Three Components of a Comprehensive COI Program
While conflicts of interest - perceived or real - cannot be eliminated, proper oversight and effective internal controls can help protect institutions and researchers.
Universities and academic medical centers operate in an increasingly complex regulatory and ethical climate surrounding conflicts of interest (COI). Specifically, within the context of an institution’s research mission, financial COI is governed by the Public Health Service (PHS)1 and the Food and Drug Administration (FDA)2. These regulations address objectivity in research, requiring that institutions and investigators identify, manage and mitigate COI; however, complying with these rules as well as addressing broader ethical concerns can be challenging.
Complying with increasingly complex regulations as well as addressing broader ethical concerns can be challenging.
Implementation of the Physician Payments Sunshine Act (Sunshine Act)3 in 2013 added a new layer of complexity to the research COI environment, requiring applicable pharmaceutical and medical device manufacturers and group purchasing organizations to disclose financial payments to physicians and teaching hospitals. Disclosures made under the Sunshine Act are publicly searchable in the Open Payments database maintained by the Center for Medicare and Medicaid Services (CMS), providing a massive amount of data to interested third parties. Institutions have struggled to respond to the Sunshine Act due to the difficulty reconciling disparate PHS, FDA and CMS regulations while often being unable to compel physicians to dispute inaccurate reports.
This complex regulatory environment and recent developments impacting government agencies and institutions highlight the need for institutions to manage real and perceived COIs. To proactively address these challenges, institutions should consider three key components of a COI program:
- Create a COI infrastructure designed to minimize administrative burden on disclosers and provide streamlined, consistent management of COI. This infrastructure includes aligning disclosure requirements across applicable federal and state regulations and institutional policies when possible and minimizing disparate disclosure requirements and disclosure frequency. Also, avoid spreading COI responsibilities across multiple offices or systems, as singularity provides a clear line of sight into potential risk areas and allows tracking and trending of disclosures for simplified mitigation strategies. Finally, develop institutional guidelines for managing common types of COI and reporting COI to governing bodies. Guidelines promote consistent application of policies and procedures and simplify executive reporting lines.
- Engage faculty and researchers to promote understanding of and compliance with COI requirements. Establish training that provides easy-to-follow guidance on disclosure submission and reviews recent COI enforcement activity. Position your program as a partner in protecting an investigator’s career and identify a high-level faculty sponsor for the program. The faculty sponsor should serve as a COI program representative, providing input into processes and facilitating peer follow-up for delinquent disclosers. Additionally, it’s important to create messaging that promotes an understanding that holding financial interests or COI is not inherently unethical. Disclosure and transparency around financial interests should be emphasized as key components of ethical research.
- Harness the influence of administrators to enhance the COI program, using administrators' connection to research to improve the perception of the COI program. Educate administrators on the significance of accurate and timely disclosures. Much like faculty education, administrators should understand the impact that incorrect handling of COI can have on an investigator or research program. Be sure to encourage ownership of COI disclosures by administrators. Incentives encourage administrators to facilitate faculty disclosures and promote compliance. Additionally, create formal and informal feedback loops to engage administrators with COI staff. Provide and publicize multiple communication mechanisms to obtain feedback, update COI staff and allow for anonymous reporting.
While conflicts of interest – perceived or real – cannot be eliminated, proper oversight and effective internal controls can help protect institutions and researchers. Contact one of Huron’s COI experts here.
1. 45 C.F.R. § 50.604 Subpart F – Promoting Objectivity in Research; 45 C.F.R. § 94 – Responsible Prospective Contractors.
221 C.F.R. § 54 – Financial Disclosure by Clinical Investigators.
3Patient Protection and Affordable Care Act § 6002.Contact Us