Reduce COI issues by focusing area attention

Big changes on COI rules are coming soon

Research coordinators and investigators sometimes fail to imagine all of the different types of institutional responsibilities that could be affected by a conflicts of interest (COI) policy.

A large academic medical center that conducts research could have separate COI policies and processes for its medical center and its research activities. But physician investigators would be subject to both sets of policies, says Charlotte Talman, MSN, MBA, director of the conflict of interest office in the office of the vice president for research at the University of Iowa in Iowa City, IA.

"Research is the one that's guided by federal regulations while the other processes are guided by whatever their internal policy is," Talman says.

The Food and Drug Administration (FDA) and the U.S. Department of Health and Human Services (HHS) have regulations pertaining to COI, and they have some different features, she notes.

"The more stringent one is HHS because they fund a lot of research through the National Institutes of Health," she adds. "That's what most investigators adopt to cover all research at their university, and that's the policies we've had in place since 1995."

Research institutions like the University of Iowa now need to revisit and revamp these dusty COI policies since HHS has proposed some big changes in COI regulations, Talman says.

The proposed changes have had two comment periods so far, and substantial changes are expected to be made final sometime this summer.

One major proposed change would reduce the disclosure burden from a per study basis to an annual basis.

"They're moving from a per-project to annual disclosure, and the thresholds are lower," she says.

"That will help us dovetail with what our medical center has been doing for the past two years," Talman says. "At the beginning of the year, researchers would have a two-month period to disclose what their outside interests are, including intellectual property, and so on."

The research institution would need to evaluate that information based on what the researcher's study portfolio contains to look for conflicts of interest, she adds.

Talman worked on a committee on conflict of interest with the Association of Academic Medical Colleges. A number of organizations like AAMC have had suggestions for HHS about the proposed changes. (See best practice suggestions for preparing for changes, below.)

Expert's suggestions for COI policy best practices

Proactive disclosure works well

Research institutions have conflicts of interest (COI) policies that likely will need to change when new regulations are rolled out from the U.S. Department of Health and Human Services (HHS).

As they prepare for these changes and increased regulatory burden there are some best practice strategies they could follow, suggests Charlotte Talman, MSN, MBA, director of the conflict of interest office in the office of the vice president for research at the University of Iowa in Iowa City, IA.

Here are some of Talman's suggestions:

• Merge clinical care and research COI policies and procedures: "We're merging our whole system at our medical center and our research system so that everyone only has to do one disclosure form per year," Talman says. "They have to update it if something changes, but it's one-stop shopping."

Talman and her counterparts at the institution's medical center are working together to write a web-based form that cover both side's COI policies and procedures.

"We have 7,000 to 8,000 disclosure forms a year that will come to us, and that's a lot," Talman says. "When I see that somebody has submitted a grant proposal seeking funding and I look at the list of names involved in that research, we have to either manually or automatically make sure there's a disclosure form on record for them."

An electronic and merged system will lessen the administrative burden, and the merged system will make the process far more efficient for clinician researchers.

"I don't want researchers to have two disclosures," Talman says. "I want to make it more efficient and user friendly because it's too confusing otherwise."

• Address the perception of COI, as well as the actual conflicts: "A negative perception of a conflict of interest can be just as damaging as if there were actual bias on the research," Talman says. "The name of the game is transparency."

Proactive disclosure is a good policy.

"When we manage what we view as a conflict of interest in research, our usual management plan is to tell everyone, including students who work in the lab, participants, readers of publications and presentations," Talman says. "Explain that you have a consulting agreement with a company that has some interest in the research results, and then they can make up their minds."

For example, one change would be that the NIH requires institutions to disclose any compensation from outside interests in excess of $5,000, which is half of the current $10,000 threshold, Talman says.

"We question the $5,000 threshold," she adds. "It seems arbitrary."

The proposed regulations would impact researchers who have an issued patent.

"Anyone who has an issued patent creates in the eyes of the federal government a financial interest related to research," Talman says. "Not a lot of those issued patents go on to be commercialized or licensed: 95% never get picked up to be commercialized and do not earn money for anyone, so why do they base this on issued patents?"

Instead it should be based on patents that are licensed, she adds.

The question is whether HHS is correctly interpreting its COI goal of preventing the possibility of introducing bias in research based on a conflict of interest.

"If you have some technology that has been patented, and you're using that technology in your research then that could create bias in how you interpret the findings," Talman says. "You could introduce bias into your research because you slant the findings toward making your patent look more favorable."

Then if the patent is licensed, the investigator or research institution would receive revenue from it. But if it's not licensed, maybe it will suffice to disclose the conflict, she adds.

The proposed rules would increase the amount of information that research sites send to the NIH when they have a conflict of interest, Talman says.

"Currently we provide a minimal amount of information to them, but now it's hugely changed, and the amount has increased, putting a big burden on research institutions," she says. "This will require four times the amount of information we currently have to give them, and that's a real drain on institutions when everyone is hurting financially and we can't hire more staff."

Also, the proposed rules would require mandatory training on research COI every two years.

"That's a pretty big change," Talman says. "Every two years every person who has a key role in research must be up to date on their COI training."

Public disclosure of COI also takes on new meaning in the proposed rules.

"The other big change is that the information needs to be publicly available on the Internet and posted on the Web, so it's really public disclosure," Talman says. "Even posting information on the Internet puts a huge burden on institutions."

Research institutions will have to develop a system for posting the COI information, updating it, and providing context.

"You can't just add another web page, and we're not going to be funded to do that," Talman says.