ºÚÁÏÉçÇø

Policy

General

ºÚÁÏÉçÇø requires all individuals who are listed on proposals to a federal agency to disclose to the University, via the Vice President for Research and Innovation, prior to submittal of the proposal, any Significant Financial Interest (including those of spouse and dependent children) that would reasonably appear to be related to the Individual’s Institutional Responsibilities. Such a disclosure is facilitated within the proposal submission process.

Definitions

Individual

“Individual” means the project director or principal investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research which may include, for example, collaborators or consultants. For the purpose of clarity, graduate ºÚÁÏÉçÇø researchers and undergraduate ºÚÁÏÉçÇø researchers may qualify if they satisfy the elements of this definition. 

Senior Personnel

“Senior Personnel” means any person (including a project director, principal investigator, or any individual) who is identified by the University as senior or key personnel in a grant application, progress report, or other report submitted to the federal funder. 

Institutional Responsibilities

“Institutional Responsibilities” are defined as an Individual’s professional responsibilities on behalf of Miami, which may include, but are not limited to, activities such as research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.  

Significant Financial Interests

“Significant Financial Interests” has the meaning set forth below.

Required Disclosures 

1. All listed Individuals must disclose all significant financial interests. (1) A “Significant Financial Interest” is a financial interest consisting of one or more of the following held by the Individual (or the Individual’s spouse and dependent children) that reasonably appears to be related to the Individual’s responsibilities at Miami:
   1. With regard to any publicly traded entity, a Significant Financial Interest exists if the monetary amounts received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, together, exceeds $5,000.  Equity interest includes any stock, stock option, or other ownership interest;
   2. With regard to any non-publicly traded entity, a Significant Financial Interest exists if the value of any monetary amounts received from the entity in the twelve months preceding the disclosure exceeds $5,000, or when the Individual (or the Individual’s spouse or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest); or
   3. Receipt of income by the Individual (or the Individual’s spouse or dependent children) related to intellectual property rights and interests (e.g. patents, copyrights).  
2. Individuals also must disclose the occurrence of any reimbursed or sponsored travel related to their responsibilities at Miami, only if the Individual was not reimbursed or sponsored by Miami or any of the following: a U.S. federal, state, or local government agency, a U.S. institution of higher education, a U.S. academic teaching hospital, a U.S. medical center, or a U.S. research institute that is affiliated with a U.S. institution of higher education.  The details of this disclosure must include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration.  
3. Individuals must disclose all foreign financial interests (which includes income from seminars, lectures, or teaching engagements, income from service on advisory committees or review panels, and reimbursed or sponsored travel) received from any foreign entity, including foreign institutions of higher education or a foreign government (which includes local, provincial, or equivalent governments of another country) when such income is in excess of $5,000.  
4. Individuals are required to update these financial disclosures:
   1. during the time in which the proposal is pending,
   2. on an annual basis when awarded federal funding, and
   3. within thirty (30) days of acquiring or discovering a new Significant Financial Interest or when a Significant Financial Interest was not timely disclosed.

Exempted From Disclosure

The term Significant Financial Interest does not include the following:

1. Salary, royalties, or other remuneration paid by Miami to the Individual, including intellectual property rights assigned to Miami and agreements to share in royalties related to such rights;
2. Income from investment vehicles, such as mutual funds and retirement accounts, as long as the Individual does not directly control the investment decisions made in these vehicles;
3. Income from seminars, lectures, or teaching engagements sponsored by a U.S. federal, state, or local government agency, a U.S. institution of higher education, a U.S. academic teaching hospital, a U.S. medical center, or a U.S. research institute that is affiliated with a U.S. institution of higher education; or
4. Income from service on advisory committees or review panels for a U.S. federal, state, or local government agency, a U.S. institution of higher education, a U.S. academic teaching hospital, a U.S. medical center, or a U.S. research institute that is affiliated with a U.S. institution of higher education.

Subrecipient Disclosures

The University is responsible for ensuring any subrecipient’s compliance and reporting identified financial conflicts of interests for all individuals listed on the subrecipient’s proposal to the federal agency.  Subrecipients on a proposal being submitted by ºÚÁÏÉçÇø must enter into a written agreement with the University to establish whether this Policy or the financial conflict of interest policy of the subrecipient’s institution will control for purposes of the subrecipient’s compliance with conflicts of interest regulations. 

Subrecipient Institutions who rely on their financial conflict of interest policy must report identified financial conflicts of interests to Miami in sufficient time to allow Miami to report the conflict of interest to the funder to meet its reporting obligations. 

Subrecipient institutions that agree to comply with Miami’s policy must ensure that all Individuals listed on the subaward complete ºÚÁÏÉçÇø’s disclosure of Significant Financial Interests prior to proposal submission in sufficient time to allow for proposal review.

ºÚÁÏÉçÇø is responsible for monitoring subrecipient’s compliance with financial conflict of interest regulations, management plans, and for reporting all identified financial conflicts of interest to the funder.

Required Training

All listed Individuals, including subrecipients, must complete training prior to engaging in funded research (and at least once every four years). Training is also required immediately under the following circumstances:

1. Miami’s financial conflict of interest policies change in a manner that affects Individual requirements;
2. An Individual is new to Miami; or 
3. Miami finds that an Individual is not in compliance with this Policy. 

Identification of Actual or Potential Conflicts of Interest 

The Vice President for Research and Innovation or their designee will review each disclosure that is submitted in the Proposal Approval process. In consultation with the Office of General Counsel, the Vice President for Research and Innovation will make a determination of whether a Significant Financial Interest is related to the federally funded research by determining if the Significant Financial Interest: 

1. Could be affected by the federally funded research; or 
2. Is connected to an entity whose financial interest could be affected by the research. 

For purposes of clarity, a financial conflict of interest exists when the Vice President for Research and Innovation or their designee determines that the Significant Financial Interest could directly and significantly affect the design, conduct, or reporting of the funded research project.

Individuals may request review of this determination by the Office of General Counsel.

When an Individual who is new to participating in the research project, failed to timely disclose, or  discloses a new Significant Financial Interest, the Vice President for Research and Innovation shall within sixty (60) days review the disclosures; determine whether a financial conflict of interest exists; and, if so, implement, on at least an interim basis, a management plan that shall specify the actions that have been, and will be, taken to manage such financial conflicts of interest.

Actions as necessary are to be undertaken to manage financial conflicts of interest, including any financial conflicts of a subrecipient, if applicable, and compliance is to be monitored with management plans until completion of the project.

Plan for Addressing Conflicts of Interest

When an actual or potential financial conflict of interest has been determined to exist, the Individual and the department chair will propose a plan for addressing and managing any financial conflict of interest, detailing what conditions or restrictions, if any, should be imposed by Miami to manage, reduce, or eliminate the conflict of interest. Examples of conditions or restrictions that may be imposed to manage, reduce, or eliminate conflicts of interest include, but are not limited to:

1. requiring the Individual to publicly disclose any financial conflicts of interest, as determined by the Vice President for Research and Innovation or their designee, in any publications or presentations; to research staff working on the study; to the Institutional Review Board; or any other means of public disclosure proposed by the Individual; 
2. monitoring of project by independent reviewers;
3. modification of the project plan;
4. disqualification from participation in the portion of the funded project that would be affected by the Significant Financial Interests;
5. divestiture of Significant Financial Interests; or
6. severance of relationships that create actual or potential conflicts.

Such plans must be agreed to by the Individual, department chair, dean, Vice President for Research and Innovation, and Provost prior to the beginning of the funded project.

Enforcement Policy

Violations of this Financial Disclosure Policy will be handled by the University in accord with the policy titled “Procedures for Disciplinary Action”, which provides for sanctions where appropriate.

Whenever a financial conflict of interest is not identified or managed in a timely manner, including:

1. Failure by the Individual to disclose a Significant Financial Interest that is determined by Miami to constitute a financial conflict of interest;
2. Failure by the University to review or manage a financial conflict of interest; or 
3. Failure by the Individual to comply with a financial conflict of interest management plan;

ºÚÁÏÉçÇø shall, within 120 days of a determination of noncompliance, complete a “retrospective review” of the Individual’s activities and the federally funded research project to determine whether any federally funded research, or portion thereof, conducted during the time period of the noncompliance was biased in the design, conduct, or reporting of such research.

The Vice President for Research and Innovation, or their designee, shall document the retrospective review which must include at least the following key elements: 

1. Project number;
2. Project title;
3. Project Director/Principal Investigator (PD/PI) or contact PD/PI if a multiple PD/PI model is used;
4. Name of the Individual with the financial conflict of interest;
5. Name of the entity with which the Individual has a financial conflict of interest
6. Reason(s) for the retrospective review;
7. Detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review panel, documents reviewed, etc.);
8. Findings of the review; and
9. Conclusions of the review.

If bias is found, Miami must notify the federal sponsor of the research promptly and submit a mitigation report.  If a financial conflict of interest was previously reported to the federal sponsor, the mitigation report is submitted as a “Revised Financial Conflicts of Interest Report.” The mitigation report must include, at a minimum, the key elements documented in the retrospective review described above and a description of the impact of the bias on the research project and Miami’s plan of action or actions taken to eliminate or mitigate the effect of the bias (i.e., impact on the research project, extent of harm done, including any qualitative and quantitative data to support any actual or future harm; analysis of whether the research project is salvageable).  Thereafter, Miami will submit financial conflicts of interest reports annually as prescribed by any applicable federal, state, or local regulation. 

In instances whereby the research project’s purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment, Miami shall require any Individual involved that has a financial conflict of interest that was not timely reported to Miami to: disclose the financial conflict of interest in each public presentation of the results of the research, and to request an addendum to previously published presentations.

Notification of Funding Agency

Annual (i.e., ongoing) and revised financial conflict of interest reports will be submitted to the funding agency as specified below:

1. Prior to the expenditure of funds;
2. Within sixty (60) days of identification for an Individual who is newly participating in the project;
3. Within sixty (60) days for new, or newly identified, financial conflicts of interest for existing Individuals;
4. At least annually, the annual report will provide the status of the financial conflict of interest and any changes to the management plan, if applicable, until the completion of the project;
5. After a retrospective review to update a previously submitted report, if new information is discovered following completion of the review.

The funder will be notified promptly if bias is found with the design, conduct or reporting of funded research and a mitigation report will be submitted to explain what action(s) have been or will be taken to mitigate the effects of the bias. Reporting will include at a minimum the following elements:  entity name, name of the Individual with the financial conflict of interest, nature of Significant Financial Interest, value of the Significant Financial Interest, and any additional information required by the funder/regulation.

The funder will be notified promptly if an Individual fails to comply with this Policy; a financial conflict of interest management plan; or appears to have biased in the design, conduct, or reporting of the funded research. Corrective action will be taken for noncompliance with this policy or the management plan.

Records

In accord with federal regulations, ºÚÁÏÉçÇø will maintain records of all financial disclosures (whether or not a disclosure resulted in a determination of a financial conflict of interest)  and of all actions taken to resolve actual or potential conflicts of interest until at least three (3) years after the latter of the termination or completion of the grant to which they relate, or until the resolution of any civil, government, or university action involving those records, or, where applicable, from other dates specified in .

Records Request: Upon request by a member of the public for information on the financial conflicts of interest of Senior Personnel in a federally funded project, the University shall provide a written response, within five days of receipt of the request, that contains the following information regarding financial conflicts of interests for Senior Personnel:

1. The Senior Personnel’s name;
2. The Senior Personnel’s role and title with respect to the research project;
3. The name of the entity in which the Significant Financial Interest is held;
4. The nature of the Significant Financial Interest; and 
5. The approximate dollar value of the Significant Financial Interest (ranges are permissible) or a statement that the interest is one whose value cannot be readily determined. 

Subrecipients that agree to comply with Miami’s policy shall also be subject to this disclosure requirement. The University is only required to provide this information to the public when the following criteria are met: (1) a Significant Financial Interest was disclosed and is still held by the Senior Personnel; and (2) Miami has determined that the Significant Financial Interest is a financial conflict of interest. 

Inquiries regarding financial conflicts of interest of Senior Personnel in a federally funded research project should be directed to the Office of Research and Innovation (or in the event of a name change, its equivalent).

Sponsor Specific Requirements

Depending on the source of the external funds, some external funders may have specific requirements for the University and researchers to follow regarding conflicts of interest in research, which are not identified in this Policy. Researchers and ºÚÁÏÉçÇø employees working on the externally funded project shall cooperate with the external funder and the Office for Research and Innovation to satisfy any additional conflicts of interest requirement.

Related Form(s)

Not applicable.

Additional Resources and Procedures

Not applicable.

FAQ

Not applicable.

Policy Administration

Next Review Date

Responsible Officers

• Vice President for Research and Innovation
• Office of the Provost

Legal Reference

Compliance Policy

Yes

Recent Revision History

Reference ID(s)

• MUPIM 15.5
• OAC 3339-15-05

Reviewers

• ºÚÁÏÉçÇø Senate
• Vice President for Research and Innovation
• Office of the Provost