The Designated Official will determine if the Significant Financial Interest identified in a COI disclosure is related to the Investigator’s Institutional Responsibilities. The Designated Official will be the Conflict of Interest Officer, the Department, Lab, or Center Head, or another member of the senior administration, depending on the circumstances.
The Conflict of Interest Officer will review all disclosures, and when possible, make the determination. In complex cases, the Department, Lab, or Center Head or member of the senior administration will make the determination If the Designated Official determines that the Significant Financial Interest is related to the Investigator’s Research, the disclosure will be submitted to the COI Committee for determination as to whether the Significant Financial Interest constitutes a Financial Conflict of Interest or the appearance of a Financial Conflict of Interest and, if so, whether it can be managed.
The COI Committee will submit a recommendation to the Institutional Official. The Institutional Official will then undertake his or her own evaluation and will determine whether the Investigator will be required to eliminate or manage the Financial Conflict of Interest, as appropriate. The Institutional Official may suspend all relevant activities until the Financial Conflict of Interest is resolved.
Financial Conflict of Interest Disclosure Review Process
Step |
Process |
|---|---|
Step 1 |
Investigator discloses SFIs, describes how it is or is not related to his/her research |
Step 2 |
Designated Official considers Investigator's disclosure, determines whether the SFI is related to the research; where there is a relationship, discusses with DLC heads |
Step 3 |
COI Officer works with Investigator and DLC heads to clarify details and draft management plan; COI Officer submits plan to COI Committee |
Step 4 |
COI Committee reviews disclosure and drafts a management plan; determines if there is a FCOI and recommends to Institutional Official whether the FCOI can be managed |
Step 5 |
Institutional Official makes final determination on FCOI and whether it can be managed; COI Committee informs Investigator of determination and next steps |
Elimination. A Financial Conflict of Interest may be eliminated by divestiture of Equity Interests; termination of the relationship that gives rise to the Significant Financial Interest (such as consulting); abandoning the proposal; terminating the sponsored project; and similar measures.
Management. If the Investigator does not want to eliminate a Financial Conflict of Interest or the appearance of a Financial Conflict of Interest and the Institutional Official determines that it can be managed, the Investigator must develop a written management plan. The Conflict of Interest Officer will assist the Investigator in developing the plan.
Each management plan must be approved and signed by the Investigator, his or her Department Head and, if the research will be carried out in a Laboratory or Center, the Laboratory or Center Head. Where the Investigator is the Department, Lab or Center Head, the plan must be co-signed by the Dean with oversight responsibility for the unit. The management plan will then be submitted to the COI Committee for comment and approval.
Once the COI Committee has approved the management plan, the plan will be submitted to the Institutional Official for approval. The Investigator may not commence or participate in the research that gives rise to the Financial Conflict of Interest or the appearance thereof until all approvals are obtained. Management plans are maintained by the Conflict of Interest Officer and are updated annually.
Each management plan must be approved and signed by the Investigator, his or her Department Head and, if the research will be carried out in a Laboratory or Center, the Laboratory or Center Head. Where the Investigator is the Department, Lab or Center Head, the plan must be co-signed by the Dean with oversight responsibility for the unit.
The management plan will then be submitted to the COI Committee for comment and approval. Once the COI Committee has approved the management plan, the plan will be submitted to the Institutional Official for approval. The Investigator may not commence or participate in the research that gives rise to the Financial Conflict of Interest or the appearance thereof until all approvals are obtained. Management plans are maintained by the Conflict of Interest Officer and are updated annually.
Financial Conflict of Interest Disclosure Management Process
Step |
Process |
|---|---|
Step 1 |
Investigator finalizes the management plan with the help of the COI officer |
Step 2 |
Department, Lab and Center heads review and approve the management plan; COI Officer submits the plan to the COI Committee |
Step 3 |
COI Committee reviews and recommends changes to the Investigator or recommends approval to the Institutional Official |
Step 4 |
Institutional Official issues approval, after which research may commence |
The goals of a management plan are to ensure open and timely dissemination of research results, protect students, and preserve the objectivity of the research. Examples of conditions or restrictions that may be imposed by a management plan include:
- public disclosure of Significant Financial Interests (e.g., when presenting or publishing Research);
- disclosure of Financial Conflicts of Interest directly to participants in human subjects research;
- appointment of an independent monitor or oversight committee capable of taking measures to protect the design, conduct, and reporting of research against bias;
- 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 gradual elimination of the Significant Financial Interest (e.g., sale of an Equity Interest);
- severance of the relationship that is the source of the Significant Financial Interest;
- expedited dissemination of research results so that the Related Entity does not receive preferential access; and
- monitoring of involvement of students and postdoctoral appointees by independent reviewers or oversight committees.
For more information, contact the Conflict of Interest Officer at coi-help@mit.edu.