Non-financial Conflicts Of Interest Research Articles

Perspectives on non-financial conflicts of interest in health-related journals: A scoping review

ABSTRACT The objective of this scoping review was to systematically review the literature on how non-financial conflicts of interest (nfCOI) are defined and evaluated, and the strategies suggested for their management in health-related and biomedical journals. PubMed, Embase, Scopus and Web of Science were searched for peer reviewed studies published in English between 1970 and December 2023 that addressed at least one of the following: the definition, evaluation, or management of non-financial conflicts of interest. From 658 studies, 190 studies were included in the review. nfCOI were discussed most commonly in empirical (22%; 42/190), theoretical (15%; 29/190) and “other” studies (18%; 34/190) – including commentary, perspective, and opinion articles. nfCOI were addressed frequently in the research domain (36%; 68/190), publication domain (29%; 55/190) and clinical practice domain (17%; 32/190). Attitudes toward nfCOI and their management were divided into two distinct groups. The first larger group claimed that nfCOI were problematic and required some form of management, whereas the second group argued that nfCOI were not problematic, and therefore, did not require management. Despite ongoing debates about the nature, definition, and management of nfCOI, many articles included in this review agreed that serious consideration needs to be given to the prevalence, impact and optimal mitigation of non-financial COI.

Conflicts of Interest in Radiology Publishing

Lack of disclosure of Conflicts of Interest (COI) in radiology research can undermine trust in medical recommendations and patient care. A recent study found significant discrepancies between disclosed COIs and those listed in the Open Payments Database (OPD). This commentary discusses the importance of transparency in financial and nonfinancial COIs, the implications of undisclosed COIs on research integrity and clinical decision-making, and the challenges and controversies surrounding current disclosure practices. The field of radiology should discuss and update COI management and ethical standards, for more practical accountability in radiology publishing.

Surviving Sepsis Campaign.

It was the turn of the millennium. For most, sepsis was an obscure entity of importance only to intensivists, clinical academics, and basic science investigators. The molecular biology was beginning to be unraveled and industry was increasingly hopeful that sepsis might be treated with innovative biologic therapies. Consensus definitions had been created a decade earlier but had received little attention outside of clinical trialists. Then, in short order, came a series of randomized controlled trials (RCTs) supporting successful treatment of sepsis with protocolized early resuscitation, anticoagulant therapy, and steroids (1–3). This caught the attention of the frontline clinical community caring for sepsis patients as signaled by the intense interest in these trial results at scientific meetings. The stage was now set for engaging these enthused clinicians as to how sepsis might be diagnosed sooner and treated more effectively to improve outcomes. Sepsis outcomes based on analysis of control group clinical trial data were at this time disappointing (1–3). THE ORIGINS OF THE SURVIVING SEPSIS CAMPAIGN The Surviving Sepsis Campaign (SSC) was introduced at the 2002 European Society of Intensive Care Medicine (ESICM) annual meeting in Barcelona with the “Barcelona Declaration” (4). Mitchell Levy, Phil Dellinger, and Graham Ramsay presented the concept to the leadership of three professional organizations (the ESICM, the Society of Critical Care Medicine [SCCM], and the International Sepsis Forum [ISF]). The SSC was initially administered by these three organizations. The “Barcelona Declaration” committed the three organizations to strive to reduce mortality of sepsis by 25% within 5 years by improving recognition and treatment. In addition, the “Barcelona Declaration” urged governments and healthcare providers to recognize the growing burden of sepsis and to commit to providing adequate resources to combat it. A 5-point action plan was developed: Diagnosis—Facilitate early and accurate diagnosis through the adoption of one, single, clear definition of sepsis. Treatment—Ensure appropriate and timely use of treatments and interventions via consistent clinical protocols. Referral—Recognize universally acceptable referral guidelines in all countries of the world. Education—Provide leadership, support, and information to clinicians about sepsis management. Counseling—Provide a framework for improving and accelerating access to continuing post-ICU care and counseling for patients. The plan was for the SSC to be rolled out in three phases: 1) The initial declaration and commitment; 2) The development of evidence-based guidelines for sepsis management; and 3) A performance improvement initiative (on a global scale) to implement the guidelines and reduce sepsis mortality. DEVELOPMENT AND EVOLUTION OF THE GUIDELINES OVER THE YEARS The first set of SSC guidelines was published in 2004 (5). Since then, updates have been published on a roughly 4-year cycle (2008, 2012, 2016, and 2021) (6–9) (Fig. 1). Each edition has seen an evolution of the methodology for the data analysis and an evolution in the clinical guidance for optimal management. The field of sepsis management was evolving quickly and the SSC was a major driver in identifying problems and promoting advances. In consideration of the worldwide impact of the COVID-19 pandemic leading to hospitals and ICUs filled with critically ill COVID-19 patients, the SSC published separate guidelines on management of the critically ill COVID patient (10).Figure 1.: Surviving Sepsis Campaign (SSC) guidelines publication timeline and metrics. Guideline mastheads are displayed from original 2004 publication through the 2021 revision. The timeline displays and contrasts page numbers and numbers of references. To the left is the original SSC logo (2004 and 2008 editions) and the revised logo (2012 and forward).Innovative and dedicated leadership has been key to the success of the SSC. A broad coalition of sponsoring organizations has been built over the years, beginning with 11 in 2004 and with 21 in 2021 (Table 1). TABLE 1. - Organizations Endorsing the 2021 Surviving Sepsis Guidelines Society of Critical Care Medicine European Society of Intensive Care Medicine American Association of Critical Care Nurses American College of Chest Physicians American College of Emergency Physicians American Thoracic Society African Sepsis Alliance Asia and Pacific Sepsis Alliance Association De Medicina Intensiva Brasileira Australian and New Zealand Intensive Care Society Canadian Critical Care Society Chinese Society of Critical Care Medicine European Respiratory Society European Society of Clinical Microbiology and Infectious Diseases Indian Society of Critical Care Medicine Infectious Diseases Society of North America Japanese Society of Intensive Care Medicine Latin American Sepsis Institute Society for Academic Emergency Medicine Scandinavian Critical Care Trials Group Key areas where the guidelines have evolved include funding streams, the management of potential conflicts of interest (COI), the evidence-based methodology, ensuring adequate panel diversity, authorship issues, and the decision that the guidelines need to be relevant to the entire world including children. In addition, the last two sets of guidelines have introduced the public/patient voice into the process to ensure that they are relevant for our patients, who may receive care directed by them. CONFLICTS OF INTEREST From the outset, the guidelines’ leadership recognized the importance of potential COI. At no point has the panel had any members from industry and industry has had no input into the guidelines development process. In addition, no member of the guidelines panel has received any reimbursement or honoraria for their work in relation to these activities. All panelists complete a COI declaration, which has been actively managed, either through the guideline’s leadership group or, since 2012, through an independent panel made up of very senior past officers of ESICM and SCCM. In recent iterations, there has been additional focus directed toward academic (nonfinancial) COI. Based on COI, guideline panelists have been asked either to abstain from voting on recommendations with potential conflict or in certain circumstances asked not to participate in the evidence synthesis process. PANEL SELECTION/DIVERSITY Since 2012, there has been greater recognition that the panel needs to adequately represent the populations of healthcare patients and providers it serves with greater race and gender balance as well as national, geographical, and income-setting representation. The process has matured but remains a work in progress. For example, the number of women on the guidelines committee over the five renditions of the guidelines (2004, 2008, 2012, 2016, and 2021) are 4 (10%), 5 (9%), 13 (19%), 11 (19%), and 17 (28%). Another example is geographical representation outside of North America and Europe which has progressed over the five renditions of the guidelines: 2 (5%), 5 (9%), 11 (16%), 10 (17%), and 15 (25%). In addition, with the last two iterations, a target was established of at least 33% panel turnover from the previous version. It was felt that this would adequately maintain the organizational memory of the process while allowing new thinking to emerge that did not leave the product stale and old. AUTHORSHIP While initial versions of the guideline (2004–2008) had a mast head author writing committee that drafted the article for subsequent sign-off by the entire committee, since 2012, all panelists have been asked to sign the paper as a named author. This gave greater transparency over who and what was behind the development processes and gave authors more sense of responsibility for the content of the entire document. PEDIATRICS From the beginning of the development of the SSC guidelines, it was recognized that children should be considered separately from adults. The first guidelines, in 2004, as well as the updates in 2008 and 2012, included a section called “Pediatric Considerations” pointing out important differences between children and adults. The critical care community, however, recognized the limitations of this approach, and the SSC leadership formed a task force with broad international representation to develop SSC guidelines for children, first co-published in Pediatric Critical Care Medicine and Intensive Care Medicine in 2020 (11). LOW- AND MIDDLE-INCOME COUNTRIES Recent versions of the guideline have put more focus on optimizing recommendations relevancy for different parts of the world. This goal was facilitated by ensuring that low- and middle-income country (LMIC) settings are represented in each working group of the panel. The SSC guidelines have several recommendations as to therapies or tools that should not be used, which is relevant to set priorities in resource-limited settings. Other recommendations highly relevant for LMICs include the prompt administration of antibiotics with adequate dosage and de-escalation strategies. However, recommendations for lower-income countries remain challenging due to scant LMIC-specific data. Limited resources for organ support may also bear on optimal therapy, for example, aggressiveness of fluid resuscitation. The work of the SSC Sepsis in Resource-Limited Nations Workgroup includes publication of a before and after feasibility trial of increasing evidence based interventions in LMIC (12). EVOLUTION OF SSC GUIDELINE METHODOLOGY A trustworthy guideline results from rigorous methodology that minimizes personal biases, allows transparent assessment of the total body of evidence, and incorporates all essential variables to formulate recommendations. The first iteration of the SSC guideline was completed before significant advancement in guideline development methodology. The panel used an evaluation system developed by Sackett (13), classifying evidence according to study design and precision (grades A, B, and C). During that period, most guideline developers used a modified Delphi process to formulate recommendations. Guideline development methodology at that time lacked a systematic summary of the evidence, comprehensive assessment of the quality of evidence, a structured framework to transition from evidence to recommendation, and did not assign strength to recommendations. From 2008, the SSC guideline structured the questions in the Population, Intervention, Control, and Outcome (PICO) format, which provided explicit criteria for study selection and allowed judgment of the quality of the evidence at an outcome level (6). As the methodology of guideline development evolved, the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach emerged as a comprehensive, rigorous, and transparent methodology (14). Therefore, the SSC leadership adopted the GRADE approach with GRADE experts represented on the guidelines committee and charged to guide the methodology of the process. Unlike traditional approaches, the GRADE approach allowed assessment of the quality of evidence considering crucial factors that went beyond basic study design, such as inconsistency, indirectness, imprecision, and publication bias. In addition, it allowed the panel to develop recommendations considering not only quality of evidence but also balance of benefit and harm, patients’ values, cost, equity, and feasibility. The panel assigned a strength (strong vs weak) to each recommendation which reflected the confidence in the overall balance between desirable and undesirable consequences. In 2016, best practice statements were included in the guidelines. Best practice statements are recommendations the committee feels are important but not amenable for formal recommendations because the evidence is difficult to summarize or assess using GRADE methodology. These recommendations represent ungraded strong recommendations that are typically used when the benefit or harm is unequivocal. In the 2021 guidelines, the structure expanded to include librarians, systematic review experts, methodologists, and public members that collaborated with the panel. Professional medical librarians facilitated the electronic searches tailored to each PICO question. The systematic review team assisted the panel to identify and summarize the relevant evidence. Working with the methodology team, the quality of evidence was assessed and the evidence-to-decision framework was used to support the panel in formulating recommendations (15). Public members provided input on patients’ values and preferences. Table 2 shows the evolution of methodology over the five renditions of the guidelines. TABLE 2. - Surviving Sepsis Campaign Guideline Methodology Category SSC 2004 SSC 2008 SSC 2012 SSC 2016 SSC 2021 Panela 44 members 55 members 68 members 55 members 60 members Number of recommendations 46 recommendations 78 recommendations 84 recommendations 71 recommendations 75 recommendations 18 BPS 15 BPS COI managementb Financial COIs Financial COIs Financial COIs Financial COIs Financial and academic COIs Topic prioritizationc Panel discussion Panel discussion Panel discussion Panel discussion Multifaceted approachd Structured Patient/Problem, Intervention, Comparison, and Outcome questions No Yes Yes Yes Yes Outcome prioritizatione Not formally done Not formally done Not formally done Not formally done Yes Search strategyf Panel members Panel members Panel members A professional medical librarian with input from panel A team of professional medical librarians with input from panel Source of evidenceg Medline database Medline database At least one electronic database At least two electronic databases At least two electronic databases Assessment of the quality of evidenceh Approach by Sackett (13) GRADE approach GRADE approach GRADE approach GRADE approach Involvement of patients No No No No 11 public members were involvedi Formulating recommendation Modified Delphi approach GRADE approach GRADE approach GRADE approach GRADE approach and evidence to decision frameworkj Types of recommendations and statements Recommendations with no distinction of strength Level 1k Level 1k Strong recommendation Strong recommendation Level 2 Level 2 Weak recommendation Weak recommendation Ungraded statements BPSl BPSl Implications of recommendationsm No Yes Yes Yes Yes BPS = best practice statement, COI = conflicts of interest, GRADE = Grading of Recommendations, Assessment, Development, and Evaluation, SSC = Surviving Sepsis Campaign.aThe total number of panel members that participated in the guideline.bTypes of COI that were adjudicated and managed in each guideline.cUsing a systematic approach to select topics of high priority to address in the guideline.dUsing a framework based on practice variability (based on surveying 800 intensivists globally), awareness of new evidence, and panel ranking.eUsing a systematic approach to identify outcomes that are relevant most to patients for each recommendation.fThis category outlines who performed the electronic literature searches for relevant evidence.gElectronic databases that were searched for relevant studies.hAlso known as confidence or certainty in the evidence.iPublic members provided input on outcomes importance, patients’ values, and reviewed the final list of recommendations especially for the long-term outcomes subgroup.jEvidence to decision framework asks the panel to consider the following factors when formulating the recommendation: priority of topic, magnitude of benefit and harm, balance of effect, patent values, cost and resources, acceptability, and feasibility.kLevel 1 recommendation corresponds to a strong recommendation, while level 2 corresponds to a weak recommendation.lAll BPSs followed strict criteria, a BPS is an ungraded strong recommendation.mThis step involves clearly stating the implications of recommendations for stakeholders including patients, healthcare providers, and policymakers. EVOLUTION OF SPECIFIC GUIDELINE RECOMMENDATIONS OVER THE YEARS High-quality studies, adequately designed and powered to assess patient-centered outcomes, have facilitated updates of guidelines’ recommendations over time. Earlier editions of the guidelines included recommendations supported by publications reporting positive results with the testing of promising science-based interventions in sepsis (1,2). Progress, however, is often not linear. Confirmatory trials are needed and these confirmatory trials, even when they are negative, still move the field forward. The first study published (2001) that appeared to show a significant impact of a specific treatment of sepsis was that of “early goal-directed therapy (EGDT),” which supported resuscitation of sepsis-induced tissue hypoperfusion targeting first central venous pressure (CVP) and then superior vena cava oxygen saturation (Scvo2) measured with catheter insertion into the superior vena cava (1). The 2004, 2008, and 2012 SSC guidelines recommended these two EGDT targets. However, after three multicenter and multinational studies failed to confirm improved outcomes with CVP and Scvo2 targets, the 2016 guidelines no longer recommended them (16–18). Nonetheless, SSC maintained the principles of early resuscitation with clear statements that sepsis and septic shock are medical emergencies and individualized resuscitation targets remain important. Similarly, recommendations for choice of resuscitation fluids have changed throughout the years. In 2004, results of a meta-analysis in general critically ill patients supported a weak recommendation to use either crystalloids or colloids as first-line fluids for sepsis resuscitation (19). Subsequent large RCTs demonstrated worse outcomes with artificial starch colloids (20–23). In 2012, the SSC guidelines recommended the use of crystalloids as first-line fluids and recommended against the use of starches (24). Albumin was recommended in the fluid resuscitation of severe sepsis and septic shock when patients require substantial amounts of crystalloids. The 2016 guidelines supported either balanced solutions or saline for crystalloid resuscitation. This recommendation was revisited in 2021 based on the Saline against Lactated Ringer’s or Plasma-Lyte and Isotonic Solutions and Major Adverse Renal Events Trial trials and modified to preferential use of balanced crystalloid solutions (25,26). Following publication of the 2021 guidelines, two large randomized trials and a meta-analysis comparing normal saline and balanced crystalloids were published (27–29). The subgroup of septic patients in the meta-analysis including these two new studies was reported to have an estimated effect on mortality using balanced crystalloids that ranged from a 14% relative reduction to a 1% relative increase in mortality. This new evidence should be taken into consideration in the next interaction of the SSC guidelines. After a single study showed a large reduction in mortality with the use of low dose (200 mg/d) IV hydrocortisone, the 2004 SSC guideline issued a recommendation to use corticosteroids in patients with septic shock (3). However, a subsequent study in septic patients with less severe shock failed to show improved outcome and the 2008 guidelines suggested corticosteroids be given only to adults with septic shock after blood pressure is identified to be poorly responsive to fluid resuscitation and vasopressor therapy (30). The wording of the recommendation changed subtly in 2012 and 2016 to suggest against IV hydrocortisone to treat adult septic shock patients if adequate fluid resuscitation and vasopressor therapy were able to restore hemodynamic stability. Two major RCTs published in 2018, Adjunctive Corticosteroid Treatment in Critically Ill Patients with Septic Shock and Activated Protein C and Corticosteroids for Human Septic Shock, led to a weak recommendation in the 2021 guidelines in favor of corticosteroids in patients with ongoing shock following fluid resuscitation. The committee follows this recommendation with a remark that supports a specific threshold vasopressor dose for triggering administration, with steroids commenced when the dose of norepinephrine or epinephrine is greater than or equal to 0.25 µg/kg/min at least 4 hours after vasopressor initiation (31,32). Using steroids as an example, the timeline depicted in Figure 2 gives a sense of how clinical trial results of corticosteroids in septic shock influenced guidelines recommendations between 2002 and 2021.Figure 2.: Timeline of interaction of clinical trial results of corticosteroids in septic shock on guidelines recommendations between 2002 and 2021. 1 - 2004 Surviving Sepsis Campaign (SSC) - recommends IV hydrocortisone for septic shock. 2 - 2008 SSC suggests IV hydrocortisone only when blood pressure is poorly responsive to fluids and vasopressors. 3 - 2012, 2016 SSC suggests against IV hydrocortisone if fluids and vasopressors restore hemodynamic stability. 4 - 2021 SSC suggests IV hydrocortisone use with ongoing requirement for higher vasopressor therapy. ADRENAL = Adjunctive Corticosteroid Treatment in Critically Ill Patients with Septic Shock, APROCCHSS = Activated Protein C and Corticosteroids for Human Septic Shock, JAMA = Journal American Medical Association, NEJM = New England Journal of Medicine.SURVIVING SEPSIS CAMPAIGN GUIDELINES INFLUENCE Five sets of SSC guidelines were published in the journals Critical Care Medicine and Intensive Care Medicine, totaling 10 source publications. In Scopus, the guidelines have been cited 21,158 times in over 7,000 publications, 25 non-English languages, representing authors from over 125 countries. The influence of the SSC guidelines on sepsis thinking is demonstrated through two Scopus citation metrics: the Field Weighted Citation Impact (FWCI) and the Citation Benchmark. The FWCI demonstrates how well cited a publication is compared with similar publications. A FWCI greater than 1.00 signifies greater citations than expected according to the average. A FWCI of 1.48 means 48% more citations accrued than expected. The SSC guideline publication FWCI ranged from 19 to 186.51 (Table 3). The Citation Benchmark demonstrates how citations compare with the average for similar publications. Every SSC published guideline since the inaugural publication in 2004 is in the 99th percentile indicating all SSC guidelines ranked in the top 1% globally for the number of generated citations. TABLE 3. - Surviving Sepsis Campaign Guideline Publication Impact by Scopus and Year Guidelines Year Journal Title Publication Date Metric Dates Citations (n) Field Weighted Citation Index Citation Benchmark Percentile 2004 CCM 2004 2004–2019 2,562 72.93 99th 2004 ICM 2004 2004–2019 671 19 99th 2008 CCM 2008 2008–2022 3,909 119 99th 2008 ICM 2008 2008–2022 1,358 37.62 99th 2012 CCM 2013 2012–2022 4,327 186.51 99th 2012 ICM 2013 2012–2022 3,172 120.03 99th 2016 CCM 2017 2016–2022 1,755 71.31 99th 2016 ICM 2017 2016–2022 3,214 181.2 99th 2020a CCM 2020 2020–2022 430 51.63 99th 2020a ICM 2020 2020–2022 980 119.87 99th 2021 CCM 2021 2021–2022 75 30.27 99th 2021 ICM 2021 2021–2022 115 45.19 99th CCM = Critical Care Medicine, ICM = Intensive Care Medicine.aSurviving Sepsis Campaign COVID Guidelines.Guidelines year is the year during which work was completed. Publication year is the year the document was published. Scopus allows for 15 yr of continuous data from publication date. Field Weighted Citation Impact demonstrates how well cited an article is compared with like publications. It considers the year of publication, document type, and disciplines associated with its source. It is the ratio of the publication’s citations to the average number of citations received by all similar publications over a 3-yr window. An FWCI > 1 means the output is more cited than expected according to the global average (Field Weighted Citation Impact of 1.48 mean 48% more cited than expected). The Citation Benchmark demonstrates how citations received by a publication compare with the average for similar publications in an 18-mo window. It accounts for the publication year, document type, and source disciplines. The 99th percentile is high and indicates a publication is in the top 1% globally for the number of citations. Scopus access date: June 5, 2022. The Altmetric Attention Score indicates the amount of attention the work received through additional outlets such as news, blogs, and social media. All SSC guidelines publications scored in the top 5% of all research outputs ever tracked by Altmetric. When comparing articles of a similar publication period, the SSC guidelines ranked higher than 97% to 99% of its contemporaries (Table 4). Additional impact is demonstrated through several domains including related nursing publications (33,34) and a nursing complement to the SSC guidelines, which ranked in the 85th percentile for citations compared with like articles in Scopus with a FWCI of 1.82 (34). TABLE 4. - Surviving Sepsis Campaign Guideline Publication Impact by Altmetric Attention Score and Year Guidelines Year Journal Title Publication Date Altmetrics: Attention Score Altmetrics Attention Score: Percentile of All Research Outputs Ever Tracked by Altmetric Altmetrics High Attention Score: Percentile Compared With Articles of Similar Age 2004 CCM 2004 37 96 97 2004 ICM 2004 ND ND ND 2008 CCM 2008 47 96 98 2008 ICM 2008 38 96 97 2012 CCM 2013 120 98 99 2012 ICM 2013 62 97 98 2016 CCM 2017 381 99 99 2016 ICM 2017 694 66 99 2020a CCM 2020 456 99 99 2020a ICM 2020 591 99 99 2021 CCM 2021 638 99 99 2021 ICM 2021 1,284 99 99 CCM = Critical Care Medicine, ICM = Intensive Care Medicine, ND = no data.aSurviving Sepsis Campaign COVID Guidelines.Guidelines year is the year during which work was completed. Publication year is the year the document was published. The Altmetric Attention Score functions as an indicator of the amount of attention the work received through additional outlets such as news, blogs, and social media. All the Surviving Sepsis Campaign (SSC) guidelines publications scored in the top 5% of all research outputs ever tracked by Altmetric. When comparing articles of a similar publication period, the SSC guidelines ranked higher than 97% to 99% of its contemporaries. Altmetric data accessed from source journals, access date: June 5, 2022. SSC PERFORMANCE IMPROVEMENT PROGRAM After publication of the 2004 guidelines, the SSC set about creating an international quality improvement program that would facilitate hospitals in implementing evidence-based interventions. The SSC approached the Institute for Healthcare Improvement (IHI) (Boston, MA) to collaborate on designing this approach (35). The IHI had been pioneering the use of “bundle technology,” groupings of evidence-based interventions in disease management that when performed reliably have been shown to improve outcomes (36) in management of other diseases. The key to bundles is two-fold: first that bundle elements should be easy to measure and second, that elements should be linked in time. Working with IHI’s critical care leaders, the 6- and 24-hour sepsis bundles, based on the new guidelines, were developed. Other improvement strategies gleaned from IHI included the importance of measuring the change in clinical care that is associated with bundle implementation—“How do you know if the changes you are making are leading to improvement?” (37) and developing collaborative communities who learn from each other as they improve care (37). Novel at the time, the SSC commissioned the design of a database with a graphic user interface to screen patients, collect data, provide results of that data to bedside practitioners and produce improvement reports that demonstrated progress over time. The local version of the database, installed at hospitals worldwide, captured patient-level information related to sepsis bundle interventions and transmitted data back to a master database at the SCCM. To encourage site participation, a downloadable version of the database translated into seven languages was deployed in 2006. Between 2005 and 2012, the SSC conducted a number of learning collaboratives with global reach. In the United States, individual collaboratives were sponsored on the East Coast, Midwest, and West Coast comprising 59 hospitals. Similarly, successful sepsis performance improvement collaboratives were also conducted in other countries including England, Spain, and Brazil (38–40). These efforts, plus SSC list serve and website promotion, were sufficient to catalyze substantial participation in the SSC performance improvement campaign. In 2010, analyzing 15,022 patients’ data from 165 sites worldwide, Levy et al (41) reported that the adjusted odds ratio for mortality improved the longer a site was in the Campaign, resulting in an adjusted absolute drop of 0.8% per quarter and 5.4% over 2 years (95% CI, 2.5–8.4 yr). By 2015, data from 29,470 patients were available for analysis demonstrating that each 10% increase in compliance and additional quarter of participation in the SSC initiative was associated with a significant decrease in the odds ratio for hospital mortality (42). As the evidence base supporting sepsis interventions evolved, the SSC revised the sepsis bundles to reflect changes in guidelines, recommendations and contemporary practice. Following studies challenging the efficacy of tight glucose control in the medical ICU, administration of hydrocortisone for shock and use of recombinant activated protein C, the 6- and 24-hour bundles were replaced with the 3- and 6-hour bundle in 2012 (30,43,44

Evaluation of Financial and Nonfinancial Conflicts of Interest and Quality of Evidence Underlying Psoriatic Arthritis Clinical Practice Guidelines: Analysis of Personal Payments From Pharmaceutical Companies and Authors' Self-Citation Rate in Japan and the United States.

To assess financial conflicts of interest (COI) and nonfinancial COI among psoriatic arthritis (PsA) clinical practice guideline (CPG) authors in Japan and the US, and to evaluate the quality of evidence and strength of recommendations of PsA CPGs. We performed a retrospective analysis using payment data from major Japanese pharmaceutical companies and the US Open Payments Database from 2016 to 2018. All authors of PsA CPGs issued by the Japanese Dermatological Association (JDA) and American College of Rheumatology (ACR) were included. Of 23 CPG authors in Japan, 21 (91.3%) received at least 1 payment, with a combined total of $3,335,413 between 2016 and 2018. Regarding 25 US authors, 21 (84.0%) received at least 1 payment, with a combined total of $4,081,629 during the same period. The 3-year combined mean± SD payment per author was $145,018 ± $114,302 in Japan and $162,825 ± $259,670 in the US. A total of 18 authors (78.3%) of the JDA PsA CPG and 12 authors (48.0%) of the ACR PsA CPG had undisclosed financial COI worth $474,663 and $218,501, respectively. The percentage of citations with at least 1 CPG author relative to total citations was 3.4% in Japan and 33.6% in the US. In sum, 71.4% and 88.8% of recommendations for PsA in the JDA and ACR were supported by low or very low quality of evidence. More rigorous cross-checking of information disclosed by pharmaceutical companies and self-reported by physicians and more stringent and transparent COI policies are necessary.

Debate: We need data infrastructure as well as data sharing - conflicts of interest in video game research.

Industry data sharing has the potential to revolutionise evidence on video gaming and mental health, as well as a host of other critical topics. However, collaborative data sharing agreements between academics and industry partners may also afford industry enormous power in steering the development of this evidence base. In this paper, we outline how nonfinancial conflicts of interest may emerge when industry share data with academics. We then go on to describe ways in which such conflicts may affect the quality of the evidence base. Finally, we suggest strategies for mitigating this impact and preserving research independence. We focus on the development of data infrastructure: technological, social, and educational architecture that facilitates unfettered and free access to the kinds of high-quality data that industry hold, but without industry involvement.

Education: Retinal racemose hemangioma arteriovenous malformation investigations, clinical course and management.

The authors report no financial or nonfinancial conflicts of interest that are directly or indirectly related to this manuscript.

Evaluation of Conflicts of Interest among Participants of the Japanese Nephrology Clinical Practice Guideline.

Rigorous and transparent management strategies for conflicts of interest and clinical practice guidelines with the best available evidence are necessary for the development of nephrology guidelines. However, there was no study assessing financial and nonfinancial conflicts of interest, quality of evidence underlying the Japanese guidelines for CKD, and conflict of interest policies for guideline development. This cross-sectional study examined financial and nonfinancial conflicts of interest among all 142 authors of CKD guidelines issued by the Japanese Society of Nephrology using a personal payment database from all 92 major Japanese pharmaceutical companies between 2016 and 2019 and self-citations by guideline authors. Also, the quality of evidence and strength of recommendations underlying the guidelines and conflicts of interest policies of Japanese, US, and European nephrology societies were evaluated. Among 142 authors, 125 authors (88%) received $6,742,889 in personal payments from 56 pharmaceutical companies between 2016 and 2019. Four-year combined median payment per author was $8258 (interquartile range, $2230‒$51,617). The amounts of payments and proportion of guideline authors with payments remained stable during and after guideline development. The chairperson, vice chairperson, and group leaders received higher personal payments than other guideline authors. Of 861 references in the guidelines, 69 (8%) references were self-cited by the guideline authors, and 76% of the recommendations were on the basis of low or very low quality of evidence. There were no fully rigorous and transparent conflicts of interest policies for nephrology guideline authors in the United States, Europe, and Japan. Most of the Japanese CKD guideline recommendations were on the basis of low quality of evidence by the guideline authors tied with pharmaceutical companies, suggesting the need for better financial conflicts of interest management.

PERSONAL CONFLICTS OF INTEREST IN THE PUBLISHING ENTERPRISE: FOCUS ON JOURNAL EDITORS

Editors play a central role and form an essential link in the publication process. Consequently, they hold considerable influence as to how the literature is molded, and what eventually gets published. In addition to their standard editorial responsibilities, holding that amount of power, editors have extremely high responsibilities to declare any conflicts of interest (COIs) internal to, and external to, the peer review process, particularly those involving personal relationships and networks. This is because they also exist in the peer community, can be high-profile public figures, and form a very unique and restricted – in terms of size, membership and exclusivity – set of individuals. Consequently, editors need to declare their COIs openly, transparently, and publicly on their editor board profiles, and as part of their curriculum vitae. Without such declarations, the greater risk is that editors might have unregulated freedom to enforce their own individual or group biases, through hidden relationships and networks, including the possibility of hiding instances of favoritism, cronyism and nepotism. In the worst-case scenario, this might reflect editorial corruption. Hidden COIs in authors, which tend to be the focus of the academic publishing establishment, including in codes of conduct and ethical guidelines such as those by COPE and the ICMJE, tend to down-play editorial COIs, or restrict them to scrutiny during the peer review process. This opinion piece examines whether there is a systemic problem with under-reported editorial COIs, particularly personal and non-financial COIs, that extend beyond the peer review process and their editorial positions. Greater awareness, debate, and education of this issue are needed.

Watching the watchers: A report on the disclosure of potential conflicts of interest by editors and editorial board members of dental journals.

Reporting potential conflicts of interest (COIs) by all parties involved in the publication process is of pivotal importance to increase trust in research. The present study assessed the disclosure of potential COIs of editors and editorial board members of high-ranked dental journals. From 28 April 2021 to 05 May 2021, the websites of 91 dental journals classified by impact factor (IF) were scrutinized to obtain information on the reporting of COI forms of editors and board members, and whether these individuals reported their detailed curriculum vitae (CV). The COI forms were assessed to understand the potential financial and non-financial COIs of editors and board members. Only 11 (12.1%) journals reported COI forms of editors-in-chief (EICs) and associate editors (AEs). No journal reported a COI form of the editorial board members. Of the 100 editors (EICs plus AEs), 25 (25.%) declared connections to for-profit organisations, and seven (7%) to not-for-profit organisations. Five (5%) editors (all AEs) reported non-financial COIs, and 35 (35%) editors reported nothing to declare. Nine (9.9%) journals reported a short CV of editors, which were not informative regarding potential COIs. Editors and editorial board members of high-ranked dental journals should report in more detail their potential COIs.

Nonfinancial conflict of interest in peer-review: Some notes for discussion

ABSTRACT Strong beliefs can influence the way we deal with emotionally charged topics. Researchers, editors, and reviewers are not an exception. Declaring such nonfinancial conflict of interest when handling or reviewing submitted articles is often obligatory; however, the declaration is not a license to submit a biased review with personal insults or to break the journal’s guidelines. This kind of poor practice can be a clear sign of the seriousness of conflict of interest. In this article, I argue that hostile, unethical, and biased behavior of reviewers and editors often arises from a serious nonfinancial conflict of interest, which should not be ignored or undermined.

Expanding Conflicts of Interest in Public Health Research

Photo by Mehdi Imani on Unsplash
 ABSTRACT
 Non-Profit and Non-Governmental Organizations (NPOs/NGOs) often receive research funds from private for-profit corporations through Corporate Social Responsibility (CSR). Harm industries such as tobacco and alcohol have utilized this opportunity to clear themselves of any blame in contributing to the disease burden, thus obscuring the real danger of their products. The association of public health institutions with such harmful industries has given rise to both financial and non-financial Conflicts of Interest (COIs). To resolve conflicts that arise out of this association, institutions have sought prohibition and full disclosure models. This article highlights the necessity to expand conflict of interest and include industries of implicit harm (fast fashion, mining, cosmetics, and sugary drinks) and not limit itself to just tobacco and alcohol. Simultaneously, the article underlines the hurdles in such an expansion. In conclusion, the article provides a hybrid model for conflict assessment that attempts to account for the limitations of a prohibition model as well as a full disclosure model.
 INTRODUCTION
 As public health research lacks funding, corporations fill a funding gap by allocating money to non-governmental organizations and non-profits.[1] However, the financial involvement of private corporations in public health research raises questions about conflicts of interest and research integrity.[2] Conflicts of interest must be a consideration in the philosophical framework that public health institutions ought to adopt. 
 The recent focus on promoting a “socially conscious capitalistic environment” has led to the inception of corporate social responsibility[3] or an obligation of corporations to address social concerns their products or operations might bring about. Corporations engage in responsible actions to improve transparency and be more accountable for their actions.[4] Some corporations are motivated to be good corporate citizens through ethically profitable practices; they recognize a self-imposed obligation to use their resources to protect, and benefit society and they adhere to a social contract.[5]
 Corporate social responsibility has strong parallels with entrepreneurial philanthropy. By investing in research, that benefits the socio-economically disadvantaged, social responsibility initiatives further social goals.[6] There are two distinct problems with corporate social responsibility models: First, they attempt (but fail) to make up for a poor corporate endeavor like selling cigarettes. Some companies abuse their responsibilities and produce unhealthy goods or engage in practices that are contrary to social good. Furthermore, their philanthropic engagement may be ill-motivated. It enables them to access the socio-political domain, benefit from tax breaks, and profit directly from the “generosity” label without changing their core practices.[7]
 Second, corporate social responsibility leads to conflicts of interest in public research. Corporations fund public health research as a way to “act” responsible and to further a social goal.[8] Corporations that fund research at academic institutions, and non-profits pose financial conflicts of interest.[9]
 l.     Conflict of Interest: Funding Effect and Ethical Engagement
 Arguably, tobacco and alcohol industries are in stark contrast to the goals of public health.[10] Their involvement in and contribution towards public health research may be motivated by a desire to improve their reputation. Harm industries engaging in public health research create a fundamental ethical tension.[11]
 Many scholars have defined conflict of interest in a variety of ways. In this article, we take the definition of conflict of interest as "a set of circumstances that creates a risk that professional judgement or actions regarding a primary interest will be unduly influenced by a secondary or a competing interest" [12]
 Thus, a financial conflict of interest occurs when funding leads to the risk of compromising the research project that is financed by the corporation. "Funding Effect" was coined after a study showed significant differences in research outcomes of private and public-funded drug efficiency safety studies.[13] Private-industry-sponsored research produced commercially favorable outcomes in comparison to publicly sponsored studies.[14] Research sponsored by the tobacco industry had scientists produce biased data, often making the best case for industrial interests.[15]  Receiving funds from for-profit corporations has also led to reduced dissemination of unfavorable results and under-reporting of negative findings.[16] There is not enough research to assess the value of corporate funding to those in academics.[17] Qualitative and quantitative empirical research may help shape best practices when engaging with private corporations.
 Corporate social responsibility creates an illusion of righteousness. Tobacco companies have funded public health research designed to influence tobacco control policies.[18] Corporations have used research to further the narrative that personal responsibility plays an outsized role in alcohol consumption, thereby ignoring the social determinants of addiction and programs that include alcohol supply reduction.[19] A similar narrative has pervaded the sugary drinks discussion.[20]
 While there are many considerations, there is no homogenous policy to help tackle conflicts of interest in public health research.[21] Academic journals mandate declaring financial conflicts of interest. [22]  However, declarations should attempt to incorporate an institutional view of values and not restrict themselves to personal convictions. Rather than approaching each conflict of interest and using declarations, journals should evaluate conflicts of interest in terms of risk. Such an evaluation also would address embedded research practices that may appear ethical on the surface but represent unrecognized bias.[23] The Mohammed Ali effect is a good example of this phenomenon. Self-reporting of ethical research behavior by scientists is under representative of actual occurrences of misconduct simply because peers are held to different standards than self.[24]
 ll.     The Prohibition Model – A Deontological Framework
 The prohibition model discards any research in association with industries that would create a conflict of interest.[25] Academic institutions or journals that prohibit research by industry limit the ability of harm industries to engage in philanthropic public health research that may reflect pro-industry bias. The non-association with harm industries draws from Kant’s categorical imperative. In From the Groundwork of the Metaphysics of Morals, Kant[26] believes that moral behavior exists a priori. If we consider ethics a posteriori, we only deal with what we ‘already did,’ which is not the basis for a moral system. In a Kantian analysis, non-association with harm industries is the starting point of ethical behavior. Furthermore, in Metaphysics of Morals, Kant[27] outlines the motivations to act. He posits that ethical actions are motivated by duty and not by self-interest or immediate inclination. Thus, the prohibition model grounds itself in strong ethical imperatives. However, it would limit public health research funding.
 lll.     The Disclosure Model: Conflicts of Interest are Inevitable
 The disclosure model claims that transparent disclosure procedures are enough to manage conflicts of interest. Often, a placating response to any concern is the disclosure of otherwise unavailable information.[28] Any disclosure should include enough information about the nature, scope, duration, and monetary forces within the for-profit organizational web to allow institutions to assess the risk to their own reputation of engaging in partnership or publishing research conducted by corporations.[29] In addition to transparency, disclosure allows for weighing risks and benefits by assessing proportionality. The proportionality principle requires that the benefits of the association or accepting funds from for-profits be great to justify the conflict of interest.[30] As a result of full disclosure, there is scope for increased accountability from private corporations and public health scholars to ensure that values are upheld throughout the association.
 However, disclosure is not always effective as it does not prevent or remedy a conflict of interest.[31] Disclosure rests on a presumption of wrongdoing and can deter prospective corporate engagement in public health research. However, the risk of deterring research participation is not a concern strong enough to loosen the values a public health institution must strive to achieve. Values such as transparency, proportionality, precautionary measures, and accountability make it easier to navigate disclosure requirements. Disclosure as a standalone method is not a foolproof technique.[32] Thus, a tailor-made model that can switch between the prohibition model and the disclosure model on a case-by-case basis might be more effective. Furthermore, academics need to ensure reasonable confidence that corporations would disclose financial conflicts of interest as the disclosure requirement often acts on an honor system. In case of non-compliance, either terminating the ties or establishing a legal recourse could be sought as alternatives.
 lV.     The Case for Expanding the Definition of Conflicts of Interests
 Many industries are explicitly harmful to people. Tobacco and alcohol corporations engage in actions and create products that work against the ideals of public health. Industries like fast fashion, cosmetics, and many others that are seemingly harmless contribute significantly to the deterioration of public health through their treatment of workers, environmental impacts, and lobbying efforts that include relaxing laws meant to protect consumers and workers.
 The fashion industry produces large amounts of inexpensive clothing by outsourcing labor to lower- and middle-income countries,[33] creating environmental and occupational hazards for their citizens. Many countries lack institutional structures to prevent abuse of workers.[34] Fast fashion also leads to the production of solid waste that ends up in landfills with no efficient mechanism for its disposal.[35] The cosmetic industry releases a great number of micro-plastics into aquatic systems through face products which lead to a shift in their chemical composition.[36] The gambling industry harms health as gambling is addictive and can financially harm individuals, families, and interpersonal relationships.[37] The mining industry has occupational hazards such as inhaling of toxic substances as well as environmental hazards.[38] The sugary drink industry increases the burden of obesity, diabetes, and cardiovascular disease.[39]
 A prohibition model works well with industries that explicitly harm. Thus, non-association with the tobacco and alcohol industry becomes obvious. The difficulty in deciphering conflict of interest through association arises when public health institutions are looking to expand their non-association to industries of implicit harm. When looking to expand non-association into industries such as mining, fast fashion, sugary drinks, etc., we need to move away from a one-size-fits-all approach. Disclosure is not enough as it does not resolve the risk of bias; it merely provides transparency. Yet, a prohibition model would require academic institutions and journals to research funding relationships as well as harmful practices and would lead to less funding for research.
 V.     The Traffic Light Model: A tailor-made hybrid of prohibition and disclosure
 Academic institutions, non-profits, and public health organizations might shape market practices and unearth latent intentions to contradict the social determinants of health if they are able to eliminate bias in public health research.
 This section presents a hybrid model for conflict-of-interest assessment and resolution that takes the metaphor of a traffic light. Figure 1 represents a schematic of the hybrid.
 
 Figure 1: A Schematic of the Traffic Light Hybrid
 As the schematic represents, industries that project values against public health, such as tobacco and alcohol, fall under the red light and hence can be put under non-association, i.e., the prohibition model. Expanding non-association to industries implicit in their harms, such as fast fashion, sugary drinks, mining, companies that exploit labor, would require us to proceed with the disclosure model. As mentioned before, disclosure would require assessing the conflict of interest in terms of proportionality, transparency, accountability, and ensuring that the precautionary principle has been met. Providing a legal recourse at every significant point during research might be helpful to eliminate conflicts that surface during the intermediate stages of research. The entire disclosure model falls under the yellow light urging us to go slow and err on the side of caution.
 The green light comprises pro-public health values corporations and exercises impactful operational methods that do not devalue public health goals. However, this should not be taken for face value. Any suspicion of conflict must be dealt with disclosure, and risk-based assessment should precede every funding decision.
 The three categories serve as a starting point for public health researchers to invest more in building a framework that helps assess such conflicts. Conflicts of interest are rather dynamic and require constant attention. Examining research practices and funder objectives is crucial. The impact of private corporations on public health research needs to be widely discussed in the academic community. Although the hybrid provides a starting point in designing a more dynamic and flexible framework, the presence of an institutional conflict of interest policy and committee with independent review and oversight of research is also a necessity.[40]
 Considering decreased federal funding, scholars have argued the necessity for corporate funding. Besides meeting the financial demand, corporate funding has brought in benefits such as employment opportunities, access to otherwise unavailable tools and technology, and turning academic research into commercially viable practice.[41] Although the goals of public health research, such as the creation of public goods, affordable and safe housing, access to vaccines, etc., may seem utilitarian, it is important to understand that corporations influence research practices that are more deontological in nature. Research integrity has to do with ethical conduct of research and shaping best practices. Thus, an efficient way to deal with research practice and bias is by invoking the Kantian categorical imperative grounded in procedural ethics rather than consequentialist ethics. A Kantian perspective allows considering conflicts of interest as an institutional value. In addition to focusing on individual research practices, public health institutions need to develop an institutional conflict of interest framework where the values of a public health institution shape corporate engagement.
 Another closely related discourse that has a significant bearing on corporate involvement is commercial determinants of health. It considers corporations as contributors to disease burden and holds them as part of a structural problem.[42] By shaping research practices and investing in designing conflicts of interest policies, public health institutions can redefine the narrative of accountability. By actively evaluating financial links within the corporation and assessing risks of bias and influence in research, public health institutions can check the power imbalance that corporations tend to misuse.[43] More importantly, furthering a narrative that defines disease burden in terms of corporate contribution signals support to those who fight against the injustices perpetrated by large-scale corporations. People from lower- and middle-income countries and several indigenous communities have been forced out of their neighborhoods for corporate expansion.[44] As a public health institution, it is important to support vulnerable groups outpowered and forced into poor living conditions by global corporations.
 CONCLUSION
 The consumption of tobacco, alcohol, polluting motor vehicles, and other products of disease-promoting corporations have presented a significant struggle in improving public health. Engaging with such corporations through corporate social responsibility ventures into the highly contentious ethical territory. From a fundamental difference in the values endorsed, for-profit corporations present a conflict of interest in public health research. Public health institutions should be wary of the influence of corporate funding provided through social responsibility programs. Academic bias and the use of corporate social responsibility as a backdoor to legitimizing questionable practices are problematic.  The prohibition and disclosure models independently do not perform efficiently against the dynamic nature of conflicts of interest. The hybrid model for institutional conflict-of-interest policy incorporates both the prohibition and disclosure models and allows for switching between them on a case-by-case basis.  Managing corporate power requires dealing with conflict of interests broadly and as a risk-susceptibility issue rather than an occurrence issue.
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 [1] Denier, Y. (2008). Mind the gap! Three Approaches to Scarcity in Health Care. Medicine, Health Care and Philosophy, 11(1), 73-87.
 [2] Gupta, A., Holla, R., & Suri, S. (2015). Conflict of Interest in Public Health: Should There be a Law to Prevent It? Indian J Med Ethics, 12(3), 172-7.
 [3] de Vries, H. (2016). Invited Commentary: Corporate Social Responsibility and Public Health: An Unwanted Marriage; Resnik, D. B. (2019). Institutional Conflicts of Interest in Academic Research. Science and Engineering Ethics, 25(6), 1661-1669.
 [4] Lee, K., & Bialous, S. A. (2006). Corporate Social Responsibility: Serious Cause for Concern. Tobacco Control, 15(6), 419-419.
 [5] Macassa, G., da Cruz Francisco, J., & McGrath, C. (2017). Corporate social responsibility and population health. Health Science Journal, 11(5), 1-6.
 [6] Harvey, C., Gordon, J., & Maclean, M. (2021). The Ethics of Entrepreneurial Philanthropy. Journal of Business Ethics, 171(1), 33-49.
 [7] Harvey, C., Gordon, J., & Maclean, M. (2021). The Ethics of Entrepreneurial Philanthropy. Journal of Business Ethics, 171(1), 33-49.
 [8] Resnik, D. B. (2019). Institutional Conflicts of Interest in Academic Research. Science and Engineering Ethics, 25(6), 1661-1669.
 [9] Royo Bordonada, M., & García López, F. (2018). What Is and What Is Not a Conflict of Interest in Public Health Research. European Journal of Public Health, 28(suppl_4), cky213-750.
 [10] de Vries, H. (2016). Invited Commentary: Corporate Social Responsibility and Public Health: An Unwanted Marriage.
 [11] Lee, K., & Bialous, S. A. (2006). Corporate Social Responsibility: Serious Cause for Concern. Tobacco Control, 15(6), 419-419.
 [12] Gupta, A., Holla, R., & Suri, S. (2015). Conflict of Interest In Public Health: Should There Be A Law To Prevent It?. Indian J Med Ethics, 12(3), 172-7.
 [13] Krimsky, S. (2013). Do Financial Conflicts of Interest Bias Research? An Inquiry into The “Funding Effect” Hypothesis. Science, Technology, & Human Values, 38(4), 566-587.
 [14] Ibid.
 [15] Ibid.
 [16] Nakkash, R. T., Mugharbil, S., Alaouié, H., & Afifi, R. A. (2017). Attitudes of Public Health Academics Toward Receiving Funds from For-Profit Corporations: A Systematic Review. Public Health Ethics, 10(3), 298-303.
 [17] Nakkash, R. T., Mugharbil, S., Alaouié, H., & Afifi, R. A. (2017). Attitudes of Public Health Academics Toward Receiving Funds From For-Profit Corporations: A Systematic Review. Public Health Ethics, 10(3), 298-303. (An attempt to review the research failed as there was not data on the “Attitudes of Public Health Academics towards receiving funds from for-profit corporations.”)
 [18] de Vries, H. (2016). Invited Commentary: Corporate Social Responsibility and Public Health: An Unwanted Marriage.
 [19] Yoon, S., & Lam, T. H. (2013). The illusion of Righteousness: Corporate Social Responsibility Practices Of The Alcohol Industry. BMC Public Health, 13(1), 1-11.
 [20] Gupta, A., Holla, R., & Suri, S. (2015). Conflict of interest in Public Health: Should There Be A Law To Prevent It?. Indian J Med Ethics, 12(3), 172-7.
 [21] Shamoo, A. S., & Resnik, D. B. (2015). Responsible Conduct of Research (3rd ed.). New York: Oxford University Press.
 [22] Resnik, D. B. (2019). Institutional Conflicts of Interest in Academic Research. Science And Engineering Ethics, 25(6), 1661-1669.
 [23] Field, M. J., & Lo, B. (Eds.). (2009). Conflict of Interest in Medical Research, Education, And Practice.
 [24] Fanelli, D. (2009). How Many Scientists Fabricate and Falsify Research? A Systematic Review and Meta-Analysis Of Survey Data. PloS one, 4(5), e5738.
 [25] Field, M. J., & Lo, B. (Eds.). (2009). Conflict of Interest in Medical Research, Education, and Practice.
 [26] Kant, I. (2008). Groundwork for the Metaphysics of Morals. Yale University Press.
 [27] Kant, I. (2008). Groundwork for the Metaphysics of Morals. Yale University Press.
 [28] Field, M. J., & Lo, B. (Eds.). (2009). Conflict of Interest In Medical Research, Education, And Practice.
 [29] IbId.
 [30] Childress, James F., R. Gaare Bernheim, R. J. Bonnie, and A. L. Melnick. "Introduction: A Framework For Public Health Ethics." Essentials Of Public Health Ethics 1 (2015): 1-20.
 [31] Fleishman, J. L. (1981). The Disclosure Model and Its Limitations. Hastings Center Report, 15-17.
 [32] Ibid.
 [33] Bick, R., Halsey, E., & Ekenga, C. C. (2018). The Global Environmental Injustice of Fast Fashion. Environmental Health, 17(1), 1-4.
 [34] Anguelov, N. (2015). The Dirty Side of The Garment Industry: Fast Fashion and Its Negative Impact on Environment and Society. CRC Press.
 [35] Wicker, A. Fast Fashion Is Creating an Environmental Crisis. Newsweek. September 1, 2016; Available from: https://www.newsweek.com/2016/09/ 09/old-clothes-fashion-waste-crisis-494824.html. Accessed 13 Aug 2021
 [36] Alabi, O. A., Ologbonjaye, K. I., Awosolu, O., & Alalade, O. E. (2019). Public and Environmental Health Effects of Plastic Wastes Disposal: A Review. J Toxicol Risk Assess, 5(021), 1-13.
 [37] Wardle, H., Reith, G., Langham, E., & Rogers, R. D. (2019). Gambling and Public Health: We Need Policy Action to Prevent Harm. BMJ, 365.
 [38] Hendryx, M. (2015). The Public Health Impacts of Surface Coal Mining. The Extractive Industries and Society, 2(4), 820-826.
 [39] Flynn, A., & Okuonzi, S. A. (2016). Coca-Cola's Multifaceted Threat to Global Public Health. The Lancet, 387(10013), 25.
 [40] Resnik, D. B. (2019). Institutional Conflicts of Interest in Academic Research. Science And Engineering Ethics, 25(6), 1661-1669.
 [41] Bayer, R., & Sampat, B. N. (2016). Corporate Funding for Schools of Public Health: Confronting the Ethical and Economic Challenges. American Journal of Public Health, 106(4), 615-618.
 [42] McKee, M., & Stuckler, D. (2018). Revisiting The Corporate and Commercial Determinants of Health. American Journal of Public Health, 108(9), 1167-1170.
 [43] Daube, M. (2018). Shining a Light on Industry Research Funding. American Journal of Public Health, 108(11), 1441.
 [44] Munarriz, G. (2008). Rhetoric and Reality: The World Bank Development Policies, Mining Corporations, and Indigenous Communities in Latin America. International Community Law Review, 10(4), 431-443.

Adherence to conflicts of interest policy in Cochrane reviews where authors are also editorial board members: A cross-sectional analysis.

Cochrane devolves most editorial governance of the Cochrane Database of Systematic Reviews (CDSR), including title prioritization, protocol registration, peer-review, editorial oversight and subsequent review deposition, to specific Cochrane Review Group (CRG) editorial boards. Current Cochrane policy stipulates authors of reviews who are also members of the supporting CRG declare this non-financial conflict of interest and confirm no involvement in the review editorial process. The aim of this cross-sectional analysis was to assess adherence to Cochrane's editorial conflict of interest policy. All 260 published Cochrane reviews (CR) in issues 1 to 6 from 2019 of the CDSR were reviewed. A total of 133 (51.2%, 133/260) of CRs had at least one author that was also listed as an editor in the CRG. Of these, only five (3.8%, 5/133) appropriately declared the conflict according to Cochrane policy. In 6.5% (17/133) CRs, the contact author had a leading editorial position within the CRG and in only four of 17 was this declared according to Cochrane policy. No CR with the contact author who also had a leading editorial position described methods to prevent any potential issues related to this scenario during the editorial process in accordance with Cochrane policy. We propose a specific form to improve the transparency and reliability of editorial conflict of interest reporting in CRs. The suggested form can be adapted to other contexts.

Sales Representatives in the Operating Room: Conflict of Interest or Clinical Support?

The Physician Payment Sunshine Act, which became federal law in January 2012, mandated that medical device manufacturers must disclose any financial support provided to individual physicians on a publicly available Web site. The law reflects increasing concern about physician-industry relationships. The connection between surgeon and sales representative creates possibilities for both financial and non-financial conflicts of interest (COIs). Indeed, COIs may be inherent when a sales representative is motivated by profit while also serving a critical role in many surgeries. The potential benefits and risks for patients, who may not even be aware of the sales representative's presence in the operating room, must be considered. This paper adds to the national discussion about neurosurgical physician-industry conflicts of interests and the issues relative to sales representatives in the operating room.

A Politics of Objectivity: Biomedicine's Attempts to Grapple with "non-financial" Conflicts of Interest.

Increasingly, policymakers within biomedicine argue that "non-financial" interests should be given equal scrutiny to individuals' financial relationships with industry. Problematized as "non-financial conflicts of interest," interests, ranging from intellectual commitments to personal beliefs, are managed through disclosure, restrictions on participation, and recusal where necessary. "Non-financial" interests, though vaguely and variably defined, are characterized as important influences on judgment and thus, are considered risks to scientific objectivity. This article explores the ways that "non-financial interests" have been constructed as an ethical problem and the implications for research integrity. I conducted an interpretive, qualitative study, which triangulated two data sources: documents (including published accounts of identifying and managing "non-financial" interests and conflict of interest policies) and in-depth interviews with 16 leaders within evidence-based medicine, responsible for contributing to, directing, or overseeing conflict of interest policy development and implementation. This article outlines how evolutions in the definition of conflict of interest have opened the door to include myriad "non-financial" interests, resulting in the generalisation of a statistical concept-risk of bias-to social contexts. Consequently, biases appear equally pervasive among participants while in reality, a politics of objectivity is at play, with allegations of conflict of interest used as a means to undermine others' credibility, or even participation. Iterations of the concept of conflict of interest within biomedicine have thus consistently failed to articulate or address questions of accountability including whose interests are able to dominate or distort evidence-led processes and why. Consequently, current policy solutions meant to mitigate bias may instead serve exclusionary purposes under the guise of impartiality while remaining vulnerable to interference from powerful stakeholders.

Community and informal care providers at the heart of universal health coverage in sub-saharan africa: A position paper

Globally, increased demand on often scarce healthcare resources and those challenges incumbent in responding to the coexistence of infectious and non-communicable diseases warrant the need to address persistent health inequities. Understanding the complex intersectionality of vulnerability and reaching those in most critical need of healthcare lies at the heart of fostering and sustaining resilient healthcare systems. Harnessing the long-recognised value of Community and Informal Care Providers (CICPs) is instrumental to Universal Health Coverage (UHC). The present COVID-19 context serves as a poignant example of where access to formal healthcare services by many has become increasingly difficult. Here, the value of informal or volunteer-led health services has been a lifeline for many. For several decades, formal reportage has evidenced the established role of CICPs, particularly across Sub-Saharan Africa with quantifiable efficacy across a number of domains, such as, maternal and child health, neglected tropical disease prevention, tuberculosis care and malaria control.  CICPs have been sustainable and effective as a conduit between the formal and informal health sectors, and between health facilities and the remotest of communities. Maximising the function of CICPs relies on socio-culturally, geographically sensitive, and bespoke support; psychosocial, practical, and logistical capacitation coupled with situationally and culturally appropriate monitoring and evaluation. The Astana Declaration highlights the centrality of building on existing knowledge, insight and resource.  We therefore argue that CICPs are indispensable in Africa’s move towards UHC, and hold promise for acceptable, accessible, affordable, and quality healthcare to everyone who needs to get, be and stay healthy.      Source of funding: The WHO African Regional Office and Hidayo Noguchi African Prize (HNAP) for Medical Services sponsored the processing fee for this article.   Conflict of interest statement: The authors declare no financial or non-financial conflicts of interest.   Acknowledgments: The authors acknowledge the mentorship of Professor Margaret Gyapong, Director of the Institute of Health Research, University of Health and Allied Sciences, Ghana.   Authors’ contributions: EK contributed to the body of the essay and managed correspondences with the mentor and WHO African Regional Office; ELM wrote the outline, abstract and introduction of the essay; BOO made contributions to the body of the essay, wrote the conclusion and compiled the first complete draft; and MAK contributed to the body of the essay.

Reply to: Beyond Money: Conscientious Objection in Medicine as a Conflict of Interests.

Giubilini and Savulescu in their recent Journal of Bioethical Inquiry symposium article presented an account of conscientious objection that argues for its recognition as a non-financial conflict of interest. In this short commentary, I highlight some problems with their account. First, I discuss their solicitor analogy. Second, I discuss some problems surrounding their objectivity claim about standards of medical care. Next, I discuss some issues arising from consistently applying their approach. Finally, I highlight that conscientious objection should be viewed not as a conflict of interest but as something that society has an interest in preserving. I conclude by arguing that clinicians who have a conscientious objection can be treated in the same way as those who decide to subspecialize and do not need to give up work in their specialty. While Giubilini and Savulescu present an interesting argument about conscientious objection, theirs is not a compelling view. Indeed, the way we approach conscientious objection has more to teach us about conflicts of interest than the other way around.

Non-financial conflict of interest in social intervention trials and systematic reviews: An analysis of the issues with case studies and proposals for management

Research suggests that effect sizes are larger when program developers conduct studies compared to independent researchers. This is sometimes attributed to biases linked to conflicts of interest (CoI). While potential financial CoI is often acknowledged, non-financial CoI is more subtle, rarely reported and just as likely to lead to biased results. This paper highlights key arguments about non-financial CoI in the field of social and behavioral intervention research. It presents three cases studies of widely-disseminated child and family interventions which have been the subject of critical appraisals and debates related to potential non-financial CoI as a source of bias. The case studies illustrate how evidence appraisal can differ depending on the independence of the appraisers and how this may affect decisions around what is considered ‘good’ evidence. The case studies highlight the complex issues involved in trying to substantiate non-financial CoI, the unsatisfactory and fragmented ways that it is currently addressed, and the need for improved guidance to prevent and redress it.

The Policies for the Disclosure of Funding and Conflict of Interest in Surgery Journals: A Cross-Sectional Survey.

Industry through its funding of research and through its relationships with study authors can influence the results of research. Most journals have policies for reporting funding and disclosing conflict of interest (COI) to mitigate the influence of industry on research. The objective of this study is to assess the policies of surgery journals for the reporting of funding and the disclosure of COI. We described the prevalence and characteristics of funding and COI policies of journals indexed under "Surgery" in the Journal Citation Reports. We extracted data from publicly available information and through simulation of manuscript submission. Of the 186 eligible journals, 171 (92%) had policies for reporting of funding. None of the policies described procedures to deal with non-reporting or underreporting of funding. Of the 186 journals, 183 (99%) had a policy for disclosure of COI. All journals with a COI policy required disclosure of financial interest, while 96 (52%) required the disclosure of non-financial interests. Only 24 (13%) policies described how non-disclosure of COI affects the editorial process, and none described procedures to verify COI disclosure. Of the policies that required disclosing COI, 94 (51%) also required reporting the source of financial COI. Most journals have policies for reporting of funding and disclosure of financial COI. However, many do not have clear policies for disclosing non-financial COI. Major limitations in the policies include the lack of processes for the verification of disclosed interests and for dealing with underreporting of funding and of COI.

Governance of conflicts of interest in the publication of health research – perspectives on ways forward from a journal

Abstract Identifying corporate influence and biases in the publication of academic research is fraught with difficulty, as this presentation explores. Journals often rely on authors' own disclosures of interests, which may intentionally or unintentionally omit relevant conflicts. Financial conflicts of interests may be easier for authors and editors to identify, allowing some mitigation, but non-financial conflicts of interest and corporate influence can be harder to tease out. Both authors and journals make multiple judgements on which interests are relevant and it is easy for opaque conflicts to slip through the cracks. Even if these conflicts of interests are declared, moreover, many journals rely on transparency to inform their policy on publishing research by authors with links to industry; this transparency assumes that readers are able to discern the potential bias arising from these relationships. However - while we know that readers consider research papers written by authors with declared financial links to industry to be less important, relevant, rigorous, and believable - this may lead readers to place unwarranted trust in research from authors whose conflicts are less clearly visible. For example, from authors aligned with academic institutions whose departments may experience corporate influence, but in a manner too indirect to be declared. In order to consider these issues in context, delegates will be asked to make judgements on whether particular conflicts of interest statements would exclude authors from publishing with one leading journal, the British Medical Journal. They will hear how journals are now moving beyond transparency in order to better engage with these themes: via such initiatives as, for example, registries of interests; the re-definition of competing interests as relationships; and increasingly widespread policies that entirely exclude authors with financial ties to industry from publishing.

Reporting of conflicts of interest by authors of primary studies on health policy and systems research: a cross-sectional survey

ObjectivesThe objective of this study was to assess the frequency and types of conflict of interest (COI) disclosed by authors of primary studies of health policy and systems research (HPSR).DesignWe...