1. February 26, 2014, 4:33 PM ET
Businesses have been contending with an ever-increasing number of rules and
regulations governing all aspects of their operations. The same is true at universities,
especially large state universities that have multiple campuses, hundreds of thousands of
students and, in some cases, research components that bring in billions of dollars a year.
Bloomberg News
Sections of the human brain are stored at the Brain Observatory at the
University of California San Diego in April 2011.
One distinction between compliance in private enterprise and universities is that
universities must adhere to strict guidelines regarding the use of government and
corporate research grants, and ensure university researchers don’t violate conflict of
interest rules that could influence study outcomes or provide financial reward to the
researchers involved in those studies.
At the University of California system, investigators must disclose certain financial
interests at the time of any proposal submitted to the National Institutes of Health, the
National Science Foundation and for all research sponsored by for-profit companies and
certain non-profit organizations. Each campus appoints a conflict of interest committee to
conduct a standard case analysis for each research proposal, said Sheryl Vacca, senior
vice president and chief compliance and audit officer for the University of California
system. The system includes 10 campuses, five medical centers and three national
laboratories, more than 230,000 students and 198,000 employees, and has annual
The ABCs of Campus Compliance
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2. revenue of $24 billion
Ms. Vacca provided examples of some of the questions these committees deal with. One
involved a principal university researcher who receives honoraria and travel
reimbursements from a pharmaceutical company that is proposing to sponsor a clinical
trial for a drug that the researcher would oversee. In that case, the committee ruled the
researcher cannot be recompensed for any activity during the duration of the clinical trial.
In a second example, a researcher owned a 7% equity stake in a medical devices
company that wanted to sponsor a clinical trial for a product the researcher helped to
invent, and the company wanted to put the researcher in the role of chief investigator of
the trial. The committee ruled someone else with no financial interests in the company or
the product should serve as the chief investigator.
With so much research money at stake, Ms. Vacca said it’s no surprise this is an area
receiving close regulatory scrutiny. And because many researchers are scientists and
entrepreneurs more concerned about their work than making sure they know all the
regulations and constraints, it’s up to the compliance staff to make sure those rules are
followed.
“We encourage and want these individuals to go forward in science and make these
unbelievable and innovative scientific explorations, but on the flip side we’ve got to have
something that balances the administrative piece to ensure we meet all the regulations,”
she said.
Larry Plutko, the systemwide compliance officer for the University of Texas system said
his priority is on compliance issues governing those areas that are tied to university
revenue, such as research, which brings in more than $4 billion annually, and the
system’s medical centers, where compliance encompasses medical records, privacy
issues, billing and administrative matters. The UT system encompasses nine academic
institutions, six medical institutions, more than 215,000 students, 87,000 employees and
has annual revenue of $14.4 billion.
“These are not only the most important to us, these are the areas that regulators are most
interested in, too,” Mr. Plutko said. “What are the greatest risks from these particular
lenses? We do ongoing enterprise risk assessments, we look at specific goals within our
work plan to move the program, then assign our budgeted dollars to those particular
priorities.”
Greater emphasis is being put on transparency of the relationships between researchers,
government agencies and companies who also fund research, Mr. Plutko said. “The
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public is asking for that, government officials are asking for that and the university has to
be committed to transparency,” he said. To that end, the university has made public the
relationships it has with pharmaceutical and medical device makers who sponsor
research and, starting in April, will have online the annual conflict-of-interest reports that
senior administrators, researchers and faculty are required to file.
Mr. Plutko said the most costly part of his budget is information security and privacy, and
with good reason, given the tremendous threats and importance of protecting research
data, protecting patients’ privacy and security records. On the flip side of those
protections, Ms. Vacca said, is the need to ensure academic freedom and the right to free
speech that is essential to any vibrant university campus. “It is a real fine balance. Higher
education really has a problem with this area. We are all still working on it. I don’t know if
an answer is close by.”
Write to Ben DiPietro at ben.dipietro@dowjones.com, and follow him on Twitter
@BenDiPietro1.
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