Pharmacists and Industry: Guidelines for Ethical Interactions

American College of Clinical Pharmacy

Disclosures

Pharmacotherapy. 2008;28(3):410-420. 

In This Article

Guideline 7

Pharmacists should only participate as authors for publications that meet accepted ethical, regulatory, and scientific standards. In addition, pharmacists who serve as peer reviewers should disclose any conflicts of interest and/or recuse themselves from reviewing a manuscript for which they have a relationship with a sponsor or competitor of the sponsor.

Publication of research results, editorials, and review articles is an important component of an academic or research pharmacist's professional life. Collaboration with industry may be necessary in these writing endeavors. Guidelines for author responsibilities when submitting an article linked to industry are available from the International Committee of Medical Journal Editors.[58] The guidelines address ethical considerations in the conduct and reporting of research and include such topics as defining authorship, editorial freedom, peer review, conflicts of interest, and privacy and confidentiality. An ad hoc industry group also drafted a publication guideline, Good Publication Practice Guidelines for Pharmaceutical Companies, designed to establish standards for the publication of industry-sponsored trials.[59] This guide addresses publication standards, relationships between the company and external investigators, authorship, and ghost writers.

Pharmacists should understand that if they meet the criteria to be a study author, they accept responsibility for conducting the study, ensuring that they had full access to all of the data, and actively participated in the decision to publish the study results.[58] When publishing articles in peer-reviewed pharmacy or medical journals, pharmacists should consider themselves authors only if criteria for authorship are met and may take credit only for work they have done themselves; taking public credit for work prepared by others (e.g., ghost writers) is unacceptable.[58,59] Pharmacists should request peer review of their work prior to publication.

Full disclosure is mandatory whenever pharmacists are paid by industry (e.g., pharmaceutical companies or medical education companies) to prepare articles for publication.[57,58,59] Disclosure of potential conflicts of interest is a well-defined component of the International Committee of Medical Journal Editors' requirements for manuscripts submitted to biomedical journals, stated as follows: "Public trust in the peer review process and the credibility of published articles depend in part on how well conflict of interest is handled during writing, peer review, and editorial decision-making. Conflict of interest exists when an author (or the author's institution), reviewer, or editor has financial or personal relationships that inappropriately influence (bias) his or her actions (such relationships are also known as dual commitments, competing interests, or competing loyalties). These relationships vary from those with negligible potential to those with great potential to influence judgment, and not all relationships represent true conflict of interest. The potential for conflict of interest can exist whether or not an individual believes that the relationship affects his or her scientific judgment. Financial relationships (such as employment, consultancies, stock ownership, honoraria, paid expert testimony) are the most easily identifiable conflicts of interest and the most likely to undermine the credibility of the journal, the authors, and of science itself. However, conflicts can occur for other reasons, such as personal relationships, academic competition, and intellectual passion. All participants in the peer review and publication process must disclose all relationships that could be viewed as presenting a potential conflict of interest."[58]

This definition serves as the basis for the disclosure requirements for many major biomedical journals. Most pharmacy journals also adhere to these requirements, but specific instructions on disclosure of conflicts of interest are often vague or absent. Journal editors recognize that industry ties or involvement do not automatically produce loss of objectivity,[60] and that industry connections may provide access to data not otherwise available. However, full disclosure of potential conflicts of interest allows the reader to use the information in assessing the merits of any article.

The anonymous nature of the peer review process makes it particularly vulnerable to the possibility of industry-associated conflicts of interest. The reviewer could have an ongoing relationship with the sponsor of the research or a competitor of the research sponsor, which could affect the reviewer's recommendation to the editor (positively or negatively). Disclosure of these conflicts to the editor is appropriate.[58] Declining the invitation to review a manuscript for which there is a potential conflict is a reasonable option.

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