We discuss the role of prior authorization (PA) in supporting patient-centered care (PCC) by directing health system resources and thus the ability to better meet the needs of individual patients. We begin with an account of PCC as a standard that should be aimed for in patient care. In order to achieve widespread PCC, appropriate resource management is essential in a healthcare system. This brings us to PA, and we present an idealized view of PA in order to argue how (...) at its best, it can contribute to the provision of PCC. PA is a means of cost saving and as such it has mixed success. The example of the US demonstrates how implementation of PA has increased health inequalities whereas best practice has the potential to reduce them. In contrast, systems of universal coverage, like those in Europe, may use the cost savings of PA to better address individuals' care and PCC. The conclusion we offer therefore is an optimistic one, pointing towards areas of supportive overlap between PCC and PA where usually the incongruities are most evident. (shrink)

Why does it matter that those who fight wars be authorized by the communities on whose behalf they claim to fight? I argue that lacking authorization generates a moral cost, which counts against a war's proportionality, and that having authorization allows the transfer of reasons from the members of the community to those who fight, which makes the war more likely to be proportionate. If democratic states are better able than non-democratic states and sub-state groups to gain their community's authorization, (...) this means that some wars will be proportionate if fought by democracies, disproportionate if not. (shrink)

This article answers questions about the consistency, coherence, and motivation of Hobbes's account of the right to punish. First, it develops a novel account of authorization that explains how Hobbes could have consistently held both that the subjects do not give the sovereign the right to punish and also that they authorize the sovereign to punish. Second, it shows that, despite appearances, the natural and artificial elements of Hobbes's account form a coherent whole. Finally, it explains why Hobbes thought it (...) was important to establish the sovereign's right to punish apart from the sovereign's power to punish. (shrink)

In this commentary on an article by Jennifer Blumenthal-Barby (AJOB 16:5-15, 2016), we discuss how external influences on decisions affect personal autonomy. Specifically, we introduce the idea of “pre-authorization” as an evaluative stance by which an individual gives a certain agent preferential access to influencing her decision-making processes. Influences arising from pre-authorized agents may then be seen as promoting, rather than infringing upon, autonomy. While the idea that an external influence can be autonomy-promoting may be inconsistent with individualistic conceptions of (...) autonomy, it aligns well with more relational conceptions that recognize the social milieu in which decisions are made. We suggest that pre-authorization provides a framework for thinking about how relational accounts of autonomy might work mechanistically. (shrink)

Two recent articles in this journal – one by Morris, the other by Pfleegor & Rosenberg – have revived the philosophical discussion of the ethics of deception in sport which had largely laid dormant since the 1973 publication of Pearson’s ‘Deception, Sportsmanship, and Ethics’. Morris and Pfleegor & Rosenberg both share with Pearson the view that ethical deceptive sport acts are those that relate to sport-specific skills. However, whereas Pearson ultimately grounds this view in the agreement she takes to obtain (...) amongst sport participants, both recent treatments overlook this fundamental aspect of her account and offer alternative justifications for that view. I argue, though, that in both cases the arguments offered are incomplete precisely because they require an appeal to the agreement amongst participants that lies at the foundation of Pearson’s account. On all three treatments, I argue, what ultimately determines an action’s ethical status is not its relation to sport-specific skills, but its conformit... (shrink)

In a recent analysis of the principle of civilian immunity, Igor Primoratz asks whether the circle of legitimate targets in war might be expanded so as to include at least some civilian bystanders. However Primoratz’ formulation of the ‘responsible bystander’ argument depends for its cogency on there being natural or non-acquired positive duties, and this is controversial. Furthermore, we feel that the citizens of a government unjustly at war are primarily and specially obliged to undermine that war, and that this (...) is not simply a function of their being in the best position to do so, (which may not always be the case). Primoratz’ version of ‘responsible bystander’ cannot account for this. Here I develop an alternative formulation that does, and which is not reliant on controversial premises. I argue that to empower a government democratically is to assume a positive obligation to prevent that government from using its power to prosecute an unjust war, and that the neglect of this duty may render a significant portion of the duty-bound collective legitimate targets of necessary and proportionate violence. In closing I dispute Primoratz’ claim that this conclusion has “very little purchase on reality” or is irrelevant for practical purposes. (shrink)

On 9 August 1994 the German legislature revised the German Drug Law (AMG). Included in the revision is a passage requiring, for the first time, that the sponsors and investigators of clinical studies involving human subjects first obtain the approval of an ethics committee before carrying out such studies. According to the legislation, which takes effect on 17 August 1995, approval is to come from 'an independent ethics committee, set up and administered according to state law [emphasis added]' (1). Although (...) it is clear according to the text that the 16 federal states have been empowered to establish ethics committees within their jurisdictions, this does not mean that the state governments are free to transfer exclusive authority in the matter to their respective medical associations, a step that would effectively abolish Germany's private ethics committees. First, the legislation does not rule out the authorization of private ethics committees. Second, as legal scholars attest, the exclusive control of ethics committees by the medical associations would constitute an illegal monopoly. Third, it is arguable that medical-association ethics committees fail to meet the one prior federal requirement, that of independence. There is a great deal of confusion in Germany today about which kinds of ethics committees (public and/or private) the states will sanction before 17 August 1995. In an attempt to sort things out we present a brief explanation of how ther came to be two kinds of ethics committees in Germany, review the legal battle between the two over the issue of authorization, point out how the German legislature, in passing the recent bill, has missed an opportunity to clarify the issue and, finally suggest why the administration of ethics committees by the medical associations may be incompatible with the requirement that ethics committees be independent. (shrink)

Compared with data that is initially collected for research purposes, the mandatory authorization of a government database for secondary use deserves greater scrutiny because it consists of information that is collected initially for administrative purposes. Using the case of Taiwan’s National Health Insurance (NHI) Database as an example, this paper analyzes the ethical issues that emerge when the research participants are “participated” in studies without their consent, according to the current policy. The proponents of secondary use for research purposes maintain (...) that the authorized use of the NHI Database is necessary for public interests, while the opponents argue that the potential lack of democratic accountability and the infringement on people’s rights to privacy and information autonomy is unwarranted. Drawing on the solidarity‐based approach, this paper proposes a temporal solution as a possible reform direction for better ethical justification of the secondary use of the NHI Database. (shrink)

Background In the EU, clinical assessors, rapporteurs and the Committee for Medicinal Products for Human Use are obliged to assess the ethical aspects of a clinical development program and include major ethical flaws in the marketing authorization deliberation processes. To this date, we know very little about the manner that these regulators put this obligation into action. In this paper, we intend to look into the manner and the extent that ethical issues discovered during inspection have reached the deliberation processes. (...) Methods To gather data, we used the Dutch Medicines Evaluation Board database and first searched for the inspections, and their accompanying site inspection reports and integrated inspection reports, related to central marketing authorization applications of drugs submitted to the European Medicines Agency from 2011 to 2015. We then extracted inspection findings that were purely of ethical nature, i.e., those that did not affect the benefit/risk balance of the study. Only findings graded at least major by the inspectorate were included. Lastly, to identify how many of the ethically relevant findings reach the application deliberation processes, we extracted the relevant joint response assessment reports and reviewed the sections that discussed inspection findings. Results From 2011 to 2015, there were 390 processed applications, of which 65 had inspection reports and integrated inspection reports accessible via the database of the Dutch Medicines Evaluation Board. Of the 65, we found ERFs in 37. The majority of the ERFs were graded as major and half of the time it was informed-consent related. A third of these findings were related to research ethics committee processes and requirements. Of the 37 inspections with ERFs, 30 were endorsed in the integrated inspection reports as generally GCP compliant. Day 150 joint response assessment reports and Day 180 list of outstanding issues were reviewed for all 37 inspections, and none of the ERFs were carried over in any of the assessment reports or list of outstanding issues. Conclusion None of the ethically relevant findings, all of which were graded as major or critical in integrated inspection reports, were explicitly carried over to the joint assessment reports. This calls for more transparency in EMA application deliberations on how ERFs are considered, if at all, in the decision-making processes. (shrink)

Allocating access to unapproved COVID-19 drugs available via Pre-Approval Access pathways or Emergency Use Authorization raises unique challenges at the intersection of clinical care and research....

The Authority and Authorization of the Torah in the Persian Period. By Kyong-Jin Lee. Contributions to Biblical Exegesis and Theology, vol. 64. Leuven: Peeters, 2011. Pp. x + 296. €46.

In her interesting paper on cross-jurisdictional legal approaches to brain death, Ariane Lewis considers whether informed consent is required for DNC testing in the UK, and proposes that it is not...

Prevailing ethical thinking about informed consent to clinical research is characterized by theoretical confidence and practical disquiet. On the one hand, bioethicists are confident that informed consent is a fundamental norm. And, for the most part, they are confident that what makes consent to research valid is that it constitutes an autonomous authorization by the research participant. On the other hand, bioethicists are uneasy about the quality of consent in practice. One major source of this disquiet is substantial evidence of (...) the “therapeutic misconception”—the tendency of patient-subjects in clinical trials to confuse participating in research with receiving personalized medical care. This .. (shrink)

It is generally thought that the reclamation of slurs is restricted to the in-group. Bianca Cepollaro and Dan Lopez de Sa challenge this assumption by presenting cases in which slurs are successfully reclaimed by members of out-groups. I agree with the idea that the out-groups often participate in reclamation. In this paper, I present a view which accommodates the fact that sometimes out-groups successfully reclaim slurs. At the same time, the view preserves the central role of the in-group in reclamation.

The article explores the Israeli Supreme Court main judgment regarding the legality of the use of special interrogation methods in order extract information concerning future acts of terror. The Judgment's main conclusion was that while there might be a justification for using exceptional interrogation measures in order to save lives, based on the concept of lesser evil as embedded in the criminal defense of necessity, the government is nevertheless not authorized to use such means in the absence of explicit legislation (...) to that effect. The article presents and evaluates the Judgment, particularly the relation between the substantive moral questions involved and the aspect of authorization. (shrink)

This article offers a legal-ethical analysis of recent UK and Dutch proposals to regulate surrogacy proactively through a national system of pre-conception authorization of surrogacy agreements. Wi...

Background Genetic databases are becoming increasingly common as a means of determining the relationship between lifestyle, environmental exposures and genetic diseases. These databases rely on large numbers of research subjects contributing their genetic material to successfully explore the genetic basis of disease. However, as all possible research questions that can be posed of the data are unknown, an unresolved ethical issue is the status of informed consent for future research uses of genetic material. Discussion In this paper, we discuss the (...) difficulties of an informed consent model for future ineffable uses of genetic data. We argue that variations on consent, such as presumed consent, blanket consent or constructed consent fail to meet the standards required by current informed consent doctrine and are distortions of the original concept. In this paper, we propose the concept of an authorization model whereby participants in genetic data banks are able to exercise a certain amount of control over future uses of genetic data. We argue this preserves the autonomy of individuals at the same time as allowing them to give permission and discretion to researchers for certain types of research. Summary The authorization model represents a step forward in the debate about informed consent in genetic databases. The move towards an authorization model would require changes in the regulatory and legislative environments. Additionally, empirical support of the utility and acceptability of authorization is required. (shrink)

Images of brains circulate today as rationales for decision-making and selectivity in policies, curriculum, preservice teacher education and inservice professional development. The excitement over brain-based research, its visual reach and authorizing role accompanies longstanding debates in which the status attributed to biology, physiology and allied psychological approaches has been considered prejudicial. This article traces a series of dislocations in the linkages forged between discourses of vision and epistemic authorization, and how they still inhere in contemporary debates over brain imaging. The (...) critical history that the article offers within the general framework of Visual science and technology studies requires questioning some of the core tenets of visual culture, including what gets to count as the visual, ‘its’ role in legitimation, and the primacy assigned to looking and observation as strategies of truth-production. (shrink)

One response to the chronic shortage of organs for transplant in the United States has been the passage of laws establishing first-person authorization for donation of organs, providing legal grounds for the retrieval of organs and tissues from registered donors, even over the objections of their next of kin. The ethical justification for first-person authorization is that it is a matter of respecting the donor’s wishes. The objection of some next of kin may be that the donor would not have (...) wished for his or her loved ones to have their preferences overridden, had they considered that possibility. This article examines the basis of the conflict and suggests a remedy grounded in the provision of donor-intent options that have the ability to clarify the donor’s wishes. (shrink)

In Italy in recent years, an exponential increase in the frequency of medical malpractice claims relating to the issue of informed consent has substantially altered not only medical ethics, but medical practice as well. Total or partial lack of consent has become the cornerstone of many malpractice lawsuits, and continues to be one of the primary cudgels against defendant physicians in Italian courtrooms. Physicians have responded to the rising number of claims with an increase in ‘defensive medicine’ and a prevailing (...) preoccupation with the purely formal aspects of consent. The result is a plethora of consent forms, believed to be a guarantee of ‘informed consent’, as well as a growing reliance on informed consent as a shield against judicial action brought by the patient. Physicians ‘inform’ patients without really sharing information, often delegating the task of communication to other professionals who are not doctors. Italian judges always condemn the physician when information to the patient has been inadequate, thus leading insurance companies to consider the lack of valid informed consent as the total responsibility of the physician and/or the hospital. It is necessary to change tack, to remove this idea of consent which permeates the defensive culture of medical practice. Italian physicians need to be trained, first of all, to become aware that information and consent are two distinct processes, albeit closely connected. Valid communication demands a higher level of professionalism from physicians. (shrink)

One of the most conspicuous features of law, as it works in the world of our experience, is that legal norms are characteristically backed by coercive enforcement mechanisms. Nevertheless, many legal philosophers specializing in conceptual jurisprudence believe that coercion is not a conceptually necessary feature of law. In this essay, I argue that the authorization of coercive enforcement mechanisms is a conceptually necessary feature of law. I ground the argument in the Hartian claim that the sense of ‘law’ requiring explication (...) picks out municipal legal systems in the modern state; widely accepted Razian claims about how our legal practices construct the content of our legal concepts; claims showing the centrality of coercive enforcement mechanisms in every paradigm instance of law we have ever known; and logical difficulties arising in connection with explaining legal normativity in a system without such mechanisms. (shrink)

Hobbes claims that the sovereign's absolute authority is consistent with the subjects' retaining liberties to resist certain commands. In this essay, I explore what it means for subject to authorize a sovereign with a right to command. I show how retained rights are compatible with sovereignty. Though any given subject does not authorize the sovereign to do anything, I argue that the sovereign power is absolute. The sovereign has the most power anyone could command.

_ Source: _Volume 31, Issue 1, pp 30 - 47 In this article, I show that Hobbes’s account of the generation of the commonwealth in both _The Elements of Law_ and _De Cive_ relies on ideas that he would come to theorise in terms of authorisation and representation in _Leviathan_. In this respect, I argue that the _Leviathan_ account is better understood as filling in gaps and resolving equivocations in Hobbes’s theory, rather than marking a decisive break in his (...) thinking. This argument is developed by substantiating two more specific theses. First, while Hobbes only explicitly distinguishes between the “alienation” and “authorisation” clauses of the covenant in _Leviathan_, the earlier versions of his theory rely on a two-clause account. Second, in the earlier versions of his theory, Hobbes equivocates between suggesting that the relation between the state and sovereign should be understood in terms of representation or identity; an equivocation that he would only resolve in _Leviathan_. (shrink)

The report from the Organ Donation Taskforce looking at the potential impact of an opt-out system for deceased donor organ donation in the UK, published in November 2008, is probably the most comprehensive and systematic inquiry to date into the issues and considerations which might affect the availability of deceased donor organs for clinical transplantation. By the end of a thorough and transparent process, a clear consensus was reached. The taskforce rejected the idea of an opt-out system. In this article (...) we acknowledge the life saving potential of organ transplants and seek to highlight the difficulties that arise when the issue of organ shortage competes with concerns over choice and authorisation in the context of deceased donor organ donation. (shrink)

A key aspect of Oliver O’Donovan's approach to ethics and theology is the notion of Scripture's ‘authorisation’ of concepts. Authorisation is an organic process of concepts and Scripture illuminating each other, where Scripture has ultimate authority over concepts. That is, while concepts from various disciplines can illuminate biblical texts, the biblical texts in return shape those concepts. Here concepts are formed organically guided by the Spirit. Such a notion of authorisation lies dormant in O’Donovan's earlier political theology, (...) The Desire of the Nations, and comes to fuller expression in his relatively recent Ethics as Theology. (shrink)

Hobbes’s theory of authorisation poses numerous puzzles to scholars. The weightiest of these conundrums is a supposed contradiction between chapter 17 of Leviathan, that calls for unconditional submission to the sovereign, and chapter 21, that defends the liberties of the subject. This article offers a fresh perspective on the theory’s consistency, function and addressees. While existing research doubts the theory’s consistency, focuses on its immunisation function and on the subjects as the theory’s main addresses, the paper argues that Hobbes’s (...) theory of authorisation is consistent with the doctrine of the liberty of subjects, and that it serves the dual purpose of immunising the sovereign against criticism and disciplining the sovereign via a counsel of memento mori: A hitherto underexplored element of authorisation theory is a reminder of the mortality of sovereignty directed at the sovereign to convince him to make restricted use of his absolute right to rule. Hobbes’s theory of authorisation can thus be read as part of a complex argumentative strategy for peace, rooted in a ‘liberal absolutism’ which is not as paradoxical as it sounds, and which is reflected in the frontispiece by the friendly smile of the sovereign. (shrink)

Standards for professional training and practice are defined by accrediting organisations or statutory bodies. These describe the arena in which the practitioner may speak with authority. The sphere of authorised practice is further delineated by the external resources available. Within this explicit framework, unconscious mental processes can affect the professional response in potentially adverse ways. This is particularly important in mental health practice. Professionals must be prepared to examine their own responses on this basis in order to enhance their knowledge (...) of the patient and minimise the possibilities of the patient becoming the victim of the professional's own psychopathology. The maintenance of such a position in an institution or organisation requires a similar process within its structure in order to provide the necessary setting and define the limits of good practice. In this paper, the field of adolescent mental health is specifically examined. (shrink)

The core of Kelsen's strong views onauthority emerging from his concept of law is this:Authority of law, authority in law andauthority about law are one and the same thing.The conceptual problems suggested by these threedifferent prepositions must and can be solved in onefell swoop. Kelsen's core view will first be probed bygiving an account of what is a promising approachoffered in a fairly early text, Das Problem derSouveränität, namely, what it means to`set' or `posit' the law. Inevitably, this leadsto an (...) interpretation of the Grundnorm, one thatintends to accommodate as many Kelsenian emphases aspossible. The Grundnorm will be presented as ashield against hypostatising authority. From there,some characteristics will be inferred of the type ofauthority that arises from Kelsen's account of legalknowledge, which will be called, somewhat polemically,authority without an author. (shrink)

Relative to the abundance of literature devoted to the legal significance of UN authorisation, little has been written about whether the UN’s failure to sanction an intervention can ever make it immoral. This is the question that I take up here. I argue that UN authorisation (or lack thereof) can have some indirect bearing on the moral status of a humanitarian intervention. That is, it can affect whether an intervention satisfies other widely accepted justifying conditions, such as proportionality, (...) “internal” legitimacy, and likelihood of success. The more interesting question, however, is whether the UN’s failure to provide a mandate can make a humanitarian operation unjust independently of these other familiar considerations. Is a proportional, internally legitimate humanitarian intervention, with a just cause and strong prospect of success, still morally unacceptable if it is not approved by the United Nations Security Council? This is the question that I turn to in the second half of the paper. (shrink)

In response to the COVID-19 pandemic, large-scale research and pharmaceutical regulatory processes have proceeded at a dramatically increased pace with new and effective, evidence-based COVID-19 interventions rapidly making their way into the clinic. However, the swift generation of high-quality evidence and the efficient processing of regulatory authorisation have given rise to more specific and complex versions of well-known research ethics issues. In this paper, we identify three such issues by focusing on the authorisation of Molnupiravir, a novel antiviral (...) medicine aimed at reducing the ability of SARS-CoV-2 to multiply in the body, for clinical use by the National Health Service in England and the concomitant testing of Molnupiravir through the large-scale PANORAMIC randomised control trial. By analysing the ways in which the authorisation and clinical use of Molnupiravir complicate standard approaches to clinical equipoise, standard of care, and participant consent in the PANORAMIC randomised control trial we will explain some of ethical implications for clinical trials that aim to study the efficacy and safety of new COVID-19 and other therapeutics when conditional authorisation has already been granted and when such treatments have already been made available to patients by national health providers. (shrink)

Since the late 1960s, the legal doctrine of consent has occasionally been subject to severe criticism from within the bioethical discourse. The criticism was often based on observations indicating that consents and refusals, which had been considered valid from legal or institutional points of view, had frequently failed to reflect genuinely autonomous decision making, hence genuinely autonomous choices.This has led several critics to conclude that informed consent is a legal fiction. To clarify the concept, a legal fiction is a supposition (...) of fact taken to be true by the courts of law, irrespective of whether it is true or not, and even though it might not be true .1 What these critics probably meant to say was that the law deems any person who has given a legally valid consent to be genuinely task specifically autonomous, regardless of whether this is true or not and even though it might not be true. In other words, informed consent is a legal fiction, since it presupposes—that is, claims to reflect—genuine task specific autonomy, however baselessly.It was precisely this potentially embarrassing conclusion that prompted Faden and Beauchamp to develop a brilliant and remarkably effective argument in defence of the legal doctrine of consent. In their seminal work, AHistory and Theory of Informed Consent, they indeed acknowledged that effective consent often fails to be compatible with autonomous authorisation . Indeed, they recognised that effective consent does not necessarily entail autonomous authorisation. They argued, however, that the former is not a legal fiction, since it does not presuppose the …. (shrink)

In response to the COVID-19 pandemic, large-scale research and pharmaceutical regulatory processes have proceeded at a dramatically increased pace with new and effective, evidence-based COVID-19 interventions rapidly making their way into the clinic. However, the swift generation of high-quality evidence and the efficient processing of regulatory authorisation have given rise to more specific and complex versions of well-known research ethics issues. In this paper, we identify three such issues by focusing on the authorisation of molnupiravir, a novel antiviral (...) medicine aimed at reducing the ability of SARS-CoV-2 to multiply in the body, for clinical use by the National Health Service in England and the concomitant testing of molnupiravir through the large-scale Platform Adaptive trial of Novel antiviRals for eArly treatMent of COVID-19 In the Community randomised control trial. By analysing the ways in which the authorisation and clinical use of molnupiravir complicate standard approaches to clinical equipoise, standard of care and participant consent in the PANORAMIC randomised control trial, we will explain some of ethical implications for clinical trials that aim to study the efficacy and safety of new COVID-19 and other therapeutics when conditional authorisation has already been granted and when such treatments have already been made available to patients by national health providers. (shrink)

The diagnosis of idiopathic short stature refers to children who are considerably shorter than average without any identified medical reason. The US Food and Drug Administration authorised marketing of recombinant human growth hormone for ISS in 2003, while the European Medicines Agency refused it in 2007. This paper examines the arguments for these decisions as detailed in selected FDA and EMA documents. It combines argumentative analysis with an approach to policy analysis called ‘What’s the problem represented to be’. It argues (...) that the FDA presents its approval as an argument for equity of access to the treatment, describing short stature as a potential disadvantage, and assuming that height normalisation is a clinically meaningful result. The EMA, instead, refuses marketing authorisation with an argument that there is an imbalance of risks and benefits, describing ISS as a healthy condition, and arguing that hGH should provide some psychosocial and/or quality of life benefits to children with ISS other than height gain. This paper then discusses how these arguments could be read through different models of disability, particularly through the medical model of disability and the relational, experiential, and cultural understandings of disability. (shrink)

The core of Kelsen's strong views on authority emerging from his concept of law is this:Authority of law, authority in law and authority about law are one and the same thing. The conceptual problems suggested by these three different prepositions must and can be solved in one fell swoop. Kelsen's core view will first be probed by giving an account of what is a promising approach offered in a fairly early text, Das Problem der Souveränität, namely, what it means to (...) `set' or `posit' the law. Inevitably, this leads to an interpretation of the Grundnorm, one that intends to accommodate as many Kelsenian emphases as possible. The Grundnorm will be presented as a shield against hypostatising authority. From there, some characteristics will be inferred of the type of authority that arises from Kelsen's account of legal knowledge, which will be called, somewhat polemically, authority without an author. (shrink)

Classic, influential study of Greek tragedy.