Readership Awareness Series - Paper 2: Conflict of Interest

A ‘Conflict of Interest (COI)’ is a broad term that can encompass anything and everything; hence it is hard to define it accurately. Although the definition can be contextual, several similar definitions are used across healthcare by different organizations.

“A conflict of interest can be defined as any situation in which a decision (or an action) taken by a professional in his/her duty is influenced by his/her relationship with a third party, providing directly or indirectly to the professional and/or to the third party, personal benefits whether financial or not.”^1,2

“The potential for conflict of interest and bias exists when professional judgment concerning a primary interest (such as patients’ welfare or the validity of research) may be influenced by a secondary interest (such as financial gain).”^2,3

“The term “conflict of interest (COI) in research” refers to situations in which financial or other personal considerations may compromise — or have the appearance of compromising — an investigator’s professional judgment in conducting or reporting research.”⁴

There are several ways to classify COI. Financial COI is common and more easily recognized than non-financial COI (NFCOI). Financial COI can be direct or indirect and include employment, consultancy, honoraria, royalties, stock ownership, paid expert testimony, paid advisory boards, industry speakers bureau, patent applications or registrations, intellectual properties, industry-sponsored travel and conference grants, and interests with sources of funds/grants.^1–5 These are also applicable to immediate family members of the physician or researcher. The cut-off value of the financial benefit to call it a financial COI and conflicted durations are debatable and vary with different organizations. A financial COI arises if an individual has a financial incentive to violate their professional and statutory obligations. The NFCOIs include personal COI (e.g., religious beliefs), professional COI (e.g., an author submits a manuscript to the editor, who is his supervisor), and Institutional COI (e.g., institutional interest affecting the results of a study). The COI can also be classified as ‘actual’ (is directly influencing), ‘potential’ (could be influencing), or ‘perceived’ (could appear to be influencing). It is essential to note that the resolution of ‘perceived’ COIs are as important as the others.

Conflict of Interest is increasingly being recognized as a public health concern. Due to a trend of decreasing public funding allocation for research, it is not surprising that the external funding collaborations between the industry and academia have more than doubled from 12000 in 2012 to 26000 in 2016, half of which were in life sciences.⁶ Parallelly, although the reporting of COI in scientific publications has dramatically increased since the 1990s, the actual reporting is still dismal.⁷

Why is a COI a problem? There are several ways in which COI can be an issue in both clinical and laboratory-based research.⁸ A researcher with a COI can potentially have an undue influence on the study design (to sway the results) and testing of a drug or device (to benefit the industry). There was a significant association between the industry-sponsored studies and the pro-industry conclusion (Odds Ratio – 3.60, 95% CI 2.63–4.91).⁹ This can potentially harm the patients recruited for these studies or who take the drug or device following their market approval. Another significant collateral damage due to undisclosed COI is the lack of public trust or confidence in medical research. The continued and significant increase in scientific publications is paralleled with an increased incidence of inappropriate authorship practices.^10,11 Retraction watch database shows that up to 1% of retraction notices were on account of conflict of interest.¹² While this may seem a minuscule; its significance cannot be underestimated.

Variable approaches have been designed to resolve COI across healthcare organizations and journals. Regulation of COI is one significant approach.^1–5,13 All stakeholders request elaborate disclosures of COIs. The International Committee of Medical Journal Editors (ICMJE) has recommended an elaborate and uniform format for the disclosure of COIs. Several organizations curtail the scope of the activities of members with COIs (e.g., for an industry advisory board member). They may be recused from voting, chairing a task force, and being on important guideline committees. Their activities may be supervised by third parties. While the best way is to terminate the conflicting relationship for a specified project or research duration, it is not a sustainable solution. The legislatures in various countries have also stepped in to regulate COIs. For example, the Sunshine Act in the United States mandates that any financial gift or in-kind payment of 10 US$ or more (including meals!) to the physician or healthcare organizations by the medical industry is to be reported to the Center for Medicare and Medicaid Services.^1,8 Similar laws have been enacted within the European Union. This approach has several flaws and is not without notoriety for errors.⁸

What is the best way forward? There cannot be a one-stop solution for managing the conflicts for a complex issue like COI. There need to be multipronged strategies. The foremost being is increasing the awareness and the level of education right from the medical schools. Several researchers may either be unaware of the COIs or their negative influence. Hence, educational programs should have clear, concise, and well-defined learning objectives. The role of individual institutions is vital to increase transparency in research. They should have a regularly updated and effective policy on COIs. They should actively identify ‘at-risk’ areas, promote integrity, regulate ethics boards, and establish transparent sanctions for defaulters.¹ The institutions should obtain complete disclosures at appointments, promotions, and regularly at defined time intervals.¹

There is no doubt that the scope of COI should be better defined and better exemplified with a constant regulatory process to ensure universal compliance for full disclosure. However, it is equally important to understand that the mere presence of COI is not unethical or does not amount to professional misconduct. Just the presence of a COI does not necessarily lead to biased decisions and may not diminish the research’s value or the researcher’s integrity. The whole process is about providing full disclosure. The COI rules and regulations aim to enable constant vigilance for any negative influence on science arising out of any conflict of interest and to promote transparency and trust in the research process.