Ohio Admin. Code 3339-15-05

Current through all regulations passed and filed through October 28, 2024

Section 3339-15-05 - Policy on management of conflicts of interest in projects with external funding

(A) General

Miami university requires investigators on proposals to all external agencies, public and private, to disclose to the university, via the associate provost for research, prior to submittal of the proposal, any significant financial interest (including those of spouse and dependent children) that would reasonably appear to be affected by the activities proposed for funding. Such a disclosure is facilitated by a question on the university's proposal approval form and, in the event of a possible conflict of interest, use of the university's financial disclosure form.

(B) Required disclosure

Investigators must disclose to Miami university all significant financial interests:

(1) That would reasonably appear to be affected by the research or educational activities funded or proposed for funding;

(2) In entities whose financial interest would reasonably appear to be affected by such activities.

A significant financial interest means anything of monetary value, including but not limited to salary or other payments for services (e.g., consulting fees or honoraria); equity interests (e.g., stocks, stock options, or other ownership interest); and intellectual property rights (e.g., patents, copyrights, and royalties). "Investigator" means the principal investigator, co principal investigator, and any other person at Miami university who is responsible for the design, conduct, or reporting of the research or educational activities funded or proposed for funding.

(C) Exempted from disclosure

Investigators need not disclose:

(1) Salary, royalties, or other remuneration from Miami university;

(2) Ownership interest in a business enterprise which is an applicant under phase one of the small business innovation research or small business technology transfer programs;

(3) Income from lectures or teaching engagements sponsored by public or nonprofit entities;

(4) Income from service on advisory committees or review panels for public or nonprofit entities;

(5) Financial interests in business enterprises or entities if the value of such interests does not exceed ten thousand dollars, and represent more than a five per cent ownership interest, for any one enterprise or entity when aggregated for the investigator and the investigator's spouse and dependent children.

Investigators are required to update these financial disclosures during the time in which the proposal is pending and during the period of an award, on an annual basis and as new reportable significant financial interests are obtained.

(D) Identification of actual or potential conflicts of interest

The associate provost for research will review each financial disclosure form that is submitted in the proposal approval process. In consultation with the office of the general counsel, the associate provost for research will make a determination of whether a conflict of interest exists that could directly and significantly affect the design, conduct, or reporting of the proposed sponsored project. Principal investigators may request review of this determination by the office of general counsel.

(E) Plan for addressing conflicts of interest

When an actual or potential conflict of interest has been determined to exist, the principal investigator(s) and the department chair will propose a plan for addressing and managing any conflict of interest, detailing what conditions or restrictions, if any, should be imposed by the institution 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) Public disclosure of significant financial interests;

(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 principal investigator, department chair, dean, associate provost for research, and provost prior to the beginning of the funded project, using the Miami university financial disclosure form.

If the associate provost for research, in consultation with the office of general counsel, determines that imposing conditions or restrictions would be either ineffective or inequitable, and that the potential negative impacts that may arise from a significant financial interest are outweighed by interests of scientific progress, technology transfer, or the public health and welfare, then the university may allow the project to go forward without imposing such conditions or restrictions.

(F) Enforcement policy

Violations of this financial disclosure policy will be handled by the university in accord with rule 3339-8-03 of the Administrative Code ("Procedures for Disciplinary Action") which provides for sanctions where appropriate.

(G) Notification of funding agency

Miami university will promptly notify the funding agency if it finds that it is unable to satisfactorily manage an actual or potential conflict of interest situation within a funded project.

(H) Records

In accord with federal regulations, Miami university will maintain records of all financial disclosures and of all actions taken to resolve actual or potential conflicts of interest until at least three years after the later of the termination or completion of the grant to which they relate, or the resolution of any civil, government, or university action involving those records.

Replaces: 3339-15-05

Ohio Admin. Code 3339-15-05

Effective: 3/6/2015
Promulgated Under: 111.15
Statutory Authority: 3339.01
Rule Amplifies: 3339.01
Prior Effective Dates: 12/15/92, 9/30/99, 9/30/01, 11/7/03