FCOI Standard Operating Procedure

The Financial Conflict of Interest (“FCOI”) regulations promote objectivity in research by establishing regulations that provide a reasonable expectation that the design, conduct, and reporting of research funded under the Public Health Service (“PHS”) and Department of Energy (“DOE”) grants, cooperative agreements, and technology investment agreements will be free from bias resulting from researcher Financial Conflicts of Interest (“FCOI”): The Public Health Service (“PHS”) Policies Promoting Objectivity in Research, 42 C.F.R. 50 Subpart F and 45 C.F.R., Part 94, “Responsible Prospective Contractors” and the Department of Energy Interim Conflict of Interest Policy Requirements for Financial Assistance.

Michigan State University’s Conflict of Interest and Conflict of Commitment Identification and Disclosure Policy (“Policy”) and this Standard Operating Procedure (“SOP”) applies to MSU Covered Individuals, researchers and Investigators, as defined in the Policy.

The University is also required to comply with the FCOI regulations, including maintaining and enforcing its written Conflict of Interest and Conflict of Commitment Identification and Disclosure Policy, managing and reporting identified conflicts to federal agencies within prescribed timeframes.

The University is required to follow sponsor-specific regulations and guidance for proposed or funded projects (e.g., the Public Health Service (PHS) and other funding organizations that explicitly require compliance with PHS Financial Conflict of Interest (FCOI) regulations). The University also applies standard review requirements to other sponsored research agreements.

Disclosure Requirements
1. Covered Individuals and Investigators as defined in the Policy must complete an electronic Conflict of Interest disclosure (“disclosure”) in the MSU Kuali Research system.
2. Covered Individuals and Investigators are required to submit a disclosure annually, regardless of engagement in Outside or Scholarly Activities.
3. MSU’s disclosure requires the disclosure of certain domestic and non-domestic Outside Activities/Scholarly Activities and domestic and non-domestic Significant Financial Interests (SFI), as defined by the policy.
4. Covered Individuals and Investigators must update their disclosures within thirty (30) days if they acquire or discover a new Financial Interest/activity or changes to previously reported activities.
5. Covered Individuals and Investigators must complete a disclosure no later than the time of application for PHS or DOE funded research.
Review
1. Disclosures are reviewed by the Institutional Official or their designees (e.g. Office of Conflict Disclosure and Management (CDM) in the Office of Research and Regulatory Support.)
2. CDM may consult with the Faculty Member or MSU leadership during the review process.
3. If it is determined that the SFI is reasonably related to an Investigator’s Institutional Responsibilities or research, and may present a Financial Conflict of Interest (FCOI) with university research, including specific research projects or protocols, then it will be recommended that a conflict management plan (CMP) be implemented.
4. A Financial Conflict of Interest (FCOI) in Research is defined as a Significant Financial Interest that could directly and significantly affect the design, conduct, or reporting of the funded research, or present the appearance thereof.
5. Furthermore, if it is determined that a Financial Interest, Outside Activity, or Scholarly Activity presents a potential conflict or requires MSU Board of Trustees approval, then it will be recommended that a CMP be implemented.
Conflict Management
1. If a potential conflict exists, referral to the MSU Conflict Review Committee (“CRC”) will occur to confirm that a conflict exists, and the CRC will recommend a conflict management plan (CMP). The CMP aims to:
  1. Promote transparency;
  2. Protect research integrity;
  3. Safeguard MSU students and trainees; and
  4. Protect the safety of human subjects research, etc.
2. The CRC, in collaboration with CDM, provides the outcome and recommended CMP to the Covered Individual or Investigator.
3. Covered Individuals and Investigators are responsible for reviewing and accepting their CMP, and for providing documentation of their agreement to abide by their CMP. Covered Individuals Investigators are responsible for abiding by the terms, conditions and actions set forth in the CMP. This responsibility carries with it the responsibility to respond to requests from CDM or the CRC for information and/or meetings related to the University's responsibility to monitor compliance with this Policy, the applicable CMP, if any, and applicable federal regulations.
4. CMPs may include the following requirements (non-exhaustive list):
  1. Public disclosure of FCOIs when presenting or publishing research; to staff members working on the project; to MSU’s Institutional Review Board, etc.;
  2. For research projects involving human subjects research, disclosure of FCOIs directly to human subjects participating in research;
  3. Appointment of an independent monitor empowered to take measures to protect the design, conduct, and reporting of the research against bias resulting from the FCOI;
  4. Modification of the research plan;
  5. Change of personnel or personnel responsibilities, or disqualifications of personnel from participation in all or a portion of the research;
  6. Reduction or elimination of the financial interest; or
  7. Severance of relationships that create financial conflicts
5. IRB Studies: CDM shall communicate relevant CMPs related to human subjects research that were approved by the CRC to the Institutional Review Board (IRB). The IRB has the final authority on whether the proposed research shall be approved for the role of the conflicted Investigator on a protocol.
Reporting Requirements
1. The University (CDM in collaboration with CGA and OSP as needed) shall provide FCOI reports to Research sponsors as required by federal FCOI regulations (42 C.F.R. §§ 50.604(h) and 50.605(b)).
2. In accordance with federal FCOI regulations, Michigan State University must submit an annual Financial Conflict of Interest (FCOI) report to the Public Health Service (PHS) or Department of Energy (DOE) at the time the investigator’s annual progress report is due. This report must include the current status of any previously disclosed financial interests and detail any updates or modifications to the associated conflict management plan.
3. As described in section V. (d) in the Policy, per Michigan Law, MCL - Act 317 of 1968, the MSU Board of Trustees (BOT) must approve certain proposed agreements. Related to this, CMPs may be provided to the BOT office.
Financial Conflict of Interest (“FCOI”) Training
1. FCOI regulations state that Investigators are required to complete FCOI training identified by MSU at a minimum, every four (4) years, or before engaging in research related to any PHS or DOE funded grant.
2. FCOI training may also be administered if an Investigator is not in compliance with this Policy or their management plan.
3. MSU’s required FCOI training is in CITI and is administered through MSU’s Ability system.
4. More information related to training is
5. NIH FAQs
Obligations and Non Compliance
1. PHS, Department of Energy (DOE), and National Science Foundation (NSF) Covered Individuals and Investigators who receive research funding from the PHS, DOE, or NSF must comply with agency regulations, which ensure that significant financial interests do not affect research integrity and the design, conduct, or reporting of federally-funded research.
  1. The PHS regulations on “Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought” (42 C.F.R. Part 50, Subpart F) and “Responsible Prospective Contractors” (45 C.F.R. Part 94) can be found at http://www.gpo.gov/fdsys/pkg/FR-2011-0825/pdf/2011-21633.pdf
  2. The DOE Interim Conflict of Interest Policy Requirements for Financial Assistance, 2 C.F.R. 200.112, Conflict of Interest (2 C.F.R. 200.112) can be found at https://www.energy.gov/management/financial-assistance-letter-no-fal-2022-02
  3. The NSF conflict of interest policy can be found in Chapter V, Grantee Standards, Section 510, Conflict of Interest Policies, in the NSF Grant Policy Manual at http://www.nsf.gov/pubs/manuals/gpm05_131/gpm5.jsp#510 .
2. Non-compliance will be addressed according to Section X, Violations, in the Policy. The University will also comply with federal FCOI regulations 42 C.F.R. 50 Subpart F and 45 C.F.R., Part 94, “Responsible Prospective Contractors” and the Department of Energy Interim Conflict of Interest Policy Requirements for Financial Assistance. If the failure of a faculty member to comply with this Policy has biased the design, conduct, or reporting of funded research, the University may, and in some cases is required to, notify the awarding agency of the compliance failure and corrective actions and complete a retrospective review.
3. An overview of the research retrospective review process is located
Resources
1. NIH FAQs