HRPP Manual Section 10-1

Conflict of Interest

All significant financial interests and other opportunities for tangible personal benefit related to the design, review, conduct or reporting of human research projects that could, or appear to, affect the rights and welfare of human participants or the objectivity of the research results must be disclosed in accordance with the procedure established by the Office of Conflict Disclosures and Management (CDM) and the Human Research Protection Program (HRPP). Review of reported conflict situations must consider the associated risk to human participants and the integrity of the research findings. This includes conflict of interest situations for all projects regardless of the funding source, including non-sponsored research, for all Institutional Review Board (IRB) members, HRPP staff, investigators, research staff, or consultants serving in any capacity. Organizational conflict of interest situations must also be considered for the same reasons. The keys to managing conflicts are disclosure and transparency.

MSU faculty and academic staff must report conflicts of interest according to MSU policies. See MSU Board of Trustees (BOT) Policy 414: Conflict of Interest and Conflict of Commitment Identification and Disclosure and HRPP Manual 10-1 “Conflict of Interest.”

No member of the IRB (or HRPP staff) shall serve as a reviewer, or contribute to the review, of a proposal for which they have a conflict of interest. Such conflicts are satisfactorily managed by the IRB (or HRPP staff) member’s recusal from participating in, or contributing to, the review. Individuals who are responsible for business development cannot serve as a member on the IRB or carry out day to day operations of the IRB review process.

Definitions

Immediate Family Member: An Individual or Investigator’s spouse, domestic partner, and dependent children and stepchildren.

Individual Conflict of Interest (COI): A potential conflict of interest happens when an individual’s outside relationships or activities outside of the University affect, appear to affect, or have the potential to affect their professional judgment or obligations and responsibilities to the University.

IRB Member or HRPP Staff Conflict of Interest: Includes, but is not limited to, situations related to review of initial applications, continuing reviews, modifications, unanticipated problems involving risk to subjects or others, non-compliance investigations, or suspension/termination decisions. The following examples are illustrative and not exhaustive. Other situations that may create conflicts of interest must be disclosed by IRB members or staff.

Conflict situations include, but are not limited to reviewing or managing a project involving:

An IRB/HRPP-staff member’s immediate family (spouse, domestic partner, dependent children and stepchildren) or relatives as defined by the Conflict of Interest in Employment Policy, or persons with whom there is a consensual amorous or sexual relationship.
A graduate student for which the IRB member serves on the thesis or dissertation committee.
An IRB member who serves as an investigator or provides support on a project being reviewed.
Funding by a company or other entity in which the IRB/HRPP-staff member holds a significant financial interest.
Another MSU faculty member who has a financial interest in a company or other entity in which the IRB member conducting the evaluation also holds a significant financial interest.
Funding by, or that affects, a company that has provided or offers gifts of goods, property, or services, like airline tickets, resort or hotel accommodations, or other recreational or personal amenities to an IRB/HRPP staff member.

The judgment about what to report as a conflict of interest lies first and foremost with the IRB (or staff) member. Holding an appointment in the same academic unit as the person whose project is being reviewed, does not, without more, constitute a conflict of interest.

Financial Interest: A financial interest is any monetary or equity interest held by an individual or investigator or their immediate family member that could create an actual or potential COI.

Financial interests include, but are not limited to compensation such as income, consulting fees, honoraria, royalties, an interest in a business consisting of stocks, stock options, private equity or other similar ownership interest (excluding any interest arising solely from a pension, mutual fund, or other investment fund in which the Covered Individual or Investigator does not exercise control), or any other form of compensation from an entity.

A financial interest may arise from a relationship with any kind of legal entity including but not limited to a corporation or limited liability company; a partnership, limited partnership, or joint venture; a trust or estate; a firm, franchise, “dba” (doing business as), sole proprietorship, unincorporated association, or other business.

Financial Conflict of Interest (FCOI) in Research: A Significant Financial Interest that could directly and significantly affect the design, conduct, or reporting of the funded research, or present the appearance thereof.

Significant Financial Interest: Significant financial interests are defined under the BOT Policy 414: Conflict of Interest and Conflict of Commitment Identification and Disclosure and must be reported.

A significant financial interest includes, but is not limited to, a financial interest in the sponsor, product, or service being tested.

A significant financial interest includes the following:

For a publicly traded entity, when the value of any remuneration received from the Entity in the 12 months preceding the disclosure and the value of any equity interest in the Entity as of the date of disclosure, when aggregated, exceeds $5,000; or
For a non-publicly traded Entity (e.g., a startup company), when the value of any remuneration received from the Entity in the 12 months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (and those of the Investigator's Immediate Family Members) holds any equity interest (e.g., stock, stock option, or other ownership interest); or
Income from intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests (e.g., royalty payments); or
The occurrence of any reimbursed or sponsored travel from an Entity in the 12 months preceding the disclosure, however, that this disclosure requirement does not apply to travel that is 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.

A significant conflict of interest does not include the following:

Salary, royalties, or other remuneration paid by MSU to the Investigator if the Investigator is currently employed or otherwise appointed by MSU;
Intellectual property rights assigned to MSU and agreements to share in royalties related to such rights;
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;
Income from seminars, lectures, or teaching engagements sponsored by a Federal, state, or local government agency, a qualifying institution of higher education², academic teaching hospital, a medical center, or a research institute that is affiliated with a qualifying institution of higher education;
Income from service on advisory committees or review panels for a Federal, state, or local government agency, a qualifying institution of higher education, an academic teaching hospital, a medical center or a research institute that is affiliated with an institution of higher education.

Organizational Conflict of Interest (OCOI): An “Organizational Conflict of Interest” exists for research involving human subjects when MSU’s financial interests, or those of its “institutional leaders”, may affect or reasonably appear to affect institutional processes with which the IRB or other offices responsible for supporting Human Research Protection efforts carry out their responsibilities in reviewing a proposed human research protocol and/or managing a human research project once it has been approved by the IRB.

Financial interests creating an organizational conflict arise in research on drugs, devices, biologics, or other questions of potential value from:

protected intellectual property, licenses for commercialization of patented intellectual property, or receipt of royalties or other fees from licensed intellectual property, and/or
gifts exceeding $50,000 from organizations or individuals that would stand to benefit, or reasonably expect to benefit, as a result of the research.

“Institutional Leaders” means Deans, Separately Reporting Directors, and Executive Managers who have direct authority for faculty appointments, allocation of institutional resources, assurance of institutional compliance, application of disciplinary standards, and other similar administrative tasks. Obligations regarding conflicts of interest (See Faculty & Academic Staff Policies & Procedures: Standards of Official Conduct for Senior University Administrators) related to institutional responsibilities address the following:

Use of confidential information,
Outside influence through personal gifts,
Use of authority, University resources,
Conflicting or incompatible service, and
Competition with the University.

MSU recognizes and supports the principle that individual scholars are free to select the subject of their research and to seek support for their research from any source, under provisions that are stated in the Faculty Handbook, Faculty Rights and Responsibilities (See Section IV. Academic Human Resources Policies). Consideration of organizational conflicts of interests for research involving human subjects is intended to address circumstances having the potential to adversely impact a faculty member’s research if it is not managed appropriately or eliminated.

Procedures

Investigator and Research Staff COI

Investigators, research staff, and consultants (including agents of MSU, or others not employed by MSU) are required to report significant financial interests or other opportunities for tangible personal benefit when they relate to, could affect, or could be affected by the proposed project. The following situations are also reported at the time of an initial study application:

Any ownership interest, stock options, or other ownership interest related to the research where there is an arrangement entered into where the value of the ownership interests could be affected by the outcome of the research
Any compensation related to the research where there is an arrangement entered into where the amount of compensation would be affected by the outcome of the research

In addition, individuals must submit disclosures as required by the CDM and update such disclosures annually.

When a potential conflict of interest is disclosed through the initial IRB submission, CDM is assigned as an ancillary reviewer to review the disclosure. This includes studies reviewed by an MSU IRB, studies reviewed by an External (non-MSU) IRB, or studies submitted for an exempt determination.

If a potential conflict of interest arises after MSU IRB approval, release of the MSU HRPP acknowledgement letter for reliance on an External IRB, or an MSU HRPP exempt determination, the individual with the interest must promptly report its details as required by the BOT Policy 414: Conflict of Interest and Conflict of Commitment Identification and Disclosure and notify the MSU HRPP through a modification or update to the study addressing the conflicting interest. The review of the conflict will follow the process described below. Additional requirements of the BOT Policy 414: Conflict of Interest and Conflict of Commitment Identification and Disclosure should be followed by covered individuals and investigators

Process When a Conflict is Disclosed

When a person discloses a potential conflict of interest, the CDM obtains details of the situation. CDM assists in making a determination of whether the disclosed interest constitutes a financial conflict of interest in accordance with the BOT Policy 414: Conflict of Interest and Conflict of Commitment Identification and Disclosure and related procedures. When a financial conflict of interest is identified, the conflict can often be managed through a written management plan. The management plan is developed according to the MSU BOT Policy 414: Conflict of Interest and Conflict of Commitment Identification and Disclosure. CDM works with the HRPP director, IRB Chair, or HRPP staff to communicate with the IRB regarding determinations and recommendations provided by CDM. CDM will indicate whether the financial conflict of interest has the potential to affect the study (e.g., affect the rights and welfare of human subjects participating in the project) and recommend whether management alone is suitable or some other resolution is required.

A statement in the informed consent that discloses the nature of the financial conflict of interest is typically required. If a statement is not included in the consent, the investigator must explain why such a statement is not necessary.

Studies Reviewed as Exempt

CDM works with the HRPP director, HRPP manager, or HRPP staff to communicate regarding determinations and recommendations provided by CDM. The results of the CDM evaluation, including any management plan, will be provided to the HRPP director, HRPP manager, or HRPP staff. The determinations and recommendations will be incorporated into the exempt study, including a statement in the informed consent. Any questions or concerns about the CDM evaluation will be communicated to CDM by the HRPP director, HRPP manager, or HRPP staff. If unable to come to a resolution, the study may be required to undergo a non-exempt review by the MSU IRB.

Reviewed by an External IRB

CDM works with the HRPP director, HRPP manager, or HRPP staff to communicate regarding determinations and recommendations provided by CDM. The results of the CDM evaluation, including any management plan, will be provided to the External (non-MSU) IRB. How this information is communicated may be dependent upon the SMART IRB agreement, SMART IRB implementation checklist, or Institutional Reliance Agreement between MSU and the reviewing institution. Any External IRB determinations or feedback regarding the CDM evaluation will be communicated to the CDM office by the MSU HRPP.

Reviewed by an MSU IRB

CDM works with the HRPP director, HRPP manager, IRB chair or HRPP staff to communicate with the IRB regarding determinations and recommendations provided by CDM. The results of the CDM evaluation, including any management plan, will be provided to the MSU IRB.

The MSU IRB will consider whether they agree with the CDM’s conflict of interest recommendations, including any management plan. The evaluation criteria do not vary by funding agency or regulatory oversight. Evaluation considerations may include whether the management plan is sufficient to protect human subjects, if disclosure in the consent form is adequate, or if additional safeguards are needed. The CDM will be notified if the MSU IRB requests changes to the CDM determinations and the HRPP director, HRPP manager, HRPP staff, or IRB chair will work with CDM as appropriate.

Organizational Conflict of Interest

Annually, all institutional leaders are required to report individual financial interests with organizations that do business, or intend to do business, with the University and to affirm that they have complied with the Standards of Official Conduct Policy during the previous year and will comply with the Standards of Official Conduct Policy during the next year. Disclosure of interest in an entity will be forwarded to the Institutional Official (IO) for determining if any of the reported financial interests might significantly and directly influence or be influenced by human subject research project(s). When such relationships are deemed to exist, the IO will communicate this information to the HRPP Director and the IRB Chair.

When an organizational conflict of interest exists, the IO will work closely with OCDM and the IRB chair to determine if the conflict could affect the rights and welfare of subjects participating in the project, the integrity of data collected, or objectivity by which the human research protocol is managed. Actions may be dependent upon whether the study is reviewed by an External IRB, by an MSU IRB, or is being reviewed for an exempt determination. The IO should also consult the Associate Vice President for the Office of Research Regulatory Support (AVP ORRS).

At a minimum, conflicted individual(s) will be excluded from the decision-making process and oversight of the research and will not take direct or administrative actions on the research. The evaluation criteria do not vary by funding agency or regulatory oversight. Evaluation considerations will include whether disclosure in the consent form is adequate to protect human subjects or if additional safeguards are needed. If the IRB determines that an organizational conflict of interest could affect the rights and welfare of participants, the integrity of data collected, or objectivity by which the human research protocol is managed, then the conflict of interest must be eliminated or a management plan implemented so that the rights and welfare of participants and integrity of the research project are not affected by the interest. Details of organizational financial conflicts will be reported in the IRB minutes, including details of deliberations related to the conflicting interest.

The IO will communicate with the Provost to assure that conflicted institutional leaders are relieved of administrative oversight of related human research projects when necessary. The key to avoiding these situations is awareness of what constitutes such conflicts, disclosure of potential situations before activity is undertaken, and a review of the situation. A determination may be made by the IO to, in certain cases, permit an activity, which may otherwise be considered a conflict, if it is (1) purely personal to the individual or beneficial to the university and (2) performed in full compliance with all legal, regulatory and other requirements. Issues of actual or possible conflict, once disclosed to the IO, will typically be resolved by the IO and the General Counsel.

HRPP Staff COI

If an HRPP staff member has been assigned to a project with which they have a potential conflict of interest, the HRPP staff member will notify the HRPP manager. The HRPP staff member shall be recused (excluded) from reviewing the project.

Information about conflict of interest is included in the pre-review forms completed by HRPP staff when reviewing projects.

Consultant COI

Non-IRB members solicited for their additional expertise pursuant to Section 5-4, “Additional Expertise,” HRPP Manual must not have a conflict of interest when reviewing a protocol. If the individual or a member of their immediate family has a conflict of interest, they will be excluded from consideration as a consultant on the project. See Section 5-4, “Additional Expertise,” HRPP Manual for procedures.

IRB Member COI

If an IRB member (including the IRB chair) has been assigned to review a project with which they have a potential conflict of interest, the IRB member should alert the HRPP staff. The HRPP staff will notify the HRPP manager, IRB chair, or IRB member of the conflict so a different IRB member can be assigned the review.

At convened IRB meetings, IRB members with a conflict of interest are:

Excluded from discussion except to provide information requested by the IRB.
Excluded from voting.
Must leave the meeting room (physical or virtual) for discussion and voting (except to provide information requested by IRB).
Not counted towards quorum.

The HRPP staff will document in the IRB minutes that the IRB member left the room (physical or virtual) during the discussion and voting on the proposal, with an indication that a conflicting interest was the reason for the absence.

Several mechanisms are used to remind IRB members about conflict of interest. These include but are not limited to:

Reminders on review checklists for initial, continuing review, and modification submissions.
A statement in the MSU IRB online system generated email alert sent to IRB members for applications assigned for review.
A declaration of no conflict of interest when submitting a designated review in the IRB online system.
Reminders at the convened IRB meeting to disclose conflicts of interests.

IRB Review of Projects with Individual Conflicts of Interest

In situations where the MSU IRB deems that the conflict of interest management plan approved by the Vice President for Research and Innovation under the BOT Policy 414: Conflict of Interest and Conflict of Commitment Identification and Disclosure is not sufficient to protect the rights and welfare of human subjects and they are unable to come to agreement with CDM on changes to the management plan, the MSU IRB may refuse to approve the participation of human subjects in that project. The HRPP director, HRPP manager, or IRB chair will communicate and consult with CDM and the Vice President for Research and Innovation if the MSU IRB has concerns regarding any plan for the management of a conflict of interest relating to a research project involving human subjects.

The HRPP director, HRPP manager, or IRB chair will communicate and consult with CDM if the study is being reviewed by an External IRB and the External IRB has expressed concerns about the conflict and/or management plan. If the External IRB is unable to come to agreement with CDM on the conflict and/or the management plan, the HRPP director, HRPP manager, or IRB chair will communicate and consult with CDM and the Vice President for Research and Innovation. The External IRB may disapprove the study if unable to come to resolution.

Management

A management plan specifies the actions that have been and will be taken to manage financial conflicts of interest. Examples of strategies to manage financial conflicts of interest include, but are not limited to:

Public disclosure of financial conflicts of interest (e.g., when presenting or publishing the research);
Disclosure of financial conflicts of interest directly to human subjects;
Appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of the research against bias resulting from the financial conflict of interest;
Modification of the research plan;
Change of personnel or 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; or
Retrospective review and a mitigation report if necessary.

When a management plan is implemented for a human research project, CDM shall oversee the compliance monitoring of the management plan on an ongoing basis until the completion of the research project. The management plan identifies who will perform monitoring (e.g., department chair, supervisor, Dean) and at what intervals.

Any concerns identified by the HRPP regarding compliance with the management plan will be provided to CDM for review and enforcement, as appropriate. See the BOT Policy 414: Conflict of Interest and Conflict of Commitment Identification and Disclosure for enforcement mechanisms in response to noncompliance such as disciplinary actions, corrective actions, and/or notification of the awarding agency. Concerns that also constitute noncompliance with federal regulations and university policies and procedures are subject to policies and procedures in HRPP Manual 9-2 “Noncompliance.”

Education

Education regarding conflict of interest is required of each individual and is incorporated into MSU’s required human research protection training. See HRPP Manual Section 11 for requirements.

Education is required immediately when:

Financial conflict of interest policies are revised in a manner that changes investigator requirements
An investigator is new to MSU
An investigator is non-compliant with financial conflict of interest policies and procedures

The mechanism of immediate education varies by circumstance and may include education by email (e.g., a notification of changes to the BOT Policy 414: Conflict of Interest and Conflict of Commitment Identification and Disclosure and/or reporting requirements), through additional required human research protection training, or personalized individual training sessions.

This policy and procedure supersedes those previously drafted.

Approved By: Vice President of Research and Graduate Studies, 4-21-2005. Revision 1 approved by VP Research & Graduate Studies on 3-9-2008. Revision 2 approved by VP Research & Graduate Studies on 1-10-2010. Revision 3 approved by VP Research & Graduate Studies on 8-26-2011. Revision 4 approved by VP Research & Graduate Studies on 12-14-2011. Revision 5 approved by VP Research & Graduate Studies on 11-20-2014. Revision 6 approved by Assistant VP Regulatory Affairs on 11-29-2021. Revision 7 approved by Associate VP Research Regulatory Support on 7-26-2022. Revision 8 approved by Associate VP Research Regulatory Support on 3-14-2023. Revision 9 approved by Associate VP Research Regulatory Support on 12-11-2025.

Human Research Protection Program Office of Research Regulatory Support