans know whether an object is moving or changing size. About 250 people, many of them undergraduate students, were used as subjects for the research.
The projects were suspended in December. Most were stalled for two to nine weeks, then were renewed individually.
The director of the university's laboratory for infant studies, Dr. Bennett I. Bertenthal, said three students had needed to finish projects to receive degrees. All three later were allowed to complete their work.
Dr. David J. Hudson, the university's associate vice provost for research, attributed the deficiencies to a creeping volume of work. ``Sometimes it may take the government coming in and saying, `You need more help here,' to really get the assistance you need,'' he said.
Hudson said the school had hired an additional clerk, set up a computer system to track projects and told researchers that reports would be monitored more carefully.
``We try to make it as easy as we possibly can for the researchers to comply,'' he said. ``But they clearly know that we are paying much more attention.''
|The New York Times|
CHARLOTTESVILLE - The University of Virginia said last week that it had been required to suspend 35 medical and psychological studies this winter after the National Institutes of Health reprimanded the school for violating regulations governing the use of humans in experiments.
University officials said no one was hurt and no crucial data were lost. All but a handful of the studies have been resumed, but some professors said the restrictions could have disrupted careers.
Some researchers viewed the unusually broad sanction imposed by the Federal agency as a sign of increased vigilance.
Dr. J. Thomas Puglisi, a compliance official for the agency, said, ``It may be perceived that we are being more aggressive, but it is simply that we have gotten many more complaints, and we pursue them all.''
The university's spokeswoman, Louise M. Dudley, said the violations were ``procedural and record-keeping matters'' that had been overlooked as the university's research enterprise grew at the same time that budgets were being cut.
In a report last month, the agency cited ``serious noncompliance'' with Department of Health and Human Services regulations and ``substantial confusion'' among those involved in the university's research about some rules.
Puglisi said the investigation began after the university reported errors in obtaining the informed consent of research subjects.
Federal regulation require such errors be reported. An agency inspection uncovered violations that included failure to review continuing research regularly, failure to include a nonscientist on all oversight committees and inadequate meeting minutes.
Dr. Gary B. Ellis, the director of the agency's Office for Protection from Research Risks, said: ``What we found was a systemic problem, and we are very pleased that the university took immediate steps to correct it. It is, fortunately, unusual that it is necessary to restrict activities at a research institution.''
Puglisi said his agency conducted investigations at eight to 12 institutions each year and restricted research in about half the cases. But he said the UVa investigation was unusual because a large category of research was involved.
The projects included tests of experimental drugs and treatments, a study of language acquisition by infants, and an investigation of how humans know whether an object is moving or changing size. About 250 people, many of them undergraduate students, were used as subjects for the research.
The projects were suspended in December. Most were stalled for two to nine weeks, then were renewed individually.
The director of the university's laboratory for infant studies, Dr. Bennett I. Bertenthal, said three students had needed to finish projects to receive degrees. All three later were allowed to complete their work.
Dr. David J. Hudson, the university's associate vice provost for research, attributed the deficiencies to a creeping volume of work. ``Sometimes it may take the government coming in and saying, `You need more help here,' to really get the assistance you need,'' he said.
Hudson said the school had hired an additional clerk, set up a computer system to track projects and told researchers that reports would be monitored more carefully.
``We try to make it as easy as we possibly can for the researchers to comply,'' he said. ``But they clearly know that we are paying much more attention.''
by CNB