Conflict Of Interest Policies Research Articles

Evaluating Financial Conflicts of Interest Among Contributors to Clinical Practice Guidelines of the American College of Obstetricians and Gynecologists.

Patient care is an essential part of the practice of obstetrics and gynecology, and patient care is directed by clinical practice guidelines. To increase the validity of these guidelines, we must make sure that there is no outside influence by financial conflicts of interest. To investigate the existence of and reporting patterns regarding payments received by contributors to guidelines from the American College of Obstetricians and Gynecologists (ACOG), ACOG executive committee members, and companies making these payments and to examine the compliance of those receiving payments to ACOG's conflict of interest policies. The Center for Medicare and Medicaid's Open Payments database was used to search practice bulletin committee members and practice bulletin collaborators from 2014-2016, as well as current executive committee board members. Open Payments was also used to evaluate companies that provided payments, and amounts were totaled. The main outcome measure was the monetary values of payments received and the compliance with disclosure statements enforced by ACOG. Manufacturer payments to physicians in the database were analyzed descriptively. General and research payments were calculated among 65 physicians in the Open Payments database: 44 physician members of both the obstetrics and the gynecology practice bulletin committees, 4 2016 ACOG executive board physician members, and 17 contributing physician authors. Research payments accounted for greater than 78% of all payments. Consulting, travel and lodging, and speaking fees totaled greater than $90,000 and contributed to more than 90% of the total amount of general payments. Food and beverage payments contributed to 10% of all general payments. Three covered members were noncompliant with the financial conflicts of interest guidelines, receiving industry payments exceeding $5000. A small number of companies provide the majority of contributions; however, there is no evidence to suggest bias toward manufactures within ACOG practice bulletins. Future investigations into pharmaceutical manufacturer payments, specifically for consulting fees, may be warranted. (Clinical Trial Registry UMIN-CTR, UMIN000029165).

Lessons from Corporate Influence in the Opioid Epidemic: Toward a Norm of Separation.

There is overwhelming evidence that the opioid crisis—which has cost hundreds of thousands of lives and trillions of dollars (and counting)—has been created or exacerbated by webs of influence woven by several pharmaceutical companies. These webs involve health professionals, patient advocacy groups, medical professional societies, research universities, teaching hospitals, public health agencies, policymakers, and legislators. Opioid companies built these webs as part of corporate strategies of influence that were designed to expand the opioid market from cancer patients to larger groups of patients with acute or chronic pain, to increase dosage as well as opioid use, to downplay the risks of addiction and abuse, and to characterize physicians’ concerns about the addiction and abuse risks as “opiophobia.” In the face of these pervasive strategies, conflict of interest policies have proven insufficient for addressing corporate influence in medical practice, medical research, and public health policy. Governments, the academy, and civil society need to develop counterstrategies to insulate themselves from corporate influence and to preserve their integrity and public trust. These strategies require a paradigm shift—from partnerships with the private sector, which are ordinarily vehicles for corporate influence, to a norm of separation.

Lessons from Corporate Influence in the Opioid Epidemic: Toward a Norm of Separation

There is overwhelming evidence that the opioid crisis which has cost hundreds of thousands of lives and trillions of dollars (and counting) has been created or exacerbated by webs of influence woven by several pharmaceutical companies. These webs involve health professionals, patient advocacy groups, medical professional societies, research universities, teaching hospitals, public health agencies, policymakers, and legislators. Opioid companies built these webs as part of corporate strategies of influence that were designed to expand the opioid market from cancer patients to larger groups of patients with acute or chronic pain, to increase dosage as well as opioid use, to downplay the risks of addiction and abuse, and to characterize physicians’ concerns about the addiction and abuse risks as “opiophobia.” In the face of these pervasive strategies, conflict of interest policies have proven insufficient for addressing corporate influence in medical practice, medical research, and public health policy. Governments, the academy, and civil society need to develop counter-strategies to insulate themselves from corporate influence and to preserve their integrity and public trust. These strategies require a paradigm shift from partnerships with the private sector, which are ordinarily vehicles for corporate influence, to a norm of separation.

A comparison of policy provisions for managing “financial” and “non-financial” interests across health-related research organizations: A qualitative content analysis

ABSTRACTIt is largely taken-for-granted, and sometimes advocated that the same strategies to identify, assess, and manage financial conflicts of interest may also be applied to so-called non-financial conflicts of interest. We conducted a qualitative content analysis of 22 conflict of interest policies from prominent organizations engaged in health-related research to compare and critically analyze the range of policy approaches for managing financial and non-financial interests. We extracted and analyzed policy content using an instrument based on the normative framework for evaluating conflict of interest policy proposed by the Institute of Medicine. Policy authors implicitly applied the same principles and provisions to both financial and non-financial conflicts of interest or failed to specify how they might be treated separately. Provisions related to the identification of “perceived” conflicts of interest, consequences for non-disclosure, ineligibility for participation, and management strategies thus, tended to under-regulate financial and over-regulate non-financial conflicts of interest. Consequently, these approaches may particularly violate principles of proportionality and fairness and risk interference from industry, sometimes intentionally so. Policymakers should strengthen approaches to identification and prevention of financial conflicts of interest and explore alternative approaches to enhancing individuals’ accountability for their positions and perspectives.

Daikenchuto for reducing postoperative ileus in patients undergoing elective abdominal surgery.

Reason for withdrawal: Serious breach of Cochrane's conflict of interest policy. A ruling by Cochrane's Funding Arbiters that a Cochrane Review has seriously breached Cochrane's conflict of interest policy.

Strong Conflict of Interest Policies are not Associated With Decreased Industry Payments to Academic Urology Departments

ObjectiveTo identify whether institutions with strong conflicts of interest (COI) policies receive less industry payments than those with weaker policies. While industry-physician interactions can have collaborative benefits, financial COI can undermine preservation of the integrity of professional judgment and public trust. To address this concern, academic institutions have adopted COI policies. It is unclear whether the strength of COI policy correlates with industry payments in urology. Materials and Methods131 US academic urology programs were surveyed on their COI policies, and graded according to the American Medical Student Association (AMSA) criteria. Strength of COI policy was compared against industry payments in the Center for Medicare and Medicaid Services Open Payments database. ResultsFifty-seven programs responded to the survey, for a total response rate of 44%. There was no difference between COI policy groups on total hospital payments (P = .05), total department payments (P = .28), or dollars per payment (P = .57). On correlation analysis, there was a weak but statistically nonsignificant correlation between AMSA Industry Policy Survey Score and Open Payments payments (ρ = −0.14, P = .32). ConclusionStrength of conflicts of interest policy in academic urology did not correlate to industry payments within the Open Payments database. Establishment of strong COI policy may create offsetting factors that mitigate the intended effects of the policy. Further studies will be required to develop the evidence base for policy design and implementation across various specialties.

The concept of «conflict of interest» in the administrative law of the Russian Federation

Introduction. The analysis of the nature, conditions and reasons for the occurrence and practice of resolving (preventing and settling) conflict of interest issues is not only an important applied, but also significant research problem. Situations related to conflict of interest issues, both in the public-state and private sectors, have given rise not only to special scientific research, but also to legislative regulation and managerial practice. A number of countries have adopted special laws on conflict of interest policy norms, established office of state commissioner for conflict of interest policy, and introduced rules regulating employee conflict of interest policy.Materials and methods. The source of the research is regulatory, theoretical, educational, scientific, journalistic works by domestic and foreign authors. The theoretical and methodological basis is the dialectical-materialistic approach to the analysis of the essence of social phenomena, the laws of their development, the features of legal regulation and the controlling effect on them. The research tools are classical: comparative legal analysis, formal logical, concrete historical and system-functional methods. The results of the study. The article presents the author’s interpretation of the of “conflict of interests” concept. Its essence is a conflict situation between public law obligations and individual’s interests, which provokes situations in which the interests of one person lead to potential or real harm to the rights, freedoms and legitimate interests of others persons. Conclusion: the conflict of interests must be managed, which means that it is timely to identify, diagnose, objectively assess possible risks and negative consequences, take adequate organizational and legal measures to resolve the conflict situation. If a public servant does not serve, in accordance with his status and powers, the public and the state, but only cares about his/her own well-being, then such public employees must be dismissed from public office.Discussion and conclusion. Improving the mechanisms for identifying, qualifying, regulating the suppression and punishment of perpetrators, eliminating the negative consequences of breaching the conflict of interest policy are strategically important and rather difficult tasks that challenge not only the state, the law enforcement system and local authorities, but also business, civil society institutions and every citizen . Its solution requires systematic monitoring, comprehensive analysis, decisive and coordinated actions.

Corrigendum: Quantitative Electrochemical DNA Microarray on a Monolith Electrode with Ten Attomolar Sensitivity, 100 % Specificity, and Zero Background

Prof. Ravi F. Saraf of this publication discloses financial interest in Vajra Instrument as its Founder and President. In accordance with its Conflict of Interest policy, the University of Nebraska-Lincoln's Conflict of Interest in Research Committee has determined that this must be disclosed. The original manuscript failed to acknowledge that Ravi F. Saraf was affiliated with Vajra Instruments, Inc. or disclose financial interest. The amended Conflict of Interest statement appears below. The authors apologize for this oversight. Prof. Ravi F. Saraf discloses financial interest in Vajra Instrument, Inc. as its Founder and President.

Corrigendum: Quantitative Electrochemical DNA Microarray on a Monolith Electrode with Ten Attomolar Sensitivity, 100 % Specificity, and Zero Background

Prof. Ravi F. Saraf of this publication discloses financial interest in Vajra Instrument as its Founder and President. In accordance with its Conflict of Interest policy, the University of Nebraska-Lincoln's Conflict of Interest in Research Committee has determined that this must be disclosed. The original manuscript failed to acknowledge that Ravi F. Saraf was affiliated with Vajra Instruments, Inc. or disclose financial interest. The amended Conflict of Interest statement appears below. The authors apologize for this oversight. Prof. Ravi F. Saraf discloses financial interest in Vajra Instrument, Inc. as its Founder and President.

An audit of reporting of conflict of interest policies among three stakeholders in Indian biomedical journals.

Background:A conflict of interest (COI) in publication exists when the primary interest of publication is influenced by a secondary interest (financial or non-financial). International guidelines are available that can be used by journal editors to formulate their own COI policies. The present study was carried out with the objective of evaluating COI policies existing among Indian biomedical journals.Materials and Methods:MEDLINE/PubMed and MedIND/IndMed databases were searched. Inclusions were journals that were active and indexed. Outcome measures were proportion of journals: (a) mentioning COI disclosure statement for authors, reviewers, and editors, (b) adequately explaining COI, (c) referring to three international guidelines, and (d) the proportion of PubMed/other than PubMed indexed journals mentioning COI policy for authors, reviewers, and editors and providing an adequate explanation for COI. Apart from descriptive statistics, associations between indexing and COI Policy for all three stakeholders were evaluated.Results:A total of n = 106 journals formed the final sample. Among them, 82 (77%) were PubMed and 24 (23%) were MedIND/IndMed indexed. COI disclosure statement was mentioned in 93 (87.7%) journals for authors, 10 (9.4%) for reviewers, and 06 (5.6%) for editors. Only 35 (33%) journals adequately explained COI. A total of 61 (57.5%) journals endorsed all the three international guidelines. PubMed indexing was found to be associated with approximately 19 times the odds of COI policies being present on the journal's home page relative to the journals indexed with other indexing agencies (crude odds ratio - 18.8, 95% confidence interval [4.6, 77],P < 0.0001).Conclusion:Very few Indian biomedical journals have COI policies for reviewers and editors and most did not explain it adequately. Nearly, a fifth of the journals we evaluated did not follow any guideline for disclosing COI.

SARS-CoV-2 Infection Depends on Cellular Heparan Sulfate and ACE2

We show that SARS-CoV-2 spike protein interacts with cell surface heparan sulfate and angiotensin converting enzyme 2 (ACE2) through its Receptor Binding Domain. Docking studies suggest a putative heparin/heparan sulfate-binding site adjacent to the domain that binds to ACE2. In vitro, binding of ACE2 and heparin to spike protein ectodomains occurs independently and a ternary complex can be generated using heparin as a template. Contrary to studies with purified components, spike protein binding to heparan sulfate and ACE2 on cells occurs codependently. Unfractionated heparin, non-anticoagulant heparin, treatment with heparin lyases, and purified lung heparan sulfate potently block spike protein binding and infection by spike protein-pseudotyped virus and SARS-CoV-2 virus. These findings support a model for SARS-CoV-2 infection in which viral attachment and infection involves formation of a complex between heparan sulfate and ACE2. Manipulation of heparan sulfate or inhibition of viral adhesion by exogenous heparin may represent new therapeutic opportunities.Funding: This work was supported by RAPID grant 2031989 from the National Science Foundation and Project 3 of NIH P01 HL131474 to J.D.E.; The Alfred Benzon Foundation to T.M.C; NIH R01 AI146779 and a Massachusetts Consortium on Pathogenesis Readiness MassCPR grant to A.G.S.; DOD grant W81XWH-20-1-0270 and Fluomics/NOSI U19 AI135972 to S.K.C; a Career Award for Medical Scientists from the Burroughs Wellcome Fund to A.F.C.; Bill and Melinda Gates Foundation grant OPP1170236 to A.B.W.; COVID19 seed funding from the Huck Institutes of the Life Sciences and Penn State start-up funds to J.J.; and T32 training grants GM007753 for B.M.H. and T.C and AI007245 for J.F.; J.P. received funding from the Innovation Fund Denmark and VAR2 Pharmaceuticals.Conflict of Interest: J.D.E. is a co-founder of TEGA Therapeutics. J.D.E. and The Regents of the University of California have licensed a University invention to and have an equity interest in TEGA Therapeutics. The terms of this arrangement have been reviewed and approved by the University of California, San Diego in accordance with its conflict of interest policies. C.A.G and B.E.T are employees of TEGA Therapeutics.Ethical Approval: The collection of human tissue in this study abided by the Helsinki Principles. This work included postmortem human tissue, collected at the University Hospital, at the University of Copenhagen in Denmark. The patient provided informed consent for the tissue to be used for research purposes. All samples were completely deidentified before transfer to the researchers and this did not need specific IRB approval.

SARS-CoV-2 Can Infect the Placenta and Is Not Associated with Specific Placental Histopathology: A Series of 19 Placentas from COVID-19+ Mothers

Background: Congenital infection of SARS-CoV-2 appears to be exceptionally rare despite many cases of COVID-19 during pregnancy. Robust proof of placental infection requires demonstration of viral localization within placental tissue. Only 2 of the few cases of possible vertical transmission have demonstrated placental infection. None have shown placental expression of the ACE2 or TMPRSS2 protein, both required for viral infection. Methods: We examined 19 COVID-19 exposed placentas for histopathologic findings, and for expression of ACE2, and TMPRSS2 by immunohistochemistry. Direct placental SARS-CoV-2 expression was studied by two methods - nucleocapsid protein expression by immunohistochemistry, and RNA expression by in-situ hybridization. Findings: ACE2 membranous expression in the syncytiotrophoblast of the chorionic villi is predominantly in a polarized pattern with expression highest on the stromal side of the trophoblast. In addition, cytotrophoblast and extravillous trophoblast express ACE2. No ACE2 expression was detected in villous stroma, Hofbauer cells, or endothelial cells. TMPRSS2 expression was only present weakly in the villous endothelium and rarely in the ST. In 2 of 19 cases SARS-CoV-2 RNA was present in the placenta focally in the syncytiotrophoblast and cytotrophoblast. There was no characteristic histopathology present in our cases including the 2 placental infections. Interpretation: We found that the placenta is capable of being infected but that this event is rare. We propose one explanation could be the polarized expression of ACE2 away from the maternal blood and pronounced paucity of TMPRSS2 expression in trophoblast. Funding Statement: Vickery-Colvin Award from the Department of Pathology, Massachusetts General Hospital and Advanced Cell Diagnostics. Research reported in this publication was partially supported by the Career Development Program in Substance Use and Addiction Medicine of the National Institutes of Health under award number K12DA043490. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institute of Health. Declaration of Interests: Disclosures: D.T.T. has received consulting fees from Merrimack Pharmaceuticals, Ventana Roche, Foundation Medicine, Inc., and EMD Millipore Sigma, which are not related to this work. D.T.T. is a founder and has equity in PanTher Therapeutics and TellBio, Inc., which is not related to this work. D.T.T. is co-founder and own equity in ROME Therapeutics, which is not related to this work. Parts of this work were supported by ACD-Biotechne (N.D., V.D., D.T.T.). Dr. Ting’s interests were reviewed and are managed by Mass General Brigham in accordance with their conflict of interest policies. M.M.-K. has received consulting fees rom H3 Biomedicine and AstraZeneca and institutional grant support from Novartis, all of which are not related to this work. D.J.R. received royalties from UpToDate and Cambridge University Press as an author, not related to this work. All other authors declare no competing interests. Ethics Approval Statement: Institutional review board approval (IRB2020P001116 and IRB2020P001001) and Research support agreement (RSA2020A005296).

Clinically Applicable Approach for Predicting Future Mechanical Ventilation in Patients with COVID-19 Infection

Background: COVID-19 patients requiring mechanical ventilation have a high mortality and resource utilization. The ability to predict which patients may require mechanical ventilation, prior to clinical decompensation, allows increased acuity of care and targeted interventions to potentially mitigate deterioration. Methods: We included COVID-19 positive hospitalized patients in this single-center retrospective observational study. Our primary outcome was mechanical ventilation or death within the subsequent 24-hours prediction window. As clinical decompensation is likely more recognizable, but less modifiable, as the prediction window shrinks, we also assessed 4-hour and 12-hour, and, for more notice, 48-hour prediction window. General classes of model features included demographic information, laboratory results, comorbidities, medication administration, and vital signs. We created a Random Forest model and assessed performance using 10-fold cross validation. The model was then compared to models derived from generalized estimating equations using discrimination.Findings: Ninety-three (23%) of the 398 COVID-19 positive patients meeting our inclusion criteria required mechanical ventilation or died within 14-days of admission. The Random Forest model predicts pending mechanical ventilation with good discrimination (c-statistic = 0.858, 95% confidence interval 0.841 to 0.874), which is comparable to the discrimination of the generalized estimating equation regression. Vitals sign data including SpO 2 /FiO 2 ratio (Z-score = 8.56), respiratory rate (5.97), and heart rate (5.87) had the highest predictive utility in our algorithm. In our highest risk cohort, the number of patients needed to identify (NNI) a single new case of mechanical ventilation was 3.2 and for our second risk quintile, NNI was 5.0. Interpretation: Machine learning techniques can be leveraged to improve the ability to predict which COVID-19 patients are likely to require mechanical ventilation, identifying unrecognized bellwethers and providing insight into the constellation of accompanying signs of respiratory failure in COVID-19.Funding : National Institutes of Health and the Foundation for Anesthesia Education and ResearchFunding: MRM reports grants from the National Institutes of Health (K01-HL141701). NJD reports a grant from the Foundation for Anesthesia Education and Research. All other author declare no funding. Declaration of Interest: CBD is paid consultant for Thrive Earlier Detection. He is also an inventor on various technologies unrelated to the work described in this manuscript. Some of the licenses are or will be associated with equity or royalty payments. The terms of all these arrangements are being managed by Johns Hopkins University in accordance with its conflict of interest policies. All other authors declare no competing interests.Ethical Approval Statement: For this retrospective observational study performed at our academic quaternary care center, we obtained Institutional Review Board approval (Ann Arbor, MI; HUM00052066). As no patient care interventions were made through conducting the study, patient consent was waived. This manuscript follows multidisciplinary guidelines for reporting machine learning predictive models in biomedical research.14 Study outcomes, data collection, and statistical analyses were established a priori and presented at a multidisciplinary peer-review forum on May 20, 2020 prior to data access.

Mental Health, Substance Use, and Suicidal Ideation Among Unpaid Caregivers in the United States During the COVID-19 Pandemic: Relationships to Age, Race/Ethnicity, Employment, and Caregiver Intensity

Background: Unpaid caregivers for adults play critical roles in health care systems by providing care to older adults and those with chronic conditions. The COVID-19 pandemic has heightened the need for care, forcing some into caregiving roles and disrupting others. Research is needed to estimate the prevalence of caregiving and identify factors associated with adverse mental health.Methods: In June 2020, Internet-based surveys with questions about demographics, caregiving responsibilities, and mental health were administered to US adults aged ≥18 years. Demographic quota sampling and survey weighting to improve cross-sectional sample representativeness of age, gender, and race/ethnicity. Prevalence ratios for adverse mental health symptoms were estimated using multivariable Poisson regressions.Findings: Of 9,896 eligible invited adults, 5,412 (54·7%) completed surveys; 5,011 (92·6%) respondents met screening criteria and were analysed, including 1,362 (27·2%) caregivers. Caregivers had higher prevalences of adverse mental health symptoms than non-caregivers, including anxiety or depressive disorder symptoms (57·6% vs 21·5%, respectively, pInterpretation: Caregivers, who accounted for one in four US adult respondents in this nationally representative sample, more commonly reported adverse mental health symptoms than non-caregivers. Increased visibility of and access to mental health care resources are urgently needed to address mental health challenges of caregiving.Funding Statement: Monash University; Austin Health; Phillips Respironics; Whoop Inc; Alexandra DraneDeclaration of Interests: All authors report grants from Whoop, Inc., which supported in part administration of the survey in June 2020, and other support from ARCHANGELS, which permitted the investigators to use the proprietary ARCHANGELS Caregiver Intensity Index for this study without cost. Mr Czeisler reports grants from Australian-American Fulbright Commission administered through a 2020 Fulbright Future Scholarship funded by The Kinghorn Foundation, and personal fees from Vanda Pharmaceuticals, outside the submitted work. Ms Drane is co-founder of and employed by ARCHANGELS and receives salary and has equity. Ms Drane reports grants from Ralph C Wilson Junior Foundation; personal fees from Prudential Financial Services and Walmart; and other from RAND Health, Rosalynn Carter Institute for Caregivers, United States of Care - Entrepreneurs Council, Open Notes, Executive Council for Division of Sleep Medicine – Harvard Medical School, Massachusetts Technology Collaborative, C-TAC, EndWell, Beth Israel Deaconess Medical Center, MassChallenge Health Tech, Boston Children's Hospital, Health Evolution, Edenbridge Health, WHOOP, and HPT Development/Drane Associates, outside the submitted work. Ms Stephens Winnay reports a grant from Ralph C Wilson Junior Foundation (RCWJF), outside the submitted work. In addition, Ms Drane and Ms Winnay have a patent ARCHANGELS - Planned pending on the ARCHANGELS Caregiver Intensity Index, and a patent ARCHANGELS CII - Trademark pending on the ARCHANGELS Caregiver Intensity Index. Ms Capodilupo is employed by WHOOP, Inc., from which she receives salary and is a company shareholder, and is on the board of advisors at ARCHANGELS, and is a company shareholder. Dr Czeisler reports institutional education and research support from Cephalon, Inc. and from Philips Respironics Inc.; institutional grants from National Institute of Occupational Safety and Health R01-OH-011773; personal fees from and equity interest in Vanda Pharmaceuticals Inc; personal fees from Teva Pharmaceuticals Industries Ltd, Teva Pharma Australia, outside the submitted work. In addition, Dr Czeisler has a patent for the Actiwatch-2 and Actiwatch-Spectrum devices, with royalties paid from Philips Respironics Inc. Dr Czeisler's interests were reviewed and managed by Brigham and Women's Hospital and Mass General Brigham in accordance with their conflict of interest policies. Dr Czeisler served as a voluntary board member for the Institute for Experimental Psychiatry Research Foundation, Inc. Dr Shantha Rajaratnam reports grants from Turner Institute for Brain and Mental Health, Monash University; grants and personal fees from Cooperative Research Centre for Alertness, Safety and Productivity; grants and institutional consulting fees from Vanda Pharmaceuticals, and Teva Pharmaceuticals; and institutional consulting fees from BHP Billiton, Circadian Therapeutics, and Herbert Smith Freehills, outside the submitted work. Dr Mark Howard reports a grant from the Institute for Breathing and Sleep, Austin Health. No other potential competing interests were declared.Ethics Approval Statement: The Monash University Human Research Ethics Committee reviewed and approved the study protocol on human subjects research (ID #24036). This activity was also reviewed by CDC and was conducted consistent with applicable federal law and CDC policy (45 CFR part 46, 21 CFR part 56; 42 USC Sect 241(d); 5 USC Sect 552a; 44 USC Sect 3501 et seq).

Conflict of interest in systematic reviews and its implications for public health policy.

This paper examines the issues related to conflict of interest (COI) in generation and dissemination of evidence from systematic reviews and its influence on evidence in developing public health policy. Several examples exist on COI in the health and nutrition field due to the influence of private corporations and funding institutions. COI is an important factor contributing to publication bias in primary studies because of dynamics such as delayed publication, suppression of negative findings, and falsifying of data, thus influencing systematic review findings. Systematic review findings have also been found to be biased because of financial and/or non-financial COI. A set of recommendations, such as increased government funding towards research, explicit COI policies in journals, clinical trial data transparency, and methodological guidelines, including COI compliance while conducting and reporting systematic reviews, is proposed. The government has a larger role in regulating COI in production and reporting of evidence and its use in public policy decision-making.

A Content Analysis of Patient Advocacy Organization Policies Addressing Institutional Conflicts of Interest

Introduction: Patient advocacy organizations (PAOs) provide patient education, raise public awareness, and influence health policy for a wide range of diseases. These organizations frequently receive financial support form from drug, device, and biotechnology companies. Though PAOs often develop policies to address institutional conflicts of interest arising from industry relations, little is known about the substance of these policies. Methods: We sampled all PAOs that are members of the National Health Council. Using a standardized search strategy, all policies were obtained from each organization if publicly available. We reviewed policies for content related to restrictions on corporate partnerships, disclosure of corporate funding, and governance and monitoring of corporate partnerships. Results: We found that 24 of 47 (51%) organizations had policies that addressed institutional conflict of interest. A total of 9 of those 24 (38%) policies placed any restriction on the types of corporations that the PAO would or would not partner with. While 16 of the 24 (67%) outlined some process for disclosure of the organization’s corporate donors, only 5 of 24 (21%) specified a manner for disclosing the financial value of those donations. Further, 15 of the 24 (63%) policies identified the person or persons responsible for approving corporate partnerships. However, 17 (71%) failed to address or specify the person(s) responsible for ongoing review of those partnerships. Conclusion: Nearly half of the organizations studied did not have publicly available conflict of interest policies. Among those that did, few policies had a substantial level of detail or limitations to guard against conflicts of interest.

How Single Institutional Review Boards Manage Their Own Conflicts of Interest: Findings From a National Interview Study.

Conflicts of interest (COIs) are important ethical concerns because they may affect scientific decision making, research integrity, and the safety and fairness of studies. No research to date has examined COIs of single institutional review boards (sIRBs), which are now mandated by the National Institutes of Health, and will be by the revised Common Rule in 2020, for all multisite research. This study investigated how different types of sIRBs manage their own COIs by documenting existing processes for and comparing commercial, government, and academic sIRBs. One hundred three personnel from 20 commercial, government, or academic sIRBs participated in semistructured interviews about their processes for and experiences with managing COIs when conducting multisite research review. Variability in COI management policies exist across types of sIRBs. Commercial sIRBs were aware of their own COIs given their for-profit model, and managed them by using firewalls, relying on external reviewers, and turning down potential clients. Government sIRBs described unique COIs stemming from the same agency funding the sIRB and the research being reviewed. They addressed these by discussing concerns about COIs, using firewalls, relying on nonaffiliated reviewers, and having broad COI policies. In contrast to commercial and government sIRBs, academic sIRBs did not report any specific policies to manage their COIs, which are similar to those of local IRBs. As sIRBs become increasingly common, researchers will need to weigh the different COIs inherent to each type of sIRB. Additionally, academic sIRBs may consider implementing specific policies for managing their COIs.

Disclosures and Conflicts of Interest: Solving the Riddle, Wrapped in a Mystery, Inside an Enigma

PurposeConfusion exists around the nature and best practices for authors in biomedical fields seeking to disclose conflicts of interest (COIs) and other information that can produce bias. Guidelines often provide principles for action and to avoid granularity that can limit their general usefulness. Journal editors must also interpret various guidelines to produce and enhance their own disclosure and COI policies. We discussion COIs and present heuristics that can enhance disclosure practices by individual authors and inform policy and practice among medical journal editors. MethodsThe authors reviewed the biomedical literature and drew on professional and academic experience to develop examples and a suggested matrix for decision making. FindingsMost COI commentary centers on financial relationships. Disagreement still exists about the nature and impact of various forms of COI, making critical reasoning essential when making and interpreting disclosures. Journal editors, authors, critics, and other experts express varying opinions about best practices regarding COIs. Policy decisions should be balanced and reasonable. Narrative context may help readers understand the meaning and relevance of disclosures and COIs. ImplicationsA balance of personal responsibility and critical thinking can enhance disclosure practices as well as confidence in the medical literature. Using a heuristic to think through possible areas of conflict can help authors provide more complete disclosure information. Providing narrative context can ease the burden of peer reviewers, editors, and readers trying to understand disclosures.

Pharmaceutical payments to certified oncology specialists in Japan in 2016: a retrospective observational cross-sectional analysis

ObjectiveThis study investigated payments made by pharmaceutical companies to oncology specialists in Japan, what the payments were for and whether the receipt of such payments contravened any conflict of interest...

Sponsorship of national and regional professional paediatrics associations by companies that make breast-milk substitutes: evidence from a review of official websites

ObjectivesProfessional paediatrics associations play an important role in promoting the highest standard of care for women and children. Education and guidelines must be made in the best interests of patients....