Søren Holm

The University of Manchester · Centre for Social Ethics and Policy

Putting a specific value on human life is important in many contexts and forms part of the basis for many political, administrative, commercial, and personal decisions. Sometimes, the value is set explicitly, sometimes even in monetary terms, but much more often, it is set implicitly through a decision that allows us to calculate the valuation of a...

Background Although many people are supportive of their deidentified health care data being used for research, concerns about privacy, safety, and security of health care data remain. There is low awareness about how data are used for research and related governance. Transparency about how health data are used for research is crucial for building p...

BACKGROUND Medical data sharing initiatives are crucial for advancing research, improving patient outcomes, and fostering innovation in healthcare. With the advent of blockchain technology, there has been significant interest in exploring its potential to enhance the security, transparency, and efficiency of medical data sharing. OBJECTIVE This st...

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 t...

This report provides specific proposals—co-created with expert stakeholders—to address the regulatory gaps and areas of over-regulation identified and detailed in our previous deliverable report (Lewis and Holm 2022). It is beyond our remit to supply substantive answers to questions regarding the regulatory gaps or uncertainties (i.e., in the form...

Decentralized autonomous organizations (DAOs) have emerged as a novel governance mechanism that operates through distributed ledgers and smart contracts, enabling members to direct an organization's actions. The widespread adoption of DAOs has occurred in response to their utility in managing emergent semi‐structured projects and has led to the dev...

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 s...

Research ethics committees and institutional review boards spend considerable time developing, scrutinising, and revising specific consent processes and materials for survey-based studies conducted on crowdsourcing and online recruitment platforms such as MTurk and Prolific. However, there is evidence to suggest that many users of ICT services do n...

BACKGROUND Although many people are supportive of their deidentified health care data being used for research, concerns about privacy, safety, and security of health care data remain. There is low awareness about how data are used for research and related governance. Transparency about how health data are used for research is crucial for building p...

Abortion remains a highly controversial issue in many countries and subject to intense public debate. The aim of this chapter is to summarize the most prominent assumptions and arguments concerning the moral and legal dimensions of abortion on which this debate rests. Where the moral justifiability of abortion is concerned, this chapter focuses on...

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...

In response to the COVID-19 pandemic, large-scale research and pharmaceutical regulatory processes have proceeded at a dramatically increased pace with new and effective, evidence-based COVID-19 interventions rapidly making their way into the clinic. However, the swift generation of high-quality evidence and the efficient processing of regulatory a...

Smajdor argues that “recognition” is the solution to the “reifying attitude” that results from “the urge to protect ‘vulnerable’ people through exclusion from research”. Drawing on theories of reification, we argue that it is the concepts of autonomy and vulnerability themselves that have been reified, resulting in the impoverishment of approaches...

“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 p...

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...

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 clini...

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 s...

Background: It is unknown if changes have been made to the original participant's information sheet/informed consent form (PIS/ICF) provided by the WHO Solidarity Plus team when it was transferred to participating countries. Methods: National principal investigators from 30 countries were asked if the original PIS/ICF was edited in their countri...

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 on...

The Covid-19 pandemic has led to an unprecedented acceleration of research. Thousands of papers have been published in a very short time across a wide range of academic disciplines. This has already led to instances of research misconduct and articles have been withdrawn from prominent journals very soon after being published. It has also led to ca...

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 pa...

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...

In the 1970s, both Denmark and Norway passed abortion legislation that is still the basis for the regulation of abortion in these countries. The legislation was fairly liberal with abortion on demand until 12 weeks of gestation and a permission system for later abortions. This article provides a brief history of the developments leading up to these...

In this paper, we argue that patients who are subjects of Artificial Intelligence (AI)-supported diagnosis and treatment planning should have a right to a second opinion, but also that this right should not necessarily be construed as a right to a physician opinion. The right to a second opinion could potentially be satisfied by another independent...

Frailty is a state of increased vulnerability to poor resolution of homeostasis after a stressor event. Frailty is most frequently assessed in the old using the Clinical Frailty Scale (CSF) which ranks frailty from 1 to 9. This assessment typically takes less than one minute and is not validated in patients with learning difficulties or those under...

This report integrates the two maps produced in WP2 (of the organoid and organ-on-a-chip research and patent landscapes) and WP3 (of the regulatory landscape) of the HYBRIDA Project (Grant Agreement No. 101006012). The result is a multi-dimensional “Super Map,” showing which organoid and organoid-related activities are regulated in which ways and b...

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 systemat...

This is the Super Map presented in its original form as a tabular data set. It has been produced by Work Package 6 for the HYBRIDA Project ("Embedding a comprehensive ethical dimension to organoid-based research and resulting technologies") as part of Deliverable 6.1: "Systematic and Structured Gap Analysis". The Super Map is based on an integrat...

Phenomenology gives rise to certain ontological considerations that have far-reaching implications for standard conceptions of patient autonomy in medical ethics, and, as a result, the obligations of and to patients in clinical decision-making contexts. One such consideration is the phenomenological reduction in classical phenomenology, a core feat...

In recent years we have seen the adoption of distributed ledger technology (DLT), originally the mechanism underpinning the operation of the Bitcoin crypto currency, across a wider range of technology sectors including healthcare. DLT allows for the design of informatics systems with the properties of immutability, security, and decentralization. O...

In the debates regarding the ethics of human organoid biobanking, the locus of donor autonomy has been identified in processes of consent. The problem is that, by focusing on consent, biobanking processes preclude adequate engagement with donor autonomy because they are unable to adequately recognise or respond to factors that determine authentic c...

This paper considers the relation between medical ethics (ME) and common morality (CM), professional norms, and moral philosophy. It proceeds by analyzing two recent book-length critical analyses of this relationship by Bob Baker in “The Structure of Moral Revolutions—Studies of Changes in the Morality of Abortion, Death, and the Bioethics Revoluti...

Metadata: European Union (EU); Horizon 2020; Euratom; HYBRIDA; Grant Number: 101006012

The first two oral antivirals, molnupiravir and nirmatrelvir–ritonavir, are now becoming available in many countries. These medicines will be indicated to treat mild-to-moderate COVID-19 in non-hospitalised patients who are at high risk of progressing to severe COVID-19. These antivirals should be prescribed within 5 days of symptom onset, and afte...

The issue of COVID-19 vaccine allocation is still highly controversial on the international as well as on the national level (particularly in many low- and middle-income countries), and policy-makers worldwide struggle in striking a fair balance between different ethical principles of vaccine allocation, in particular maximum benefit, reciprocity,...

Background Certain types of artificial intelligence (AI), that is, deep learning models, can outperform health care professionals in particular domains. Such models hold considerable promise for improved diagnostics, treatment, and prevention, as well as more cost-efficient health care. They are, however, opaque in the sense that their exact reason...

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., N9...

Data providers holding sensitive medical data often need to exchange data pertaining to patients for whom they hold particular data. This involves requesting information from other providers to augment the data they hold. However, revealing the superset of identifiers for which a provider requires information can, in itself, leak sensitive private...

This collection features comprehensive overviews of the various ethical challenges in organ transplantation. International readings well-grounded in the latest developments in the life sciences are organized into systematic sections and engage with one another, offering complementary views. All core issues in the global ethical debate are covered:...

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 underexplore...

Artificial intelligence (AI) systems advising healthcare professionals will be widely introduced into healthcare settings within the next 5–10 years. This paper considers how this will sit with tort/negligence based legal approaches to compensation for medical error. It argues that the introduction of AI systems will provide an additional argument...

Despite the benefits biobanks are expected to bring, there have recently been concerns raised that the public and private non-profit biobanks still prevailing in Europe often fail to reach their initial objectives due to a variety of reasons, including a shortage of funding and insufficient utilization of collections. The necessity to find new ways...

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%...

During 50 years of extracorporeal life support (ECLS), this highly invasive technology has left a considerable imprint on modern medicine, and it still confronts researchers, clinicians and policymakers with multifarious ethical challenges. After half a century of academic discussion about the ethics of ECLS, it seems appropriate to review the stat...

Large-scale deployment of COVID-19 vaccines will seriously affect the ongoing phases 2 and 3 randomised placebo-controlled trials assessing SARS-CoV-2 vaccine candidates. The effect will be particularly acute in high-income countries where the entire adult or older population could be vaccinated by late 2021. Regrettably, only a small proportion of...

Background The areas of Research Ethics (RE) and Research Integrity (RI) are rapidly evolving. Cases of research misconduct, other transgressions related to RE and RI, and forms of ethically questionable behaviors have been frequently published. The objective of this scoping review was to collect RE and RI cases, analyze their main characteristics,...

This article considers the claim that gender diverse minors and their families should not be able to consent to hormonal treatment for gender dysphoria. The claim refers particularly to hormonal treatment with so-called ‘blockers’, analogues that suspend temporarily pubertal development. We discuss particularly four reasons why consent may be deeme...

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 exception...

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...

BACKGROUND Certain types of artificial intelligence (AI), that is, deep learning models, can outperform health care professionals in particular domains. Such models hold considerable promise for improved diagnostics, treatment, and prevention, as well as more cost-efficient health care. They are, however, opaque in the sense that their exact reason...

In the view of many, heritable human genome editing (HHGE) harbors the remedial potential of ridding the world of deadly genetic diseases. A Hippocratic obligation, if there ever was one, HHGE is widely viewed as a life-sustaining proposition. The national go/no-go decision regarding the implementation of HHGE, however, must not, in the collective...

https://www.fhi.no/publ/2020/rad-om-prioriterte-grupper-for-koronavaksinasjon-i-norge/ Folkehelseinstituttet har fått i oppdrag fra Helse- og omsorgsdepartementet å organisere koronavaksinasjonsprogrammet. Som en delleveranse av oppdraget har Folkehelse- instituttet etablert en ekstern ekspertgruppe i etikk og prioritering. Denne etikk- rådgivning...

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...

Pre-diabetes is a risk factor for the development of diabetes, not a disease in its own right. The prevalence increases with age and reaches nearly 50% of those aged over 75 years in the USA. While lifestyle modification and treatment are likely to benefit those with many years of life ahead of them, they are unlikely to benefit patients with a lim...

The concept of solidarity has received increasing attention in discussions about public health interventions, both as a possible justification for such interventions and as a possible motivating factors for individual action. This chapter provides an analysis of whether thinking through a lens of solidarity is likely to be helpful in devising strat...

Current guidelines to predicting 'poor' neurological outcome in post-arrest unconscious adults have not previously been analyzed in detail and, authoritative guidance to prediction of 'good' neuroprognosis does not exist. A narrative appraisal of guideline statements and presented clinical indices of 'poor' neuroprognosis and, a systematic review...

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, a...

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. T...

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 mi...

The problem of the explainability of AI decision-making has attracted considerable attention in recent years. In considering AI diagnostics we suggest that explainability should be explicated as ‘effective contestability’. Taking a patient-centric approach we argue that patients should be able to contest the diagnoses of AI diagnostic systems, and...

This chapter considers a number of ethical issues that are raised by sedation at the end of life (also known as palliative sedation or terminal sedation). The first sections consider terminology and whether or not some sedation practices are life-shortening. Later sections analyse whether all kinds of suffering are valid indications for sedation at...

Abstract Background The utility and timing of current guidelines to predicting 'poor' neurological outcome in post-arrest unconscious adults have not been analysed in detail. Authoritative guidance to 'good' outcome prediction does not exist. Methods Narrative appraisal of Guideline statements and acknowledged clinical signs of 'poor' neuropro...

Should doctors shove their patients to choose in ways that are aligned with the patients' desired goals, when the patients' choices go wrong because of magical beliefs? I argue that doctors should not shove their patients in this way, but push them towards better and more reflective decision making. We can do this by nudging techniques or by more d...

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...

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 a...

In this response to Neil Manson’s latest intervention in our debate about the best consent model for biobank research we show, contra Manson that the ‘expiry problem’ that affects broad consent models because of changes over time in methods, purposes, types of data used and governance structures is a real and significant problem. We further show th...

For more than 25 years, research misconduct (research fraud) is defined as fabrication, falsification, or plagiarism (FFP)—although other research misbehaviors have been also added in codes of conduct and legislations. A critical issue in deciding whether research misconduct should be subject to criminal law is its definition, because not all behav...