An Example of an Individual Financial COI
An individual financial COI is when an individual has a commercial interest in the outcome of their research. For example, if researchers are interested in their research and the outcomes produced, they can earn personal income. This concern should not necessarily affect whether or not a study/article should be published, as these are usually ethical topics.
When you’re doing your research and think it will yield commercial benefits, you need to ensure that your work is done ethically.
A researcher may have a conflict of interest if he is engaged in research that may benefit a publicly-traded pharmaceutical company. Another example is if a researcher’s spouse owns equity in a company that sponsors the researcher’s study. In such a situation, a conflict of interest occurs if the researcher’s responsibilities and interests conflict with those of the company.
An example of an individual financial COI is when a researcher has a financial interest in a research project that has a potential conflict of interest with their research. For example, if a researcher has equity in a pharmaceutical company that sponsors the study, that interest could conflict with the researcher’s research.
To resolve this conflict, an investigator with a financial COI will work with Emily Bradford and obtain approval from the Associate Dean for Research. A management plan is then submitted to the Research Conflict of Interest Committee. The RCOIC will review the management plan and make a recommendation to the Vice President for Research.
A conflict of interest may arise when a personal interest influences a researcher’s professional judgment. It may be either actual or apparent, depending on whether a reasonable person would believe that a personal interest influences an individual’s decision-making. A conflict of interest implies potential bias in the researcher’s research.
RAND’s Conflict of Interest Policy outlines the guidelines for identifying and mitigating conflicts of interest. The policy requires researchers to complete the necessary training and disclose any Financial Interests. In addition, investigators are responsible for mitigating and minimizing the risks of Significant Financial Interests (SFIs).
A nonfinancial COI is any conflict of interest that generates a bias in the scientific process. It can arise from any source and include personal, political, academic, ideological, or religious interests. However, in a scientific environment, the impact of nonfinancial COIs is often mysterious.
The extent of reported COIs in systematic reviews varies across journals. The Cochrane method of reporting COIs has the most significant rate of reporting. However, the reports focus on the individual, not institutional, COIs. Additionally, the reported COIs differ in their duration.
Authors may report several individual financial conflicts of interest in a Cochrane review. One of the most common subtypes was the authorship of primary studies that were not included in the review. Another common subtype was whether an individual had a financial or intellectual conflict of interest.
Requesting Financial COI from a Primary Reviewer or Research Integrity Staff
When a researcher seeks external funding or submits a funding application, they must disclose their financial interests. These disclosures must be maintained up to date, and the disclosure must comply with the Public Health Service’s COI regulations. Researchers must also disclose financial interests if they have a conflict of interest related to a study of human subjects.
A primary reviewer or research integrity staff member may ask for additional information if a financial COI might affect a study. For example, the staff member may request a Conflict of Interest Disclosure form or additional documentation from the COI Designated Official of the research institution and the primary reviewer.
When a research staff member notices a conflict of interest, the IRB staff member must disclose it at the start of each meeting. When the conflicted member cannot vote on the project, they should leave the meeting. Depending on the nature of the conflict, the member may not count toward the quorum. Sometimes, the researcher may provide the requested information before leaving the meeting.
The University of Michigan has responded to requests for financial COI within five business days. It has adopted PHS COI standards. In addition, many sponsors have adopted the COI requirements of this institution. The university’s Office of Research Integrity and Compliance will respond to requests for financial COI within five business days.
Source of Financial COI
The source of financial COI for an individual is essential for various reasons. COIs may include personal or institutional financial interests. The most common types of COIs reported in journals are financial and non-financial. Financial COIs were more likely to be reported than other types, and authors were more likely to report financial COIs than nonfinancial COIs.
A COI Disclosure Form should be filled out each year. Although it is not mandatory, researchers should fill out an updated version if significant changes occur or they acquire Significant Financial Interests. The updated information will automatically pre-populate the annual form. Once completed, a COI disclosure form should be sent to the individual.
COIs may influence published scientific articles. In some cases, authors with relevant COIs may be more likely to favor the products they discuss. Authors who receive monetary support from a specific industry may favor a company’s product. Researchers must consider the source of financial COI for an individual’s publication before making recommendations.