Managing the science in the presence of financial conflict of interest.

We consider the question of why (primarily) and how (secondarily) to perform scientific oversight of research performed by investigators with a financial conflict of interest (COI). One way to frame the trade-off of having investigators with financial COI participate in research is through a decision rule: "Our institution is willing for financially conflicted investigators to participate in research around their intellectual property if (a) the science is likely to be significantly better with their participation (or if other significant benefits accrue); and (b) the COI can be adequately managed". A key component of COI management is the demonstration that the underlying science is sufficiently rigorous and transparent, and in turn, a scientific oversight plan is a key element of that demonstration. Scientific oversight plans should be proactively generated, by individuals (i.e., scientific reviewers) who are independent and expert, and they should assess the rigor and transparency of the research, in a fashion which is fair and efficient. Abbreviations: COI: conflict of interest; SOP: scientific oversight plan.

A single, open access journal may prevent the primary publishing problems in the life sciences.

Herein, we discuss a novel way to knit current life sciences publishing structures together under the scope of a single life science journal that would countermand many of the issues faced in current publishing paradigms. Such issues include, but are not limited to, publication fees, subscription fees, impact factor, and publishing in more "glamorous" journals for career health. We envision a process flow involving (i) a single, overall, life sciences journal, (ii) divided into sections headed by learned societies, (iii) to whom all scientific papers are submitted for peer review, and (iv) all accepted scientific literature would be published open access and without author publication fees. With such a structure, journal fees, the merit system of science, and unethical aspects of open access would be reformed for the better. Importantly, such a journal could leverage existing online platforms; that is to say, it is conceptually feasible. We conclude that wholly inclusive publishing paradigms can be possible. A single, open access, online, life sciences journal could solve the myriad problems associated with current publishing paradigms and would be feasible to implement.

Robotic-assisted versus standard unicompartmental knee arthroplasty-evaluation of manuscript conflict of interests, funding, scientific quality and bibliometrics.

PURPOSE: Robotic-assisted unicompartmental knee arthroplasty (UKA) has gained popularity over the last decade claiming enhanced surgical precision and better joint kinematics, with peer-reviewed publications about this new technology also increasing over the past few years. The purpose of our study was to compare manuscripts about robotic-assisted UKA to those about standard UKA in terms of industry funding, author conflict of interest, scientific quality, and bibliometrics. METHODS: A systematic search using PRISMA guidelines on PubMed and Google Scholar from 2012 to 2016 resulted in 45 papers where robotic technology was performed for UKA and 167 papers that UKA were performed without the assistance of a robot. Between the two groups, we compared (1) rate of manuscripts with reported conflict of interest or industry funding, (2) journal impact factor, (3) level of evidence, and (4) relative citation ratio. RESULTS: Fifty-one percent (23/45) of robotic UKA manuscripts were industry-funded or had authors with financial conflict of interest, compared to 29% ([49/167], p < 0.01) of non-robotic UKA papers. Significantly more robotic UKA papers (24% [11/45] vs 9% [16/167), p < 0.01) were published in journals that were not assigned an impact factor by the Journal Citations Report. There was no difference in regard to bibliometrics or level of evidence. CONCLUSION: Manuscripts in which UKA was performed with the assistance of a robot were more likely to be industry funded or be written by authors with financial conflicts of interest and published in less prestigious journals. There were no differences in scientific quality or influence between the two groups. Readers analyzing published data should be aware of the potential conflicts of interests in order to more accurately interpret manuscripts data and conclusions.

Differentiating predatory scholarship: best practices in scholarly publication.

OBJECTIVE: The intent of this article is to define predatory publishing, identify the risks and costs associated with publishing scholarship with these types of organizations and to provide recommendations for best practices how a potential author can protect themselves against predatory organizations. METHODS: A thorough review of the literature concerning predatory publishing was conducted and gleaned for best practices along with the authors' experiences. KEY FINDINGS: Pharmacy scholars and researchers worldwide recognize the virtues of the open access (OA) publication system, which is intended to freely disseminate research electronically, stimulate innovation and improve access to scholarship. Both subscription-based and OA publication systems, however, have potential areas of conflicts, including coordination of the peer-review process and the potential for the publisher to capitalize on selling the commodity in a capitalistic society. The intent of OA is welcomed; however, publishers are still in a business and profits need to be made. It is by the exploitation of the model that has given rise to a small but growing subset known as predatory publishers. CONCLUSIONS: Pharmacy researchers and clinicians alike need to be aware of predatory organizations, both publishers and meeting organizers, when seeking a venue to publish their own scholarly research. Additionally, this knowledge is critical when evaluating medical literature in providing direct patient care services to assure the best available evidence is utilized.

Strategies to Prevent or Reduce Gender Bias in Peer Review of Research Grants: A Rapid Scoping Review.

OBJECTIVE: To review the literature on strategies implemented or identified to prevent or reduce gender bias in peer review of research grants. METHODS: Studies of any type of qualitative or quantitative design examining interventions to reduce or prevent gender bias during the peer review of health-related research grants were included. Electronic databases including MEDLINE, EMBASE, Education Resources Information Center (ERIC), PsycINFO, Joanna Briggs, the Cochrane Library, Evidence Based Medicine (EBM) Reviews, and the Campbell Library were searched from 2005 to April 2016. A search for grey (i.e., difficult to locate or unpublished) literature was conducted and experts in the field were consulted to identify additional potentially relevant articles. Two individuals screened titles and abstracts, full-text articles, and abstracted data with discrepancies resolved by a third person consistently. RESULTS: After screening 5524 citations and 170 full-text articles, one article evaluating gender-blinding of grant applications using an uncontrolled before-after study design was included. In this study, 891 applications for long-term fellowships in 2006 were included and 47% of the applicants were women. These were scored by 13 peer reviewers (38% were women). The intervention included eliminating references to gender from the applications, letters of recommendations, and interview reports that were sent to the committee members for evaluation. The proportion of successful applications led by women did not change with gender-blinding, although the number of successful applications that were led by men increased slightly. CONCLUSIONS: There is limited research on interventions to mitigate gender bias in the peer review of grants. Only one study was identified and no difference in the proportion of women who were successful in receiving grant funding was observed. Our results suggest that interventions to prevent gender bias should be adapted and tested in the context of grant peer review to determine if they will have an impact.

Disclosure of Financial Conflicts of Interests in Interventions to Improve Child Psychosocial Health: A Cross-Sectional Study.

Academic journals increasingly request a full disclosure of financial conflict of interest (CoI). The Committee for Publication Ethics provides editors with guidance about the course of action in the case of suspected non-disclosure. No prior study has examined the extent to which journal articles on psychosocial interventions disclose CoI, and how journal editors process requests to examine suspected undisclosed CoI. Four internationally disseminated psychosocial interventions were examined. 136 articles related to an intervention, co-authored by intervention developers and published in health sciences journals were retrieved as requiring a CoI statement. Two editors refused consent to be included in the study. COI disclosures and editor responses were coded for 134 articles. Overall, 92/134 (71%) of all articles were found to have absent, incomplete or partly misleading CoI disclosures. Disclosure rates for the four programs varied significantly between 11% and 73%. Journal editors were contacted about 92 published articles with no CoI disclosure or a disclosure that was considered problematic. In 65/92 (71%) of all cases the editors published an 'erratum' or 'corrigendum'. In 16 of these cases the journal had mishandled a submitted disclosure. The most frequent reason for non-publication of an erratum was that the journal had no disclosure policy at the time of the publication (16 cases). Consumers of research on psychosocial interventions published in peer-reviewed journals cannot currently assume that CoI disclosures are adequate and complete. More efforts are needed to achieve transparency.

Conflict(s) of interest in peer review: its origins and possible solutions.

Scientific communication takes place at two registers: first, interactions with colleagues in close proximity-members of a network, school of thought or circle; second, depersonalised transactions among a potentially unlimited number of scholars can be involved (e.g., author and readers). The interference between the two registers in the process of peer review produces a drift toward conflict of interest. Three particular cases of peer review are differentiated: journal submissions, grant applications and applications for tenure. The current conflict of interest policies do not cover all these areas. Furthermore, they have a number of flaws, which involves an excessive reliance on scholars' personal integrity. Conflicts of interest could be managed more efficiently if several elements and rules of the judicial process were accepted in science. The analysis relies on both primary and secondary data with a particular focus on Canada.

Time to finger point or fix? An invitation to join ongoing efforts to promote ethical authorship and other good publication practices.

In this commentary, we present evidence that unethical authorship (eg, guest and ghost authoring) and other publication practices are not restricted to the pharmaceutical industry; they also occur in academia. Such practices are not an industry problem--they are a research problem. To enhance trust in industry-sponsored research, companies have made rapid and far-reaching changes to their publication guidelines, policies, and procedures. Professional medical writers have adopted, and continue to implement, these changes. Although evidence indicates that industry practices are improving, there is certainly more to do, both in industry and academia. We invite readers to join ongoing efforts to promote ethical publication practices.

Ghost- and guest-authored pharmaceutical industry-sponsored studies: abuse of academic integrity, the peer review system, and public trust.

Industry-sponsored ghost- and guest-authored clinical research publications are a continuing problem in medical journals. These communications are written by unacknowledged medical communication companies and submitted to peer-reviewed journals by academicians who may not have participated in the writing process. These publications, which are used for marketing purposes, usually underestimate the adverse effects and medical risks associated with the products evaluated. Since peer-reviewed data are used to develop health care paradigms, misleading information can have catastrophic effects. A failure to curb ghost and guest authorship will result in an erosion of trust in the peer-review system, academic research, and health care paradigms.

Peer review of validation studies: an assessment of the role of the OECD by reference to the validation of the uterotrophic assay for endocrine disruptors.

The involvement of the OECD in managing the validation of the rat uterotrophic assay for endocrine disruptors, and in organising the peer review of the results of this study, has been assessed and compared with the many conclusions and recommendations in several published reports of international workshops on validation, and information in guidance documents, produced by the European Centre for the Validation of Alternative Methods (ECVAM), the US Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and the OECD itself. It is concluded that the OECD has not followed the recommendations for full transparency and independence of the peer-review process. This is based on the fact that it has published a draft guidance document that differs from the report of a recent OECD workshop on validation, in such a way as to give the OECD the flexibility to fully control the peer-review process and, in so doing, to avoid full transparency. Comparison of the timing of the organisation of workshops by the OECD and the progression of the validation study, together with the fact that a draft test guideline for the assay was written before completion of the peer review, suggest that the OECD has given a higher priority to the expedition of the validation and regulatory acceptance of the uterotrophic assay than it has to good scientific and logistical practice. This severely undermines its credibility in the validation process, so, in order for the OECD to be rightly perceived as an honest broker, it is recommended that the OECD should play no role in the validation of new or revised tests, until after they have been successfully validated, peer reviewed, and endorsed by the appropriate authorities, and are ready for test guideline development. With regard to the on-going OECD validation studies of other in vivo assays for endocrine disruptors, the OECD should take immediate steps to ensure full independence and transparency of their peer review.