19.058: Conflict of Interest in Sponsored Programs
|Status:||Approved on August 3, 2012||Signatures and dates
on archival copy
|Initiated by:||Joseph Shields|
Vice President for Research and Creative Activity
|Endorsed by:||Pam Benoit|
Executive Vice President and Provost
|Approved by:||Roderick J. McDavis|
- I. Safeguarding the Integrity of University Research and Creative Activities
This policy sets forth procedures designed to safeguard the integrity of university research and creative activities and to avoid even the appearance of bias or impropriety resulting from the significant financial interests, as defined within this policy, of university researchers. Faculty and administrators engaged in research and creative activities have an obligation to avoid conflicts of interest related to these activities. Significant financial interests that could give rise to conflicts of interest must be disclosed to the University. The Office of Research, in consultation with deans, chairs and directors, will work with researchers to develop management plans to eliminate conflicts of interest. If it is determined that a management plan cannot be developed, the affected researcher must take appropriate steps to eliminate the significant financial interest giving rise to conflict.
- II. Scope
This policy applies to university employees who serve as Investigators on Sponsored Activity Projects.
- III. Responsibility for the Administration of this Policy
The Office of the Vice President for Research and Creative Activity ("VPRCA") will develop Conflict of Interest Disclosure Guidelines and forms and procedures necessary for the administration of this policy. Deans, chairs and directors will have joint responsibility with the Office of the VPRCA for the review and approval of Financial Disclosure Screening Statements and the development and enforcement of Conflict of Interest Management Plans.
- IV. Definitions
- "Family" means an Investigator's spouse and dependent children.
- "Financial Conflict of Interest" means a Significant Financial Interest that could directly and significantly affect the design, conduct, or reporting of Sponsored Activities.
- "Financial Interest" means anything of monetary value, whether or not the value is readily ascertainable.
- "Sponsored Activities" means research and other programs funded by agencies of the federal, state or local governments, or by private profit or non-profit entities.
- "Institutional Responsibilities" means the services for which an Investigator is compensated by the University. For a member of the faculty, Institutional Responsibilities means teaching, research, and service activities in his or her area of professional expertise. For administrators it means activities that are within the scope of the work for which they are compensated by the university.
- "Investigator" 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 Sponsored Activities. Investigator may include collaborators or consultants. Persons intending to submit proposals for funding should be aware that the requirements for management of any identified conflict of interest must be in place at the time of submission for some funding sources and thus the financial conflict of interest disclosure process should be completed well before the planned submission.
- "Significant Financial Interest" means an interest of an Investigator or his or her family that reasonably appears to be related to the Investigator's Institutional Responsibilities and meets one of the following:
- remuneration received from any publicly traded entity during the 12 months preceding the disclosure and the value of any equity in the entity as of the date of the disclosure that, when aggregated, exceeds $5,000;
- remuneration received from any non-publicly traded entity during the 12 months preceding the disclosure that when aggregated exceeds $5,000;
- any equity interest in a non-publicly traded entity;
- intellectual property rights and interests, if the Investigator receives income related to such rights and interests.
"Significant Financial Interest" does not include:
- Salary, royalties, or other remuneration paid by the University;
- 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, an institution of higher education, an academic teaching hospital, a medical center or research institute that is affiliated with an institution of higher education;
- income from service on advisory committees or review panels for a Federal, state or local government agency, an institution of higher education, an academic teaching hospital, a medical center or research institute that is affiliated with an institution of higher education.
- Remuneration means salary and any payment for services not otherwise
identified as salary (e.g., consulting fees, honoraria, paid authorship).
- Equity interest means any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value.
- V. Financial Disclosure Screening Statements
- Each Investigator who is planning to participate in Sponsored Activities must submit a Financial Disclosure Screening Statement to his or her department chair or director no later than the time of application for funding of the Sponsored Activity. If the Activity does not involve an application process, the Statement must be submitted prior to the execution of a contract between the university and the funding entity.
- Each Investigator who is participating in Sponsored Activities must submit an Annual Financial Disclosure Screening Statement in accordance with the Conflict of Interest Disclosure Guidelines. The Annual Financial Disclosure Screening Statement shall include updated information on any matters previously disclosed.
- Each Investigator who is participating in Sponsored Activities must submit an updated Financial Disclosure Screening Statement within 30 days after discovering or acquiring a new Significant Financial Interest.
- A Financial Disclosure Screening Statement shall report the following information:
- Significant Financial Interests, as defined in item IV G, above;
- Any reimbursed or sponsored travel related to an Investigator's Institutional Responsibilities. This disclosure requirement does not apply to any travel that is reimbursed or sponsored by a Federal, state or local government agency, an institution of higher education, an academic teaching hospital, a medical center or a research institute that is affiliated with an institution of higher education.
- VI. Review of Financial Disclosure Screening Statements
- Investigators shall submit their Financial Disclosure Screening Statements to their department chairs or directors and then to their deans for review and approval. The chairs or directors and the deans will review the statements to determine whether Significant Financial Interests that relate to the Investigator's Institutional Responsibilities exist and whether they constitute potential conflicts of interest.
- Deans will report any identified potential Financial Conflicts of Interest to the Office of the VPRCA and together they will develop a Conflict of Interest Management Plan in consultation with the Investigator.
- Chairs, directors and deans will be responsible for monitoring compliance with Conflict of Interest Management Plans and for reporting any violations to the Office of the VPRCA.
- Prior to the establishment of a Sponsored Activity expenditure account, the Financial Disclosure Screening Statements of Investigators participating in the research must be reviewed and approved and any necessary Conflict of Interest Management Plans must be in place.
- Significant Financial Interests disclosed or discovered after a Sponsored Activity Project has begun must be reviewed and approved and any necessary Conflict of Interest Management Plans must be in place within 60 days.
- If an Investigator fails to disclose a Significant Financial Interest that is determined to be a Financial Conflict of Interest, if the University fails to review or manage a Financial Conflict of Interest, or if an Investigator fails to comply with a Conflict of Interest Management Plan, the University will within 120 days of discovery complete a retrospective review of the Investigator's research to determine whether there was any bias in the design, conduct or reporting of the research. The Office of the VPRCA will keep a record of the retrospective review and make any necessary reports to funding agencies in accordance with Federal regulations.
- The Office of the VPRCA will develop guidelines and training to assist chairs, directors, and deans in performing their responsibilities under this provision.
- VII. Training for Investigators
Investigators must complete a training program in accordance with the Conflict of Interest Disclosure Guidelines prior to engaging in Sponsored Activities and at least every four years thereafter. The training program must also be completed when the University makes a substantial revision to this Policy and when an Investigator is found not to be in compliance with this Policy or a conflict of interest management plan.
- VIII. Disclosure and Reporting of Financial Conflicts of Interest
- In compliance with Federal regulations and consistent with the Ohio Public Records Law, the University will ensure public disclosure of information concerning any Financial Conflict of Interest and associated Conflict of Interest Management Plan via a publicly accessible website or written response to any requester within five days of a request.
- The University will report to Federal funding agencies all Financial Conflicts of Interest and associated Conflict of Interest Management Plans relevant to research funded by those agencies when required to do so by relevant Federal regulations.
- IX. Sub-recipients of Federally Funded Research
The University will require sub-recipients of federally funded research to certify that they have adopted financial conflict of interest policies that comply with Federal regulations promoting objectivity in research.
Proposed revisions of this policy should be reviewed by:
- Chairs and Directors
- General Counsel
- Faculty Senate
- Administrative Senate
- Forms, References, and History
- A. Forms
The following forms are specific to this policy:
- The Financial Disclosure Screening Statement is available from the Office of Research Compliance, or the Office of Research and Sponsored Programs, or online from http://www.ohio.edu/research/compliance/Conflict-Forms.cfm.
- B. References
The following items are relevant to this policy:
- The Conflict of Interest Disclosure Guidelines are available online, linked through http://www.ohio.edu/research/compliance/.
- 42 CFR 50.603, 42 CFR 50.604, and 42 CFR 50.605 are online, linked from Title 42, Chapter V, Subchapter D, Part 50, Subpart F.
- C. History
Draft versions of this policy that were circulated for review, their cover memos, their forms, and Reviewers' comments on them are available on the password-protected Review site, at https://www.ohio.edu/policy2/19-058/.
Prior versions of this policy were approved on April 30, 2003, and October 1, 1995.