Financial Conflict of Interest (FCOI) in Research

by Zoya Davis-Hamilton on Tuesday, February 28, 2017

Existing federal regulations regarding the financial conflicts of interest (FCOI) of investigators require reporting on such conflicts to promote accountability, add transparency, enhance compliance and improve oversight on the institutional level. The regulations establish standards that provide a reasonable expectation that the design, conduct and reporting of research will be free from bias resulting from investigator financial conflicts of interest. 

This month we asked our fellow research administrators how their institutions manage and administer FCOI in research and how their institutions meet the public accessibility mandate. To contextualize our results, we also asked survey participants to let us know at what kind of institution they work. This anonymous survey was distributed to the subscribers of the RESADM-L listserv.

The survey was open between January 6th and January 20th, 2017 and collected 102 responses. Below, we describe what we have learned from our colleagues.

Survey Participants
The majority of respondents (70%) reported working at a university, with a smaller number working at a hospital (14%), a nonprofit organization other than a university or hospital (9%), and a research institute (7%). One response came from an employee of the Federal government. It is possible given the survey design that individual institutions may be represented by multiple respondents.

FCOI Management
The management of FCOI is split fairly evenly among our respondents’ institutions. About half of the survey respondents’ institutions manage FCOI as part of the overall management of conflict of interest institution-wide. The other half manages FCOI separately from other kinds of conflicts of interest. "Other" responses included “unsure” and “hybrid of research disclosures pulling in already disclosed business conflict information.”

Software
The use of software to manage FCOI was also a nearly even split across institutions. Close to half of the institutions (45%) reported using software for FCOI management, while the other half (50%) do not. Most responses from the remaining 5% indicated that systems are being purchased or are in development.

We further asked those survey participants that use software to let us know whether it is commercially available or homegrown. Once again, the responses were almost equally split: 49% developed an internal solution at their institution, and 51% use software that is commercially available. In many instances, those that had commercially-available software, it had been customized for use at their institution. Software that was named included Kuali COI module, COI Smart, Click Commerce suite, eDisclosure, Osperey, Infoed, Qualtrics and Surveymonkey, Key Solutions, RAMSeS, Compliance 360 and an unnamed Huron Consulting software. Additionally, respondents noted that they utilize CITI training available online in FCOI management.

Administration of FCOI disclosures
We asked the survey participants how they administer FCOI disclosures. About 66% administer them annually and require a disclosure when there is a change in financial conflict of interest circumstances of the investigator. The same number of responses (although not necessarily the same respondents) stated that their institutions require the disclosures at the time of each proposal submission, with one reporting limiting additional disclosures to those proposals submitted to PHS agencies. No other modes of administration were noted, indicating that 36% of the survey participants utilize a single FCOI administration avenue (whether annually and at the time of submission, or at the time of each proposal) and the remaining institutions use both avenues.

Meeting public accessibility mandate
Finally, we asked about how institutions meet the FCOI public accessibility mandate. Most of the respondents (42%) were not sure how their institutions meet the mandate, with one response indicating that requests for information would likely be handled under the state’s open record request law. Thirty-seven percent of responses stated that a written response would be provided in response to information request within five business days. Twenty percent maintain information on publicly accessible website.

Conclusion
Our colleagues’ responses point to two major approaches to most elements of managing FCOI. Be it managing of the FCOI with or separate from other conflicts, using software, administration of disclosures to investigators, and meeting public accessibility mandate, the results were largely an even split.

The Pulse is written by Zoya Davis-Hamilton, Director, Research Administration Initiatives, and Sarah Marina, Assistant Director, Offices of Research Development and Administration, at Tufts University. We will continue to check the “pulse” of research administrators on various topics periodically. 

If you have any topics or questions that you want to see addressed in Pulse in the future, please let us know. Send feedback, ideas, questions and inquiries to Zoya Davis-Hamilton at zoya.hamilton@tufts.edu.


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