Research subjects and patients may wish to show their thanks in any number of ways. For one male physician, that gratitude came in the form of a Mikimoto pearl necklace, a treasure that, at least online, can cost more than $100,000, depending on style and features.
But it wasn’t just the value of the necklace that got Craig Conway’s attention.
For Conway, associate vice president for institutional compliance at the University of Texas Medical Branch (UTMB), it was also that the patient came from a culture whose members would feel deeply insulted were the pearls to be returned.
“We were in a predicament where we couldn’t really give them back,” said Conway, but the physician keeping the pearls also would have gone against UTMB’s gift policy and possibly may have violated Texas law.
Conway, whose duties include managing both research and institutional conflicts of interest (COI), discussed the pearls in the context of a larger presentation on managing COIs, as part of HCCA’s Research Compliance Conference. The event was held virtually this year from June 1-3. HCCA is the publisher of RRC. Following the presentation, Conway also responded to follow-up questions from RRC.
While he discussed some details of UTMB’s policies, Conway also provided strategies to boost compliance, including a framework for how to assess the seriousness of COI policy violations and better match up sanctions that could be imposed.
The pearl necklace story might have a lighthearted aspect to it, but as the research compliance community has recently witnessed, the issue of violating COI-related requirements has become an urgent matter due to recent failures to disclose foreign research support.
NIH is currently investigating some 400 researchers, and has determined that of the approximately half it has probed in more detail, 70% had an undisclosed foreign grant, and 54% had failed to disclose support from the Chinese government’s Thousand Talents Program. A number of investigators are facing criminal charges as a result. Some organizations, such as Memorial Sloan Kettering Cancer Center, have experienced the resignations of top officials over COI violations.
Multiple Policies Address COIs
UTMB’s gift policy, Conway said, is combined with ethics and is just one of five COI policies. Other policies address:
• Research-related COIs
• Individual COIs
• Interactions with industry sponsors
• Vendor/purchasing disclosures
• Federal reporting and disclosure laws, such as the Physician Payments Sunshine Act
But this was not always the case, said Conway. When he arrived 10 years ago, UTMB had two “substantive policies pertaining to COI,” which were a combined ethics and gifts policy and a research COI policy, “but we didn’t even have a COI committee,” and the policies were separately managed by different departments.
Foundational to any COI discussion is an understanding of what constitutes a COI. While noting there are a number of definitions of a COI, Conway said he prefers the University of Florida’s (his alma mater), which defines it as “when an individual’s financial, academic, professional, commercial or personal interests or activities outside of the institution affects, or appears to affect, their professional judgment or obligations to the institution.”