Sunday, April 5

Research approval process questioned


Professors, students say long procedure is detrimental to their studies

By Karen Albrecht
Daily Bruin Contributor

During last week’s town hall forum, administrators
addressed the concerns of some North Campus faculty and students
who fear stringent human research standards are hindering their
work.

Some professors say social science research does not pose the
same risks that biomedical studies do, and the process to obtain
approval for research protocol is too time consuming to be
practical.

“We do not want to get into a situation where research
subjects get hurt,” Executive Vice Chancellor Wyatt Hume said
at the forum. “But we also do not want research to get shut
down (by the approval process).”

About 60 faculty members and a handful of graduate and
undergraduate students attended the forum, which was mediated by
Hume.

Restrictions, outlined in UCLA’s
“Investigator’s Manual on Research with Human
Subjects,” are intended to ensure respect for study subjects.
The standards are designed to protect research participants from
unnecessary or uncompensated physical and psychological pain.

Questionnaires and surveys are the most widely used methods of
research on campus, but with the current privacy and anonymity
requirements, it is exceedingly difficult to do follow-up research,
said Linda Bourque, a professor of public health.

“You can conduct this research as a citizen, but not as a
member of the university,” she said.

The National Research Act of 1974 created a commission to
outline guidelines for conducting biomedical and behavioral
research on humans. Some research forms, including certain
anonymous surveys, are exempt from these regulations as they do not
pose a threat to the subject’s reputation or mental and
physical health.

Formerly at UCLA, researchers independently determined which
experimental protocols were exempt from these federal regulations
and which required government or university approval, said Steve
Peckman, associate director of Human Resources.

In 1989, UCLA’s Office of Protection for Research Subjects
created universal standards for the campus, clearly defining
exemptions and outlining guidelines for non-exempt protocol, he
said.

Experimental procedures not falling into the specific exempt
categories listed in the investigator’s manual created by the
OPRS must undergo review by one of UCLA’s three Institutional
Review Boards before research is conducted.

But the review process is lengthy, and some faculty at the forum
said it commonly took three to six months before receiving approval
for research.

“We are being asked to do far more than federal
regulations are in fact asking us to do,” Bourque said.

Jean Savage, administrative specialist in epidemiology, said
that the current situation is especially problematic with young
researchers. She said some students pursuing their
master’s degree have been encouraged not to do research
because the approval process takes too long.

The same obstacles are discouraging undergraduates as well, she
said.

Foreign students wishing to conduct research and complete their
dissertation in the United States find an even longer delay before
their projects are approved, according to Savage.

A six-month delay is standard in such cases, she said.

Present regulations are also hindering hyper acute phase medical
studies on trauma patients in emergency rooms. Because the injured
subject is unable to give informed consent when medical personnel
wish to attempt experimental surgery, important research
opportunities are lost while waiting for family members to
arrive.

New federal laws implemented less than four years ago allow
consent for experimental trauma surgery to be obtained from the
community in the form of wide-spread surveys, Peckman said. This
means that if the results of a survey indicate a community gives
general consent, the doctor may experiment on the patient.

While this may be effective in socially homogeneous areas,
Peckman said, religious and social diversity in Los Angeles make
such community consent more difficult to accomplish because
different beliefs are represented.

One investigator at UCLA attempted to obtain community consent
for research, but gave up the effort after 10 weeks, according to
Peckman.

While no immediate solution to the stringent research
restrictions was reached at the forum to accommodate studies in the
social sciences, Hume told faculty their concerns would be
considered and steps would be taken to streamline approval
processes.

“We had a group wanting to conduct genetics research,
which involves significant ethical issues,” he said.
“We worked out something there, and we should be able to do
the same here.”


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