Conflicts of interest in research may occur when outside financial interests compromise, or have the appearance of compromising, the professional judgment of a researcher with responsibility for the design, conduct, or reporting of research.
NIH and NSF Specific Conflict of Interest Compliance Requirements
U.S. Public Health Service, Including the National Institutes of Health
The U.S. Public Health Service (PHS), which encompasses the NIH, has detailed regulations that require annual disclosure of any related financial interest, subject to monetary thresholds, from all investigators who propose, conduct, or report research funded by the agency (NIH 2014). The investigators must disclose the information to their organization, which thenhas to review and manage any conflicts of interest.
Under regulations revised in 2011, investigators seeking NIH funding must report all outside financial interests that relate to their professional responsibilities regardless of whether they create a conflict of interest or not. The organization must review the disclosures to identify any conflict of interest. The organization already had the responsibility to report any conflict of interest to the NIH. In addition, it must now either provide a list of current conflicts involving NIH funding on a public website or in writing to anyone who requests the information. These changes point to an effort to increase transparency surrounding conflicts of interest related to federal research funding and to the importance that the government places on proper management and disclosure of conflict of interests, especially those that are financial in nature.
National Science Foundation and Other U.S. Federal Funding Agencies
Other U.S. federal agencies, including the National Science Foundation (NSF), have conflict of interest policies that affect those who are seeking funding. In general, federal sponsors require disclosure and management of conflicts of interests. Noncompliance with these terms can result in suspension or termination of a sponsored project.
While both require that the organization have a system to identify and manage conflict of interests, NSF's policy is somewhat different than NIH's. At present, the NSF only requires that "unmanageable" conflict of interests be reported and there is no requirement to make a researcher's conflicts of interest public. As with organizational policies, conflict of interest policies from federal agencies can vary in terms of which information needs to be disclosed, what counts as a conflict of interest, and how conflict of interests should be managed.
Conflict of Interest Training
Externally sponsored research and educational activities are a vital part of Southeast Missouri State University’s mission. When accepting external funds for these projects, the University has a responsibility to promote objectivity in research and other sponsored programs by establishing standards to ensure that there is no reasonable expectation that the design, conduct, or reporting of research and project activities under grants and cooperative agreements will be biased by any conflicting financial interest of an investigator.
A potential Conflict of Interest occurs when there is a divergence between an individual’s personal interests and his or her professional obligations to the University, such that an independent observer might reasonably question whether the individual’s professional actions or decisions are determined by considerations of personal gain, financial or otherwise. A potential Conflict of Interest or the appearance of a Conflict of Interest may be complex and can include both ethical and financial considerations. Federal and other regulations also address the roles of the spouse, dependent children, and other close relatives as potential sources of Conflict of Interest. Even when the behavior itself is exemplary, the appearance or perception of a Conflict of Interest should be avoided.
Project personnel with an actual or potential Conflict of Interest are required to take Conflict of Interest training, however, anyone who is uncertain whether he or she may have a Conflict of Interest is strongly encouraged to take the training to help determine if a disclosure may be necessary.
To facilitate this training, Southeast Missouri State subscribes to the Collaborative Institutional Training Initiative (CITI) Program. CITI’s web-based training materials meet federal requirements and are used by millions of learners at academic institutions, government agencies, and commercial organizations in the U.S. and around the world. Using this web-based training allows learners to work on their own time and at their own pace in completing the training requirements. The training consists of a series of modules, which do not have to be completed in one session. CITI training can be accessed at about.citiprogram.org/. Once on the CITI homepage, users should
- Click on the Register button.
- Select an organizational affiliation by typing in the University’s name. Hint: by the time you type Southeast, the University name should appear in the drop-down list, and you can select it.
- Follow the prompts to set up an affiliated account and username and password.
- Select the required training, which, in this instance, will be the Conflict of Interest (COI) training modules. Project personnel should complete the course for Researchers; those with administrative responsibilities should take the course for Administrators and may also wish to take the course for Researchers as well.