May 13, 2019
BOSTON — Although there are plenty of horror stories about bad actors who manipulate investigations for their own financial gain, conflicts of interest can also be subtle and even unintentional.
And those potential conflicts aren’t always captured when reporting requirements are focused only on financial conflicts and the reporting thresholds set by government entities such as the FDA, HHS and NIH.
Instead, COI policies should require investigators and executives to disclose all external relationships, not just ones where the investigator received monetary compensation, said experts speaking at the 2019 MAGI East clinical research conference last week.
Focusing on conflict in relationships can be a “real cultural shift” for professionals used to thinking in terms of money,” said Katherine Cohen, research compliance director at MedStar Health. Cohen said MedStar has set its financial reporting threshold at zero in order to uncover some of those relationships that might not have been disclosed under a policy with a higher dollar amount.
“Even the appearance of a conflict can undermine subjects’ and the public’s confidence in research integrity,” said Quincy Byrdsong, executive director for research administration for the WellStar Research Institute. One way to avoid the appearance of conflict is to avoid having such relationships in the first place, Byrdsong and Cohen agreed.
Case in point: Memorial Sloan Kettering recently adjusted its COI policy after media reports surfaced that several of its top executives and board members had profited from relationships with drug companies, outside research ventures or corporate board memberships.
An internal review at the New York- and New Jersey-based cancer center concluded that hospital leaders’ ties to pharmaceutical companies were likely considered on an ad hoc basis rather than through rigorous vetting and that researchers were often unaware that some senior executives had financial stakes in the outcomes of their studies.
The organization made a number of changes to its COI policy, including barring executives from sitting on boards of pharmaceutical companies altogether.
But adopting relationship-based COI policies requires careful messaging, Cohen said, to encourage compliance with the rules and to avoid painting all relationships as a negative. “We don’t want to discourage people from having these relationships,” she said. “This is about transparency.”
Byrdsong agreed. “We can’t talk about disclosure of relationships the same way we talk about disclosure of [financial] conflict of interest,” he said.
Because they don’t always see relationships as conflicts, researchers may get defensive about disclosing them, Cohen said. “Plenty of our investigators don’t think this is our business,” she said, adding she does sometimes get pushback. But she’s firm about the rules: “It is my business and I do get to ask about it,” she told the audience.
Further, once you have a policy about disclosing relationships — or any other COI disclosure requirements — be sure to manage and enforce it consistently, Cohen added. All of your positive messaging could be undone if one investigator finds out she has a different management plan than a colleague with similar interests.
“Connections, relationships and other arrangements can result in conflicts, but with the right policies in place, they can be managed,” Byrdsong said.
-By Gienna Shaw