A conflict of interest (COI) management plan is a document that outlines and implements measures to actively reduce, mitigate, or eliminate an actual, potential, or perceived conflict of interest held by an employee. The COI management plan aims to manage the conflict of interest and make it as transparent as possible at each stage of the working process.
Explanation:
The term “interest” refers to a commitment, goal, or value held by an individual or an institution. Generally, two types of COI are distinguished, namely, individual COI and institutional COI. An individual COI is when an official has private-capacity interests which could improperly influence the performance of their official duties and responsibilities. An example of individual COI is when an independent researcher with no affiliation to the university or the training organization may also have a conflict of interest related to bias or theoretical allegiance to an alternative program or theoretical paradigm.
An institutional COI arises when an institution’s own financial interests or the interests of its senior officials pose risks to the integrity of the institution’s primary interests and missions. For example, a financial interest of the university (e.g., investments held by the university in a company) or a Covered Official has the potential to bias, or appear to bias, research conducted by its employees or students. Regardless of their nature, conflicts of interest may have legal ramifications. They should be well managed to escape the undermining of work and damaging the reputation of an entire company.
Conflicts of interest are subject to managing by a special committee that aims to disclose all interests of stakeholders, and manage conflicts in a transparent and proportional manner. At a certain stage of a project or a working process all stakeholders must disclose their interests and report on any potential COI.
The committee reviews the disclosures, diagnoses potential COIs, grades them as low-, moderate-, or high-level and manages them accordingly. As a rule, the disclosures and pertaining management decisions are publicly reported. The committee is authorized to create the COI management plan and may request the assistance of others on its implementation.
In case there is something on a stakeholder’s COI disclosure that might be judged as a potential conflict of interest, a COI management plan is drawn. The purpose of the plan is to explain the nature of the conflict and outline the measures that should be taken to prevent the conflict from escalating.
Components of a good management plan in education include several essential clauses. They provide a full disclosure of financial/business interests; ensure research integrity; safeguard for students engaged in directed research activities; and managing potential conflicts of interest by divestiture or removing the situation.
On the federal level, specific organizations are authorized to regulate the conflict of interest cases. For example, the Food and Drug Administration (FDA) and other organizations developed rules to limit the impact of conflict of interest. Thus, the FDA regulations governing disclosure of individual COIs require each clinical investigator to provide the sponsor with sufficient accurate financial information for complete disclosure or certification and to update this information during the study. According to the Public Health Service (PHS) regulations of financial COI, a failure to accurately and timely complete the disclosure and to provide updates could result in disciplinary action, up to and including termination.