Conflict of interest: a research integrity and research ethics perspective
ThemesConflict of interest: a research integrity and research ethics perspective
What is this about?
In the context of research, “a conflict of interest (COI) is a set of circumstances or conditions in which professional judgement of a primary interest, such as the integrity and quality of the research, tends to be unduly influenced by a secondary interest, such as personal financial gain”.[1] Consequently, COIs can incline researchers towards bias in favor of their secondary interest and thus undermine the reliability of research results. COIs as such are not breaches of research integrity or research ethics, but researchers having a COI are, all else equal, more likely to act inappropriately or unethically because they have unusually strong incentives to depart from good scientific practice. Thus, COIs require specific safeguards to ensure principles of research integrity and research ethics are followed.
This theme page describes in more detail what COIs are and why they can have detrimental effects on the reliability of research. It also provides an overview of different types of COIs and outlines how adequate safeguards can help avoiding and managing COIs.Why is this important?
COI is a core concept in research integrity. It can even be argued that most research integrity issues are in some way related to underlying COIs, especially if integrity is understood to refer to doing what is right even if confronted by countervailing incentives.[2] Authorship conflicts, for example, often occur because researchers have a strong secondary interest to be listed as authors on as many papers as possible to advance their career, even if they have not contributed to a paper (or if their contribution does not constitute authorship). Usually, discussions on COIs in the research integrity literature focus on the narrower aspect of how COIs can bias research results and thus decrease the reliability of research results, however. In line with most of the relevant literature, this theme page adopts a narrow perspective on COIs.
In addition to their potential effects on research integrity, COIs have an important research ethics dimension as well, especially in biomedical research.[3] An example is the specific role of medical doctors in clinical research: According to the International Code of Medical Ethics, they are obliged to “be dedicated to providing competent medical service in full professional and moral independence, with compassion and respect for human dignity”.[4] However, if they act as researchers in clinical research, they are confronted with two potentially conflicting interests: a duty to care (primary duty) and the responsibility to generate new knowledge (which in this case is a secondary interest that can under certain circumstances conflict with the duty to care).[5]
Therefore, it is crucial to understand what COIs are, how they affect research integrity and research ethics, and what the research community as well as individual researchers can do to minimize their potential detrimental effects.For whom is this important?
What are the best practices?
The ENERI Classroom as well as the ENERI Research Ethics and Research Integrity Manual describe in more detail what COIs are and how they can be avoided and managed responsibly.
Path2Integrity has developed a learning card (instruction for a learning unit) on COIs (card Y7).
The Research Ethics Program of the University of California, San Diego has developed an educational resource on COIs.
The Office of Research Integrity (ORI) has collected resources on COIs and commitment.
The Committee on Publication Ethics (COPE) has developed guidelines for addressing COIs in the realm of publication ethics.
The International Committee of Medical Journal Editors (ICMJE) has disclosure of interest form.In Detail
While all COIs are related to contradictory primary and secondary interests, they can be traced to different causes and result in different types of detrimental research practices. Moreover, safeguards to address COIs vary depending on whether they are avoidable and how they can be mitigated. It is important to emphasize that while COIs can lead to intentional breaches of research integrity and research ethics, conflicting interests are more likely to result in unintentional bias.
In general, it is common to distinguish between financial and non-financial COIs. Financial COIs occur if researchers receive direct payments from the sponsor of a study, hold stocks in the sponsoring company, receive financial benefits from the sponsor for services, or have any other financial relationship with the producer of the product investigated in a study.[6] Due to the resulting incentive structure, financial COIs increase the likelihood of bias towards results favorable to the company directly or indirectly paying the researchers.
Non-financial COIs, by contrast, are unrelated to financial remuneration and tend to be more difficult to identify. At least three types of non-financial COIs can be differentiated: personal COIs, intellectual COIs, and medical COIs.[7]
Personal COIs are usually attributable to positive or negative personal relationships, even though conflicts of conscience (that is, conflicts between the personal values of researchers and the demands placed on them by their institution) also fall into this category. Biased peer-review is a well-known example of the detrimental effects of personal relationships because the peer review system is based on the premise of reviewer neutrality. Reviewers who have recently collaborated with the author(s) of a paper or grant application or who work in the same department might have a more favorable view on the paper or application under review than reviewers without such personal associations. Even if reviews are based on a blinded system, reviewers might know or be able to guess who the authors are, especially in highly specialized and rather small fields of research or when researchers can suggest reviewers. Negative personal relationships, by contrast, can have the opposite effect.[8]
Intellectual COIs occur when researchers become so convinced of the truth of a particular finding or paradigm that they become biased against alternative explanations and dismissive of contradictory findings, regardless of the quality of the evidence.[9]
Medical COIs refer to situations where the personal medical experiences of researchers could bias their research in that area. For example, a researcher who has suffered from a particular disease, could be inclined to view this disease in a way colored by personal experiences.[10] This may have methodologically unjustifiable effects on research design or, in the same way as intellectual COIs, lead to biased interpretations of results.
COIs are addressed by three types of safeguards: disclosure, management and prohibition. They can be disclosed to the research institution, research ethics committees or institutional review boards, journal editors and readers, and research participants. Management refers to erecting procedures that mitigate the risk of COIs, for example by replacing researchers with a COI with researchers without a COI for certain parts of a research project. Prohibition refers to prohibiting certain types of research if a COI exists. Employees of pharmaceutical companies cannot lead clinical drug trials of drugs produced by their company, for example.[11]
According to current regulations, financial COIs must be declared so that readers are made aware of conflicting interests and can scrutinize papers accordingly. Non-financial COIs are regulated less stringently and perhaps also less amenable to formal regulation. Overall, it is strongly recommended to avoid personal COIs by refraining from suggesting reviewers who might be biased as well as by refraining from accepting to review manuscripts or grant applications one cannot assess neutrally. Intellectual COIs can perhaps best be managed by regular self-reflection and regular participation in reflection-based research integrity trainings, such as, for example, the VIRT2UE training or the PRINTEGER Upright program. Medical COIs could potentially be declared, yet this is not usually done and would be challenging both legally and ethically because it would require the disclosure of sensitive personal information.
Overall, COIs can take many forms and be mitigated through different types of safeguards. As such, COIs are not breaches of research integrity or research ethics, yet they increase the likelihood of violations of good scientific practice. Therefore, the research community has adopted mitigatory measures to manage COIs that might require further refinement in the future.
References
[1] Emanuel E.J., & Thompson D.F. (2008). The concept of conflict of interest. In: Emanual, E.J., Grady, C., Crouch, R.A, Lie, R.K., Miller, F.G., & Wendler, D.D. The Oxford Textbook of Clinical Research Ethics. Oxford: Oxford University Press, 758-766.
[2] https://eneri.mobali.com/content/conflict-interest, Key issues
[3] Ibid.
[4] WMA International Code of Medical Ethics, 2006. https://www.wma.net/policies-post/wma-international-code-of-medical-ethics/
[5] https://eneri.mobali.com/content/conflict-interest, Learning objectives and introduction
[6] Ibid.
[7] https://eneri.mobali.com/content/conflict-interest, Key issues
[8] Ibid.
[9] Ibid.
[10] Ibid.
[11] Ibid.Tom Lindemann contributed to this theme. Latest contribution was Oct 15, 2021
