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Conflict of Interest (COI)

Working together, academia and industry discover and develop new therapies and products for patients. While there is much to be gained from these collaborations, our interactions must be managed to ensure that objective research results are obtained and appropriate ethical and safety processes are followed to ensure the protection of the rights and welfare of human subjects. By complying with OSU conflict of interest policies and processes, we instill trust in our relationships with the research community, gain support from the public, and partner responsibly with industry

Applicable OSU policies and governing law

OSU policies cover individual and organizational financial conflicts of interest. The policies are based on federal and state laws, and recommendations from the Association of American Medical Colleges and Institute of Medicine. In accordance with these policies, OSU requires faculty and select research staff members and students to complete an annual financial disclosure, and to update disclosures upon 30 days of acquiring or discovering a new financial interest. Training must be completed every four years. Training, submission of the annual disclosure and disclosure updates can be completed at go.osu.edu/coi. Note that the Office of Sponsored Programs will not process proposals when the principal investigator or other faculty named on the ePA005 has not completed the annual COI disclosure. In addition, protocols and sponsored research awards utilizing those protocols will not be finalized if key personnel have not completed their annual financial conflict of interest disclosure.

Individual Conflict of Interest policies and processes

The OSU Conflict of Interest Policy for Faculty sets forth the process for identifying, evaluating and managing individual financial interests that may exert (or may appear to exert) improper influence on professional judgment in exercising university duties and responsibilities. For those individuals receiving PHS funding, “significant financial interest” requiring management means renumeration received from an external entity of $5,000 or more, equity holdings in a publicly traded entity of $5,000 or more (or 5% or more of equity ownership), and any equity interest in non-publicly traded entities. For individuals who do not receive PHS funding, “significant financial interest” means renumeration received from an external entity or equity holding of $10,000 or more (or 5% or more of equity ownership). In addition, individuals receiving PHS funding must also disclose all travel by researchers and research staff that is not sponsored by a federal agency, state or local government, or a U.S. academic teaching hospital or university-affiliated research institution.

Additional Scrutiny for Human Subjects Research

Note that OSU follows the guidance from the AAMC in establishing a rebuttable presumption that an individual who holds a significant interest in research involving human subjects may not serve as the principal investigator for such research. Only in the event of compelling circumstances, can an individual holding a significant financial interest in human subjects research be permitted to conduct the research. Whether the circumstances are compelling will be determined by the OSU Conflict of Interest Advisory Committee and will depend in each case on: the nature of the research, the nature of the financial interest, how closely the interest is related to the research, and the degree to which the interest may be affected by the research. Any approval will require a management plan and approval by the responsible Institutional Review Board.

Organizational Financial Conflicts of Interest

In 2012, Ohio State approved and implemented a new Organizational Financial Conflicts of Interest policy to identify, evaluate and manage situations in which the financial interests of the institution or the officials acting on its behalf may affect or appear to affect research, education, clinical care or other activities of the institution.

Wexner Medical Center Vendor Interaction Policy

The Wexner Medical Center Vendor Interaction Policy defines acceptable business practices and ethical principles to guide the interactions of all OSUMC faculty, staff, and trainees with vendors and vendor representatives. The policy touches on conflicts of interest in research, and importantly requires medical center staff members to disclose any financial conflicts to the IRB, and further to disclose substantial conflicts of interest to prospective research subjects as part of the informed consent process.

State law

The Ohio Ethics Law and related state law generally prohibit public officials and employees from misusing their official positions for their own personal benefit or the benefit of their family members or business associates. The Ethics Law and related statutes are criminal laws; penalties for convicted violations include fines and jail sentences. See Ohio Revised Code provisions 102.03, 2921.42, and 2921.43.

Regulations requiring disclosure by Drug, Medical Device and Medical Supply Manufacturers

The Physician Payment Sunshine Act signed into law in 2010 as part of the Patient Protection and Affordable Care Act will require drug, medical device and medical supply manufacturers to track and report publicly payments made to physicians and teaching hospitals. The new requirements are very broad requiring disclosures for compensation of $10 or more, and disclosure of any financial or equity interest that physicians (or their immediate family members) have in companies that manufacture, purchase or sell drugs or medical supplies. These rules when released and enacted, are expected to provide greater transparency to the relationships between industry and academia and will give heightened attention to the disclosure and management of financial interests by physicians and teaching hospitals.

Other Related OSU Policies

There are several policies related to financial conflict of interest governed by the Office of Academic Affairs including:

Contact Frank White​, (614) 685-1734, at Ohio State’s College of Medicine Office of Research with any questions.​