Conflict of Interest (COI)
A conflict of interest is a situation in which financial or other personal considerations may adversely affect, or have the appearance of adversely affecting, an employee’s professional judgment in exercising any Lohocla duty or responsibility in administration, management, research, and/or any other professional activities. The bias that such conflicts could conceivably impart may inappropriately affect the goals of research or administrative programs, which must be free of the undue influence of outside interests. Both actual and apparent conflict should be disclosed. A financial conflict of interest (FCOI) is a significant financial interest that could directly and significantly affect the design, conduct, or reporting of research or directly and significantly affect an individual’s responsibility to Lohocla. A conflict of commitment is a situation in which outside relationships or activities adversely affect, or have the appearance of adversely affecting, an employee’s commitment to his or her duties or responsibilities to Lohocla. All key personnel on a federal grant or contract or personnel on an IRB protocol are required to disclose outside relationships annually. Lohocla will require each investigator (including subrecipient investigators, if applicable) to complete training prior to engaging in NIH-supported research and at least every four years, and immediately under the designated circumstances noted in the NIH Grants Policy Statement. Annual training completed by investigators at a COI-compliant institution will be considered to satisfy this requirement.
a) What needs to be disclosed
Any and all relationships, paid or unpaid, that reasonably appear to relate to the covered individual’s Lohocla responsibilities must be disclosed (including financial interest of the individual’s spouse/domestic partner and/or dependent children), and disclosure must include relationships within the 12 months preceding the disclosure. Similarly, relationships that will likely occur or continue in the 12 months following disclosure should be disclosed. In this regard, a significant financial interest includes: equity value greater than $5,000 or 5% ownership in a single publicly traded entity; equity interests including stock options of any amount in a non-publicly traded company; receiving compensation for services as a consultant or advisor to another commercial sponsor of research in excess of $10,000 annually; personally accepting a payment from a research sponsor, for non-research related gifts equal in value to more than $5,000; serving as a director, officer, or other decision-maker for another commercial sponsor; royalty income or the right to receive future royalties of any amount under a patent, license, or copyright where the research is directly related to the licensed technology or work.
b) What does not need to be disclosed
Relationships or investments with entities that do not have a business relationship with Lohocla; are not within your field of research or profession; are not related to your Lohocla responsibilities; that ended more than 12 months ago; that belong to members of your extended family; interest in mutual funds or other similar investment vehicles where the individual has no control over the selection of the holdings.
Review and mitigation of conflict of interest
The President and/or CEO of Lohocla will perform the duties of the COI Official. The COI official will consult the Federal Demonstration Partnership website (the fdp.org/default/ (COI clearinghouse) to determine if key personnel (including subrecipients, if applicable) are at a COI-compliant entity. If so, they will not be required to submit a COI disclosure to Lohocla. Lohocla will incorporate, as part of a written agreement with a subrecipient, terms that establish that the FCOI of the subrecipient will apply to subrecipient investigators and include time periods to meet disclosure and/or FCOI reporting requirements. Subrecipient institutions who rely on their FCOI policy must report identified Financial Conflicts of Interest to Lohocla in sufficient time to allow Lohocla to report the FCOI to the NIH in order to meet its reporting obligations. For each individual who is not at a COI-compliant entity, during November of each fiscal year, the comptroller will provide the individual with a copy of the above conflict of interest information and will obtain a Financial Conflict of Interest (FCOI) Form (appended). The completed forms will be forwarded to the COI official for review and investigation if deemed warranted. In instances where further investigation is pursued, the COI will form a FCOI Review Committee. The committee will determine if a COI occurs and will take steps to mitigate the conflict. All steps performed and decisions made will be documented. If Lohocla determines that an FCOI exists, an initial report will be submitted to NIH in a timely manner, providing the required information, using the eRA Commons FCOI Module. The report will include the management plan to mitigate risk. Lohocla will also submit an annual FCOI report to the NIH through the eRA Commons FCOI Module at the end of each year, until a FCOI no longer exists. When requested, Lohocla will promptly make information available to NIH relating to any investigator disclosure of financial interests and Lohocla’s review of, and response to, such disclosure, whether or not it resulted in determination of an FCOI. Lohocla will make certain information available concerning identified FCOI held by senior/key personnel as defined in the regulation via a publicly accessible website or by a written response to any requester within five business days of a request, and update such information as specified in the regulation. Lohocla’s FCOI Policy will be published on the company website and will be included as part of the policy manual, in accordance with 45 CFR part 94.4.