Frequently Asked Questions (FAQ)

• Why were changes made to the existing Policy?

  Federal and state requirements mandate that financial conflict of interest policies and procedures be in place. Ultimately, we need the policy to protect the reputation and interests of the University and its faculty, staff, and students. In addition, institutions maintain conflict of interest policies to promote objectivity in research and scholarship. MSU’s policy ensures that there will be a reasonable expectation that the design, conduct or reporting of research and other scholarly activities will not be biased by any personal financial interest of an investigator at MSU that might appear to conflict with his or her University obligations.

  Changes were made in the MSU Policy to maintain consistency with standards at peer institutions as well as consistency with guidelines of professional associations such as the American Association of Universities, Federation of American Societies for Experimental Biology, Institute of Medicine, and many others. In addition, rules and regulations relating to federal and private funding organizations have changed requiring revisions in the disclosure and management of significant financial interests at MSU.

   

• Why Did PHS revise its rules for Conflict of Interest?

  Some individuals involved in PHS-funded research failed to disclose their interests in entities closely related to the research, which may have affected research subject safety and well-being. As a result, PHS issued regulations and guidance that are perhaps more stringent than institutions and other federal agencies may have otherwise imposed.

   

   

   

• What MSU unit is responsible for gathering this information?

  The Conflict of Interest Office is managed by the Faculty Conflict of Interest Officer (FCOIO) Brian Mattes (mattesbr@msu.edu). He has responsibility for development of policies and procedures related to the identification and disclosure of significant financial interests, and the initial determination of potential conflicts of interest. The Office of Regulatory Affairs has overall responsibility of ensuring compliance with federal regulations governing conflicts of interest.

   

• I don’t want everyone to know my finances. Will this information be kept private?

  The university respects the confidentiality of private financial and other information supplied by faculty, and will not release this information publicly unless:

  • It is legally required to do so; or/li>
  • The resolution or elimination of the conflict of interest requires public disclosure of the information; or>
  • The faculty member consents to its public disclosure.
  • The Public Health Service requires MSU to inform the public on our website that information regarding conflicts related to PHS funding is available to the public. When requested, MSU must provide the information within 5 working days.

   

• To Whom Does the Policy Apply? Who Has To Disclose?

  To whom does the Policy apply?

  The Policy applies to individuals appointed through the academic personnel system with research, teaching, outreach, or service institutional responsibilities.  This Policy also applies to other individuals who have independent responsibility for proposing, conducting, or reporting the results of University research and other sponsored projects. Faculty and research leaders will need to determine which individuals in their group meet these definitions. An annual disclosure must be completed within 12 months of your initial/previous disclosure, regardless of whether you are applying for grants.

  Examples of those who are required to disclose include:

  • Fixed term and tenure track professors
  • Postdoctoral fellows
  • Research associates
  • MSU extension positions (e.g. program directors, specialists, etc.)

  This does not include (unless they are working on a PHS or NSF project):

  • Professors emeritus
  • Lecturers
  • Students

  While the institutional policy will apply to everyone, some federal agencies and private funding organizations have specific rules and regulations which must also be applied.

  Do different colleges at MSU have different rules?

  Each college (or relevant non-college unit) is encouraged to prepare, in consultation with the FCOIO, a supplement to the conflict of interest handbook, with frequently asked questions, that addresses conflict of interest issues specific to the disciplines and activities of the faculty of that college. A college may also adopt its own addendum to this Policy to address specific conflict situations which occur in that college. Please confer with your chairperson or dean to determine if additional standards have been implemented in your college.

  Do the new PHS regulations apply to all grants? Even fellowships?

  The PHS rules apply to all grants, except Phase I Small Business Innovative Research (SBIR) Small Business Technology Transfer (STTR) applications.  However, MSU’s policy does apply to these awards.

  Do PHS requirements apply to any other funding sources?

  Yes, at this time the following health-related organizations that provide funding for research require the application of PHS standards:

  • Alliance for Lupus Research
  • Alpha-1 Foundation
  • American Asthma Foundation
  • American Cancer Society
  • American Heart Association
  • American Lung Association (ALA)
  • Arthritis Foundation
  • CurePSP
  • Juvenile Diabetes Research Foundation (JDRF)
  • Lupus Foundation of America (LFA)
  • Patient-Centered Outcomes Research Institute (PCORI)
  • Susan G. Komen Foundation

  This list is not exhaustive.  Please consult your sponsor if you are unsure whether they follow PHS FCOI regulations. 

  Who is a PHS “investigator”? Is it only the Principal Investigator?

  No.  The term “Investigator” includes the project director (or Principal Investigator), key personnel, and any other person, regardless of title, who is responsible for the design, conduct, or reporting of research funded by PHS.  This may or may not apply to graduate students and post-doctoral fellows depending on how they meet the definition of “Investigator.”  See further information here.

  Are graduate and other students required to disclose interests?

  While the policy is addressed to faculty and academic staff, it does apply to other individuals, including graduate or undergraduate students “who have independent responsibility for proposing, conducting, or reporting the results of University research and other sponsored projects.” This responsibility would be determined by the Project Director or Principal Investigator, who would identify the student on the eTransmittal for the project proposal. In that case, the student would be required to disclose any related significant financial interest and resolve any conflict of interest. Since students are not MSU employees, they cannot access the online portal; contact OSP/CGA or fcoiio@msu.edu for assistance. Please see the Forms tab.

  If I have a collaborator at another institution in the United States or at a foreign institution, what do I have to do to ensure that I and MSU are in compliance with PHS regulations?

  If a PHS or NSF proposal includes involvement of entities outside of MSU (e.g. other Universities, businesses, etc.), the subrecipient entity and any investigator associated with the entity must also comply with PHS/NSF regulations regarding disclosure of conflict of interest. A list of institutions certifying that they are in compliance with the PHS Financial Conflict of Interest rules and regulations is provided in the Federal Demonstration Project Institutional Clearinghouse. If the subrecipient institution is in compliance, then associated individuals certify through their own institution.

  To ensure compliance, the MSU Principal Investigator must submit a Subrecipient Commitment form to the Office of Sponsored Programs completed by Subrecipient collaborator. On that form, the subrecipient either (a) certifies that the conflicts of interest policy of the subrecipient institution complies with PHS regulations or (b) states that the subrecipient investigators will be subject to MSU’s Policy and procedures. If the subrecipient will be subject to MSU’s Policy, they complete MSU's COI Training module (PHS only) and complete their disclosure using this form and this form to disclose entities. Please see the Forms tab.

• What/When/How to Disclose Questions:

  What information do I have to “disclose” to the University about my financial interests?  What does not need to be disclosed?

  See “What Do I Need to Disclose.”

  What do you mean by "entity"?

  Individuals are required to disclose personal significant financial interests that relate to their MSU responsibilities. Financial interests are of various types (receipt of payments, ownership equity, gifts, and others) and must be reported according to the entity or organization in which they are held or which provides the financial interest (e.g., a company, trust, non-profit organization, non-U.S. University, etc.). For more specific help, see “What to Disclose” and what constitutes a significant financial interest (SFI). When you disclose the fact of having a SFI, you must also provide information about the nature of the entity and explain how it relates to your MSU responsibilities.

  Do travel reimbursements need to be disclosed?

  Disclosure of sponsored travel is only required for PHS investigators.  PHS investigators need to disclose all travel at any value except travel reimbursed or sponsored by MSU funds, federal, state, or local government agencies, or domestic institutions of higher education, academic teaching hospitals and medical centers, and research institutes affiliated with an institution of higher education. See “What Do I Need to Disclose” for details.

  What constitutes a conflict of interest that requires reporting?

  The FCOIO shall make the initial assessment about the existence of a conflict of interest based on the extent to which a disclosed significant financial interest or opportunity for tangible personal benefit could reasonably be expected to affect, or be perceived to affect, a faculty member’s performance of a University responsibility. If the FCOIO determines that a disclosed interest may create a real or potential conflict of interest, the FCOIO shall forward the disclosure to the CRC for additional assessment. If the CRC determines that no conflict of interest exists, it shall inform the faculty member and the VPRGS of that determination in writing. If the CRC determines that a conflict of interest exists as a result of the disclosures made by the faculty member, or as a result of a report made by another party, the CRC shall develop a written plan for the resolution or management of the conflict of interest. The CRC may consult with the faculty member, the faculty member’s unit administrators,the FCOIO, and appropriate representatives of the central administration in developing a plan.

  The FCOIO shall submit the plan to the faculty member and the faculty member’s unit administrators for review and comment. If the faculty member does not agree with the CRC’s plan for the management or resolution of the conflict of interest, the faculty member may file a written objection detailing the nature of his/her objections with the VPRGS within ten days of receiving notice of the CRC’s plan. The CRC’s plan, along with any written comments submitted by unit administrators, and the objections of the faculty member shall be submitted to the VPRGS. The VPRGS may accept the CRC’s plan or decide to implement an alternative plan for the management or resolution of the conflict of interest. The VPRGS shall issue his/her decision within thirty days of his/her receipt of the CRC’s plan and any supplemental material. The VPRGS shall report his/her decision to the CRC, faculty member, unit administrators, and FCOIO.

  In devising the plan to address the conflict of interest, the CRC shall seek to employ the least intrusive management techniques that will suffice to resolve the ethical and legal concerns arising from the conflict.          

  The CRC may recommend to the Provost and VPRGS the issuance of specific guidelines to investigators and other faculty regarding common conflict situations.

  Subjective: If a faculty member believes, or is concerned, that any financial or other interest held by the faculty member will affect the way he/she performs his/her duties at the University, the conflict must be disclosed in writing under the Policy.

  Objective: Even if the faculty member is confident that his/her financial interest would not affect the exercise of his/her professional judgment, if the financial interest is such that an independent observer would reasonably question whether the faculty member’s professional actions or decisions are affected or determined by considerations of personal gain arising from that financial interest, the financial interest is significant enough for the faculty member to disclose it.

  Does a faculty member need to report a significant financial interest involving a University-funded project or a non-funded project?

  If the faculty member has a financial interest or an opportunity for tangible personal benefit which could affect the independence of judgment with which the faculty member performs the research. For example, if a faculty member has a significant financial interest in a company that will be materially affected by the outcome of a University funded research project conducted by that faculty member, that would be a reportable conflict of interest.

  Can income from consulting or other work approved under the University’s Outside Work for Pay Policy form the basis for a reportable financial interest under the Policy?

  Yes. Such income is a financial interest which should be disclosed if it totals more than $5,000 in a calendar year from a single entity.

  Is an Outside Work for Pay Policy form or a Travel Authorization form a substitute for completing a Conflict of Interest disclosure?

  No. You must still complete a disclosure through the Office of Sponsored Programs portal.

  What if I receive an honorarium as part of my travel? Do I disclose it?

  Yes, if it meets the $5,000 de minimus criteria (aggregated over the calendar year, from a single payer).  It would be disclosed as a payment and not as part of the travel reimbursement.

  When do I need to make a disclosure?

  • Annually: Disclosures must be completed no later than one year after your initial disclosure or last annual disclosure, and every 12 months henceforth.
  • Project based: PHS/NSF regulations require that each institution and investigator applying for, receiving, or being supported by PHS/NSF funds be compliant with PHS/NSF rules regarding training and disclosure prior to applying for funds and the establishment of conflict of interest management plans prior to the expenditure of funds.
  • Revising Disclosures: Disclosures must be updated within 30 days of acquiring or discovering any new significant financial interest. Additionally, any Project or Travel disclosure will prompt you to update your Master disclosure.
• If You Have a Conflict Questions

  What happens if I have a conflict of interest?

  If the designated University officials determine that a disclosed interest may create a real or potential conflict of interest, the FCOIO, with the Vice President for Research and Graduate Studies and/or the Conflict Review Committee (CRC) make a determination of appropriate action, usually the development of a conflict management plan.

  What is a Conflict Management Plan?

  It is an agreement that sets out limits and restrictions on the investigator for the purpose of reducing or eliminating a conflict of interest, and to ensure that the design, conduct, and reporting of research will be free from bias. Management plans may include the following requirements (non-exhaustive list):

  • Public disclosure of financial conflict of interest when: presenting or publishing research; to staff members working on the project; to MSU’s Institutional Review Board, etc.;
  • isclosure to human participants in research;
  • Appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of the research against bias;
  • Modification of the research plan;
  • Change of personnel responsibilities or disqualification of personnel from participation in all or a portion of the research;
  • Reduction or elimination of the financial interest (e.g. sale of an equity interest); 
  • Severance of relationships that create financial conflicts

  A proposed conflict management plan is reviewed with the individual and his/her unit director before assessment and final approval by the Vice President for Research and Graduate Studies. Conflict Management Plans are periodically reviewed for compliance and updating as appropriate by the FCOIO and staff.

• Failure to Disclose / Compliance Questions

  What happens if I fail to file a disclosure required under the Policy?

  Without a required disclosure, an application for a supported project will not be allowed to be submitted.

  A faculty member who violates this Policy is subject to disciplinary action. The VPRGS shall establish a mechanism, after consulting with the FCOIO, for investigating concerns or allegations regarding significant financial interests and other opportunities for tangible personal benefit of faculty which are not reported as required under this Policy. The review and investigation of concerns or allegations that this Policy has been violated will be conducted confidentially to the extent permitted by law, except insofar as information needs to be disclosed so that the University may effectively investigate the matter or take corrective action.

  The Public Health Service, National Science Foundation and other funding agencies may have additional rules and regulations regarding non-compliance with their policies and regulations.

  What happens if I make a mistake and forget to disclose something?

  If you made a mistake, return to the Research Administration System portal and update you disclosure.  After updating, you must re-certify your disclosure.   If you have further questions, contact the Conflict of Interest office.

  Does MSU report any information to NIH/PHS?

  MSU is required to report Financial Conflicts of Interest annually to NIH/PHS.