Authors:  Ann Hardy, DrPH, CIP and Sherry Mills, MD, MPH, Learn eCORE

 

Investigators who conduct human subjects research generally want to advance scientific knowledge that will improve people’s lives. However, there may be situations in which an investigator’s professional judgment regarding his or her research could be negatively influenced by a secondary interest such as potential financial gain or professional advancement. These secondary interests are referred to as “investigator conflicts of interest” (ICOI). For example, an investigator may let the desire to complete a research project quickly to gain financial benefits or enable rapid publication to influence the conduct of his or her research. Allowing conflicts to dictate professional actions can have negative consequences for the outcomes of research and for research participants. Such actions can also erode public trust in the research enterprise.

 

Investigator conflicts of interest are generally categorized as:

1. Non-financial: Influences other than financial reward; for example, not recusing oneself from the review of a proposal from an organization where the investigator serves as an unpaid advisor.
2. Financial: A prospect of financial gain from the research; for example, owning stock in a company that could directly benefit from the outcome of a research project.

 

To prevent the negative consequences of conflicts of interest on research, there are federal requirements that must be followed to ensure scientific integrity and the welfare of research participants.

 

Requirements for Conflict of Interest in Research

 

In the United States, federal agencies that fund research have established conflict of interest standards that investigators must follow. For example:

• The National Institutes of Health (NIH) and the National Science Foundation (NSF) require that investigators follow very detailed regulatory requirements for identifying, disclosing, and managing financial conflict of interest (FCOI).
• The Department of Defense and the Department of Justice have more general requirements for funded investigators to disclose and manage both financial and non-financial conflicts.
• Investigators involved in Food and Drug Administration (FDA)-regulated clinical studies, regardless of funding source, must make financial disclosures at the time of application to the FDA.

 

The Declaration of Helsinki that applies to many international studies requires that investigator conflicts of interest be described in research protocols and disclosed in informed consent documents and in publications.

 

Private foundations, such as the American Cancer Society, also have policies for the identification, management, and disclosure of investigator conflicts for research they support.

 

It is critical that investigators be aware of and adhere to the requirements of their funding and sponsoring entities for both financial and non-financial conflicts of interest.

 

Identification and Disclosure of Investigator Conflict of Interest

 

For Non-Financial Conflict of Interest: Investigators should identify possible activities and relationships that could present a conflict of interest with their research. If required by a funding entity, investigators may also need to disclose these potential conflicts.

 

For Financial Conflict of Interest: Investigators must identify and disclose significant financial interests to a designated institutional official. This official will determine which financial interests could impact a particular research project.

 

Managing Conflicts of Interest

 

Once identified, conflicts of interest must be managed. Many investigators mistakenly believe that the only ways to manage conflicts are by severing relationships or by complete divestiture of financial interests. However, there are other strategies. For example, conflicts can be disclosed to potential research participants during informed consent or can be mitigated procedurally, such as blinding the investigators to the interventions in a clinical trial.

 

Failure to disclose, develop, or follow conflict of interest management plans may be considered non-compliance and may lead funding agencies to take actions such as delaying or suspending funding.

 

Conflict of Interest Training Requirements

 

Because the regulations and requirements regarding investigator conflicts of interest can be quite complex, many funding agencies and institutions require that investigators take periodic training on this topic.

 

Learn eCORE offers a comprehensive online training course on investigator conflicts of interest (ICOI) that covers both financial and non-financial conflicts and meets federal training requirements. Click here for more information.

 

About Learn e-CORE:

Learn eCORE offers online self-directed courses for anyone involved in human subject research. The courses provide timely and accurate certificate training on compliance and research ethics on two high-demand topics: human subjects protection and investigator conflict of interest.  Our courses are developed by leading subject matter experts and reflect high instructional design standards to enhance learning with interactive exercises, graphics, and realistic case studies.  Other unique features include optional continuing education credits for many disciplines, a companion Faculty Guide to aid teachers using our human subjects courses in the classroom, course availability in multiple languages, and complementary access to professional soft skills online courses and related tools for human subject researchers. Learn eCORE offers affordable and flexible subscription plans for individuals and groups.   Click here for more about Learn eCORE, the “The Expert, Affordable Alternative for Research Compliance and Ethics Training”.

 

About the Authors:

Sherry Mills, MD, MPH and Ann Hardy, DrPH, CIP, the co-founders of Learn eCORE, have decades of experience conducting public health research, developing federal research policy, and creating comprehensive training programs such as the former National Institutes of Health (NIH) online course “Protecting Human Research Participants” that trained millions world-wide from 2009-2018.  Additionally, they have over 10 years of service as Institutional Review Board (IRB) members and have consulted with major federal agencies such as the Office on Human Research Protections (OHRP). Drs. Mills and Hardy also are active in teaching others about grant writing and research program development.