5 Ethical and Legal Considerations

For all reports, regardless of funding source, containing original data (research and systematic reviews), at least 1 named author should indicate that she or he “had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis” (see also , Authorship Responsibility, Authorship: Definition, Criteria, Contributions, and Requirements). This responsibility can vest with the principal investigator, the corresponding author, or the article’s guarantor. While in some research groups, particularly small ones, all authors may have access to all of the data, it is usually not ...Less

Of all the causes which conspire to blindMan’s erring judgment, and misguide the mind,What the weak head with strongest bias rules,Is pride, the never-failing vice of fools.    Alexander PopeA conflict of interest occurs when an individual’s objectivity is potentially, but not necessarily, compromised by a desire for prominence, professional advancement, financial gain, or a successful outcome. Conflicts of interest that arise from personal or financial relationships, academic competition, and intellectual passion are not uncommon in science. In biomedical publication, a conflict of interest may exist when an author (or the author’s institution, employer, or funder) has financial or other relationships that ...Less

In the event that an undisclosed financial interest on the part of an author is brought to the editor’s attention (usually during the review process), the editor should remind the author of the journal’s policy and ask the author if he or she has anything to disclose. The author’s reply may affect the editorial decision on whether to publish the manuscript.If an editor receives information (usually from a reader) alleging that an author has not disclosed a financial interest in the subject of an article that has been published, the editor should contact the author and ask for an explanation. ...Less

In addition to individual financial conflicts of interest, authors should report all financial and material support for the work reported in the manuscript. This includes, but is not limited to, grant support and funding, provision of equipment and supplies, and other paid contributions., All financial and material support should be indicated in the Acknowledgment section of the manuscript, along with detailed information on the roles of each funding source or sponsor (see also , Acknowledgments, Funding and Role of Sponsors). In addition, all individuals who provided other important paid contributions should be identified, with their names and affiliations listed in ...Less

In the interest of full disclosure, the ICMJE recommends that authors report how sponsors/funders have participated in the work reported in a specific manuscript., Journals should require authors to indicate the role of the sponsor/funding organization in each of the following: “design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of the manuscript.” If the sponsor or funder had no such role, this should be stated. This information may be included in the “Methods” or Acknowledgment section of the manuscript (see also , Acknowledgments, Funding and Role of Sponsors). Authors ...Less

Authors should disclose all relevant conflicts of interest in their work at the time of manuscript submission either in the manuscript (if so required by the journal) or in a cover letter to the editor or on the journal’s disclosure form (if the journal uses one). Journals should define conflicts of interest and the types of disclosures required (eg, all types of conflicts of interest or only financial interests). For example, JAMA requires all relevant financial disclosures of each author and coauthor to be included in the Acknowledgment section of the manuscript and to be noted in the “Financial Disclosure” ...Less

Editors may also have their objectivity influenced or biased by conflicts of interest. As a result, the ICMJE, CSE, and WAME recommend that editors follow policies on conflicts of interest that require disclosure of all relevant conflicts of interest (financial and nonfinancial) and also that they not participate in the review of or decisions on any manuscripts in which they may have a conflict of interest.,, Editors and journal editorial board members should never use information obtained during the review process for personal or professional gain. Editors and editorial board members should refrain from making any decisions or recommendations about ...Less

Following the recommendations of the ICMJE, CSE, and WAME, reviewers should disclose conflicts of interest in reviewing specific manuscripts and disqualify themselves from a specific review if necessary.,, Reviewers should never use information obtained from an unpublished manuscript to further their own interests. Following the same rationale applied to authors, the ICMJE also recommends that reviewers state explicitly if they have no relevant conflicts of interest to disclose.JAMA includes the following instructions regarding conflicts of interest in the letter sent requesting an individual to review a manuscript: While most conflicts of interest are not disqualifying, if you perceive that you ...Less

Biases are potentially introduced when sponsors are directly involved in research.,,,,, As a result, for industry-sponsored studies, JAMA and the Archives Journals require an access to data statement to be provided by an investigator who is not employed by any funding source with a proprietary interest in the outcome of the study. In addition, JAMA will not accept for publication an industry-sponsored study in which the data analysis has been conducted solely by statisticians employed by the company sponsoring the research. For these studies, an additional analysis of the data (entire raw data set, study protocol, and prespecified plan for ...Less