| 1. |
- Munthe, Christian, 1962, et al.
(författare)
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Cutting red tape to manage public health threats: An ethical dilemma of expediting antibiotic drug innovation
- 2019
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Ingår i: Bioethics. - : Wiley. - 0269-9702 .- 1467-8519. ; 33:7, s. 785-791
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Tidskriftsartikel (refereegranskat)abstract
- Antibiotic resistance, arising when bacteria develop defences against antibiotics, is creating a public health threat of massive proportions. This raises challenging questions for standard notions in bioethics when suitable policy is to be characterized and justified. We examine the particular proposal of expediting innovation of new antibiotics by cutting various forms of regulatory ‘red tape’ in the standard system for the clinical introduction of new drugs. We find strong principled reasons in favour of such a lowering of the ethical standards of research and the clinical introduction of new antibiotic formulas. However, this support is undermined by pragmatic challenges owing to expected responses from stakeholders, creating uncertainty about which policies could actually be effectively implemented. We describe an underlying dilemma on how to rationally justify compromises between ideal ethical justification and pragmatic risks that needs to be further addressed in this light. We suggest a solution to this dilemma related to proposals of expediting antibiotic drug innovation.
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| 2. |
- Munthe, Christian, 1962, et al.
(författare)
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Disputing with patients in person-centered care: Ethical aspects in standard care, pediatrics, psychiatry, and public health
- 2018
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Ingår i: Journal of Argumentation in Context. - : John Benjamins Publishing Company. - 2211-4742 .- 2211-4750. ; 7:2, s. 231-244
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Tidskriftsartikel (refereegranskat)abstract
- This article explores ethical aspects of using open argumentation in person-centered care (PCC), where health professionals (HPs) openly criticize or contradict factual claims, assumptions, preferences, or value commitments of patients. We argue that such disputing may be claimed to have an important place in advanced versions of PCC, but that it actualizes important clinical ethical aspects of doing such disputation well. This may prompt caution in the implementation of PCC, but also inspire educational and organizational reform. We also probe the notion of openly disputing with patients when PCC is applied in less standard settings (where it is nevertheless advocated), using the cases of children, psychiatry, and public health interventions, such as antibiotic stewardship programs, as examples. These contexts offer new reasons for why PCC may or should include open disputing with patients, but also introduce new ethical complications. Some of these may transform either to arguments against PCC implementation in these areas, or to a more open view of the extent a HP may seek to dominate patients in a PCC setting. We are especially skeptical of the meaningfulness of applying advanced PCC in areas of psychiatry with high levels of compulsory elements, such as forensic psychiatric detention.
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| 3. |
- Munthe, Christian, 1962, et al.
(författare)
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Health‐related Research Ethics and Social Value: Antibiotic Resistance Intervention Research and Pragmatic Risks
- 2019
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Ingår i: Bioethics. - : Wiley. - 0269-9702 .- 1467-8519. ; 33:3, s. 335-342
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Tidskriftsartikel (refereegranskat)abstract
- We consider the implications for the ethical evaluation of research programs of two fundamental changes in the revised research ethical guideline of the Council for International Organizations of Medical Sciences. The first is the extension of scope that follows from exchanging “biomedical” for “health-related” research, and the second is the new evaluative basis of “social value,” which implies new ethical requirements of research. We use the example of antibiotic resistance interventions to explore the need to consider what we term the pragmatic risks of such interventions to evaluate the so- cial value of certain kinds of health-related research. These (pragmatic) risks severely threaten the social value of interventions in every area where human and social re- sponses significantly impact on their effectiveness. Thus, the social value of health-re- lated research needed to demonstrate its effectiveness depends on the successful management of such risks. Research designed to take into account pragmatic risks also gives rise to similar types of risks, and the potential for social value in light of those risks needs to be considered in ethical reviews based on the new guidelines. We argue that, to handle this new expanded task, the international system of research ethical review addressed by the guidelines needs institutional development. In particular, we consider lifting research ethical review to a level closer to actual health policy making.
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| 4. |
- Munthe, Christian, 1962, et al.
(författare)
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Managing pollution from antibiotics manufacturing: charting actors, incentives and counterincentives
- 2019
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Ingår i: 5th International Symposium on the Environmental Dimension of Antibiotic Resistance, 9–14 June 2019, Hong Kong.
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Konferensbidrag (övrigt vetenskapligt/konstnärligt)abstract
- Question Emissions of high concentrations of antibiotics from manufacturing sites select for resistant bacteria and may contribute to the emergence of new forms of resistance in pathogens. Many scientists, industry, policy makers and other stakeholders recognize such pollution as an unnecessary and unacceptable risk to global public health. An attempt to assess and reduce such discharges, however, quickly meets with complex realities that need to be understood to identify effective ways to move forward. This paper charts relevant key actor-types, their stakes and interests, incentives that can motivate them to act to improve the situation, as well as counterincentives that may undermine such motivation. Method The actor types and their respective interests have been identified using research literature, publicly available documents, websites, and the knowledge of the authors. Result Thirty-three different types of actor-types were identified, representing e.g. commercial actors, public agencies, states and international institutions. These are in complex ways connected by differing and partly similar interests that sometimes may conflict, sometimes pull in the same direction. Some actor types can act to create incentives and counterincentives for others in this area. Conclusions The analysis demonstrates and clarifies the challenges in addressing industrial emissions of antibiotics, notably the complexity of the relations between different types of actors, their international dependency and the need for transparency. The analysis however also suggest possible ways of initiating incentive-chains to eventually improve the prospects of motivating industry to reduce emissions. High resource consumer states, especially in multinational cooperation, hold a key position to initiate such chains.
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| 5. |
- Munthe, Christian, 1962, et al.
(författare)
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Questioning the patient in person centred care: ethical aspects: children, forensic psychiatry, and public health
- 2017
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Ingår i: Medical Argumentation and Patient Centred Care, University of Amsterdam, October 26-27, 2017..
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Konferensbidrag (övrigt vetenskapligt/konstnärligt)abstract
- The paper explores the room, both conceptually and ethically, for questioning, contradicting and adapting positions to patients in three specific areas: care of patients with vulnerable cpapcities for taking responsibility (adolescents and psychiatry), contexts of constrained autonomy (forensic care), and public health (antobiotic resistance stewardship and vaccination). These areas in various ethically relevant ways exhibit non-standard settings, compared to usual assumptions about the nature of patients and institutional contexts made when person centredness and shared decision-making are held out as primarily emancipating concepts. The paper probes to what extent that ethical idea may be maintained also in such non-standard settings.
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| 6. |
- Munthe, Christian, 1962, et al.
(författare)
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Testing Interventions for Drastic Public Health Threats: "Social Value”, Pragmatic Risks and the Challenge of ”Health-related Research” Ethics – The Case of drug Resistance
- 2017
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Ingår i: Matariki Research Ethics Workshop, Bader International Study Center, Herstmonceux Castle, East Sussex, UK, August 14-17, 2017.
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Konferensbidrag (övrigt vetenskapligt/konstnärligt)abstract
- The recently revised CIOMS guidelines radically broaden both that scope of the guidelines from medical to all kinds of health research), and the basis on which such research may be assessed ethically, not least what is called ”social value” of research. This makes these guidelines less on a par with the WMA’s Declaration of Helsinki principles for biomedical research, e.g. with regard to what kind of benefits may justify risks to research subjects and others, and ethical requirements regarding the management of such risks. While DoH still mostly expresses an orthodox individualist research ethical perspective of a sort that has enjoys traditional support in bioethics, but has attracted some criticism from a public health ethical perspective, the new CIOMS guidelines seem to open up for more consideration of collective, institutional and public goods, and possibility of having these traded off against risks to individuals. This paper uses interventions meant to prevent or mitigate problems due to antibiotic resistance as a case in point, to discuss how a sound research ethical regulation should position itself with regard to research regarding health interventions of great importance for (global) public health. A particular focus will be the balancing of individual and collective goods/bads in face of threats of having core institutions and central public goods undermined.
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| 7. |
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| 8. |
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| 9. |
- Nijsingh, Niels, 1977, et al.
(författare)
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Epistemic architecture: steering the public perception of the messy problem of antibiotic resistance
- 2019
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Ingår i: Emerging Topics in Life Sciences. - : Portland Press Ltd.. - 2397-8554 .- 2397-8562. ; 3:6, s. 737-740
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Tidskriftsartikel (refereegranskat)abstract
- In this perspective, we discuss non-experts' beliefs about the complex and 'messy' problem of antibiotic resistance (ABR). First, we explain what we mean by complex and messy problems and why ABR fits that description. We then suggest that the attitudes of non-experts are particularly relevant to these problems. This gives rise to social epistemic risks; risks that involve the collective and social aspects of the formation of epistemic attitudes. Steering these epistemic attitudes as a way of handling these risks can take the form of creating what we call 'epistemic architecture'. That is, a planned design of the structure within which the formation of epistemic attitudes takes place. This entails risks of its own, which leads us to conclude that there is an important responsibility for experts to take these social epistemic risks into account when communicating on messy problems, such as ABR.
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| 10. |
- Nijsingh, Niels, 1977, et al.
(författare)
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Ethics of Screening
- 2017
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Ingår i: International Encyclopedia of Public Health, 2nd Edition, Volume 3. Stella R.Quah (ed.). - Oxford, U.K. : Academic Press (Elsevier). - 9780128037089 ; , s. 28-35
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Bokkapitel (refereegranskat)
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| 11. |
- Nijsingh, Niels, 1977, et al.
(författare)
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Justifying Antibiotic Resistance Interventions: Uncertainty, Precaution and Ethics
- 2020
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Ingår i: Jamrozik E., Selgelid M.J. (eds) Ethics and Drug-Resistance: Collective Responsibility for Global Public Health. - Cham, Switzerland : Springer. - 2211-6680. - 9783030278731
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Bokkapitel (refereegranskat)abstract
- This chapter charts and critically analyses the ethical challenge of assessing how much (and what kind of) evidence is required for the justification of interventions in response antibiotic resistance (ABR), as well as other major public health threats. Our ambition here is to identify and briefly discuss main issues, and point to ways in which these need to be further advanced in future research. This will result in a tentative map of complications, underlying problems and possible challenges. This map illustrates that the ethical challenges in this area are much more complex and profound than is usually acknowledged, leaving no tentatively plausible intervention package free of downsides. This creates potentially overwhelming theoretical conundrums when trying to justify what to do. We therefore end by pointing out two general features of the complexity we find to be of particular importance, and a tentative suggestion for how to create a theoretical basis for further analysis.
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| 12. |
- Nijsingh, Niels, 1977, et al.
(författare)
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Managing pollution from antibiotics manufacturing: charting actors, incentives and disincentives
- 2019
-
Ingår i: Environmental health. - : Springer Science and Business Media LLC. - 1476-069X. ; 18
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Tidskriftsartikel (refereegranskat)abstract
- Background Emissions of high concentrations of antibiotics from manufacturing sites select for resistant bacteria and may contribute to the emergence of new forms of resistance in pathogens. Many scientists, industry, policy makers and other stakeholders recognize such pollution as an unnecessary and unacceptable risk to global public health. An attempt to assess and reduce such discharges, however, quickly meets with complex realities that need to be understood to identify effective ways to move forward. This paper charts relevant key actor-types, their main stakes and interests, incentives that can motivate them to act to improve the situation, as well as disincentives that may undermine such motivation. Methods The actor types and their respective interests have been identified using research literature, publicly available documents, websites, and the knowledge of the authors. Results Thirty-three different actor-types were identified, representing e.g. commercial actors, public agencies, states and international institutions. These are in complex ways connected by interests that sometimes may conflict and sometimes pull in the same direction. Some actor types can act to create incentives and disincentives for others in this area. Conclusions The analysis demonstrates and clarifies the challenges in addressing industrial emissions of antibiotics, notably the complexity of the relations between different types of actors, their international dependency and the need for transparency. The analysis however also suggests possible ways of initiating incentive-chains to eventually improve the prospects of motivating industry to reduce emissions. High-resource consumer states, especially in multinational cooperation, hold a key position to initiate such chains.
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| 13. |
- Nijsingh, Niels, 1977, et al.
(författare)
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Screening for multi-drug-resistant Gram-negative bacteria: what is effective and justifiable?
- 2020
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Ingår i: Monash Bioethics Review. - : Springer Science and Business Media LLC. - 1321-2753 .- 1836-6716. ; 38:supplement 1
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Tidskriftsartikel (refereegranskat)abstract
- Effectiveness is a key criterion in assessing the justification of antibiotic resistance interventions. Depending on an intervention’s effectiveness, burdens and costs will be more or less justified, which is especially important for large scale population-level interventions with high running costs and pronounced risks to individuals in terms of wellbeing, integrity and autonomy. In this paper, we assess the case of routine hospital screening for multi-drug-resistant Gram-negative bacteria (MDRGN) from this perspective. Utilizing a comparison to screening programs for Methicillin-Resistant Staphylococcus aureus (MRSA) we argue that current screening programmes for MDRGN in low endemic settings should be reconsidered, as its effectiveness is in doubt, while general downsides to screening programs remain. To accomplish justifiable antibiotic stewardship, MDRGN screening should not be viewed as a separate measure, but rather as part of a comprehensive approach. The program should be redesigned to focus on those at risk of developing symptomatic infections with MDRGN rather than merely detecting those colonised.
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| 14. |
- Ranisch, Robert, et al.
(författare)
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Digital contact tracing and exposure notification: ethical guidance for trustworthy pandemic management
- 2021
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Ingår i: Ethics and Information Technology. - : Springer Science and Business Media LLC. - 1388-1957 .- 1572-8439. ; 23, s. 285-294
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Tidskriftsartikel (refereegranskat)abstract
- There is growing interest in contact tracing apps (CT apps) for pandemic management. It is crucial to consider ethical requirements before, while, and after implementing such apps. In this paper, we illustrate the complexity and multiplicity of the ethical considerations by presenting an ethical framework for a responsible design and implementation of CT apps. Using this framework as a starting point, we briefly highlight the interconnection of social and political contexts, available measures of pandemic management, and a multi-layer assessment of CT apps. We will discuss some trade-offs that arise from this perspective. We then suggest that public trust is of major importance for population uptake of contact tracing apps. Hasty, ill-prepared or badly communicated implementations of CT apps will likely undermine public trust, and as such, risk impeding general effectiveness.
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| 15. |
- Ranisch, Robert, et al.
(författare)
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Ethics of digital contact tracing apps for the Covid-19 pandemic response
- 2020
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Rapport (övrigt vetenskapligt/konstnärligt)abstract
- There is a growing interest in contact tracing apps (CT apps) for pandemic man- agement. These apps raise significant moral concerns. It is therefore crucial to consider ethical requirements before and while implementing such apps. Public trust is of major importance for population uptake of contact tracing apps. Hasty, ill-prepared or badly communicated implementations of CT apps will likely under- mine public trust, and as such, risk impeding general effectiveness. In response to these demands, to meet ethical requirements and find a basis for justified trust, this background introduces an ethical framework for a responsible design and implementation of CT apps. However, even prudently chosen measures of digital contact tracing carry moral costs, which makes it necessary address different trade-offs. This background paper aims to inform developers, researchers and decision-makers be- fore and throughout the process of implementing contact tracing apps.
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| 16. |
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