Developing and assessing institutional conflict of interest policy can be tricky

Here’s some expert advice

When the National Institutes of Health (NIH) recently became the target of intense public criticism and scrutiny over potential conflicts of interest (COI) among NIH directors and staff and clinical trials, it became apparent to the research world that this is an issue that could be a problem for any institution.

The best prevention strategy is to be proactive by having policies, procedures, and possibly a special committee that reviews COIs, experts say.

The reputations of some leading NIH officials were at stake when the Los Angeles Times published an article Dec. 7, 2003, that included information critical of outside consulting arrangements by Stephen I. Katz, MD, PhD, director of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMSD), and John I. Gallin, MD, director of the Warren G. Magnuson Clinical Center at NIH.

"The whole point of a conflict of interest policy is objectivity in research," says Wendy Baldwin, PhD, executive vice president for research at the University of Kentucky in Lexington. "So the concern might be that if you have a competing interest, then the problem is that it would erode the objectivity of the research," she explains. "There’s a fear that there is a competing interest there."

In some ways, a COI policy is more to address the perception of conflict than the actual conflict itself.

"We’re concerned about actual conflicts of interest, but you have to be in a person’s head to know whether a conflict is being created," says Nikki Zapol, JD, legal counsel for Partners Healthcare System Inc. of Boston.

"Because we depend on public trust, we can’t afford to have a situation where the public believes our decisions are biased due to furthering our economic situation," Zapol says.

Baldwin and Zapol offer this advice about creating a COI policy:

• Have an independent group or person review projects for COIs. Partners Healthcare System has a COI committee that looks at the nuances related to institutional and individual conflicts of interest, Zapol says.

When forming a COI committee, it might be a good idea to make it an ad hoc group that spreads oversight among different experts because a standing group may have one person at various times who has a conflict of his or her own, Baldwin notes.

In addition, if there is one person on staff who is in charge of handling the management details related to COI, the process may be more efficient. For example, an institution’s policy might allow certain institutional or individual COI so long as a management plan has been established to reduce the risk of having the research staff and institution influenced due to the COI, she notes.

"The point is to ensure objectivity," Baldwin says. "At present, I am reviewing management plans along with the head of sponsor projects."

• Determine what the investigators’ obligations are. Investigators might list all of their potential COIs, whether they are covered by the institution’s policies. Then if there is a COI that creates a problem, the COI committee can put together a management plan, Baldwin says.

"Investigators have to work with the management plan if a conflict is identified," she explains says. "If the oversight team thinks they’re not getting access to the data, then they’ll come to me."

• Assess the walls established between an institution’s financial interests and research. Large institutions often will hold a portfolio of investments that might include companies that sponsor research conducted at the institution, Zapol notes. This typically does not pose a COI problem because money managers run the portfolio.

"There is a significant wall between general investments of the institution and what’s going on in the institution," she says.

A COI policy should differentiate between these types of financial arrangements and arrangements that have a more direct connection to research-related activities, such as those financial arrangements involving technology transfer agreements.

• Consider the conflicts inherent in ongoing relationships with companies that license new technologies and products. Often, companies will sponsor basic research and obtain the right to license out the inventions of that research or the federal government may fund the research and the institution doing the research is permitted to license rights to the technology made in that research to private companies, Zapol says.

A private company that licenses technology from a research institution may reward the institution with stock and/or cash payment, and this type of financial arrangement definitely poses a COI that needs to be addressed in a COI policy, she notes.

Often in cases of technology transfer relationships, an institution has been involved with the private technology company for a number of years, and key people have had a relationship with the company’s management, Zapol says.

"So it’s not possible to say that any decisions they make are made without an awareness of that relationship," she adds. "That’s when we might worry about whether decisions will be made for either personal or institutional financial gain."

• Outline black-and-white areas and leave gray areas to a committee to decide. "We are a somewhat unusual institution in that we have a lot of black and white areas where most institutions would have a gray area," Zapol reports.

Most institutions will take COI on a case-by-case basis, with the COI committee reviewing each. However, the Partners Healthcare approach is another viable option, she says.

"We have a rule for individual conflicts of interest that says you can’t conduct clinical research when you hold equity in a company," Zapol says. "Our question is, When is the clinical conflict over?’ and our answer is, When you publish results.’"

So, at least in this case, the institution has eliminated the gray area for individual COI.

"There is another area of institutional conflict, which is one we’re struggling with right now," she says. "It’s when some senior person who is not involved with the actual research at all, but is a senior person to the people who are involved in the clinical research, holds equity.

"The public perception will be that whatever decision was made was influenced by the potential for a great upside gain," Zapol adds.

For now, Partners Healthcare has handled the issue with an interim decision that requires a management individual owning the equity to hold the stock until two years after the clinical trial is completed, she says.

"That’s a temporary measure to prevent problems," Zapol says.

• Follow the money. It’s important to address the financial flow to an institution, Baldwin notes.

While most people would say that only the financial flow tied to research is important, others would argue that any type of financial flow could be significant, she says.

"A financial flow that comes in through an endowment, are we worried about that too?" Baldwin adds. "If you have a sports promotion from a food company that is part of a conglomerate that is supporting research, do you care that you have the chicken tender franchise?"

The problem is that the issue of institutional COIs is not as well defined as individual conflicts of interest, so it’s important that any institutional COI policy address these money issues, she explains.

• Outline behaviors that could pose COIs. Consulting arrangements are yet another way that researchers and/or institutions might trigger a COI issue, Zapol notes.

"We have a policy of reviewing all individual consulting agreements," she says. "We ask individuals if they are being given equity in a company in exchange for a consulting arrangement."

Another good policy is to require all CEOs and members of the board of trustees to complete financial disclosure statements, Zapol notes.

Also, it’s important to outline an institution’s internal processes for sharing objectivity, Baldwin says. "I think if you’re going to think about this at the institutional level, then state which institutional behavior could impede objectivity and which would cause you to look at things like the deal cut on intellectual property or publication or access to data or data safety monitoring," she explains.

An institution needs a policy that outlines what will happen when these types of relationships are discovered, Baldwin adds.

Now is the time for institutions to pay attention to institutional COIs, Baldwin says. It’s better to develop their own policies, procedures, and definitions because before too long a regulatory agency will do this for them.