Utfyllende informasjon på engelsk side.
Emneord:
Medisinsk etikk,
Forskningsetikk,
bioetikk
Publikasjoner
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Holm, Søren
(2025).
Human Stem Cell-Based Embryo Models in Implantation Research: Regulation, Consistency and Potential.
Biomolecules.
15(9),
s. 1287–1287.
doi:
10.3390/biom15091287.
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The use of human stem cell-based embryo models (hSCBEM) in implantation research is developing rapidly. This raises regulatory and ethical issues as these models become more complex and get closer to morphological and functional identity with human embryos. This paper provides an analysis of two possible approaches to resolving the regulatory issues. The first approach is to try to achieve consistency with current regulation of embryo research, and the second approach is to elaborate the regulation of hSCBEMs based on their developmental potential. It is shown that both approaches are problematic. The consistency approach is problematic because the current regulation of embryo research is best understood as being the result of a historical, political compromise in most jurisdictions. And the approach based on assessment of developmental potential is problematic because of unavoidable epistemic uncertainty about the potential of a new hSCBEM, and because of problems in determining what constitutes a particular model, and what changes to a model makes it into a different model.
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Toh, Hui Jin; Chan, Hui Yun; Ploug, Thomas; Holm, Søren & Lysaght, Tamra
(2025).
Attitudes Towards the Use of Artificial Intelligence in Healthcare: A Conjoint Analysis Survey in Singapore.
Asian Bioethics Review (ABR).
ISSN 1793-8759.
doi:
10.1007/s41649-025-00380-2.
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Abstract Novel artificial intelligence (AI) is increasingly being used as a clinical decision support tool in healthcare. Despite AI’s growing use and improved quality in clinical decision-making, questions persist about potential harms and the lack of transparency in their algorithms. Implementation of AI technologies in healthcare must align with local norms and ethical standards if the purported benefits are to be achieved in specific contexts. Using choice-based conjoint analysis, we examined how Singaporeans evaluate different principles related to AI decision-making in healthcare. Six attributes were included: decision type, severity, explainability, quality, responsibility, and discrimination. Among 596 respondents, 51% reported fear that AI would unintentionally harm humans, while 87% feared increased surveillance. Responsibility had the highest relative importance (31.5%) for AI use in healthcare, followed by explainability (27.7%) and discrimination (15.9%). The most valued attribute levels were AI recommendations being as explainable as doctors’, doctors retaining responsibility for treatment decisions, and AI systems being tested for discrimination. Our respondents showed higher levels of trust, hope, and fear toward AI, with a stronger preference for explainability over doctor responsibility. While having AI outperform doctors in generating clinical suggestions is desirable, principles such as explainability, human oversight, and fairness are more important for the people whose lives AI will impact.
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Lam, Thao Minh; Aarestrup, Julie; Akker, Erica L. T. van den; Baker, Jennifer L.; Banik, Anna & Berntzen, Bram J.
[Vis alle 56 forfattere av denne artikkelen]
(2025).
Advancing knowledge, maps and tools to address obesity and related socio-economic disparities in Europe: the OBCT project.
Global health action.
ISSN 1654-9716.
18(1).
doi:
10.1080/16549716.2025.2517492.
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The steady rise in overweight and obesity in Europe disproportionately affects people and communities with a lower socio-economic position (SEP). Many obesity prevention approaches exist, but these have had limited reach and unsatisfactory effects thus far, especially in low-SEP populations. In this context, there is a need for implementation of effective individual-level and population-based preventive strategies that also tackle health inequalities. Effective strategies require consideration of the complex and cross-domain obesity risk factors across the life course. Feasible and acceptable strategies require multisectoral collaborations and innovative approaches, including a whole-of community and systems perspective. With the Horizon Europe-funded OBCT project, we aim to quantify the relative contribution of biological, socio-cultural and built environment factors to obesity and the interactions of these risks within and across various life course stages; and translate the resulting knowledge into practical, equitable, and effective tools for action. These tools will include: a comprehensive obesity risk screener; a map of the obesogenicity of neighbourhood environments as well as trends in obesity prevalence of each European country; recommendations for lifestyle behaviours (diet, physical activity, sedentary behaviours) to prevent obesity during key life transition stages; a decision support dashboard for policy makers; and co-developed toolboxes to support implementation of policy recommendations in low-SEP communities. OBCT’s outputs will highlight the areas and domains in which obesity should be targeted and will empower the research community, policymakers, health professionals and residents in Europe to adapt and implement strategies to effectively reduce obesity risk, particularly in low-SEP communities.
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Ploug, Thomas; Jørgensen, Rikke Frank; Motzfeldt, Hanne Marie; Ploug, Naomi & Holm, Søren
(2025).
The need for patient rights in AI-driven healthcare – risk-based regulation is not enough.
Journal of the Royal Society of Medicine.
ISSN 0141-0768.
118(8),
s. 248–252.
doi:
10.1177/01410768251344707.
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Dal-Ré, Rafael; Caplan, Arthur L.; Holm, Søren; Sofat, Reecha & Stephens, Richard
(2025).
What participants are told about receiving trial results when they consent to participate in a trial.
Basic & Clinical Pharmacology & Toxicology.
ISSN 1742-7835.
136(1).
doi:
10.1111/bcpt.14115.
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Holm, Søren
(2024).
The responsibility of sports federations to facilitate and fund concussion research and the role of active participant involvement and engagement.
Sport, Ethics and Philosophy.
ISSN 1751-1321.
doi:
10.1080/17511321.2024.2361915.
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It is generally accepted that we need more research into concussions and other injuries with potential long-term effects in sport because such research underpins effective, evidence-based prevention, management, support, and treatment. This paper provides an analysis of the obligations of sports federations to support and facilitate such research, as well as an analysis of the role active participants in the sport should have in the research process. The paper focuses on concussion and concussion research, though very similar arguments apply to other common sports injuries with potential long-term effects. The paper argues that sports federations have a moral obligation and a prudential interest in initiating, facilitating, and funding concussion research. This follows from their duty of care towards active participants and from considerations of reciprocity. The ability to discharge these research obligations depends on the resources available to a particular federation, but those who can discharge them should do so. The paper further argues that athletes and other active participants in sport should be involved in all aspects of the concussion research process from conception to design, i.e. that Active Participant Involvement and Engagement (APIE) should be a non-negotiable element of concussion research projects. This is supported by instrumental reasons, but also by philosophical argument based on standpoint epistemology and on ethical arguments related to the interests of active participants. Standpoint epistemology is the epistemological position that the knowledge a person has and can have depends on that person’s standpoint in the world. Keywords: Concussion, funding, participant involvement, sport, sport association, sport federation
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Warrington, Daniel Joseph & Holm, Søren
(2024).
Healthcare ethics and artificial intelligence: a UK doctor survey.
BMJ Open.
14(12),
s. 1–8.
doi:
10.1136/bmjopen-2024-089090.
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Objectives To survey UK doctors on their uses of artificial intelligence (AI) and of their views on the ethics and regulation of AI in healthcare. Design Anonymous cross-sectional e-survey. Setting An online survey of UK General Medical Council (GMC) registered doctors. Participants 272 individuals. Main outcome measures Likert-scale responses to questions covering personal use of AI, concerns about AI, requirements for introduction of AI and views on necessary AI regulation in healthcare. Results Most doctors rated themselves as slightly or moderately knowledgeable about AI, with men rating their knowledge levels higher than women. Doctors in training are more likely to have used AI than doctors after training. 37% of doctors who use AI reported using AI to help write the required reflective pieces for their portfolio. Doctors reported concerns about AI regarding patient safety and patients' right to confidentiality. They also expressed a strong desire for further regulation of AI in healthcare and, specifically, for their professional bodies to draft guidelines for the use of AI by doctors. Conclusions This study provides useful insights into UK doctors’ uses of AI in healthcare and their opinions on its introduction and regulation. It provides a case for guidance on the use of AI in the reflective practices of doctors and for further evaluation of doctors’ concerns about AI in healthcare. We call on doctors’ professional bodies (GMC, BMA and royal colleges) to draft professional guidance for doctors using AI.
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Holm, Søren
(2024).
Public Reason Requirements in Bioethical Discourse.
Cambridge Quarterly of Healthcare Ethics.
ISSN 0963-1801.
doi:
10.1017/S0963180124000094.
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This paper analyzes the use of public reason requirements in bioethical discourse and discusses when such requirements are warranted. By a “public reason requirement,” I mean a requirement that those involved in a particular discourse or debate only use reasons that can properly be described as public reasons. The first part of the paper outlines the concept of public reasons as developed by John Rawls and others and discusses some of the general criticisms of the concept and its importance. The second part then distinguishes between two types of public reason requirements in bioethics. One type is what I will call the orthodox public reason requirement since it hews closely to the original Rawlsian conception. The second is what I will call the expansive public reason requirement, which departs quite radically from the Rawlsian conception and applies the requirement not to policy discourse or policymaking, but to the actions of individuals. Both types of requirements will be analyzed, and some problems in applying public reason requirements in bioethics will be identified. It will be argued that the expansive public reason requirement is misguided. The concluding part argues that requirements of civic civility and what Rawls terms an “inclusive view” of public reason should be important in bioethical discourse.
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Lewis, Jonathan & Holm, Søren
(2023).
Towards a concept of embodied autonomy: In what ways can a patient’s body contribute to the autonomy of medical decisions?
Medicine, Health care and Philosophy.
ISSN 1386-7423.
doi:
10.1007/s11019-023-10159-7.
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Abstract “Bodily autonomy” has received significant attention in bioethics, medical ethics, and medical law in terms of the general inviolability of a patient’s bodily sovereignty and the rights of patients to make choices (e.g., reproductive choices) that concern their own body. However, the role of the body in terms of how it can or does contribute to a patient’s capacity for, or exercises of their autonomy in clinical decision-making situations has not been explicitly addressed. The approach to autonomy in this paper is aligned with traditional theories that conceive autonomy in terms of an individual’s capacities for, and exercises of rational reflection. However, at the same time, this paper extends these accounts by arguing that autonomy is, in part, embodied. Specifically, by drawing on phenomenological conceptions of the experience of autonomy, we argue that, in principle, the body is a necessary component of the capacity for autonomy. Secondly, through the presentation of two different cases, we highlight ways in which a patient’s body can contribute to the autonomy of treatment choices. Ultimately, we hope to encourage others to explore additional conditions under which a concept of embodied autonomy should be employed in medical decision making, how its underlying principles might be operationalised in clinical situations, and its consequences for approaches to patient autonomy in healthcare practice, policy, and law.
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Neumann, Victoria; Davidge, Gail; Harding, Mike; Cunningham, James; Davies, Nigel & Devaney, Sarah
[Vis alle 9 forfattere av denne artikkelen]
(2023).
Examining public views on decentralised health data sharing.
PLOS ONE.
18(3).
doi:
10.1371/journal.pone.0282257.
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In recent years, researchers have begun to explore the use of Distributed Ledger Technologies (DLT), also known as blockchain, in health data sharing contexts. However, there is a significant lack of research that examines public attitudes towards the use of this technology. In this paper, we begin to address this issue and present results from a series of focus groups which explored public views and concerns about engaging with new models of personal health data sharing in the UK. We found that participants were broadly in favour of a shift towards new decentralised models of data sharing. Retaining ‘proof’ of health information stored about patients and the capacity to provide permanent audit trails, enabled by immutable and transparent properties of DLT, were regarded as particularly valuable for our participants and prospective data custodians. Participants also identified other potential benefits such as supporting people to become more health data literate and enabling patients to make informed decisions about how their data was shared and with whom. However, participants also voiced concerns about the potential to further exacerbate existing health and digital inequalities. Participants were also apprehensive about the removal of intermediaries in the design of personal health informatics systems.
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Dal-Ré, Rafael; Voo, Teck Chuan & Holm, Søren
(2023).
Adaptive, platform trials assessing therapies for hospitalized COVID-19 patients: Informed consent forms omitted a few important elements of information.
Journal of Global Health.
ISSN 2047-2978.
13.
doi:
10.7189/jogh.13.06019.
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Background The information provided to participants of adaptive platform trials assessing therapies for COVID-19 inpatients is unknown. We aim to evaluate it by reviewing participant information sheets/informed consent forms (PIS/ICFs). Methods We searched the Cochrane COVID-19 Study Register and ClinicalTrials.gov (28 March 2022) to identify non-industry-sponsored adaptive platform phase 2+ trials with publicly available protocols and PIS/ICFs, selecting versions closest to the initial one. We assessed the elements of information included in the Good Clinical Practice guidelines and the Declaration of Helsinki as present, absent, or deficient (incompletely described). Results We included PIS/ICFs of 11 trials (ACCORD-2, ACTIV-1IM, Bari-SolidAct, CATALYST, Discovery, HEAL-COVID, ITAC, RECOVERY, REMAP-COVID, Solidarity and TACTIC-R), which were 4-32 pages long (median (md) = 11). Between two and 11 (md = 6) of the 25 different elements of information assessed were omitted or deficiently described in the PIS/ICFs of the 11 trials. Information about providing trial results, investigators’ conflicts of interest, post-study provisions, payment to and anticipated expenses for participants, number of participants, and on whether participants will receive new information that could impact their decision on staying in the trial, were omitted or deficiently described in at least five PIS/ICFs. Conclusions Investigators failed to include a few important elements of information in the trial’s PIS/ICF deemed relevant by international standards. In protocols of future trials, investigators should explain why elements of information specified in the Good Clinical Practice guidelines and/or by the Declaration of Helsinki were omitted from the PIS/ICFs.
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McNamee, Mike; Anderson, Lynley C.; Borry, Pascal; Camporesi, Silvia; Derman, Wayne & Holm, Søren
[Vis alle 16 forfattere av denne artikkelen]
(2023).
Sport-related concussion research agenda beyond medical science: Culture, ethics, science, policy.
Journal of Medical Ethics.
ISSN 0306-6800.
doi:
10.1136/jme-2022-108812.
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The Concussion in Sport Group guidelines have successfully brought the attention of brain injuries to the global medical and sport research communities, and has significantly impacted brain injury-related practices and rules of international sport. Despite being the global repository of state-of-the-art science, diagnostic tools and guides to clinical practice, the ensuing consensus statements remain the object of ethical and sociocultural criticism. The purpose of this paper is to bring to bear a broad range of multidisciplinary challenges to the processes and products of sport-related concussion movement. We identify lacunae in scientific research and clinical guidance in relation to age, disability, gender and race. We also identify, through multidisciplinary and interdisciplinary analysis, a range of ethical problems resulting from conflicts of interest, processes of attributing expertise in sport-related concussion, unjustifiably narrow methodological control and insufficient athlete engagement in research and policy development. We argue that the sport and exercise medicine community need to augment the existing research and practice foci to understand these problems more holistically and, in turn, provide guidance and recommendations that help sport clinicians better care for brain-injured athletes.
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Holm, Søren
(2023).
Bioethics Without Theory?
Cambridge Quarterly of Healthcare Ethics.
ISSN 0963-1801.
doi:
10.1017/S0963180123000348.
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Abstract The question that this paper tries to answer is Q: “Can good academic bioethics be done without commitment to moral theory?” It is argued that the answer to Q is an unequivocal “Yes” for most of what we could call “critical bioethics,” that is, the kind of bioethics work that primarily criticizes positions or arguments already in the literature or put forward by policymakers. The answer is also “Yes” for much of empirical bioethics. The second part of the paper then provides an analysis of Q in relation to “constructive bioethics,” that is, bioethics work aimed at providing an argument for a particular position. In this part, it is argued that a number of the approaches or methods used that initially look like they involve no commitment to moral theory, nevertheless, involve such a commitment. This is shown to be the case for reflective equilibrium, mid-level theory, the use of theory fragments, and argument by analogy.
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Holm, Søren & Ploug, Thomas
(2023).
Population preferences for AI system features across eight different decision-making contexts.
PLOS ONE.
18(12),
s. e0295277–e0295277.
doi:
10.1371/journal.pone.0295277.
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Artificial intelligence systems based on deep learning architectures are being investigated as decision-support systems for human decision-makers across a wide range of decision-making contexts. It is known from the literature on AI in medicine that patients and the public hold relatively strong preferences in relation to desirable features of AI systems and their implementation, e.g. in relation to explainability and accuracy, and in relation to the role of the human decision-maker in the decision chain. The features that are preferred can be seen as ‘protective’ of the patient’s interests. These types of preferences may plausibly vary across decision-making contexts, but the research on this question has so far been almost exclusively performed in relation to medical AI. In this cross-sectional survey study we investigate the preferences of the adult Danish population for five specific protective features of AI systems and implementation across a range of eight different use cases in the public and commercial sectors ranging from medical diagnostics to the issuance of parking tickets. We find that all five features are seen as important across all eight contexts, but that they are deemed to be slightly less important when the implications of the decision made are less significant to the respondents.
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Hofmann, Bjørn Morten; Thoresen, Magne & Holm, Søren
(2023).
Research Integrity Attitudes and Behaviors are Difficult to alter: Results from a ten Year Follow-up Study in Norway.
Journal of Empirical Research on Human Research Ethics.
ISSN 1556-2646.
18(1/2),
s. 50–57.
doi:
10.1177/15562646221150032.
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Background: Research integrity has obtained much attention in research communities, but also in the general public. To improve research integrity is difficult as it involves complex systems of knowledge, attitudes, and practices. The objective of this study is to investigate the knowledge, attitudes, and practices of cohorts of PhD candidates at one faculty (of medicine) over time and compare this to finished PhDs of the same cohorts. Material and method: Researchers (n = 186) awarded the degree PhD at the Faculty of Medicine at the University of Oslo in 2019 were invited to answer a questionnaire about knowledge, attitudes and actions related to scientific dishonesty. 94 responded (50.5%). The results were compared with results among first-year PhD candidates who responded to the same questionnaire during 2010–20 (n = 536) and to those who finished PhDs in 2016 (n = 86). Results: For the years 2010–2020 1.1% of the PhD candidates report to have engaged in severe scientific misconduct (FFP) while 0.9% report to have presented results in a misleading way. 2.3% report that they know of persons at their department who have engaged in FFP the last 12 months. In total 1.5% report to have experienced pressure to engage in severe scientific misconduct (FFP) while 2.1% report to have experienced pressure to present results in a misleading way. On average 12.8% report to have been exposed to unethical pressure concerning inclusion or ordering of authors during the last 12 months, and 28.8% report to have knowledge about their department's written policies about research integrity. While some attitudes improve over the years, attitudes in general are not much changed from 2010–2020. None of the PhDs that received a PhD from the Faculty of Medicine at the University of Oslo in 2019 reported to have engaged in FFT or having experienced pressure to do so.1.1% experienced pressure to present results in other misleading ways, while 26.6% of respondents had experienced unethical pressure in relation to authorship during the course of the PhD fellowship. 4.3% knew about someone at their department who had presented results in a misleading manner. Some attitudes were not in line with traditional conceptions of research integrity, but most agreed that their research environment displayed research integrity. Conclusion: This long-term follow up study shows that few PhD-candidates report to engage in severe scientific misconduct, that they experience little pressure to do so, and with some exceptions, attitudes in in line with good research integrity. However, pressure in relation to authorship is relatively common. There is some improvement in research integrity from PhD candidates to recently finished PhDs, but in general research integrity is stable over time.
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März, Julian W; Molnar, Anett; Holm, Søren & Schlander, Michael
(2022).
The Ethics of COVID-19 Vaccine Allocation: Don't Forget the Trade-Offs!
Public Health Ethics.
ISSN 1754-9973.
15(1),
s. 41–50.
doi:
10.1093/phe/phac001.
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Holm, Søren; Lewis, Jonathan & Dal-Ré, Rafael
(2022).
Equipoise, standard of care and consent: responding to the authorisation of new COVID-19 treatments in randomised controlled trials.
Journal of Medical Ethics.
ISSN 0306-6800.
49(7),
s. 465–470.
doi:
10.1136/medethics-2022-108182.
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Holm, Søren & Warrington, Daniel
(2022).
Frailty as a Priority-Setting Criterion for Potentially Lifesaving Treatment-Self-Fulfilling Prophecy, Circularity, and Indirect Discrimination?
Cambridge Quarterly of Healthcare Ethics.
ISSN 0963-1801.
32(1),
s. 48–55.
doi:
10.1017/S0963180122000494.
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Ploug, Thomas & Holm, Søren
(2022).
The right to a second opinion on Artificial Intelligence diagnosis—Remedying the inadequacy of a risk-based regulation.
Bioethics.
ISSN 0269-9702.
doi:
10.1111/bioe.13124.
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Helgesson, Gert; Holm, Søren; Bredahl, Lone; Hofmann, Bjørn Morten & Juth, Niklas
(2022).
Misuse of co-authorship in Medical PhD Theses in Scandinavia: A Questionnaire Survey.
Journal of Academic Ethics.
ISSN 1570-1727.
doi:
10.1007/s10805-022-09465-1.
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Background Several studies suggest that deviations from proper authorship practices are commonplace in medicine. The aim of this study was to explore experiences of and attitudes towards the handling of authorship in PhD theses at medical faculties in Denmark, Norway, and Sweden. Methods Those who defended their PhD thesis at a medical faculty in Scandinavia during the second half of 2020 were offered, by e-mail, to participate in an online survey. Survey questions dealt with experiences of violations of the first three of the ICMJE authorship criteria and misuse of authorship order in the thesis articles, as well as respondents’ attitudes to these matters. Both questions with fixed response alternatives and questions with free-text responses were used. Quantitative data were analysed statistically using the Table functions in SPSS 25 and Chi-2 tests. Free-text responses were analysed qualitatively using manifest content analysis. Results 287 valid questionnaires were returned (response rate: 34.1%). Almost half (46.0%) of the respondents reported that the ICMJE authorship criteria were not fully respected in at least one of the papers in their thesis, while a vast majority (96.7%) found it important that authorship is handled according to the ICMJE authorship criteria. 24.4% reported inadequate handling of authorship order in at least one paper. The qualitative results provide a wide spectrum of examples of how the ICMJE authorship criteria are circumvented. Conclusion Despite increasing educational efforts to reduce deviations from good research practice at Scandinavian universities, the handling of authorship in medical papers remains problematic.
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Holm, Søren
(2022).
What is the Foundation of Medical Ethics - Common Morality, Professional Norms, or Moral Philosophy?
Cambridge Quarterly of Healthcare Ethics.
ISSN 0963-1801.
31(2),
s. 192–198.
doi:
10.1017/S0963180121000591.
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Hofmann, Bjørn Morten; Zinöcker, Severin; Holm, Søren; Lewis, Jonathan & Kavouras, Panagiotis
(2022).
Organoids in the Clinic: A Systematic Review of Outcomes.
Cells Tissues Organs.
ISSN 1422-6405.
212(6),
s. 499–511.
doi:
10.1159/000527237.
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Research on organoids has undergone significant advances during the last decade. However, outcomes from the use of organoids in clinical trials have not yet been documented. Therefore, there is an urgent need to assess the reporting of clinically relevant outcomes from organoid research in the scientific literature. This article presents a systematic review and appraisal of the published literature in line with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, together with a synopsis of recent relevant reviews. Surprisingly, no randomized controlled trials have reported clinical outcomes with any types of organoids. We found very few ongoing and registered studies that may provide clinically relevant results within this decade. Our screening and interpretation of the literature, including review articles, indicate a focus on technical and preclinical aspects of organoid research. This is the first systematic review of clinical trials involving organoids. Few clinical studies are planned or already underway, and, so far, no high-quality evidence relating to the clinical outcomes of organoid research has been published. The many promises of organoid research still need to be translated from bench to bed.
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Holm, Søren; Kristiansen, Thomas Birk & Ploug, Thomas
(2021).
Control, trust and the sharing of health information: The limits of trust.
Journal of Medical Ethics.
ISSN 0306-6800.
47(12),
s. E35–E35.
doi:
10.1136/medethics-2019-105887.
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Clinical information about patients is increasingly being stored in electronic form and has therefore become more easily shareable. Data are collected as part of clinical care but have multiple other potential uses in relation to health system planning, audit and research. The use of clinical information for these secondary uses is controversial, and the ability to safeguard personal and sensitive data under current practices is contested. In this study, we investigate the attitudes of a representative sample of the Danish population towards transfer of clinical data from their general practice for secondary use. We specifically study: (1) patients’ trust in different types of healthcare professionals, (2) their interest in being asked about secondary use of data and (3) their willingness to dispense from a requirement of informed consent based on their trust in healthcare professionals. We find that adult Danes are positive towards research that use patient data, and they generally trust general practitioners, hospitals and researchers to treat their data confidentially. Nevertheless, they feel that they have a right to control the use of their data, only 7.3% disagreeing, and that the data belong to them, only 14.0% disagreeing. Answers to further questions about the relation between trust, information and consent show that although trust modifies the wish for information and consent, there is still a strong view that the patient should control the use of data. We find no differences between those who have frequent contact with the healthcare system and those who do not.
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Lekstutiene, Jurate; Holm, Søren & Gefenas, Eugenijus
(2021).
Biobanks and Individual Health Related Findings: from an Obstacle to an Incentive.
Science and Engineering Ethics.
ISSN 1353-3452.
27(4).
doi:
10.1007/s11948-021-00330-9.
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Xafis, Vicki; Schaefer, G. Owen; Labude, Markus K.; Zhu, Yujia; Holm, Søren & Foo, Roger Sik-Yin
[Vis alle 8 forfattere av denne artikkelen]
(2021).
Germline genome modification through novel political, ethical, and social lenses.
PLoS Genetics.
ISSN 1553-7390.
17(9).
doi:
10.1371/journal.pgen.1009741.
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Much has been written about gene modifying technologies (GMTs), with a particularly strong focus on human germline genome editing (HGGE) sparked by its unprecedented clinical research application in 2018, shocking the scientific community. This paper applies political, ethical, and social lenses to aspects of HGGE to uncover previously underexplored considerations that are important to reflect on in global discussions. By exploring 4 areas—(1) just distribution of HGGE benefits through a realist lens; (2) HGGE through a national interest lens; (3) “broad societal consensus” through a structural injustice lens; and (4) HGGE through a scientific trustworthiness lens—a broader perspective is offered, which ultimately aims to enrich further debates and inform well-considered solutions for developments in this field. The application of these lenses also brings to light the fact that all discussions about scientific developments involve a conscious or unconscious application of a lens that shapes the direction of our thinking.
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Julian, März; Holm, Søren & Michael, Schlander
(2021).
Resource allocation in the Covid-19 health crisis: are Covid-19 preventive measures consistent with the Rule of Rescue?
Medicine, Health care and Philosophy.
ISSN 1386-7423.
24(4),
s. 487–492.
doi:
10.1007/s11019-021-10045-0.
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Abstract The Covid-19 pandemic has led to a health crisis of a scale unprecedented in post-war Europe. In response, a large amount of healthcare resources have been redirected to Covid-19 preventive measures, for instance population-wide vaccination campaigns, large-scale SARS-CoV-2 testing, and the large-scale distribution of protective equipment (e.g., N95 respirators) to high-risk groups and hospitals and nursing homes. Despite the importance of these measures in epidemiological and economic terms, health economists and medical ethicists have been relatively silent about the ethical rationales underlying the large-scale allocation of healthcare resources to these measures. The present paper seeks to encourage this debate by demonstrating how the resource allocation to Covid-19 preventive measures can be understood through the paradigm of the Rule of Rescue, without claiming that the Rule of Rescue is the sole rationale of resource allocation in the Covid-19 pandemic.
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Ljubenković, Ana Marija; Borovečki, Ana; Ćurković, Marko; Hofmann, Bjørn & Holm, Søren
(2021).
Survey on the Research Misconduct and Questionable Research Practices of Medical Students, PhD Students, and Supervisors at the Zagreb School of Medicine in Croatia.
Journal of Empirical Research on Human Research Ethics.
ISSN 1556-2646.
doi:
10.1177/15562646211033727.
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This cross-sectional study evaluates the knowledge, attitudes, experiences, and behavior of final year medical students, PhD students, and supervisors at the School of Medicine of the University of Zagreb in relation to research misconduct, questionable research practices, and the research environment. The overall response rate was 36.4% (68%–100% for the paper survey and 8%–15% for the online surveys). The analysis reveals statistically significant differences in attitude scores between PhD students and supervisors, the latter having attitudes more in concordance with accepted norms. The results overall show a nonnegligible incidence of self-reported misconduct and questionable research practices, as well as some problematic attitudes towards misconduct and questionable research practices. The incidence of problematic authorship practices was particularly high. The research environment was evaluated as being mostly supportive of research integrity.
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Holm, Søren
(2021).
Allocating Organs - Fairness, Transparency, and Responsibility.
I Hansen, Solveig Lena & Schicktanz, Silke (Red.),
Ethical Challenges of Organ Transplantation
Current Debates and International Perspectives.
Transcript Verlag.
ISSN 9783837646436.
s. 169–186.
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Matthews, KRW; Iltis, AS; Holm, Søren; Marquez, Nuria Gallego; Wagner, Daniel & Robert, Jason Scott
[Vis alle 13 forfattere av denne artikkelen]
(2021).
Rethinking Human Embryo Research Policies.
The Hastings center report.
ISSN 0093-0334.
51(1),
s. 47–51.
doi:
10.1002/hast.1215.
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It now seems technically feasible to culture human embryos beyond the “fourteen-day limit,” which has the potential to increase scientific understanding of human development and perhaps improve infertility treatments. The fourteen-day limit was adopted as a compromise but subsequently has been considered an ethical line. Does it remain relevant in light of technological advances permitting embryo maturation beyond it? Should it be changed and, if so, how and why? What justifications would be necessary to expand the limit, particularly given that doing so would violate some people's moral commitments regarding human embryos? Robust stakeholder engagement preceded adoption of the fourteen-day limit and should arguably be part of efforts to reassess it. Such engagement could also consider the need for enhanced oversight of human embryo research. In the meantime, developing and implementing reliable oversight systems should help foster high-quality research and public confidence in it.
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Holm, Søren
(2020).
Er det at blive gammel tilstrækkelig årsag til dødshjælp?
I Horn, Morten Andreas; Kleiven, Daniel Joachim Heggheim & Magelssen, Morten (Red.),
Dødshjelp i Norden? Etikk, klinikk og politikk.
Cappelen Damm Akademisk.
ISSN 9788202616571.
s. 235–237.
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Holm, Søren & Ploug, Thomas
(2020).
Solidarity and Antimicrobial Resistance.
I Jamrozik, Euzebiusz & Selgelid, Michael J. (Red.),
Ethics and Drug Resistance: Collective Responsibility for Global Public Health.
Springer.
ISSN 9783030278748.
s. 345–356.
doi:
10.1007/978-3-030-27874-8_21.
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Holm, Søren
(2020).
Controlled human infection with SARS-CoV-2 to study
COVID-19 vaccines and treatments: bioethics
in Utopia.
Journal of Medical Ethics.
ISSN 0306-6800.
46,
s. 569–573.
doi:
10.1136/medethics-2020-106476.
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A number of papers have appeared recently arguing for the conclusion that it is ethically acceptable to infect healthy volunteers with severe acute respiratory syndrome coronavirus 2 as part of research projects aimed at developing COVID-19 vaccines or treatments. This position has also been endorsed in a statement by a working group for the WHO. The papers generally argue that controlled human infection (CHI) is ethically acceptable if (1) the risks to participants are low and therefore acceptable, (2) the scientific quality of the research is high, (3) the research has high social value, (4) participants give full informed consent, and (5) there is fair selection of participants. All five conditions are necessary premises in the overall argument that such research is ethically acceptable. The arguments concerning risk and informed consent have already been critically discussed in the literature. This paper therefore looks specifically at the arguments relating to condition 3 ‘high social value’ and condition 5 ‘fair selection of participants’ and shows that whereas they may be valid, they are not sound. It is highly unlikely that the conditions that are necessary for ethical CHI trials to take place will be fulfilled. Most, if not all, CHI trials will thus be well intentioned but unethical.
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Holm, Søren
(2020).
Belmont in Europe: A Mostly Indirect Influence.
Perspectives in biology and medicine.
ISSN 0031-5982.
63(2),
s. 262–276.
doi:
10.1353/pbm.2020.0018.
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This paper traces the reception of the Belmont Report in Europe and its influence on the development of European research ethics thinking and European research ethics systems. It is very difficult to trace a clear, linear reception history because it is difficult to disentangle the influence of the Report from the influence of concurrent developments, such as the 1975 revision of the World Medical Association Declaration of Helsinki and the requirement for research ethics review in the Vancouver Group’s 1978 “Uniform Requirements for Manuscript Submission.” The Report’s insistence that the focus of research ethics should be the rights and interests of the individual research subject, and the use of an ethical framework and not ethical theory as the basis of analysis and justification of recommendations, were nevertheless very important for the development of research ethics. The divergence between Europe and the US in the governance of non-biomedical research can at least partly be explained by the absence of strong drivers for the introduction of research ethics committees outside of biomedicine in Europe, and by the ability of non-biomedical researchers to mobilize effectively against the introduction of such committees.
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Ingwersen, Peter; Holm, Søren; Larsen, Birger & Ploug, Thomas
(2020).
Do journals and corporate sponsors back certain views in topics where disagreement prevails?
Scientometrics.
ISSN 0138-9130.
s. 1–27.
doi:
10.1007/s11192-020-03743-8.
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The article focuses on scientific disagreement about the use of statin-related drugs in the prevention of cardiovascular events. The study forms part of an exploration of the broader principle of research polarization, foremost in medicine. The hypothesis is that statin-positive and statin-critical researchers publish in different committed central journals, and that they are financially supported by different dedicated corporate sources. Methodologically we use Web of Science (WoS) analytic tools to perform publication analysis of a time series covering 1998–2018 in three seven-year windows. For each window data is captured based on sets of known statin-positive and statin-critical articles and researchers, and their primary and secondary co-authors. Standard deviation is used as a focused normalization and visual instrument together with Spearman’s correlation coefficient in order to compare frequency distributions of statin-positive and critical journal and sponsor articles. Z-test p-values are used to assess the probability of error concerning the distributions. Findings at general topical level showed that a few journals consistently and significantly occupied top positions, 2 of which, American Journal of Cardiology and Circulation, published articles from both positions. Besides, Journal of the American College of Cardiology served as a major publisher of statin-positive research from 2005, as did European Heart Journal from 2012, replacing American Journal of Cardiology at the top. From 2012 Atherosclerosis and European Journal of Preventive Cardiology served as top-publishers of statin-critical articles. Two central US funding agencies, US Department of Health Human Services and National Institutes of Health (NIH), operated at general topical level across the time series, but the agencies played only a minor role in the divergent research positions. From 2005 statin-positive as well as statin-critical research was mainly sponsored by multinational pharmaceutical companies, predominantly Merck, AstraZeneca and Pfizer. In conclusion, the initial hypothesis about dedicated journals and sponsors was entirely substantiated at the general topical level and at the journal level of research disagreement, but not at sponsor level. Distinct dedicated journals were extracted separately from the 2 divergent statin positions. Since the WoS coverage of sponsor data 1998–2004 was sporadic sponsor data are analyzed from 2005. Only from 2012 the WoS sponsor coverage of the topic is consistently at 60%.
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Holm, Søren
(2020).
A general approach to compensation for losses incurred due to public health interventions in the infectious disease context.
Monash Bioethics Review.
ISSN 1321-2753.
doi:
10.1007/s40592-020-00104-2.
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Abstract This paper develops a general approach to how society should compensate for losses that individuals incur due to public health interventions aimed at controlling the spread of infectious diseases. The paper falls in three parts. The first part provides an initial introduction to the issues and briefly outlines five different kinds of public health interventions that will be used as test cases. They are all directed at individuals and aimed at controlling the spread of infectious diseases (1) isolation, (2) quarantine, (3) recommended voluntary social distancing, (4) changes in health care provision for asymptomatic carriers of multi-resistant microorganisms, and (5) vaccination. The interventions will be briefly described including the various risks, burdens and harms individuals who are subject to these interventions may incur. The second part briefly surveys current compensation mechanisms as far as any exist and argue that even where they exist they are clearly insufficient and do not provide adequate compensation. The third part will then develop a general framework for compensation for losses incurred due to public health interventions in the infectious disease context. This is the major analytical and constructive part of the paper. It first analyses pragmatic and ethical arguments supporting the existence of an obligation on the part of the state to compensate for such losses, and then considers whether this obligation can be defeated by (1) resource considerations, or (2) issues relating to personal responsibility.
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Solbakk, Jan Helge; Bentzen, Heidi Beate; Holm, Søren; Heggestad, Anne Kari Tolo; Hofmann, Bjørn Morten & Robertsen, Annette
[Vis alle 10 forfattere av denne artikkelen]
(2020).
Back to WHAT? The role of research ethics in pandemic times.
Medicine, Health care and Philosophy.
ISSN 1386-7423.
s. 1–16.
doi:
10.1007/s11019-020-09984-x.
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The Covid-19 pandemic creates an unprecedented threatening situation worldwide with an urgent need for critical reflection and new knowledge production, but also a need for imminent action despite prevailing knowledge gaps and multilevel uncertainty. With regard to the role of research ethics in these pandemic times some argue in favor of exceptionalism, others, including the authors of this paper, emphasize the urgent need to remain committed to core ethical principles and fundamental human rights obligations all reflected in research regulations and guidelines carefully crafted over time. In this paper we disentangle some of the arguments put forward in the ongoing debate about Covid-19 human challenge studies (CHIs) and the concomitant role of health-related research ethics in pandemic times. We suggest it might be helpful to think through a lens differentiating between risk, strict uncertainty and ignorance. We provide some examples of lessons learned by harm done in the name of research in the past and discuss the relevance of this legacy in the current situation.
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Hofmann, Bjørn; Jensen, Lone Bredahl; Eriksen, Mette Brandt; Helgesson, Gert; Juth, Niklas & Holm, Søren
(2020).
Research Integrity Among PhD Students at the Faculty of Medicine: A Comparison of Three Scandinavian Universities.
Journal of Empirical Research on Human Research Ethics.
ISSN 1556-2646.
15(4),
s. 320–329.
doi:
10.1177/1556264620929230.
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This study investigates research integrity among PhD students in health sciences at three universities in Scandinavia (Stockholm, Oslo, Odense). A questionnaire with questions on knowledge, attitudes, experiences, and behavior was distributed to PhD students and obtained a response rate of 77.7%. About 10% of the respondents agreed that research misconduct strictly defined (such as fabrication, falsification, and plagiarism, FFP) is common in their area of research, while slightly more agreed that other forms of misconduct is common. A nonnegligible segment of the respondents was willing to fabricate, falsify, or omit contradicting data if they believe that they are right in their overall conclusions. Up to one third reported to have added one or more authors unmerited. Results showed a negative correlation between “good attitudes” and self-reported misconduct and a positive correlation between how frequent respondents thought that misconduct occurs and whether they reported misconduct themselves. This reveals that existing educational and research systems partly fail to foster research integrity.
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Ploug, Thomas & Holm, Søren
(2019).
The right to refuse diagnostics and treatment planning by artificial intelligence.
Medicine, Health care and Philosophy.
ISSN 1386-7423.
s. 1–8.
doi:
10.1007/s11019-019-09912-8.
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In an analysis of artificially intelligent systems for medical diagnostics and treatment planning we argue that patients should be able to exercise a right to withdraw from AI diagnostics and treatment planning for reasons related to (1) the physician’s role in the patients’ formation of and acting on personal preferences and values, (2) the bias and opacity problem of AI systems, and (3) rational concerns about the future societal effects of introducing AI systems in the health care sector.
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Hofmann, Bjørn Morten & Holm, Søren
(2019).
Research integrity: environment, experience, or ethos?
Research Ethics.
ISSN 1747-0161.
15(3-4),
s. 1–13.
doi:
10.1177/1747016119880844.
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Background: Research integrity has gained attention in the general public as well as in the research community. We wanted to investigate knowledge, attitudes, and practices amongst researchers that have recently finished their PhD and compare this to their responses during their PhD fellowship. In particular, we wanted to investigate whether their attitudes are related to their experiences of their immediate research environment. Material and method: Researchers (n = 86) awarded the PhD degree at the Faculty of Medicine at the University of Oslo in 2016 were invited to answer a questionnaire about knowledge, attitudes, and actions related to scientific dishonesty. Seventy-two responded (83.7%). The results were compared with results among first-year doctoral students who responded to the same questionnaire during 2010–2017. Results: Overall, 13% of PhDs reported that they knew of people in their immediate research environment who had committed serious forms of scientific dishonesty. A small percentage of PhDs (1.4%) indicated that they themselves had committed such acts. About 3% of the candidates had experienced pressure to commit serious forms of dishonesty and nearly a third of respondents had experienced unethical pressure with respect to authorship during the course of their fellowship. Thirteen percent reported that they had experienced unethical pressure in relation to other forms of dishonesty and 11% had experienced the consequences of some form of scientific dishonesty. Eighteen percent of the respondents believed that one or more actions, which in the literature were perceived as scientific misconduct, were not wrong. We find a connection between attitudes and the perceived research integrity of their research environment. The results also show a difference between PhD students and graduated PhDs in terms of scientific dishonesty. In some areas, the PhDs’ norms are stricter, such as for the use of statistical analysis methods, while there is little change in others, such as in misconduct in order to expedite publications. Conclusion: Many PhDs knew about serious forms of scientific misconduct from the research environment in which they are trained, and some also report misconduct themselves. Some experienced pressure to serious forms of misconduct and a large proportion of the respondents had experienced unethical pressure with respect to authorship during their fellowship. Attitudes change during the PhD studies, but ambiguously. Scientific misconduct seems to be an environmental issue as much as a matter of personal integrity.
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Holm, Søren
(2019).
Let Us Assume That Gene Editing is Safe — The Role of Safety Arguments in the Gene Editing Debate.
Cambridge Quarterly of Healthcare Ethics.
ISSN 0963-1801.
28(1),
s. 100–111.
doi:
10.1017/S0963180118000439.
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This paper provides an analysis of the statement, made in many papers and reports on the use of gene editing in humans, that we should only use the technology when it is safe. It provides an analysis of what the statement means in the context of nonreproductive and reproductive gene editing and argues that the statement is inconsistent with the philosophical commitments of some of the authors, who put it forward in relation to reproductive uses of gene editing, specifically their commitment to Parfitian nonidentity considerations and to a legal principle of reproductive liberty. But, if that is true it raises a question about why the statement is made. What is its discursive and rhetorical function? Five functions are suggested, some of which are more contentious and problematic than others. It is argued that it is possible, perhaps even likely, that the “only when it is safe” rider is part of a deliberate obfuscation aimed at hiding the full implications of the arguments made about the ethics of gene editing and their underlying philosophical justifications.
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Holm, Søren & Hofmann, Bjørn
(2018).
Associations between attitudes towards scientific misconduct and self-reported behavior.
Accountability in Research.
ISSN 0898-9621.
25(5),
s. 290–300.
doi:
10.1080/08989621.2018.1485493.
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We investigate the relationship between doctoral students’ attitudes towards scientific misconduct and their self-reported behavior. 203 questionnaires were distributed to doctoral candidates at the Faculty of Medicine, University of Oslo 2016/2017. The response rate was 74%. The results show a correlation between attitudes towards misconduct and self-reported problematic behaviors among doctoral students in biomedicine. The four most common reported misbehaviors are adding author(s) who did not qualify for authorship (17.9%), collecting more data after seeing that the results were almost statistically significant (11.8%), turning a blind eye to colleagues’ use of flawed data or questionable interpretation of data (11.2%), and reporting an unexpected finding as having been hypothesized from the start (10.5%). We find correlations between scientific misbehavior and the location of undergraduate studies and whether the respondents have had science ethics lectures previously. The study provides evidence for the concurrent validity of the two instruments used to measure attitudes and behavior, i.e. the Kalichman scale and the Research Misbehavior Severity Score (RMSS). Although the direction of causality between attitudes and misbehavior cannot be determined in this study the correlation between the two indicates that it can be important to engender the right attitudes in early career researchers.
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Holm, Søren
(2018).
Mitochondrial Replacement Therapy and Identity: A Comment on an Exchange Between Inmaculada de Melo-Martin and John Harris.
Cambridge Quarterly of Healthcare Ethics.
ISSN 0963-1801.
27(3),
s. 487–491.
doi:
10.1017/S0963180117000883.
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devaney, sarah & Holm, Søren
(2018).
The Transmutation of Deference in Medicine: An Ethico-Legal Perspective.
Medical Law Review.
ISSN 0967-0742.
26(2),
s. 202–224.
doi:
10.1093/medlaw/fwy013.
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This article critically considers the question of whether an increase in legal recognition of patient autonomy culminating in the decision of the Supreme Court in Montgomery v Lanarkshire Health Board in 2015 has led to the death of deference to doctors, not only within the courts and healthcare regulatory arenas in England and Wales but also in the consulting room and the health care system more broadly. We argue that deference has not been eradicated, but that the types of deference paid to doctors and to the medical profession have changed. In addition, whilst traditionally deference was extended towards the medical profession, increasing instances of deference being shown to other parties in the healthcare setting can be identified, allowing wider debate or recognition of the complexity of understandings, interests and aims of all those involved. Finally, we note instances in which deference to the medical profession has become more hidden.
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Ploug, Thomas & Holm, Søren
(2017).
Clinical genome sequencing and population preferences for information about `incidental' findings-From medically actionable genes (MAGs) to patient actionable genes (PAGs).
PLOS ONE.
12(7),
s. 1–13.
doi:
10.1371/journal.pone.0179935.
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Whole genome or exome sequencing is increasingly used in the clinical contexts, and ‘incidental’ findings are generated. There is need for an adequate policy for the reporting of these findings to individuals. Such a policy has been suggested by the American College of Medical Genetics and Genomics (ACMG). We argue that ACMG’s policy is overly paternalistic, and that an adequate policy must take into account population preferences. We conducted a choice based conjoint survey of population preferences for reporting in a representative sample of the Danish population. In a 12 task survey respondents were asked about their preference for reporting in relation to three scenarios with seven different attributes. Of 1200 respondents 66.4% participated. We show that population preferences for reporting differs from ACMG’s recommendations, and suggest a new policy based on both medically and patient actionable genes.
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Ploug, Thomas & Holm, Søren
(2017).
Eliciting meta consent for future secondary research use of health data using a smartphone application - A proof of concept study in the Danish population.
BMC Medical Ethics.
18(51),
s. 1–8.
doi:
10.1186/s12910-017-0209-6.
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Background The increased use of information technology in every day health care creates vast amounts of stored health data that can be used for research. The secondary research use of routinely collected data raises questions about appropriate consent mechanisms for such use. One option is meta consent where individuals state their own consent preferences in relation to future use of their data, e.g. whether they want the data to be accessible to researchers under conditions of specific consent, broad consent, blanket consent or not at all. This study investigates whether meta consent preferences can be successfully elicited by a smartphone application in the adult Danish population. Methods A smartphone app was developed for the elicitation of meta consent preferences. An invitation to use the app was distributed to a stratified, representative sample of the Danish adult population. The meta consent choices, the use of the app, user experience data, and demographic data were logged and analysed statistically using IBM SPSS version 20. Results Of 1000 potential respondents 221 used the app. One hundred eighty-eight of the respondents were female and 103 male. The age range was 19 to 79 years with an average of 51 years (SD 16). Most users indicate 1) that they find the choices they are asked to make easy to understand (>75% find it ‘Easy’ or ‘Very easy’), 2) that the application is easy to use (>75% find it ‘Easy’ or ‘Very easy’), and 3) that this kind of choice should be offered to people (89% find it ‘Absolutely’ or ‘Somewhat’ important). Conclusions It is possible to collect meta consent preferences in the general, adult population using a smartphone app.
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Holm, Søren
(2017).
Authenticity, Best Interest, and Clinical Nudging.
The Hastings center report.
ISSN 0093-0334.
47(2),
s. 38–40.
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Holm, Søren
(2017).
The Bioethicist Who Cried "Synthetic Biology": An Analysis of the Function of Bioterrorism Predictions in Bioethics.
Cambridge Quarterly of Healthcare Ethics.
ISSN 0963-1801.
26(2),
s. 230–238.
doi:
10.1017/S0963180116000827.
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This article analyzes a specter that has haunted bioethics almost since its inception, namely the specter of the misuse of biotechnology by maleficent agents bent on mass destruction, or the complete eradication of human kind and life as we know it. The article provides a general account of why bioethicists cry “catastrophic bioterrorism potential” when new biotechnologies emerge, and an analysis of the arguments that flow from the prediction, especially in relation to synthetic biology.
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Holm, Søren
(2017).
Commentary: Modeling the social Dynamics of moral Enhancement while illustrating some basic divergencies in the Enhancement debate.
Cambridge Quarterly of Healthcare Ethics.
ISSN 0963-1801.
26(3),
s. 446–448.
doi:
10.1017/s0963180116001110.
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The article by Anders Sandberg and Joao Fabiano in this issue of Cambridge Quarterly of Healthcare Ethics is a very important addition to the enhancement literature. It reports an important simulation study of the stability of prosociality in society and at the same time implicitly illustrates some of the enduring uncertainties and divisions in the philosophical enhancement debate that often lead to participants in that debate talking at cross purposes. These come to the surface when reading Sandberg and Fabiano’s article, because specifying the mathematical model requires that terms be defined and operationalized to a degree that is unusual in the philosophical literature. In this brief comment I will outline three such uncertainties or divisions that come to the surface in Sandberg and Fabiano’s article.
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Holm, Søren & Hofmann, Bjørn
(2017).
Investigating the Reliability and Factor
Structure of Kalichman’s “Survey 2:
Research Misconduct” Questionnaire:
A Post Hoc Analysis Among Biomedical
Doctoral Students in Scandinavia.
Journal of Empirical Research on Human Research Ethics.
ISSN 1556-2646.
12(4),
s. 199–205.
doi:
10.1177/1556264617714658.
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A precondition for reducing scientific misconduct is evidence about scientists’ attitudes. We need reliable survey instruments, and this study investigates the reliability of Kalichman’s “Survey 2: research misconduct” questionnaire. The study is a post hoc analysis of data from three surveys among biomedical doctoral students in Scandinavia (2010-2015). We perform reliability analysis, and exploratory and confirmatory factor analysis using a split-sample design as a partial validation. The results indicate that a reliable 13-item scale can be formed (Cronbach’s α = .705), and factor analysis indicates that there are four reliable subscales each tapping a different construct: (a) general attitude to misconduct (α = .768), (b) attitude to personal misconduct (α = .784), (c) attitude to whistleblowing (α = .841), and (d) attitude to blameworthiness/punishment (α = .877). A full validation of the questionnaire requires further research. We, nevertheless, hope that the results will facilitate the increased use of the questionnaire in research.
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Ploug, Thomas & Holm, Søren
(2017).
Informed consent and registry-based research - The case of the Danish circumcision registry.
BMC Medical Ethics.
18(1).
doi:
10.1186/s12910-017-0212-y.
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Background Research into personal health data holds great potential not only for improved treatment but also for economic growth. In these years many countries are developing policies aimed at facilitating such research often under the banner of ‘big data’. A central point of debate is whether the secondary use of health data requires informed consent if the data is anonymised. In 2013 the Danish Minister of Health established a new register collecting data about all ritual male childhood circumcisions in Denmark. The main purpose of the register was to enable future research into the consequences of ritual circumcision. Discussion This article is a study into the case of the Danish Circumcision Registry. We show that such a registry may lead to various forms of harm such as 1) overreaching social pressure, 2) stigmatization, 3) medicalization of a religious practice, 4) discrimination, and 5) polarised research, and that a person may therefore have a strong and legitimate interest in deciding whether or not such data should be collected and/or used in research. This casts doubt on the claim that the requirement of informed consent could and should be waived for all types of secondary research into registries. We finally sketch a new model of informed consent – Meta consent – aimed at striking a balance between the interests in promoting research and at the same time protecting the individual. Summary Research participants may have a strong and legitimate interest in deciding whether or not their data should be collected and used for registry-based research whether or not their data is anonymised.
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Ploug, Thomas & Holm, Søren
(2016).
Meta Consent - A flexible solution to the problem of secondary use of Health data.
Bioethics.
ISSN 0269-9702.
30(9),
s. 721–732.
doi:
10.1111/bioe.12286.
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Glover-Thomas, Nicola & Holm, Søren
(2016).
Compulsory vaccination: Going Beyond a civic duty?
I Stanton, Catherine; devaney, sarah; farrell, Anne-marie & Mullock, Alexandra (Red.),
Pioneering Healthcare Law - Essays in Honour of Margaret Brazier.
Routledge.
ISSN 9781138861091.
s. 31–42.
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Hvidt, Elisabeth; Ploug, Thomas & Holm, Søren
(2016).
The impact of Telephone crisis services on suicidal users: A systematic review of the past 45 years.
Mental Health Review Journal.
ISSN 1361-9322.
doi:
10.1108/MHRJ-07-2015-0019.
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Holm, Søren & Oliva, Javier Garcia
(2016).
Religion and Law in Twenty-First Century England: Tradition and Diversity.
I bottoni, rosella; Cristofori, Rinaldo & Ferrari, Silvio (Red.),
Religious Rules, State Law, and Normative Pluralism - A Comparative Overview.
Springer.
ISSN 9783319283357.
s. 375–393.
doi:
10.1007/978-3-319-28335-7_23.
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Hofmann, Bjørn & Holm, Søren
(2016).
Vitenskapelig uredelighet - kunnskap, handlinger og holdninger hos doktorgradskandidater.
Tidsskrift for Den norske legeforening (Tidsskriftet).
ISSN 0029-2001.
s. 1442–1447.
doi:
10.4045/tidsskr.16.0149.
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Dal-Ré, Rafael & Holm, Søren
(2026).
Would a single centralized ethical review in Europe be feasible for multinational trials in public health emergencies?
European journal of internal medicine.
ISSN 0953-6205.
doi:
10.1016/j.ejim.2026.106949.
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Cohn, Betty; Doerr, Megan; Feliciano, Pamela; Fullerton, Stephanie M.; Hendriks, Saskia & Holm, Søren
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(2025).
Transparency and ongoing communication with participants in brain organoid research: Consensus of an interdisciplinary working group.
Stem Cell Reports.
ISSN 2213-6711.
20(9),
s. 102546–102546.
doi:
10.1016/j.stemcr.2025.102546.
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Stem cell-based models of the human brain benefit from biospecimens that can be used for a broad range of future research. But current
regulations do not address the desire of research participants to remain engaged beyond initial biospecimen donation. We present practicable strategies for engaging participants while preserving scientific potential.
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Eriksen, Mette Brandt; Drachen, Thea Marie; Hofmann, Bjørn Morten; Helgesson, Gert; Juth, Niklas & Holm, Søren
(2024).
Validated instruments for measuring responsible conduct of
research (RCR): a systematic review.
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Lewis, Jonathan; Dranseika, Vilius & Holm, Søren
(2023).
Stop agonising over informed consent when researchers use crowdsourcing platforms to conduct survey research.
Clinical Ethics.
ISSN 1477-7509.
18(4).
doi:
10.1177/14777509231211666.
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Dal-Ré, Rafael; Voo, Teck Chuan & Holm, Søren
(2023).
Leading pharmaceutical companies lacked transparency on clinical trials’ informed consent forms.
Journal of Clinical Epidemiology.
ISSN 0895-4356.
doi:
10.1016/j.jclinepi.2023.08.013.
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Holm, Søren
(2021).
Genetic information, discrimination, philosophical pluralism and politics.
Journal of Medical Ethics.
ISSN 0306-6800.
47(7),
s. 480–481.
doi:
10.1136/medethics-2021-107539.
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In the paper ‘Genetic information, insurance, and a pluralistic approach to justice’, Jonathan Pugh1 develops an argument from unresolved pluralism in our theories of justice, via the pluralism this occasions in relation to the specific question of the use of genetic test results (GTRs) in insurance underwriting, to the conclusion that the UK regulatory approach in relation to the use of GTRs in insurance is broadly correct.1 Pugh’s argument is wide-ranging and I cannot provide a complete critique of it in this short comment, but I will gesture towards some strands of the argument that are potentially problematic. The first potential problem in the argument is that Pugh bases his argument on a very extensive range of accounts of justice, including pure maximising consequentialism (he calls it ‘utilitarianism’), strict egalitarianism and libertarianism, among many others. If these are all accounts of justice, it is not strange that there is pluralism of conclusions in relation to a specific question of justice or discrimination, such as the use of GTRs in the underwriting of specific kinds of insurance contracts. Pugh’s range, for instance, includes accounts of justice that deny the direct importance of distributive concerns as well as accounts that see distributive concerns as crucial. These accounts disagree not only about the answer to Pugh’s question but also about whether taxation is theft, a legislated minimum wage can be justified and many other justice issues that are settled in modern welfare states. This matters because there is an unacknowledged slide in Pugh’s use of the fact of pluralism in his arguments, for example, when he writes,
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Lekstutiene, Jurate; Holm, Søren & Gefenas, Eugenijus
(2021).
Correction to: Biobanks and Individual Health Related Findings: from an Obstacle to an Incentive (Science and Engineering Ethics, (2021), 27, 4, (55), 10.1007/s11948-021-00330-9).
Science and Engineering Ethics.
ISSN 1353-3452.
27(6).
doi:
10.1007/s11948-021-00343-4.
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Wester, Gry; Førde, Reidun; Holm, Søren; Norheim, Ole Frithjof & Solberg, Berge
(2020).
Hvem bør få koronavaksine først?
Tidsskrift for Den norske legeforening (Tidsskriftet).
ISSN 0029-2001.
141(1),
s. 10–10.
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Hofmann, Bjørn Morten & Holm, Søren
(2019).
Research integrity of PhD-candidates in the Scandinavian countries. Results from 6 years of surveys.
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Hofmann, Bjørn Morten & Holm, Søren
(2019).
Research integrity of PhD-candidates in the Scandinavian countries. Results from 6 years of surveys.
6th World Conference on Research Integrity.
O009,
s. 8–8.
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Hofmann, Bjørn & Holm, Søren
(2017).
Scientific misconduct: Knowledge, actions and attitudes amongst Scandinavian doctoral students.
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Holm, Søren & Hofmann, Bjørn
(2017).
Response to Commentary: Investigating the Reliability and Factor Structure of Kalichman's "Survey 2: Research Misconduct" Questionnaire: A Post Hoc Analysis Among Biomedical Doctoral Students in Scandinavia.
Journal of Empirical Research on Human Research Ethics.
ISSN 1556-2646.
12(4),
s. 208–208.
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Feiring, Eli; Førde, Reidun; Holm, Søren; Norheim, Ole Frithjof; Solberg, Berge & Solberg, Carl Tollef
[Vis alle 7 forfattere av denne artikkelen]
(2020).
The Coronavirus Immunisation Programme
Advice on priority groups for coronavirus vaccination in Norway Expert group in ethics and priority setting 15 November 2020.
Folkehelseinstituttet.
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The Norwegian Ministry of Health and Care Services has commissioned the Norwegian Institute of Public Health to organise the national coronavirus immunisationation programme. As a partial delivery of the assignment, the Norwegian Institute of Public Health has established an external expert group in ethics and prioritisation (henceforth: the ethics advisory group). This ethics advisory report describes the external group's working process and conclusions concerning the order of priority of the vaccines in the first phase of the Norwegian Coronavirus Immunisation Programme. The overall objective of this ethics advisory report has been to establish clear goals for what the Coronavirus Immunisation Programme should achieve, as well as to make recommendations for which groups should be given priority in the first phase of the programme. The advisory group has proceeded from values, to goals and lastly to priority categories. The following five values were adopted as the core values to guide prioritisation: equal respect, welfare, equity, trust and legitimacy. Five goals were then proposed and ranked in order of their importance: 1) Reduce the risk of death. 2) Reduce the risk of severe illness. 3) Maintain essential services and critical infrastructure. 4) Protect employment and the economy. 5) re-open society. Based on these values and goals, three categories for prioritisation were established: risk factors for severe illness and death, the infectious situation and occupation. The ethics advisory group has suggested dynamic health priorities based on the Norwegian Government's long-term scenario for the course of the pandemic and recommended that I. risk groups and II. healthcare personnel should be prioritised in pandemic scenarios 1–2a, and that in the event of widespread infection (scenario 2b–), the priority order should instead be I. healthcare personnel, II. risk groups and III. critical societal functions. These three priority groups are in accordance with the values, goals and priority categories proposed by the ethics advisory group in this document. These are preliminary recommendations for the order of priority for coronavirus vaccines in Norway, and the ethics advisory group has taken into account that the recommendations may need to be revised if there are significant changes to the empirical evidence.
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Publisert
12. apr. 2011 16:57
- Sist endret
11. mars 2020 08:50
