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Managing COI and foreign influence in research: strategies for success

Tully Saunders (tusaunders@deloitte.com) is a Manager at Deloitte & Touche LLP in the Boston, MA, office. Grace Jodhan (grace.jodhan@ynhh.org) is Compliance & Privacy Officer for Greenwich Hospital and Senior Compliance Specialist at Yale New Haven Health, and Tanya M. White is System Compliance Operations Officer, L&M Compliance & Privacy Officer at Yale New Haven Health in New Haven, CT.

Conflict of interest (COI) and foreign influence in research issues have recently affected prominent healthcare and academic institutions. The subsequent news coverage, investigations, and high-level resignations are a call to action for organizations to review their COI programs and learn from these public failures. Here we offer eight strategies to consider to strengthen current COI programs and advance objectivity and legality in clinical care, research, and business decisions.

Healthcare and academic COI programs are charged with identifying; reviewing; and, as appropriate, managing potential COI and foreign influence for employees and the organization. While regulation exists around COI requirements, including research funded by the Public Health Services (PHS),[1] disclosure of investigator interests to the FDA,[2] and IRS requirements around 501(c)(3) status and related Form 990, COI-related risks are also reputational. As witnessed particularly over the past two years, organizations are hindered when patients, payers, vendors, donors, and the public do not have confidence in their ability to make unbiased, ethical decisions.

The following strategies can be considered to better identify and mitigate potential conflicts and influence to meet the standards and expectations of regulators and the patients and communities your organization serves.

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