Researchers
October 12, 2020

What Defines a Significant Financial Conflict of Interest for NIH Funded Research Projects

Research must be unbiased as much as possible on all ends, especially when it comes to the entity funding the work. When a financial conflict of interest arises, it’s up to all the parties involved to ensure the conflict is worked out and taken care of before the work ever progresses. This is particularly true with work funded by the National Institute of Health (NIH). A significant financial conflict of interest in the medical and healthcare field can have major repercussions, so researchers must know what designates this conflict before they start their work.

In the realm of academic and scientific research, the importance of ethical and unbiased research is a hard limit. The global population of everyone, regardless of backgrounds, education, philosophies, or socioeconomic status, turns to science for answers. Throughout history, researchers have consistently fostered this level of trust through factual research reporting, so others believe inherently that what they are reading or hearing is based on outcomes discovered through factual evidence. To keep this reputation going, all research must be evidence-based, bias-free, and neutral. When conflicting interests arise, it taints the entire scientific community with skepticism.

This is particularly true when the conflict of interest is financial. When research occurs but the funding source has more than one vested interest in the ultimate results, the entire reputation of the research, scholar, and institution hosting the experiment are questioned. For research sponsored by the National Institution of Health (NIH), where people’s lives are at stake, there can be no question of completely factual outcomes. The lack of trust between healthcare research and the intended audience may result in significant detrimental consequences in which authentic information is also seen as questionable. Because of the importance of a flawless reputation, the NIH takes care to avoid significant financial conflicts of interest in their funded research projects.

What is a Financial Conflict of Interest

By definition, a research financial conflict of interest is when the researcher/institution/other party receiving funds for the experiment comes from a funder who has an interest in how the results would affect them or their interests in economic ways. This conflict of interest would possibly have a bearing on the design, methodology, conduct, or outcome reporting of the funded research.

Because personal interests in general and financial gain in particular have to be carefully excluded from the research process, when a financial conflict of interest is possible, the researcher and all parties involved in the work should always choose the side of truth and full disclosure. However, this does not happen 100% of the time, and it’s not always on the side of the funder where the conflict of interest occurs. In some cases, researchers use unfair methods to obtain a patent or financial advantage by hindering the work of someone they see as competition.

When research outcomes are linked to a party perceived as having a financial interest in them, it must be investigated as to whether the findings were accurate or over/underemphasized. It’s also important to verify that there was no research misconduct engaged during the study itself. This can result in an expensive, complicated, and time-consuming repetition of the research done by an agreed-upon neutral party. While all of this is going on, the core values of scientific literature, objectivity, honesty, accuracy, and efficiency, are all being eroded.

The key is that not every financial interest is wrong. Researchers can benefit from their work financially. It’s a job, and they should. From there, copyrights, patents, and licenses obtained by researchers lets them sell their work to the public through the Bahh-Dole Act, with the intent that research institutions will use their work for the good of society. This act was the first step to allowing and encouraging researchers and institutions to use their financial interests similarly to the way government and private branches would. Through investments in research, economic growth continues to be stimulated.

Current NIH Regulations

Regulations are always changing, but when it comes to policies that pertain to healthcare, they tend to get more strict, not less. Current NIH regulations require that any institution receiving funding, and the investigators as well, comply with all requirements of 42 CFR 50, Subpart F, "Responsibility of Applicants for Promoting Objectivity in Research for which PHS (public health service) Funding is Sought" (FCOI Regulation). This particular version was implemented in 2011 as part of the final ruling for grants and other cooperative financial agreements.

Through these requirements, all parties involved in the research must be objective and follow the standards established by the Public Health Service’s regulations. The standards were developed to provide a framework for the study’s design, all conduct involved, and the reporting of the research to be free from bias any time it is funded under PHS money. There is to be no conflict of interest of bias by the investigator, of the person or persons in charge of designing, conducting, and reporting the research, or anyone collaborating or consulting with them.

To ensure this is achieved, the institutions are required to keep up-to-date, written policies with the financial conflict of interest regulations and to enforce them consistently.

Tags Financial Conflict Research Projects NIH
Jason Collins
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Jason is a writer for many niche brands with experience “bringing stories to life” for both startups and corporate partners.

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