Disclosure ensures that authors are aware of their responsibilities to readers, allows readers to assess and evaluate reasearch findings with greater accuracy and promotes transparency.
The biomedical literature’s reputation as the guardian of truth, high ethics and moral values has been severely tarnished recently by scientific misconduct and fraud, as well as reports that obscured harmful drug effects and deleted research findings that might have reflected unfavorably on expected research outcomes.1–3 The common thread among these types of occurrences is the advancement of private or personal interests at the expense of the public good. Such behavior is commonly branded as "conflict of interest."
Conflicts of interest are perceived when a rational, sensible observer could conclude that ulterior motives—financial rewards or other personal gains—have breached the scientific integrity of a research project. However, conflicts of interest do not necessarily equate to moral or ethical failings. A problem emerges only when an investigator’s self-interest leads to a bias. The motivation for such a bias may not be only financial. The motivation may relate to career advancement or a desire for general recognition in the researcher’s field of interest. When a bias is introduced as a matter of choice, a conflict of interest will arise.4
Traditionally, inventions and research originated chiefly from academic institutions, while industry developed and marketed the resulting products. Today, for-profit industries are directly engaged in research at their own facilities or are outsourcing financially sponsored projects.
Both pharmaceutical and equipment manufacturers have a fiduciary responsibility to their shareholders and are interested not only in the development of new products for the benefit of humankind, but also in generating profit. Such diverse goals clearly could introduce potential conflicts of interest.
Results of industry-sponsored research compared with research sponsored by nonprofit organizations have revealed some interesting findings. For instance, there is a significant trend toward selecting the experimental drug as the drug of choice in trials sponsored by the pharmaceutical industry versus trials sponsored by nonprofit entities.5 This association shows up even more prominently in surgical trials.6 Review articles also may exhibit similar biases. A study of review articles on passive smoking showed a 94 percent favorable impact when authors were sponsored by the tobacco industry, while only 13 percent of these articles showed a diminished risk of passive smoking when the authors were not affiliated with the tobacco industry.7
Ethical conflicts occur when multiple stakeholders without mutually compatible interests interact. This is not limited to an author’s financial interest in and relationship with an industry that is supporting a study. What other conflicts of interests, then, should be disclosed before publication of an article? Should all authors have to disclose participation in industry-sponsored meetings or having paid a reduced rate for a continuing education seminar sponsored by industry?
Today there are fellowships and residency programs in both rheumatology and dermatology underwritten by pharmaceutical companies.8,9 Similarly, there are orthodontic fellowships sponsored by an orthodontic practice management service company. Would residents and fellows who received financial support from for-profit entities necessarily exhibit biases in making treatment choices for their patients? And should they have to disclose to their patients how their training was funded? Probably not, but the potential for bias does exist.
Potential conflicts of interest may extend even further, in some cases raising very touchy questions. Should an author of a study on diversity have to disclose his or her ethnicity? Could an author’s political ideology or religious beliefs create a potential for bias and therefore require disclosure?
Professional journals like JADA have strict rules about disclosure and ways of detecting biases. However, it would be absolutely impossible to investigate every author and every potential conflict of interest. Highly regarded biomedical journals rely mostly on the ethical standards of their authors and the peer-review process. Furthermore, some journals, including JADA, have strict advertising policies, requiring ad messages to be examined and reviewed for accuracy. Even images contained in these ads, which can influence judgment,10 are scrutinized critically.
Conflicts of interest extend beyond scientific journals and academia and affect the private sector. Free pharmaceutical samples routinely are given to dentists and other oral health professionals. Although these samples may seem insignificant, owing to their modest value, the size of a gift may be inconsequential in terms of how it affects indebtedness or a feeling of reciprocity.11,12 Is it necessary, therefore, for dentists to disclose to their patients that a manufacturer has given them free tooth-paste and toothbrushes?
The vast majority of studies, both those supported by industry and those not so supported, are unbiased and adhere to strict scientific rigor and integrity. Fortunately, very few people are willing to risk opprobrium—the shame and contempt associated with intentionally introducing biases into their research. Most choose to perform research that enhances understanding and benefits our patients.
What is the value of requiring disclosure in the scientific literature? It will ensure that authors are aware of their responsibilities to readers. It will allow readers to assess and evaluate research findings with greater accuracy, and it will promote transparency. We need to embrace all research findings, both positive and negative, and we must accept that industry-sponsored research is essential and critical to the advancement of science and technology. Potential conflicts of interest cannot be avoided. How such conflicts are handled will define our ethical standards and integrity.
