By Melinda Young, Author
A recent report that a top cancer researcher failed to disclose in journal articles millions of dollars in payments from pharmaceutical and other companies has shed a spotlight on the uneven way conflicts of interest are managed at research institutions.
A researcher at Memorial Sloan Kettering Cancer Center in New York City had not ensured his financial ties to drug companies were published in research articles in The New England Journal of Medicine, The Lancet, and other journals (https://nyti.ms/2OdkypY).
The researcher resigned on Sept. 13, 2018, saying in a resignation letter that he hoped this incident would result in the medical community developing a more standardized system for reporting industry ties (https://nyti.ms/2N4Ohwz).
Memorial Sloan Kettering Cancer Center (MSK) senior media strategist Nicole H. McNamara said the organization was unable to speak about the physician. McNamara referred IRB Advisor, via email, to information about the steps they have taken to create a task force that will assess the institution’s policies and procedures for reporting and managing outside activities and industry-supported clinical trials. The task force will review policies, procedures, and training on conflicts of interest (COI) and identify best practices, including monetary and commitment limits. (More information on the task force can be found at: http://bit.ly/2RdQjxF.)
The MSK incident has caused some institutions to revisit their own conflicts of interest policies and practices.
“We definitely took a look at our own program after hearing that news,” says Kara Manning Drolet, PhD, associate vice president in the Oregon Health and Science University (OHSU) research integrity office in Portland. Drolet also is the chair of the conflict of interest in research committee.
“This wasn’t a shock,” says June Insco, outside interests and conflict of interest manager in the office of regulatory affairs at the University of Michigan Medical School in Ann Arbor.
“Academic publications have been reporting on this issue quite a bit in the last couple of years,” Insco says. “We know it’s an ongoing challenge to have disclosures made in research institutions.”
Ensuring researchers adhere to an institution’s COI policies might be too challenging for a single IRB office. It is a task that needs dedicated oversight, review, and checking back with investigators to assess whether their information is accurate.
“The whole IRB system is based on the honor system,” says Charlotte Coley, MACT, CIP, education and training manager in the office of human research ethics at the University of North Carolina at Chapel Hill. “I used to have an IRB chair who said, ‘Trust, but verify,’” Coley says. “I tell board members what the red flags are for when something doesn’t look right.”
The regulations related to conflicts of interest might not change very often, but the guidance is more fluid. New advances in science and technology and societal changes can prompt an institution to reconsider its COI policies, Coley notes.
For example, researchers can patent their discoveries — even when these were funded by the National Institutes of Health (NIH) — to drug companies in exchange for royalties. This was not always the case, she says.
“And sponsors now are far more involved in the design of the study, and they want the data sent to them, and in the past wanted to control publication so if there is a negative result, they wouldn’t let the researcher publish it,” Coley adds.
These factors make COI rules important for checks and balances and to ensure participant safety. They also have made research institutions come up with stricter COI rules than they had previously. At the University of North Carolina, there is a $0 minimum beyond which researchers must report all funds and gifts. This means that even a pencil or notepad must be reported or not accepted, Coley says.
If researchers are paid to speak, this must be disclosed, she adds. “I remember years ago when drug companies would come in with lunches and give the residents reference books and do educational sessions.”
Now, many medical and research institutions understand that even accepting a pen makes a person feel beholden to an institution, Coley says.
“There really is no such thing as a minimum amount that won’t make you feel an obligation,” she adds. “So I give out pens with our IRB’s name, so now researchers have no excuse not to call us with questions, and they can accept these because we’re all part of the same family.”
OHSU also prohibits gifts from vendors and pharmaceutical companies. “Researchers have to disclose all of their outside activities,” Drolet says.
When a researcher is inconsistent with COI disclosures, this could be intentional or just confusion. “In his mind, something may be minimal or small or not important and not what he thinks is a conflict of interest,” Coley says. “And when you’re working with people, they become friends, and you trust friends.”
One way to add consistency to the review of conflicts of interest is to delegate COIs that hit a certain institutional threshold to a conflict management plan.
“When we have someone on a research study that is somewhat related to a financial interest of the investigator, and if that interest is worth $5,000 or more or if they have equity in the company, then we will impose a conflict management plan for the research study,” Insco says. “This puts requirements in place, depending on the nature of the conflict and nature of the research.”
Consulting fees can be problematic, depending on the amount paid to the investigator. Research institutions should decide what amount is a threshold for what they would allow.
“If someone makes over $20,000 in consulting fees, we would not allow that person to be the principal investigator on a study unless there really are compelling circumstances,” Insco says. “If it’s $5,000 to $20,000, they could be a principal investigator with a conflict management plan, which allows them to disclose to colleagues they have an outside interest.”
All members of the study team are subject to the same disclosure rules and conflict management plan policy, she says. (See story about managing COIs in this issue.)
Faculty members taking on the role of research sponsor for undergraduate students have to complete COI disclosures, Coley says.
“If a conflict of interest has changed, then they have lots of opportunities to update it,” she says.
What IRBs and researchers should keep in mind is that even the appearance of a conflict of interest can taint research, suggesting it could be biased, Coley explains.
“Maybe it’s excellent research, but anytime there’s an IRB situation or where someone calls in to question whether you did something right, it casts a shadow over the research, and people might dismiss it,” she says.
Coley reminds the IRB of the importance of following COI rules with regular educational updates on the subject.
“I do a 10-minute education session at the beginning of every IRB meeting, and conflicts of interest show up every now and then,” Coley says. “When we were preparing for our AAHRPP renewal, we had our conflicts of interest officer come in and do an hour presentation.”
At that time, there were a number of new board members, and the presentation helped them get up to date, she says.