Financial Conflict of Interest: Policy and Procedures

New & Notable

Understanding and navigating the issues that arise when investigators acquire research related financial interests could be daunting for a new, or even experienced, investigator. Investigators seeking information about disclosure and management of research related conflicts of interest may find it useful to review a new table, Summary of Research Related Conflict of Interest Forms. The table lists forms and online applications, explains how and when to disclose financial interests, and gives definitions of relevant terms. A recent presentation on Managing Financial Conflicts of Interest in Research - Promoting Research Objectivity and Maintaining Public Trust is also available for investigators needing further clarification. Questions about research related financial interest disclosure should be sent to fcoi@purdue.edu.

New Financial Conflict of Interest Requirements for Proposals Submitted to the National Science Foundation (NSF)

The new NSF Proposal & Award Policies & Procedures Guide, effective for proposals submitted, or due, on or after February 24, 2014, includes an addition to the Certification Regarding Conflict of Interest (Chapter II.C.1.e, Proposal Certifications). Currently, NSF requires institutions to report to the agency project related conflicts of interest that cannot be managed or eliminated.  The new regulations require institutions to also report conflicts that are identified a posteriori, when NSF sponsored research has been conducted for which an existing conflict was not properly disclosed, identified, and managed (i.e., “research that proceeds without the imposition of conditions or restrictions when a conflict of interest exists, must be disclosed to NSF via use of the Notifications and Requests Module in FastLane”).

Action required: Investigators on current and pending NSF research awards are required to review and update their research related Significant Financial Interest disclosures, as needed. Financial interests acquired since the beginning of an ongoing NSF sponsored project, or proposal submission to NSF, must be disclosed or updated using the Proposal Driven Disclosure online application (please review the procedures for adding a new SFI disclosure), before the new rules take effect on February 24th, 2014.

Financial Conflict of Interest Requirements for NIH/PHS Proposals and Grants

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 (http://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.

Click to read Definitions of terms and Purdue’s procedures to implement the requirements of Policy III.B.2.

Integrity

Regulatory

Contact Information

Howard Zelaznik
Phone: 49-63824

Voichita Dadarlat
Phone: 49-61763