Conflict of Interest - Research*

Institutional responsibility regarding conflicting interests of investigators
Listed below are the basic, mandatory requirements for institutional management of potential conflict of interest for research investigators.
Requirement	Description	Location
Written policy on financial conflicts of interest.	Maintain an appropriate written, enforced policy on conflicts of interest.	Fed. Reg: 42 CFR §50.604(a)

Designation of institutional Official	Designate an institutional official to solicit and review financial disclosure statements from each investigator planning to or participating in Public Health Service (PHS) funded research.	Fed. Reg: 42 CFR §50.604 (b)

Submission of Significant Financial Interests ("SFIs")	Require each PHS-funded investigator to submit list of known SFI's - either individual or entity (including spouse and dependent children) - which would reasonably be affected by the research by time of application.	Fed. Reg: 42 CFR §50.604 (c)

Provide Guidelines and Mitigation	Provide guidelines for designated official(s) to identify conflicting interests.	Fed. Reg: 42 CFR §50.604 (d)

Maintenance of Records	Maintain records of all financial disclosures and all actions taken for three years from date final expenditures report submitted or as otherwise required by 45 CFR §74.53.	Fed. Reg. 42 CFR §50.604 (e)

Enforcement Mechanisms and Sanctions	Establish adequate enforcement mechanisms with serious incentives to encourage compliance with federal and state law and university policy.	Fed. Reg. 42 CFR §50.604 (f)

Certification and Information Provisions in Each Application	Certification that there is a written and enforced administrative process to identify, manage, reduce or eliminate conflicting interests for all PHS-funded projects.	Fed. Reg. 42 CFR §50.604 (g)

Management of Conflicting Interests	Designated official must review all financial disclosures to assure consistency, accuracy and uniformity.	Fed. Reg. 42 CFR §50.605 (a)

Remedies	Once PHS-funded research has been biased; the institution must promptly notify the PHS awarding component of corrective action taken or to be taken.	Fed. Reg. 42 CFR §50.606 (a)
* The University of Texas System Administration is currently developing a comprehensive system (policy, procedures and an e-solution) to enable all 15 campuses to increase transparency and accuracy of reporting and managing potential conflict of interests.