Introduction and Summary

In August 2012, Carleton updated the College’s policy related to financial conflicts of interest (FCOI) to ensure compliance with the FCOI policy of the National Institutes of Health (NIH).

The College chose to conform to the NIH’s comprehensive policy because other federal funders either have adopted, or we expect they will adopt, standards similar to the NIH.

The full NIH statement on FCOI can be found on the Institutes’ website, as part of the 2011 PHS Regulations (42 C.F.R. Part 50, Subpart F); along with Frequently Asked Questions on FCOI, and additional information on NIH’s Financial Conflict of Interest page.

Key Elements

Carleton’s revised FCOI policy can be found below, but the key elements of the policy can be summarized as follows.

A project director (a.k.a. principal investigator) must disclose to the College all “significant financial interests” on his or her part and/or the part of his/her immediate family that include

• at least $5,000 of payments from and/or equity interests in publicly-traded entities, or

• any equity interest in non-publicly traded entities, or

• reimbursed or sponsored travel such as a conference trip paid for by a corporate sponsor.

Note that owning stock in a company does not by itself qualify as a significant financial interest, unless you are receiving more than $5,000 in payments from that company or the company is not publicly traded.

All interests related to a PD’s institutional responsibilities, not just his/her NIH (or other federal grant) project must be disclosed to the College, with two exceptions:

• Income from seminars, lectures, or teaching, and service on advisory or review panels for government agencies, institutions of higher education, academic teaching hospitals, medical centers, or research institutes 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.

The disclosure process can be initiated by completing the Compliance and Disclosure Form available at Corporate and Foundation Relations Forms & Templates page.

For further information, contact Christopher Tassava (x5833, ctassava) or Dee Menning (x4441, dmenning) in the Office of Corporate & Foundation Relations.

Policy

POLICY ON FINANCIAL CONFLICT OF INTEREST (FCOI)

FOR ALL FACULTY AND ACADEMIC STAFF APPLYING FOR CARLETON-ADMINISTERED FEDERAL GRANTS

As set by relevant federal regulations, including                                           

National Institutes of Health: Financial Conflict of Interest within NIH’s Policy & Compliance/Grants & Funding pages

National Science Foundation: Conflict of Interest Policies in PAPPG 18-1 Chapter IX-Grantee Standards

Federal Register, Part IV, DHHS, August 25, 2011: 42 CFR Part 50, 45 CFR Part 94

1. SCOPE

   The following statement of policy applies to each member of the faculty or academic staff (Investigator) applying for a Carleton-administered grant from a federal agency or foundation. The policy was developed in response to 1995 federal rules and revised to meet 2011 regulations that govern institutional and researcher responsibilities in identifying and monitoring conflicts of interest. By assuming this responsibility for themselves, colleges and universities may avoid outside monitoring and regulation by the federal government.

2. FIDUCIARY RESPONSIBILITIES

   Employees, officers, and members of the board of the College serve the public trust and have a clear obligation to fulfill their responsibilities in a manner consistent with this fact. All decisions of the board and officers of the administration and the faculty and academic staff are to be made solely on the basis of a desire to promote the best interests of the College and the public good. The College’s integrity must be protected and advanced at all times. College faculty or academic staff applying for grants may be involved in the affairs of other organizations. It is unlikely that an effective faculty will consist of individuals entirely free from at least perceived conflicts of interest. Although most such potential conflicts are and will be deemed to be inconsequential, everyone is responsible for ensuring that the College is made aware of situations that involve business relationships that could represent a conflict of interest with respect to an outside grant. Thus, the College requires that applicants for a grant of College-administered funds from a federal agency (1) review this policy; (2) disclose any possible business relationships that reasonably could give rise to a conflict of interest for the investigator and/or his or her spouse/dependent children; and (3) acknowledge by his or her signature that he or she is in accordance with the letter and spirit of this policy. In addition to making this statement at the time of application, investigators must renew this statement a) within 30 days of identification of a new conflicting interest, and b) annually for previously identified FCOI.

3. DISCLOSURE

   Faculty or academic staff are required to list on the Compliance & Disclosure Form only those substantive business relationships (in federal parlance, “significant financial interest”) that could directly affect the design, conduct, or reporting of federally funded research. “Significant financial interest” or SFI* includes any payments or equity interests in the 12 months preceding the disclosure that, when aggregated, exceed $5,000 in remuneration and/or in equity interest in any publicly traded entity AND/OR $5,000 in remuneration or any equity interest in a non-publicly traded entity that might affect the investigator or the research. In the event that a faculty member is uncertain as to the appropriateness of listing a particular relationship, the Provost, as Institutional Grants Administrator, should be consulted. This policy per federal guidelines applies to the investigators responsible for the design, conduct, or reporting of federally-funded research; and their spouses and dependent children. This policy also applies to subgrantee investigators. Conflicts of interest frequently are matters of degree and judgment, and the College expects faculty and academic staff to be alert to the possible effect of outside activities on the integrity of their decisions and on their ability to fulfill their obligations to the institution and/or to funding agencies. As potential or actual conflicts of interest arise, the Institutional Grants Administrator will determine which conditions or restrictions might be imposed to manage, reduce, or eliminate actual or potential conflicts of interest. Records of financial disclosures will be maintained for at least three years from the date of submission of final expenditures reports. The College will make conflict information available, upon request, to federal agencies. Under the federal regulations listed above, Carleton College has certain obligations related to financial conflict of interest:

• provide public accessibility: FCOI policy in Carleton’s Campus Handbook.
• inform investigators of regulation, institutional policy, SFI disclosure responsibility, training requirements. CFR will obtain and file signed Compliance and Disclosure Forms upon proposal submission to NIH, NSF, and other select federal agencies. The Dean’s office will email annual reminders for investigators to update their FCOI status and forward to CFR, and will track and verify training of faculty/staff/students involved in research.
• provide investigator FCOI training for NIH-funded grants: prior to engaging in research and at least every four years, and immediately when FCOI policies significantly change or when an investigator is new to Carleton or an investigator is found noncompliant.
• incorporate language as part of subrecipient agreement contracts that establish FCOI policy (include terms that establish whether the FCOI policy of the awardee institution or that of the subrecipient will apply to the subrecipient investigators, and includes time periods to meet SFI disclosure, if applicable, and FCOI reporting requirements).
• designate an institutional official (Provost, acting through CFR/Sponsored Research Office) to (a) solicit and review disclosure statements from each investigator planning to participate in federally funded research at time of application and annually, (b) oversee guidelines to identify conflicting interests, (c) develop and maintain management plans that specify the actions that have been, and shall be, taken to manage FCOI.
• provide disclosure of FCOI to NIH, when FCOI is identified: prior to expenditure of funds, annually during the period of the award (at time of annual progress report or extension ask, via eRA Commons FCOI Module), and within 60 days of discovering or acquiring a new SFI.
• maintain records of all investigator disclosures of financial interests and of the institution’s review of and response to such disclosures, for at least three years from submission of final expenditures report; provide initial and ongoing reports  per NIH specifications through the eRA commons FCOI Module; make information available upon federal agency request.
• respond, within 120 days of determination, to non compliance by completing and documenting a retrospective review of the investigator’s activities and NIH-funded research project to determine if there was bias in design, conduct, or reporting.
• address these particulars if/when a management plan for FCOI Reporting is needed:  1) role and principal duties of the conflicted investigator in the research project;  2) conditions of the plan; 3) how the management plan design will safeguard objectivity in the research project; 4) confirmation of the investigator’s agreement to the plan; 5) how the plan will be monitored to ensure investigator compliance (following guidelines of Federal Register Vol. 76, No. 165, section 50.605 “Management and reporting of financial conflicts of interest”).
  

DEFINITIONS

Investigator

For the purposes of this policy, a researcher or is a person, regardless of title or position, responsible for the design, conduct, or reporting of research funded by a federal agency, or proposed for such funding. Collaborators, consultants, and subgrantees may thus be considered “investigators,” and an investigator’s spouse and dependent children are also considered (for the purposes of this policy) to be “investigators.”

Significant Financial Interest (SFI)

A significant financial interest consists of interests that reasonably appear to be related to the investigator’s institutional responsibilities:

• with regard to any publicly traded entity, a SFI exists if the remuneration received in the 12 months preceding the disclosure, and the value of any equity interest as of the date of disclosure, exceeds $5,000. “Remuneration” includes (i) salary, and any payments for services such as consulting fees or honoraria, paid authorship, reimbursed or sponsored travel and (ii) equity interest includes any stock, stock option, or other ownership interest.
• with regard to any non-publicly traded entity, a SFI exists if the value of any remuneration received in the 12 months preceding the disclosure, and the value of any equity interest as of the date of disclosure, exceeds $5,000, or when the investigator holds any equity interest.
• intellectual property rights and interests such as patents or copyrights, upon receipt of income related to such rights and interests.

An investigator also must disclose the occurrence of any reimbursed or sponsored travel (i.e., that which is paid on behalf of and not reimbursed to the investigator so that the exact monetary value may not be readily available), related to their institutional responsibilities, provided, however, that this disclosure requirement does not apply to travel that is reimbursed or sponsored by certain excluded sources provided in regulation:

• salary, royalties, or other remuneration paid by the institution to the investigator if the investigator is currently employed or appointed by the Institution;
• intellectual property rights assigned to the institution and agreements to share in royalties related to such rights;
• income from seminars, lectures, teaching engagements, or service on advisory committees or review panels sponsored by a governmental agency, an Institution of higher education, or a research institute affiliated with a higher education Institution.