Examining the role of industry in research

From being the first to grow human tissue using stem cells harvested from fat obtained during liposuction to creating new processes to better illuminate today’s plasma TV screens, UCLA has been a research powerhouse, garnering approximately $718 million in grants and contracts in 2006 alone.

Tucked away in the depths of campus buildings, some 4,000 faculty and students continue to work toward scientific and societal advancements, as 5,500 projects can be underway at any given time.

But with government funding from entities such as the National Institutes of Health dwindling, administrators and faculty say strengthening industry sponsorship is important to advancing scientific research. And some believe such funding has both scientific advantages and ethical disadvantages.

While having research contracts with industry leaders such as GlaxoSmithKline ““ a company that holds an estimated 7 percent of the world’s pharmaceutical market ““ fuses academic research with commercial enterprise, conflict-of-interest issues can arise out of these types of partnerships.

“I think people do worry about perceived conflict of interest,” said Kathryn Atchison, vice provost for the UCLA Office of Intellectual Property and Industry Relations. “They want to make sure that (the university isn’t) getting tainted, if you will.”

Ezekiel J. Emanuel, a bioethicist at the National Institutes of Health, sees growing concern among the scientific community as dominant industry relations may shift research priorities and affect the openness of research.

“You need to have a right balance and there is a worry that things are getting out of whack,” he said, emphasizing that though there is a trend toward tightening up research policies, it’s not universal. “Different institutions have different rules and that’s a bad thing in my opinion.”

Paul Wolpe, a member of the University of Pennsylvania’s Center for Bioethics, shares this concern of the possibility of skewed results.

A past study found that industry-sponsored projects and researchers who have strong relationships with industry tend to have findings that are favorable to the industry at a much higher rate than those without such ties, he said.

University policies govern the procedures for reporting potential conflicts of interest that can emerge when faculty consult for companies, reside on the board of directors for a company or hold shares with companies that have similar research interests.

But the university places trust in the faculty to disclose such relations.

“It’s really an honor system,” said Ann Pollack, assistant vice chancellor of research.

And while reliance on the integrity of faculty members to disclose these types of relationships is standard in the scientific community, some bioethicists have their reservations as industry-funded research continues to grow.

Industry Relations

According to a 2005-2006 annual report by the UCLA Office of Research Administration, 75 percent of research funds come from the federal government, in contrast to the 7 percent of funding that comes from outside industries.

“(Industry funding is) not a large component. … It’s a small fraction of the total,” said Roberto Peccei, vice chancellor for research. “I believe that number is very much true across the country.”

Charitable organizations, interest groups and the state government are some other sources of funding.

In addition, the number of total grants UCLA receives yearly hovers around 4,800, and $53.4 million of the total awards granted for research comes from private industry, Peccei said.

Some researchers and administrators are concerned that increased reliance on industry sponsorship stems from financial motives.

But Peccei said the initiative to support industry relations is fueled by the pursuit of knowledge.

Though controversial, the recent $500 million deal between oil giant Beyond Petroleum and UC Berkeley to search for new sources of energy is an example of the kinds of benefits that can arise when academic research merges with industry, Peccei said.

“Often industry is trying to attack real problems and it can be very important for faculty to be working on issues that are societally important that industry is trying to attack,” he said.

Translating research into something tangible that the public can use also underlines the importance of cultivating industry relationships, administrators said.

And while faculty members benefit from the relationship by getting the funding they need, students can also draw benefits.

“It makes the connection so that the company will ask students to be interns over the summer,” Atchison said. “These companies come on campus and hire our graduates.”

But there are also concerns that the effects of a close relationship between the university and private companies that is not adequately regulated are not healthy.

Wolpe remains wary of increasing industry sponsorship because it can result in self-censorship on the part of the university in order to preserve friendly relations.

“A larger and larger percent of grant funding comes from industry and that gives industry more clout over the university,” he said, emphasizing that this can occur even when industries do not explicitly impose control.

Contract Intricacies

General Electric, Phillips, HP, Intel, Genentech and Toyota are a few of the companies with which Atchison’s office negotiates contract grants ““ whether it be an agreement for direct money, research collaboration or the provision of equipment a company may lend to a researcher.

But whether the company or the researcher seeks the contract, certain university regulations dictate what kinds of agreements can be accepted.

“We do not allow for a publication restriction,” Atchison said. “If a company says you have to let us look at the manuscript and give you an OK to submit this publication ““ we won’t allow that,” she said.

The only caveat to that rule occurs when there is proprietary information such as trade secrets at stake, she said.

The university also requires that research be conducted in an open manner.

“We are interested in doing the type of research that will be available to the public, so we don’t do trade secrets,” she said. “Our principles for partnering with industry are that we only do the type of research that we can share in an open environment through education of students, undergraduate or graduate, or through publication with the world.”

Certain companies may request in their contracts that only U.S. citizens participate in the research because of specific government regulations prohibiting the sharing of certain information with non-citizens.

But company grant contracts excluding certain students from being involved in the research are not permitted on campus.

“One of our primary commitments is to students, so we are not going to accept a restriction from industry that says we can allow only U.S. citizens to participate because that would leave out a lot of our students,” Atchison said.

While the UCLA Office of Intellectual Property does not manage clinical research or trials, it does engage in agreements with pharmaceutical companies over preclinical research ““ an area of work which Atchison said takes a great deal of negotiating because of the companies’ strict intellectual-property control.

Those transactions are not always smooth either.

“Once in a while it simply doesn’t work. The company wants too much control for us to be able to do it in such a way where the faculty can publish and allow the student to be involved,” she said. “We can’t say yes to everything but we usually find a way to say yes to most things . We work hard and try to be accommodating because we are a public institution.”

Just as the university enforces policies for engaging in research with industry, faculty members must also follow certain guidelines when disclosing conflicts of interest they may have with these funded projects.

Conflict of Interest

As industry sponsorship starts to play a bigger role in labs ““ potentially blurring the lines between academic and financial motivations behind research ““ faculty members must ensure adherence to conflict-of-interest policies set by the federal government and UCLA.

Applicants for contracted grant money from a nongovernmental entity must follow the California disclosure process in which the researcher states potential conflicts of interest, Pollack said.

The result may be a positive disclosure, which signifies a very strong relationship between the researcher and the company. This could include a researcher who is running a clinical trial for a company in which he owns large shares.

Once a positive disclosure is stated, it is reviewed by Pollack, who oversees UCLA’s conflict-of-interest committee.

Another relationship that a researcher may have to reveal is a private consulting contract with companies that are also providing funds for their UCLA labs, Peccei said. That researcher may not receive more than $10,000 a year. Any other consulting unrelated to their lab work does not have to be reported, he said.

“There is a process which is on the trust of the faculty (to disclose),” Peccei said. “My office doesn’t go and peer into Professor X’s finances to find out whether he has a conflict.”

Wolpe said he finds it “ethically problematic” for faculty members to do research for a company in which they have a large stock holding and believes that consulting with the company should be discouraged.

M. Norton Wise, a history professor who does research on the relationship between science and industry, said though he believes the current conflict-of-interest policies are necessary, they are not sufficient, and he would like to see something done at the university level.

“In my perspective, we have to develop a means of oversight which comes from within the university-industry relationship,” he said. “How that’s to be done is the question.”

Wolpe also said some of the guidelines do not suffice.

“Very often people are under the illusion that disclosure solves all of the problems,” he said.

Of thousands of proposals submitted yearly, Pollack said 150 turn out as positive disclosures and require prompt review by a committee. Yet reporting a clear conflict of interest does not mean that a research grant will be denied.

“Our philosophy on this campus is to see whether there are ways to mitigate the conflict rather than simply prohibiting certain relationships or just saying no,” Pollack said, adding that there have been relatively few cases that the university has deemed inappropriate and thus refused the grant.

The ways to alleviate a conflict range from disclosing the relationship in the publication to asking individuals to divest themselves from some of their outside involvement such as large stock holdings, Peccei said.

While the administration encourages a “culture of disclosure,” there are instances where things go unreported, Peccei said.

“There are lots of laws in the books, but there are still thieves,” Peccei said. “We take it on the basis that people are honest and will be responsible.”

But Wise said universities could potentially jeopardize their credibility.

Universities that engage too heavily with commercial companies without effective oversight over the commercialization of research compromise the role of universities as a “supplier of trustworthy knowledge,” Wise said.

And the relationship could have consequences.

“If the university looses credibility, I think that would be dire,” he said. “It’s not as though we are facing a crisis right now, but conditions could be developing where we could be facing a crisis of credibility.”

Other institutions such as Stanford have adopted more stringent policies than UCLA, as they require a yearly report by every faculty member to clarify possible conflicts of interest.

But because UCLA has three times the faculty of Stanford, Peccei said implementing a similar policy would not be feasible.

“In truth, we haven’t felt the necessity to do that. Our system works reasonably well,” he said