Policy and Procedures
1. Investigators submitting a proposal to an external sponsor:
When a principal investigator begins to work with an SPS Pre-Award Specialist on a proposal to an external sponsor, they will be asked to identify all Investigators for their project. The names of these Investigators will be entered into the EVPRP’s Proposal-Driven Disclosure application, which will send individual emails to each Investigator asking them to disclose Significant Financial Interests associated with their University Responsibilities held by the Investigator and/or their Dependents. If the proposal is to be submitted to NIH or another PHS agency sponsor, the disclosure of Significant Financial Interests must also include reimbursed or sponsored travel associated with University Responsibilities provided by certain third-parties (see definition of SFI above). This disclosure of Significant Financial Interest must be submitted prior to submission of the proposal to the sponsor.
For proposals to NIH or other PHS agencies, the email message will also remind the Investigator of the requirement to complete a Tutorial on Financial Conflict of Interest before they participate in an NIH/PHS-funded project.
Investigators who are not Purdue employees, but are associated with Purdue proposals to external sponsors will be asked to complete interactive web-based forms for Disclosure of Significant Financial Interests (and for proposals to NIH/PHS agency sponsors, Disclosure of Reimbursed or Sponsored Travel). Once completed, these forms should be submitted to firstname.lastname@example.org as email attachments.
Disclosed SFIs (and sponsored/reimbursed travel) will be reviewed by Purdue’s Responsible Official for Research-Related Conflicts of Interest to identify financial conflicts of interest. The University will not accept grants or contracts that give rise to a financial conflict of interest unless the conflict can be eliminated or appropriately managed through administrative oversight. If a disclosed SFI creates a manageable conflict of interest, the Responsible Official will work with the Investigator to develop a Management Plan which will be implemented in the event that the project is funded by the external sponsor.
Purdue will comply with all reporting responsibilities imposed by Indiana or federal laws or regulations with respect to Significant Financial Interests that have been disclosed. The University will comply with all federal and state statutes and regulations requiring public access to disclosed individual Significant Financial Interests and Financial Conflicts of Interest; however, the University will maintain the specific fiscal details of disclosed Significant Financial Interests and Financial Conflicts of Interest as confidential information to the extent allowed by applicable laws or regulations.
Required Financial Conflict of Interest Education for NIH/PHS Investigators
Before participating in NIH/PHS-funded projects, all Investigators must complete a Tutorial concerning financial conflict of interest. Purdue Investigators may satisfy this requirement by completing the NIH FCOI Tutorial at: http://grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.htm. Upon completion of the tutorial, each Investigator should generate a Certificate of Completion and send a copy of this Certificate to email@example.com. Investigators who have not completed this brief online tutorial and sent their Certificate of Completion prior to the above date will not be able to participate in NIH/PHS funded projects until the tutorial has been completed.
2. Investigators submitting a protocol for research involving human subjects or living vertebrate animals:
When Principal investigators submit protocols to the Human Research Protection Program (HRPP) for research involving human subjects or to the Purdue Animal Care and Use Committee (PACUC) for research, teaching or testing involving living vertebrate animals, they should disclose Significant Financial Interests by responding to the relevant questions on the applicable protocol forms.
3. Voting members of University Regulatory Committees:
Voting members of Purdue’s Institutional Review Boards (IRBs), Purdue Animal Care and Use Committee (PACUC), and Institutional Biosafety Committee (IBC), should disclose to the respective Board or Committee chairperson any Significant Financial Interest (or personal or professional relationship) that may reasonably appear to be related to a protocol which is to be reviewed by the Board or Committee, and to recuse themselves from the review of that protocol.
4. Investigators associated with third parties commercializing Purdue intellectual property:
The Purdue Research Foundation Office of Technology Commercialization will inform the Responsible Official when a Purdue employee holds an equity interest in, serves as an officer for or otherwise is involved in a management role with a third party to which OTC is considering licensing University intellectual property. Upon such notification, the Responsible Official will contact the employee and determine whether the employee’s role in the third party creates a conflict of interest with respect to Purdue research activities and/or Institutional Responsibilities. If a manageable conflict of interest is identified, a Management Plan will be developed and implemented. Such Management Plans will require that when the employee is an Investigator, their Significant Financial Interest in the third party entity will be disclosed when proposals are submitted to external sponsors and when they seek approval for protocols involving human subjects and living vertebrate animals.