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The Cleveland Clinic Innovation Management and Conflict of Interest (“IM&COI”) Program implemented a policy on Conflicts of Interest in Clinical Practice in 2013. The policy requires review of financial interests greater than $20,000 in a year, or more than 5% equity in a company, when the clinician is prescribing or using products of the company with which they have a relationship. The IM&COI Committee developed definitions for low, medium and high levels of annual compensation and risk and uses a “Matrix” to guide disclosure based on these factors.
Due to their financial incentive, clinicians who earn income from a firm that markets medical devices, pharmaceuticals, tests, etc. might inappropriately prescribe their products or services. The Cleveland Clinic’s conflict of interest (CI) policy creates rules governing clinicians who accept compensation from outside firms that market products they prescribe or use in their practice (hereafter, covered financial relationships). The CI policy is implemented by the Innovation Management and Conflict of Interest Program (IM&COI) (hereafter the Committee).
We have previously described the European Medicines Agency’s (EMA) and the US Food and Drug Administration’s guidelines, each for a specific psychiatric indication, on how to design pivotal drug trials used in new drug applications. Here, we report on our efforts over 3 years to retrieve conflicts of interest declarations from EMA. We wanted to assess potential internal industry influence judged as the proportion of guideline committee members with industry conflicts of interest.
Methods
We submitted Freedom of Information requests in February 2020 to access EMA’s lists of committee members (and their declared conflicts of interest) involved in drafting the 13 ‘Clinical efficacy and safety’ guidelines available on EMA’s website pertaining to psychiatric indications. In our request, we did not specify the exact EMA committees. Here, we describe the received documents and report the proportion of members with industry interests (i.e. defined as any financial industry relationship). It is a follow-up paper to our first report (http://doi.org/10.1017/S2045796021000147).
Results
After 2 years and 9 months (November 2022), the EMA sent us member lists and corresponding conflicts of interest declarations from the Committee for Medicinal Products for Human use (CHMP) from 2012, 2013 and 2017. These member lists pertained to 3 of the 13 requested guidelines (schizophrenia, depression and autism spectrum disorder). The 10 remaining guidelines were published before 2011 and EMA stated that they needed to require permission from their expert members (with unknown retrieval rate) and foresaw excessive workload and long wait. Therefore, we withdrew our request. The CHMPs from 2012, 2013 and 2017 had from 34 to 36 members; 39%–44% declared any interests and we judged 14%–18% as having industry interests. For the schizophrenia guideline, we identified two members with industry interests to companies who submitted feedback on the guideline. We did not receive declarations from the Central Nervous System (CNS) Working Party, the CHMP appointed expert group responsible for drafting and incorporating feedback into the guidelines.
Conclusions
After almost 3 years, we received information, which only partly addressed our request. We recommend EMA to improve transparency by publishing the author names and their corresponding conflicts of interest declarations directly in the ‘Clinical efficacy and safety’ guidelines and to not remove conflicts of interest declarations after 1 year from their website to reduce the risk of stealth corporate influence during the development of these influential guidelines.
This paper explores the complexities and unintended consequences of conflict of interest (COI) disclosures in various professional settings. It highlights key psychological processes encountered by recipients of such disclosures. Notably, it describes the burden of disclosure effect, which paradoxically reduces trust while increasing compliance due to social pressures, and disclosure's expertise cue, where disclosures inadvertently increase trust and persuasiveness by signalling expertise. The paper also outlines best practices for improving COI disclosures, emphasising the need for external third-party involvement and encouraging deliberation. It concludes that effective disclosure depends not only on how recipients process information but also critically on how the disclosure influences the behaviour of advisors, underscoring the need for a holistic approach to managing COIs that goes beyond mere transparency. A version of this paper was presented as a keynote at the Second Annual International Behavioural Public Policy Conference at the University of North Carolina in September 2023.
The proclaimed duty of the state to safeguard the public interest provided a space for subordinates to engage with ruling authorities. It entailed the right of the ruled to remind the state to fulfill its obligation in the case of specific welfare grievances of its subjects. Such a right was passive, as it was derived from the state's duty to protect the public interest. The patterns of state response to popular claim-making were similar across Tudor and early Stuart England, Tokugawa Japan, and Qing China. The right to petition authorities was granted to individuals; yet the state did not allow crowd petitions, which were universally treated as disrespectful to authority and as a threat to social order. However, the state across these three cases was tolerant of collective petitions caused by cross-regional or cross-sectoral conflicts of interest, and it tried to arbitrate disputes as an impartial guardian of the public interest. The increasing scale of conflicts of interest that arose with population growth and commercialization led to larger-scale and well-organized popular petitions that were still accepted by the state. Such petitioning represented a political space that had great potential to expand with socioeconomic development.
This chapter examines the ethical regulation of participants in the arbitral process. The starting point is what is provided for and omitted by arbitration’s coordinating instruments, the New York and ICSID Conventions. While these conventions only expressly set out a few ethical rules, they determine the sources, obligations, forums, and alternatives related to ethics. Along with national arbitration laws, the conventions set limits on the content of the obligations that the parties can introduce into arbitral proceedings, such as institutional arbitration rules and soft law instruments. In terms of substantive obligations, they require that all participants uphold the fairness and integrity of arbitral proceedings while fulfilling their respective duties. The New York and ICSID Conventions also coordinate a multi-level network of forums to enforce these ethical obligations, the most prominent of which being arbitral tribunals. Yet, the imprecise delimitation of powers between national and international authorities on ethical issues is problematic today. The key to resolving this problem is not developing further substantive obligations, but rather better addressing the interplay between national and international frameworks regulating participants in the arbitral process.
As described in previous chapters, the touchstone of lawyers’ professional obligations to their clients are confidentiality and care. These duties can be understood as key elements in a relationship of trust and loyalty between client and lawyer. This chapter is chiefly concerned with this relationship of loyalty, and how it can be strained by, or overlooked because of, conflicting or competing interests and duties. The final part of this chapter traces how the different conceptions of the lawyer’s role might produce diverse legal principles, such as whether loyalty is or is not imposed beyond the end of legal relationship. As a matter of professional ethics, there are differing views about whether to allow certain conflicts to arise and be managed by the lawyer or law firm, and whether such management of conflicts should be done with or without client consent.
This study used publicly available Form 990 tax documents to quantify food industry donations to patient advocacy organisations (PAO) dedicated to supporting patients with non-communicable diseases.
Design:
Observational, cross-sectional assessment of significant national and international food industry donations to US-based non-communicable disease-focussed PAO between 2000 and 2018. Researchers recorded and categorised the: (1) frequency and value of donations; (2) reason for donation; (3) name and type of PAO recipient and (4) non-communicable disease focus of the PAO.
Setting:
Form 990 tax documents.
Participants:
Nine food and beverage companies that donated to non-communicable disease-focussed PAO.
Results:
Adjusting for inflation, nine food and beverage companies collectively donated $10 672 093 (n 2709) to the PAO between 2001 and 2018. The largest category of donations was ‘matching gifts’ (67·9 %, median amount = $115·16), followed by ‘general operations support’ (25·8 %, median amount = $107·79). Organisations focussing on cancer received the largest number and amount of donations ($6 265 861, n 1968). Eight of the nine companies made their largest monetary value of donation to PAO focussed on cancer.
Conclusions:
Publicly available tax data provide robust information on food industry donation practices. Our findings document the food industry’s role in supporting patient advocacy organisations and raise questions regarding conflicts of interest. Increased awareness of food industry donation practices involving PAO may generate pressure for policies mandating transparency or encourage donors and recipients to voluntarily disclose donations. If public disclosure becomes widespread, constituents, advocates, researchers and policymakers can better supervise and address potential conflicts of interest.
To measure incidence of conflicts of interest (COI) with food and pharmaceutical industry actors on the advisory committee for the 2020–2025 US Dietary Guidelines for Americans (DGA) and assess the adequacy of current mechanisms to disclose and manage COI among the committee’s members.
Design:
We compiled longitudinal data from archival sources on connections between members of the DGA’s advisory committee and actors. We hypothesised that these committee members, who oversee the science for the most influential dietary policy in the USA, might have significant COI that would be relevant to their decision making. Disclosure of COI on this committee was recommended in 2017 by the National Academies of Sciences in order to increase transparency and manage bias, but public disclosure of the committee’s COI does not appear to have taken place.
Setting:
The committee was composed of twenty experts.
Participants:
None.
Results:
Our analysis found that 95 % of the committee members had COI with the food and/or pharmaceutical industries and that particular actors, including Kellogg, Abbott, Kraft, Mead Johnson, General Mills, Dannon and the International Life Sciences, had connections with multiple members. Research funding and membership of an advisory/executive board jointly accounted for more than 60 % of the total number of COI documented.
Conclusions:
Trustworthy dietary guidelines result from a transparent, objective and science-based, process. Our analysis has shown that the significant and widespread COI on the committee prevent the DGA from achieving the recommended standard for transparency without mechanisms in place to make this information publicly available.
The one feature of a paper that needs to draw attention of potential readers is its Title. The importance of this being very carefully worded is stressed. The chapter also covers the small sections of a paper that give information about the authors, their affiliations, which author is dealing with correspondence, the contributions of co-authors, any conflicts of interest, who to acknowledge and how to prepare reference lists. It mentions how in this electronic age papers can be tagged using a 'DOI'.
Financial firms that offer investment advice to retail clients are beset by conflicts of interest: they may receive compensation tied to particular products, operate the financial products themselves, or be subject to other distortions. Regulators and lawmakers have looked to fiduciary and quasi-fiduciary duties to mitigate these conflicts. The paradigmatic example is the rigorous fiduciary standard imposed on registered investment advisers, but the Department of Labor’s now-defunct fiduciary rule, and the Securities and Exchange Commission’s recently adopted Regulation Best Interest similarly aim to mitigate problematic conflicts by imposing duties on those giving investment advice. These interventions largely focus on conflicts affecting which investment products investors are advised to hold, but other types of distortions, less discussed, may be just as important. This chapter offers an expanded account of conflicts of interest, how conflicts might interact, and how the fiduciary rule and Regulation Best Interest should be evaluated in light of this expanded menu of problematic incentives.
This chapter introduces normative recommendations for developing legal and science-based policy frameworks to address some of the genome-editing issues discussed throughout the book. The chapter, for instance, builds upon discussions in chapters 8–10 to propose a system to demarcate foundational rights and uses of germline genome editing (GGE) on the basis of four categories: (1) therapeutic uses to remedy disease; (2) prophylactic purposes, which may or may not be therapeutic; (3) cosmetic or enhancement purposes; and (4) uses involving modification of traits that raise concerns of unlawful discrimination. In so doing, the chapter explores conceptual and structural approaches to GGE clinical interventions and promotes dialogues about the extent to which editing the genetic composition of the human germline should be permitted and, in some instances, protected. Furthermore, to expand on concepts introduced in chapters 6–7, this chapter focuses on strategies to promote research- and science-based policy development related to GMOs and genetically modified crops. Within that backdrop, the chapter elucidates policy development as an inherently complex process that depends not only on strict science-based evidence, but on a multitude of legal, economic, social, political, and other factors that ultimately shape law and policy.
The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) produce guidelines for the design of pivotal psychiatric drug trials used in new drug applications. It is unknown who are involved in the guideline development and what specific trial design recommendations they give.
Methods
Cross-sectional study of EMA Clinical Efficacy and Safety Guidelines and FDA Guidance Documents. Study outcomes: (1) guideline committee members and declared conflicts of interest; (2) guideline development and organisation of commenting phases; (3) categorisation of stakeholders who comment on draft and final guidelines according to conflicts of interest (‘industry’, ‘not-industry but with industry-related conflicts’, ‘independent’, ‘unclear’); and (4) trial design recommendations (trial duration, psychiatric comorbidity, ‘enriched design’, efficacy outcomes, comparator choice). Protocol registration https://doi.org/10.1101/2020.01.22.20018499 (27 January 2020).
Results
We included 13 EMA and five FDA guidelines covering 15 psychiatric indications. Eleven months after submission, the EMA had not processed our request regarding committee member disclosures. FDA offices draft the Guidance Documents, but the Agency is not in possession of employee conflicts of interest declarations because FDA employees generally may not hold financial interests (although some employees may hold interests up to $15,000). The EMA and FDA guideline development phases are similar; drafts and final versions are publicly announced and everybody can submit comments. Seventy stakeholders commented on ten guidelines: 38 (54%) ‘industry’, 18 (26%) ‘not-industry but with industry-related conflicts’, six (9%) ‘independent’ and eight (11%) ‘unclear’. They submitted 1014 comments: 640 (68%) ‘industry’, 243 (26%) ‘not-industry but with industry-related conflicts’, 44 (5%) ‘independent’ and 20 (2%) ‘unclear’ (67 could not be assigned to a specific stakeholder). The recommended designs were generally for trials of short duration; with restricted trial populations; allowing previous exposure to the drug; and often recommending rating scale efficacy outcomes. EMA mainly recommended three arm designs (both placebo and active comparators), whereas FDA mainly recommended placebo-controlled designs. There were also other important differences and FDA's recommendations regarding the exclusion of psychiatric comorbidity seemed less restrictive.
Conclusions
The EMA and FDA clinical research guidelines for psychiatric pivotal trials recommend designs that tend to have limited generalisability. Independent and non-conflicted stakeholders are underrepresented in the guideline development. It seems warranted with more active involvement of scientists and independent organisations without conflicts of interest in the guideline development process.
As arbitration specialists (arbitrators and practicing lawyers) build their credentials, their paths often cross in scholarship, conferences, and arbitral proceedings. Depending on their relationships with one another, both professional and personal, an appearance of impropriety (conflict of interest) may appear. This appearance is often more an illusion than reality because to the uninitiated the arbitral process seems to be the domain of a secretive group of insiders. In fact, there is a high level of transparency in the selection of arbitrators. Required disclosures flesh out any potential conflict of interest between the arbitrators and the parties. Most arbitrators will voluntarily remove themselves from consideration in order to ensure their professional integrity in the arbitration community. This is especially the case when there are justifiable doubts as to their independence and impartiality. Also, parties may challenge the appointment or retention of an arbitrator in cases of apparent bias.
Geographical remoteness has not prevented Australia from pursuing a persistent ambition to become a major hub for international commercial arbitration (ICA). While regional competitors in the Asia-Pacific region such as Singapore and Hong Kong have already achieved great success in the arbitration world, Australia’s ‘Tyranny of Distance’1 requires that extra efforts be made to attract ICA cases. Recent marketing from Austrade within the Australian government2 emphasises the relative strengths of ICA in Australia: (1) a harmonised legal framework for ICA in line with international standards, (2) sophisticated arbitration institutions and (3) some of the world’s leading arbitration practitioners.
This chapter acts as a capstone to Part IV’s presentation of country reports. It presents the findings of a comparative analysis of arbitration laws in the different countries reported. This analysis focuses on the different issues presented in Parts I–III, including scope and interpretation of arbitration clauses, anti-arbitration laws and policies, arbitrator bias and misconduct, the public policy exception, and other limits on arbitrability. Thus, the country reports are reviewed here to determine areas of commonality and divergences across national laws relating to judicial intervention into the arbitration process. It will also assess possible trends in international commercial arbitration.
This book provides a forum for discussion of current issues and debates in international arbitration, covering the independence and impartiality of arbitrators; how conflicting interests may affect the conduct of arbitrators; the enforcement of arbitral awards, principally under grounds of procedural irregularity; how to resolve issues of misconduct by arbitrators during proceedings; and the current judicial interpretation of arbitration clauses. In England, the key legislation which governs these issues is contained in the Arbitration Act 1996 (the Arbitration Act). Also influential in shaping these issues are the procedural rules of specific arbitral institutions, and the guidance published by organisations such as the International Bar Association (the IBA).
In 1884, Edwin Abbott published his novel Flatland, in which he described a two-dimensional word with two-dimensional people.1 The story is told from the perspective of the novel’s main character, a square. One day, he is visited by a being from a three-dimensional world, a ball. Being unable to understand and believe the existence of a third dimension, the ball tears the square out of its two-dimensional life and shows it Flatland from above. Upon returning from the third dimension, and wanting to tell his fellow flatlanders about it, the square is frowned upon and not believed.
The final chapter first summarizes the main arguments made in the book, overviewing the hypotheses developed and evidence used to test them in the empirical chapters. The conclusion also addresses the question of external validity by drawing in examples of similar phenomena from other countries around the world, both developing and developed, that are experiencing significant interest in political office from businesspeople. The book paints a somewhat grim picture of the effects of businesspeople winning elected office. In this chapter, I lastly examine whether there are policy solutions that might deter those businesspeople looking to abuse their positions in their private interests from running. I close by offering a number of recommendations that emerge from the analysis, both including and going beyond ethics laws, that could be of use in containing rent-seeking by these individuals in power.
There has been a resurgence in the practice of psychosurgery in the last decade primarily for depression and obsessive compulsive disorder. This is due to the application of deep brain stimulation (which has largely replaced lesioning) and to a greater understanding of the imaging correlates of mental illness. Psychosurgery is expanding well beyond these indications. Many ethical challenges arise, including informed consent, establishing the efficacy of these procedures from the literature and in the design of new studies, the harm versus benefit ratio, and the role of institutional and governmental regulatory control over psychosurgery. Psychosurgery remains experimental or at least investigational and the ethical considerations should be of prime importance for any practitioner undertaking this surgery. We propose eighteen principles as a basis for a regulatory framework of psychosurgery. Neurosurgeons who perform psychosurgery have an immense responsibility to guard against a repeat of the failures of the past.