Procedures for NIH Notification of Financial Conflict of Interest

NIH requires grantees and investigators to comply with the requirements of 42 CFR Part 50, Subpart F, "Responsibility of Applicants for Promoting Objectivity in Research from which PHS funding is sought." This subpart establishes standards to ensure there is no reasonable expectation that the design, conduct, or reporting of research funded under PHS grants or cooperative agreements will be biased by any conflicting financial interest of the investigator.

Prior to the expenditure of any NIH funds awarded under a new award, organizations must inform the NIH grant management officer (GMO) of the existence of any conflicting financial interest.

To comply with this requirement, RSP staff will check the conflict of interest (COI) status of each investigator before accepting a new award. The COI Committee reviews Outside Activies Reports and determines when research management plans are required to eliminate the conflict of interest (http://www.grad.wisc.edu/research/policyrp/coi/index.html). The VCR COI committee maintains a database of the disclosure information and committee determinations.

For each situation where the RSP staff member finds that the PI has a management plan, RSP will notify the NIH through the NIH Commons FCOI function that the investigator has a Conflict of Interest that is being managed by the University. Any follow-up inquiries by NIH are directed to Kelly Ullrick, COI Program Manager.

For situations where NIH is the prime sponsor but funding flows through another entity, RSP will send a letter to NIH (or appropriate Sponsor in case of pass through dollars) stating the following:

As required by NIH policy (42 CFR Part 50, Subpart F), we are writing to notify you that the UW-Madison’s Conflict of Interest Committee identified a potential conflict of interest situation for the investigator named above and issued a management plan for this conflict.

UW-Madison’s Conflict of Interest Committee reviews financial disclosure information and issues management plans when it decides that an actual or potential conflict exists. These plans provide investigators with information and guidance for managing, reducing, or eliminating conflicts of interest in accordance with federal, state, and University policies and procedures. Management plans are reviewed and monitored by department chairs, directors, or deans. Standard management plan templates are posted to our web site, which also includes guidelines and procedures for faculty and staff.

General Information: http://www.grad.wisc.edu/research/policyrp/coi/index.html

RSP will copy Kelly Ullrick, who will forward the information to the COI Committee for updating of the management plan as needed.