PHS/NIH Financial Conflict of Interest Requirements

New requirements for disclosure of Significant Financial Interests associated with University Responsibilities by investigators on proposals submitted to, and awards funded by NIH and other Public Health Service agencies, and for management and reporting of resulting financial conflicts of interest have been in effect since August 24, 2012.  Purdue’s Policy on Individual Financial Conflicts of Interest (Policy III.B.2) has been revised to address these new requirements.

The full text of the new regulation titled “Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought and Responsible Prospective Contractors,” which was published in the Federal Register (Vol. 76, No. 165, August 25, 2011), is available via a link on the NIH Conflict of Interest homepage (https://grants.nih.gov/grants/policy/coi/index.htm).

This regulation includes changes to the responsibilities of project Investigators, the grantee Institution (Purdue), and the PHS agency sponsor (such as NIH).

New requirements resulting from this regulation include:

1. a modification to the definition of “Significant Financial Interest” resulting in an expansion of the information that must be disclosed by Investigators,
2. a requirement for completion of a tutorial on financial conflict of interest by all Investigators before they begin to work on an NIH/PHS-funded project,
3. an increase in the information that must be reported to the PHS agency sponsor and made accessible to the public when a conflict of interest is identified,
4. an increase in Purdue’s responsibilities for oversight of subgrantee disclosure of Significant Financial Interest and management of conflicts of interest, and
5. more explicit requirements for institutional response to Investigator non-compliance.

Links to a summary of the requirements of the new regulation and to NIH’s FAQs are also available on the NIH Conflict of Interest homepage.