From the Editor's Desk Indian Pediatrics 2003;40: 3-6 |
Declaring Competing Interests |
Editors of a medical journal have a common endeavor, the publication of a reliable scientific material(1). In this regard, Indian Pediatrics has come up with a major revision of "Instructions to Authors" that appears for the first time in this issue(2). Authors must follow the instructions as to the type and format of papers to be submitted, and other requirements including preparation and presentation of manuscript, length of articles and approved units of measurements. The revised document is in principal based on 'Uniform Requirements for Manuscripts Submitted to Biomedical Journals'(3). Authors would note that from now onwards, they also have to submit a detailed declaration on authorship criteria and responsibility, financial disclosure, acknowledgement, and copyright transfer. Declaration regarding competing interests on the manuscript was introduced by Indian Pediatrics from January 2000 issue. Since then, the journal office keeps on receiving queries on what exactly constitutes competing interest. We investigated the disclosure on competing interests of more than 600 authors whose articles appeared in Indian Pediatrics in the year 2001. To our surprise, we found that only 3 voluntary disclosures were published! Hussain and Smith(4) studied 3642 articles published over a period of four years from six sample issues of five leading medical journals (Annals of Internal Medicine, BMJ, JAMA, Lancet and New England Journal of Medicine); of these only 52 (1.4%) declared authors’ competing interests. Krimsky and Rothenberg(5) reported that only 16 percent of 1396 highly ranked scientific and biomedical journals had competing interest policies in effect during 1997 and less than 1 percent of the articles published during that year in these journals contained any disclosures of authors' personal or financial interests. The existing trend of a very small proportion of articles declaring competing interest, especially in Indian Pediatrics, could be attributed to most of our authors' ignorance of what exactly constitutes competing interests. We also need to find out (in a randomized fashion) the percentage of authors who in fact had undeclared financial/ academic competing interests at the time of writing the paper but did not declare them. The reasons thereof and the intention behind not declaring these interests also need to be ascertained to have a meaningful conclusion. For the benefit of authors and readers, a brief description on what constitutes competing interests follows. Competing interest exists when an author, reviewer or editor has financial or personal relationship or academic competition with other person(s) or organization(s) that could inappropriately influence (bias) his or her judgement concerning a primary interest (such as patients’ welfare or the validity of research), irrespective of whether the judgment is in fact affected or not. Conflict of interest is said to exist when such relationships results in creation of bias(1,6). The decision whether an existing interest is competing or has resulted in a conflict is purely judgmental. Therefore most of the journals including BMJ prefer the term ‘competing interests’ to ‘conflict of interests’ whenever such declaration is desired(6). Presence of competing interests does not necessarily represent true conflict of interest. Competing interests are also sometimes referred to as dual commitments or competing loyalties. The potential for conflict of interest can exist whether or not an individual believes that the relationship affects his or her scientific judgement. Therefore, all partici-pants in the publication process (authors, reviewer and editor) must disclose all such relationships that could be termed as competing interests(1). Competing interests related to financial support Investment in research and development by the top 20 pharmaceutical companies has more than doubled in the past 7 years(7) resulting in more sponsored trials, pro-motional incentives and large scale funding in research. There is always a risk that researchers involved in such trials may compromise the subjects’ welfare or the integrity of data, for the sake of financial or personal gains. Declaration of such affiliation may help the reader in interpreting the results of a study. A competing interest is deemed to occur if the authors in the last five years have accepted (i) reimbursement for attending the symposium, (ii) fee for speaking or organizing education, or (iii) funds for research or consulting, from an organization, that may in any way gain or lose financially from the results of their study or conclusions. Being employed by or holding stocks or shares of an organization (in the last five years) has the same connotation(8). Importantly, it is not only the present affiliations that need be declared; associations in the past are equally relevant. The source of funding is always a potential conflict. Even if a separate statement has been made on the funding source, it should be elaborated upon when declaring competing interests. If a study is funded by an agency with a proprietary or financial interest in the outcome the authors should also specify whether the sponsors had asserted controls over the authors right to publish. Editors have the right to review copies of the protocol and/ or contracts associated with sponsored project specific studies before accepting such studies for publication. Personal, academic and other competing interests All those links that might embarrass the authors or the journal if they become generally known after publication should also be disclosed. Close relationship with a person, institution, organization, political or religious commitments, that may have influenced the write-up or conclusions; and if publication of such manuscript carries a potential to affect these contacts, should also be declared. The association between competing interests and authors’ conclusions in 159 randomised clinical trials published in the BMJ from 1997 to June 2001 was investigated in a recent article(9). It was deduced that authors’ conclusions signifi-cantly favored experimental interventions, if financial competing interests were declared. However, no such association was noticed for the personal, academic and political competing interests. Competing interests pertaining to reviewers’ and editors’ commitment We avoid selecting external peer reviewer with obvious competing interests, for example, those who work in the same department or institution as any of the authors. Authors may provide editors with the names of persons they feel should not be asked to review a manuscript because of potential conflict of interest, and also justify their concerns. The final decision to honor such requests always rests with the editor. As per our revised policy, the reviewers must also disclose to editors any conflicts of interest that could bias their opinion of the manuscript, and they should disqualify themselves from reviewing such manuscripts. From now onwards, reviewers will be asked to state explicitly whether conflict do or do not exist. It is taken care that editors who make final decision about manuscripts do not have personal, professional or financial involvement in any of the issues they might judge. In case the editor(s) submit their articles to Indian Pediatrics, the editorial process and decision on such manuscript is delegated to other editorial staff. We shall strive to publish regular disclosure statements about potential conflicts of interests related to the commitments of the editors. Competing manuscripts At the time of submission, the authors should also disclose details of papers, similar papers in press and any other published report based on the same subjects. Copies of such material should be included with the submitted paper. The authors should inform if the paper has been presented at a scientific meeting or published in an abstract or conference proceedings. Editors may also receive competing manuscripts submitted simultaneously by different group of authors. The editors have the privilege to decide on publication of one or more manuscript of the submitted papers. Disclosing competing interests is first in the series of important steps towards publishing creditable information, especially when it pertains to articles having major influence on decision making and clinical practice. It has also been suggested that to obviate this problem, systematic reviews should include sensitivity analysis with regard to funding as well(10). The aim is not to eradicate competing interests, as they are bound to occur. Indian Pediatrics will not reject papers because of a competing interest, but the declaration on the competing interests of the authors is mandatory for publication. It is important to remember that the whole point about declaring a potential competing interest is that it might possibly have, and not necessarily operated(11). With this publication, Indian Pediatrics now joins several prominent journals that have declared and clarified their policy on competing/conflict of interests. Contributors: PG collected the data and wrote the paper which was edited and corrected by PC. PC proposed the idea for this editorial and shall act as guarantor. Funding: None Competing interests: PC and PG are the Editor-in-Chief and Associate Editor of the Indian Pediatrics respectively and responsible for devising its policy on competing interests. They are, however, not paid any salary by Indian Pediatrics and will not be affected financially by the success or failure of the policy on competing interests.
Piyush Gupta, |
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