To send content items to your account,
please confirm that you agree to abide by our usage policies.
If this is the first time you use this feature, you will be asked to authorise Cambridge Core to connect with your account.
Find out more about sending content to .
To send content items to your Kindle, first ensure firstname.lastname@example.org
is added to your Approved Personal Document E-mail List under your Personal Document Settings
on the Manage Your Content and Devices page of your Amazon account. Then enter the ‘name’ part
of your Kindle email address below.
Find out more about sending to your Kindle.
Note you can select to send to either the @free.kindle.com or @kindle.com variations.
‘@free.kindle.com’ emails are free but can only be sent to your device when it is connected to wi-fi.
‘@kindle.com’ emails can be delivered even when you are not connected to wi-fi, but note that service fees apply.
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.
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).
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.
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.
Surgical innovation is a major driver of progress in neurosurgery. While clinical ethics and research ethics are well-defined, there is limited knowledge about sound ethics of surgical innovation. Here, we discuss different ethical aspects of innovation, including oversight, conflicts of interest, the surgical learning curve, introducing surgical devices, informed consent, and vulnerable patient populations. A robust ethical framework can empower surgeons to innovate in a way that both protects patients and advances the neurosurgical discipline.
This is the first book to provide a comparative and critical analysis of why and how corporate governance and corporate law have been or can be used to promote and protect sustainability in the four common law jurisdictions in Asia, ie Singapore, Hong Kong, India and Malaysia. Based on theoretical, doctrinal and empirical research, I critically evaluate the rationales for, and effectiveness of, six corporate mechanisms, namely (1) sustainability reporting; (2) gender diversity on the board of directors; (3) constituency directors; (4) stewardship codes; (5) directors’ duty to act in the best interests of the company; and (6) liability on companies, shareholders and directors.
There has been a proliferation of stewardship codes around the world. There are eighteen jurisdictions in different parts of the world that have adopted stewardship codes in one form or another.1 The four common law jurisdictions in Asia are no exceptions. The Malaysian Code for Institutional Investors (MCII) was issued in 2014, the Hong Kong Principles of Responsible Ownership (HKPRO) in 2016 and the Singapore Stewardship Principles for Responsible Investors (SSP) in 2016.
Norms prohibiting conflicts of interest apply in private fiduciary relationships and also to many public office holders. Whether or not such relationships are founded on trust, such norms can cultivate trust towards those holding governance authority, whether in interpersonal, civic or political relationships. In legal and philosophical discourse, however, conflicts of interest are rarely carefully defined. It has become a commonplace that ‘not every breach of duty by a fiduciary is a breach of fiduciary duty’. We must now go on to realize that ‘not every improper action by one who must avoid conflicts of interest is a conflict of interest’. A conflict of interest arises when duty-bound judgment is exercised in the presence of a conflicting interest. There can be conflicts that are not conflicts of interest; and there can be potential conflicts as well as actual ones. The simple misuse of power is not itself conflict of interest; on the contrary, it is the problem that the rules that forbid acting in a conflict situation aim to avoid. Bias is not identical with conflict of interest, although some kinds of bias arise from conflicts. Unauthorized profits are none of the above. They represent a different dimension of the relationship: not the supervision of powers, but the simple fact that when acting for another, one may not extract benefits for oneself. The rules about conflicts can foster trust in proper decision-making, while the rule against unauthorized profits can foster trust in the proper separation between a person’s private and official actions.
Chapter 2 poses three provocative questions: Do plaintiffs’ lawyers in leadership profit from quid pro quo arrangements with one another and with repeat defense attorneys? Even if one can fairly characterize features of their deals as self-serving, what harm is there? And if the deals do harm plaintiffs in some way, what leverage do plaintiffs have? In many respects, outsiders can only guess at the answers to the first two questions because they are privy neither to the negotiations nor to the private settlement’s payouts. But there is not a complete void; this chapter grounds its suppositions in the available data on the common-benefit fees that lead plaintiffs’ attorneys receive, and the private settlements they negotiate. Examining settlements that occurred over a 12-year span, every deal featured at least one “closure” provision for defendants (that helped end the lawsuits by goading plaintiffs to take the deal), and likewise contained some provision that increased lead plaintiffs’ lawyers’ common-benefit fees. Based on that evidence (along with the scant evidence on payouts to plaintiffs), there is reason to worry that when insiders play for rules, the rules they develop may principally benefit them at the plaintiffs’ expense.
Financial conflicts of interest involving the food industry have been reported to bias nutrition studies. However, some have hypothesized that independently funded studies may be biased if the authors have strong a priori beliefs about the healthfulness of a food product (‘white hat bias’). The extent to which each source of bias may affect the scientific literature has not been examined. We aimed to explore this question with research involving sugar-sweetened beverages (SSB) as a test case, focusing on a period during which scientific consensus about the adverse health effects of SSB emerged from uncertainty.
PubMed search of worldwide literature was used to identify articles related to SSB and health risks published between 2001 and 2013. Financial relationships and article conclusions were classified by independent groups of co-investigators. Associations were explored by Fischer’s exact tests and regression analyses, controlling for covariates.
A total of 133 articles published in English met inclusion criteria. The proportion of industry-related scientific studies decreased significantly with time, from approximately 30 % at the beginning of the study period to <5 % towards the end (P=0·003). A ‘strong’ or ‘qualified’ scientific conclusion was reached in 82 % of independent v. 7 % of industry-related SSB studies (P<0·001). Industry-related studies were overwhelmingly more likely to reach ‘weak/null’ conclusions compared with independent studies regarding the adverse effects of SSB consumption on health (OR=57·30, 95 % CI 7·12, 461·56).
Industry-related research during a critical period appears biased to underestimate the adverse health effects of SSB, potentially delaying corrective public health action.
This article discusses the establishment of a governance framework for biomedical research in Singapore. It focuses on the work of the Bioethics Advisory Committee (BAC), which has been instrumental in institutionalizing a governance framework, through the provision of recommendations to the government, and through the coordination of efforts among government agencies. However, developing capabilities in biomedical sciences presents challenges that are qualitatively different from those of past technologies. The state has a greater role to play in balancing conflicting and potentially irreconcilable economic, social, and political goals. This article analyzes the various ways by which the BAC has facilitated this.
This opinion note explores some aspects of the relationship between humanitarian non-governmental organisations (NGOs) and extractive industries. Médecins sans Frontières (Doctors without Borders, MSF) has endorsed a policy of non-engagement with the corporate sector of the extractive industries, particularly when it comes to financial donations. This is coherent with MSF being first and foremost a medical organisation, and one that adheres to the humanitarian principles of independence and neutrality. For humanitarian actors, the prospect of future environmental disasters and environmental conflicts calls for the anticipation of novel encounters, not only with environmental organisations but also with the extractive sector. Unlike environmental organisations, extractive industries are prone to generating or perpetuating different forms of violence, often putting extractive companies on a par with the parties to armed conflicts. In situations where a dialogue with extractive companies would be needed to optimise care and access to victims, humanitarian organisations should carefully weigh pragmatic considerations against the risk of being co-opted as medical providers of mitigation measures.
One of the most harmful adverse consequences of conflicts of interest in research is the potential introduction of bias into the science of medicine and the denigration of the integrity of scientific research. A number of facts support the concerns that financial conflicts influence the integrity of medical research. The potential for conflicts of interest can never be eliminated, but conflicts of interest can be managed and, in some cases, reduced. Strategies for doing so are most useful when they are matters of institutional and editorial policies that are focused on preventing the adverse effects of conflict of interest and are not unduly burdensome. Disclosure is the most common first step in managing conflicts of interest. Public disclosure of raw scientific data and independent monitoring of research are additional mechanisms for managing conflicts of interest. Policies and guidance on conflicts of interest are changing rapidly.
This chapter presents a case study which contains a number of ethical issues of concern that could arise in other clinical anesthesiology research. A group of anesthesia researchers undertook a research project to determine if injection of a sedative drug into the subarachnoid space would improve effectiveness of pain control post-operatively for labor and delivery. The chapter focuses on the ethics of conducting research involving human subjects, in particular, some of the main ethical issues that arise with the kind of research conducted by anesthesiologists in clinical settings. It discusses the three areas where these issues are especially important for the ethical conduct of clinical anesthesiology research: enrollment and consent, potential conflicts of interest, and the balance of risk and benefit. Subjects should be given sufficient time to reflect on the information they are given about the research study.