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STANDARD OPERATING PROCEDURE Research Administration SOP No: A002 SOP Title: Conflict of Interest
4.1 Recognize
As referenced in the sources mentioned above, a COI can take many forms. All covered persons must evaluate their interests in order to recognize that one may exist. Raising awareness through training and education can help to help build a better understanding and ability to detect and identify COI. Therefore, it is the institution’s responsibility to provide information and training on COI and require that all employees complete the training and evaluate their interests for COI.
Careful review of the relevant regulations must be made on the part of the institution. For example, the U. S. Food and Drug Administration (FDA) has defined its own criteria for COI and under regulation 42 CFR 50, Subpart F, institutions assume more responsibility with respect to COI when conducting research from the U. S. Public Health Service (PHS). Many other governing entities, such as the National Science Foundation (NSF), AAMC, and others have different criteria for determining COI. The participating institution and the covered person should review these criteria and evaluate accordingly. The institution and governing entities are responsible for making the investigator aware of new regulations and keeping an updated, enforceable policy on financial conflicts of interests. Please, see Table 4.1 below for PHS-funded criteria for significant COI.
Table 4.1
PHS-Funded Research Criteria for Significant COI
Income of > $5,000 from a publicly traded entity.
Stock valued > $5,000.
A combination of income or stock at an aggregate of > $5,000.
Any amount of equity in a non-publicly traded entity.
Compensation > $5,000 in the past 12 months.
Intellectual property rights paid by any source than the investigator’s current institution > $ 5,000.
Reimbursed or sponsored travel paid by an entity.
Any other interests required under the institution’s policy
4.2 Disclose
After careful evaluation of one’s interests, all interests must be disclosed. All CHST employees are required to complete a COI at the time their employment begins. Annual COI assessments are to be completed through Policy Tracker. Proper disclosure of interest can protect the covered person and institution from unethical influence, tarnished reputation, and potentially litigious consequences.
With regard to research, disclosure must be made to avoid the same consequences. In addition, failure to disclose interests could result in the falsification of data or the nullification of a study. Disclosure should occur at the initiation of involvement or application for funds, the disclosure should be updated annually, and within 30 days of any new or changed COI. The institution is responsible for reporting any new FCOI
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