This is the first report describing the current status of author COI policies and the current state of COI disclosure in Korean medical journals. Our study reveals the prevalence of author-related COI policies and compliance of COI disclosure in Korean medical journals. We found that most (82.8%) of Korean domestic medical journals ask that authors disclose COIs, although half of them state their COI-related policies explicitly in a dedicated paragraph, and about one third of the journals extended the scope of their policies to include non-financial COIs. Given that potential COIs are unavoidable in many clinical situations and types of clinical research, the importance of full transparency in the disclosure of COIs in medical journals and clinical research cannot be underestimated. However, the compliance of COI disclosures in the subject papers was not satisfactory.
COI arises whenever an individual or organization is involved in multiple interests, one of which could possibly corrupt the motivation for an act in the other (12
). Medical research should be fully transparent. Otherwise, COIs might seriously influence scientific works and endanger public trust. Guidelines for the disclosure of COIs have been published by ICMJE. It is recommended that when authors submit a manuscript, they are responsible for disclosing all financial and personal relationships on a conflict-of-interest notification page whether potential conflicts do or do not exist. Since then, many medical journals follow the Uniform Requirements. Given the importance of adequate COI disclosure to ensure optimal transparency in medical publications, the majority of medical journals now specifically recommend COI disclosure in their policies (8
). Blum et al. (7
) have reported the prevalence of author COI policies among medical journals with high impact factors. They found that 89% of these journals required author COI disclosure. Comparison of their findings with those reported by Krimsky and Rothenberg (13
) suggests a substantial increase in the prevalence of COI policies over the past decade. Another study by Schneider et al. (14
) have reported that 58% of medical journals required author COI disclosure. Of these, 72% journals emphasized the importance of disclosing both non-financial and financial COIs. Our results about the prevalence of COI disclosure seemed to be similar with those reports (82.8%), but considering the conducted study period, the level was not satisfactory. Furthermore, only half of them stated their policy in explicit paragraph and the extent of COI was exclusively focused on financial concerns. The contents of their policy, even though stating in explicit paragraph, were disappointing. Only sixteen medical journals contained definition of COI, boundaries and examples of COI, and how to and whom judge COI. Comparing the status of COI disclosure before year 2008, there were somehow improvements about the prevalence and form of COI policy. However, considering the contents, medical journals have to improve their policy more comprehensive: definition, extent, example, influence, and subject of decision.
Indeed, it is a critical thing that medical journals have policies about COI disclosure for managing conflict of interests. It is more important that readers could easily find disclosure of COIs on published articles. It means that the actual prevalence of COI disclosure, not prevalence of policy about COI, is also important. Although many medical journals have COI policies, the levels of author compliance are not widely investigated. Schneider et al. (14
) indicated a very low (15%) prevalence of COI disclosure in published articles, and concluded that readers could not judge the transparency of articles whether COI exist or not. Our research also showed the actual prevalence of COI was low (57%). Almost of them stated their COI about funding sources and only seven articles stated their COI using the word 'conflict of interest'. Considering the COI policy of JKMS, it was unsatisfactory results that almost published articles had disclosed their COI as stated their funding sources. Moreover, many studies would potentially involve commercial COI statements by the authors, disclosures only occur in about 60% of these reports and the frequency of disclosure has not improved over time.
The framework that we deployed for systematic ethical analysis was not a valuable tool for analysis of the 114 JKMS papers describing various clinical trials. This is because Franklin's design feature (11
) focused on industry-sponsored placebo-controlled randomized trials, but our design included more various study designs. Instead of Franklin's systemic ethical analysis, our simple ethical grading demonstrated the current level of the relevance to ethics by considering factors such as IC, approval by IRBs, and the transparency of COIs. Generally, IC, approval by IRBs, and COI disclosure has been thought fundamental steps in study design. Disappointingly, only 46 articles rated as grade I and grade II which were satisfied all three components. Besides, the highest grade, transparent COI disclosure, was only 7 articles. However, it was considerable change that no articles rated as grade IV and V after year 2011. We believe that ethical requirements such as these could provide a more valuable tool for IRB members than our grading system for reviewing clinical research protocols, and for peer reviewers and journal editors reviewing manuscripts describing the results of clinical research. We also suggest that an ethical grading system would facilitate a more quick and simple evaluation of the ethical standard of the articles.
Our study has several limitations. We confined out search to the KoreaMed database. Therefore the results are limited by the fact that some journals which were not listed in KoreaMed at the date of search. We reviewed journal policies only by examination of online or printed guidelines for authors. We may have underestimated the prevalence of COI policies. Moreover, given that we confined our search to publications of JKMS for seven years, the data are not representative for all publications of Korea.
In conclusion, we suggest that the policies of Korean medical journals regarding the disclosure of author COIs should be both clearer and more comprehensive. Editors of Korean journals should ask authors mandatorily to disclose potential COIs in a paragraph separate from that describing author's COIs. An IRB of institutions should have its own COI policy to strengthen its review process for scientific integrity and public trust.