Tools, Resources, Guidance, and Procedures

Tools and Resources

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, entrepreneurs, students, and administrators seeking information about disclosure and management of research related conflicts of interest may find it useful to review the resources listed below.

Guidance

Researchers/Investigators

Guidelines for Writing a Complete Statement of Work, Corresponding Budget, and Budget Justification

Managing Financial Conflicts of Interest in Research - Promoting Research Objectivity and Maintaining Public Trust
A presentation with definitions and examples available for Investigators needing further clarification on research related FCOI management

Administrators/Leaders

Management of Conflicts of Interest and Commitment: a Shared Responsibility

Faculty, staff, and students mixed entrepreneurial teams

Ethical Principles and Considerations for Mixed Entrepreneurial Teams

Entrepreneurs, Inventors, and Innovators

A Significant Financial Interest (SFI)

A Significant Financial Interest (SFI) is a Financial Interest held by an Investigator and/or an Investigator's Dependent(s) that reasonably appears to be related to the Investigator's Institutional Responsibilities and that consists of one or more of the following:

Remuneration (including salary, consulting fees, honoraria, paid authorship and travel reimbursement) received from a publicly traded company during the twelve-month period preceding the date on which an Investigator is making a disclosure, and/or an Equity Interest held in such publicly traded company, if the aggregate value of such remuneration, plus the value of the Equity Interest as of the date of disclosure, exceeds $5,000.
Remuneration (including, but not limited to, salary, consulting fees, honoraria, paid authorship and travel reimbursement) received from a non-publicly traded company during the twelve-month period preceding the date on which an Investigator is making a disclosure, if the remuneration exceeds $5,000.
More than five percent Equity Interest or ownership in a publicly traded company or business.
Any Equity Interest in a non-publicly traded company or business, regardless of value.
Any Intellectual Property Rights, regardless of value, upon receipt of income related to such rights and interests.
When applied to sponsored project applications (proposals) submitted to and/or awards received from PHS agencies, any reimbursed or sponsored travel (i.e., travel that is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available), provided that the travel is not reimbursed or sponsored by a federal, state or local government agency, an institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center or a research institute that is affiliated with an institution of higher education.*

Significant Financial Interest does not include:

An Employee's salary, royalties or other remuneration received from the University and/or the Purdue Research Foundation, or, in the case of Investigators who are not Purdue Employees, salary, royalties or other remuneration from their primary employer.
Income from seminars, lectures or teaching engagements sponsored by a federal, state or local government agency or an institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center or a research institute that is affiliated with an institution of higher education.*
Income from service on advisory committees or review panels for a federal, state or local government agency or institution of higher education as defined at 20 U.S.C. 1001(a), academic teaching hospital, medical center or research institute that is affiliated with an institution of higher education.*
Income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles.
For Investigators who are not University Employees, any ownership interest in their primary employer held by the Investigator.

* Note: DHHS/PHS/NIH has issued a clarification of the definition of Significant Financial Interest (Notice Number: NOT-OD-18-160, Release Date: March 30, 2018) to specify that the definition in the FCOI regulation refers to exclusions of American Institutions of higher education (as defined in 20 U.S.C. 1001(a)) or a U.S. federal, state, or local government agency.

Therefore, Investigators, including sub-recipient Investigators, must disclose all financial interests received from a foreign Institution of higher education or the government of another country (which includes local, provincial, or equivalent governments of another country).

Dependent

An Employee's spouse or unemancipated child(ren), including stepchildren and adoptees, under the age of 18, or anyone who receives more than one-half of his or her financial support during a year from an Employee.

Financial Conflicts of Interest (FCOI)

Situations where an Employee's Financial Interest (including an Investigator's Significant Financial Interest, where applicable) compromises, or could appear to compromise, his or her judgment or ability to carry out the Institutional Responsibilities associated with his or her appointment or employment. A Financial Conflict of Interest may take many forms, but in general arises when an Employee in a relationship with an outside person or organization is in a position to influence the University's business, research or decisions in ways that could lead directly or indirectly to financial gain for the Employee or the Employee's Dependents or could give an improper advantage to others to the detriment of the University.

When applied to an Investigator, Financial Conflicts of Interest occur in situations in which such Investigator's Financial Interest (including Significant Financial Interest) compromises, or could appear to compromise, his or her professional judgment regarding the design, conduct or reporting of research or if such Financial Interest (including Significant Financial Interest) could directly and significantly affect the design, conduct or reporting of research. The bias such conflicts may conceivably impart not only affects collection, analysis and interpretation of data, but also the hiring of staff, procurement of materials, sharing of results, choice of protocol, involvement of human participants and the use of statistical methods.

Financial Conflicts of Interest also include the use of University facilities, personnel, equipment, IT Resources (as defined in the policy on IT Resource Acceptable Use (VII.A.2)), confidential information or other resources for purposes that could lead directly or indirectly to financial gain for the Employee and/or his or her Dependents.

Financial Interest (FI)

Any interest that will, could or is intended to lead to a profit or an ascertainable increase in the income or net worth of an Employee, Investigator and/or a Dependent. Such a profit or increase in income or net worth could be realized through the receipt of anything of monetary or potential monetary value, including, but not limited to, payments of any kind (e.g., salary, consulting fees, honoraria, gifts, dividends, distributions, rent, paid authorship, etc.), Equity Interests, an increase in the value of real estate or Equity Interests, or Intellectual Property Rights.

Institutional Responsibilities

An Employee or Investigator's professional responsibilities on behalf of Purdue, including, but not limited to, activities such as research, research consultation, teaching, professional practice, institutional committee memberships and service on panels such as institutional review boards or data and safety monitoring boards. Institutional Responsibilities are those activities that fall within the scope of Total University Effort as defined in the policy on Effort Reporting (II.C.1) and which are not Reportable Outside Activities as defined in the policy on Conflicts of Commitment and Reportable Outside Activities (III.B.1).

Investigator

A project director, a principal investigator of a research project and any other person, regardless of title or position, who is responsible for the design, conduct or reporting of research or project results at or involving Purdue, including Employees, subgrantees, contractors, subcontractors, collaborators and consultants. In general, any individual specifically named in a proposal and any individual identified in a report to the project sponsor or scholarly publication who is responsible for the design, conduct or reporting of research or project results is an Investigator for the purposes of this policy.

Regulatory Committee

Any University committee or board with regulatory oversight responsibilities, such as Institutional Review Boards, the Purdue Animal Care and Use Committee, the Institutional Biosafety Committee and similar boards or committees.

Responsible Official (RO)

The Responsible Official for Research-Related Financial Conflicts of Interest, who is appointed by the Office of Research to oversee the receipt and review of disclosures of Significant Financial Interests related to (i) proposing, conducting or reporting of Purdue research or scholarship, (ii) research regulatory compliance and (iii) commercialization of Purdue's intellectual property and the management of real or potential Financial Conflicts of Interest arising from these disclosed Significant Financial Interests.

Frequently Asked Questions (FAQs)

Who is Responsible for Managing FCOI?

Responsibility of all employees of Purdue University

All employees of Purdue University are required to disclose, as required by the University Policy on Individual Financial Conflicts of Interest, any and all Financial Interests that he, she or a Dependent has in University activities or transactions. Such disclosures must be made as far in advance of the contract, purchase, procurement, investment or loan as possible and may be made on an annual basis with respect to particular types of contracts or purchases of goods or services that the University makes on a repetitive basis from a particular vendor.
Upon request by the COI Officer, confirm the accuracy of and sign each Conflict of Interest Disclosure Statement prepared by the COI Officer for transmittal to the Board of Trustees and the Indiana State Board of Accounts.
Comply with the requirements of any management or mitigation plan approved by the Conflicts Committee.

How do I add a new SFI Disclosure in the Proposal Driven Disclosure online application?

If you are a Purdue employee who has previously been identified as an Investigator on a research proposal submitted to an external sponsor, you can add a new Research Related Significant Financial Interest Disclosure (RRSFID) in the Proposal Driven Disclosure (PDD) online application, by logging into the PDD (using your Purdue career account credentials) at:

https://webapps.ecn.purdue.edu/VPR/PDD

Once logged in, at the top of the webpage you will see two tabs, My Proposals and My Disclosures. Please click on the My Disclosures tab; you will be taken to your Disclosures page headlined:

My Disclosures

At the top of that page, you will see a list of your Research Related Significant Financial Interests (if you already have disclosed SFIs) and a link (in blue text), “Add New Research Related Significant Financial Interest Disclosure”. Click on the (blue) link and you will be taken to a blank RRSFID form. Please fill out all the required fields, sign the form using your career account credentials, and then click on the “Add Disclosure and Submit Signature” button at the bottom of the page. One RRSFID Form must be completed for each entity in which the Investigator has a Significant Financial Interest. Should you need to fill out more than one disclosure form, please repeat the process by clicking again on the link “Add New Research Related Significant Financial Interest Disclosure”.
If you are a new Purdue Employee or have never been an Investigator on a Purdue proposal submitted to an external sponsor, please send an email message to fcoi@purdue.edu with your request to be added to the PDD application. Once you receive an email confirmation that you have been added to the system, please follow the steps outlined in 1) above.

When you finish completing your disclosure(s), you can review your portfolio of proposals by clicking on the My Proposals tab at the top of the page.

When you complete your work, please logout by clicking on the Logout button at the upper right corner of the webpage.

I am a member of the public. How do I request information about Significant Financial Interests disclosed to Purdue?

Public Request for Information

Public Health Service regulations require that Purdue University respond in writing, within five business days, to any request for information concerning any significant financial interest disclosed to Purdue that meets all of the following criteria:

The significant financial interest was disclosed and is still held by the senior/key personnel associated with a Public Health Service grant or contract; and
Purdue determines that the significant financial interest is related to the Public Health Service-funded research; and
Purdue determines that the significant financial interest is a financial conflict of interest.

Requests for information concerning significant financial interests related to Public Health Service grants and contracts awarded to Purdue University should be addressed to Purdue University's Responsible Official for Research-Related Conflicts of Interest and sent to one of the following addresses:

If by U.S. or express mail to:
      Chris Agnew
      Responsible Official
      Purdue University
      Hovde Hall
      610 Purdue Mall
      West Lafayette, IN 47907-2040

If by facsimile to:
Chris Agnew
      Responsible Official
      Purdue University
      765-496-3824

If by e-mail to: fcoi@purdue.edu
Subject line should state: Request for Information on Significant Financial Interest

Procedures

Procedures for Disclosure of Research Related Significant Financial Interests

Questions?

Questions about:

Research related financial interests – EVPRP: fcoi@purdue.edu
Financial interests in purchasing/procurement – VPEC: vpec@purdue.edu
IP disclosure and licensing – PRF/Office of Technology Commercialization
New Start-up companies – Purdue Foundry
Financial interests in research with Human Subjects – IRB