Stricter regulations put on human researchUCLA experiments now
approved by separate committee
By Andrew Scholer
Daily Bruin Contributor
A federal investigation of a patient’s suicide at UCLA’s
Neuropsychiatric Institute has resulted in significant changes in
the university’s processes for approving the use of human subjects
in research.
One of the most significant changes requires researchers to get
approval from the campus Office for Protection of Research Subjects
instead of from their department chair.
"(The changes are) a major commitment to being state-of-the-art
in the protection of subjects," said Barbara Levey, assistant vice
chancellor for biomedical affairs. Levey, who now oversees the
Office for Protection of Research Subjects, was hired after the
federal investigation.
The office reviews the use of human subjects in experiments
ranging from measuring reaction time to testing complex new drug
therapies.
The office also provides administration and support to UCLA’s
three human subject protection committees. Following federal
guidelines, these committees – composed of faculty and community
members – make sure risks to subjects do not outweigh the benefits
to those subjects and the community.
Research methods, recruitment procedures and background
information for each experiment are evaluated by these committees
before experimentation with human subjects begins.
The only way to avoid waiting for committee approval is to claim
exemption from full review under one of the federally defined
exempt categories.
Now, review of these exemptions is done by the Office for
Protection of Research Subjects instead of department chairs, which
had been the traditional procedure.
Judith Brookshire, director of the office, said the old policy
"put too much responsibility on the investigators and the
departments to determine whether or not something was exempt."
Brookshire said essential facts for determining exempt status
were sometimes not considered because department chairs were not
necessarily experts on federal regulations.
For example, older exemption forms did not determine if research
was being conducted on what federal guidelines call "vulnerable"
subjects. Research on vulnerable populations such as children and
prisoners is less likely to be exempt from full review.
"I think most investigators took (the old exemption form)
seriously and filled it out as completely as they could, but there
was never any emphasis on it," Brookshire said.
The new form is "more complete and exacting," Brookshire said.
"If a researcher fills it out, it will be easy to determine whether
they are exempt."
Administrators hoped that having specialists in human subject
protection administer exemptions would help make researchers aware
of all the factors that might affect the exempt status of their
research.
Research that is not exempt must go to one of the human subject
protection committees for a full review. Although this process has
not changed, the composition of those committees has.
Immediately after the investigation, subject advocates were
added to the committees. These experts are unaffiliated with UCLA
and speak for the subject group involved in the experiment.
For instance, in reviewing a study of new psychiatric methods a
family member or psychiatric social worker might be brought in as a
representative of the subjects’ interests Brookshire said.
Reformers hoped that nonaffiliated advocates will be more
objective than university researchers, who may have an interest in
approving research. Avoiding this conflict of interest helps ensure
that vulnerable subjects are appropriately protected.
In addition to these two major changes, the Office for
Protection of Research Subjects has made a number of changes to
ensure better communication with researchers.
"They really work to get you through the process and to your
research," said Michele Maines, an undergraduate psychology student
working on her senior thesis. Maines was told by her sponsor that
the department chair could approve her study of the elderly but was
later informed she needed to apply for clearance with the Office
for Protection of Research Subjects.
Office staffers said they made great efforts to educate
researchers about the changes and tried to respond to applications
within three working days. This rapid turnaround is an improvement
over the week or more it often took department chairs to process an
application.
Brookshire also encouraged researchers to contact her office
with any questions, adding that a how-to style manual will soon be
available.
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