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This paper describes a dataset consisting of 47 hyperspectral-reflectance measurements of plastic litter samples. The plastic litter samples include virgin and real samples from the Port of Antwerp. They were measured in dry conditions in the Flemish Institute for Technological Research (VITO) calibration facility, and a selection of the samples were also measured in wet conditions and submerged in a water tank at Flanders Hydraulics. The construction on top of the tank allowed us to submerge the plastics and keep sediments in suspension. The spectral measurements were performed using an Analytical Spectral Devices (ASD) FieldSpec 4 and a Spectral Evolution (SEV) spectrometer. The datasets are available on the 4TU.ResearchData open-access repository (ASD dataset: https://doi.org/10.4121/12896312.v2, Knaeps et al., 2020; SEV dataset: https://doi.org/10.4121/uuid:9ee3be54-9132-415a-aaf2-c7fbf32d2199; Garaba et al., 2020).

Abstract Background Notwithstanding fears of overly permissive approaches and related pleas to refuse euthanasia for psychological suffering, some Belgian hospitals have declared that such requests could be admissible. However, some of these hospitals have decided that such requests have to be managed and carried out outside their walls. Main text Ghent University Hospital has developed a written policy regarding requests for euthanasia for psychological suffering coming from patients from outside the hospital. The protocol stipulates several due care criteria that go beyond the requirements of the Belgian Euthanasia Law. For instance, the legally required first and second consulted physicians should all be psychiatrists and be affiliated with a psychiatry department of a Flemish university hospital. Moreover, euthanasia for psychological suffering can only be performed if the advices of these consulted physicians are positive. Importantly, preliminary reflection by the multidisciplinary Hospital Ethics Committee was introduced to discuss every request for euthanasia for psychological suffering coming from outside the hospital. Conclusion In this way, the protocol supports psychiatrists faced with the complexities of assessing such requests, improves the quality of euthanasia practice by ensuring transparency and uniformity, and offers patients specialised support and guidance during their euthanasia procedure. Nevertheless, some concerns still remain (e.g. relating to possible unrealistic patient expectations and to the absence of aftercare for the bereaved or for patients whose requests have been refused).

The SeaSWIR dataset consists of 137 ASD (Analytical Spectral Devices, Inc.) marine reflectances, 137 total suspended matter (TSM) measurements and 97 turbidity measurements gathered at three turbid estuarine sites (Gironde, La Plata, Scheldt). The dataset is valuable because of the high-quality measurements of the marine reflectance in the Short Wave InfraRed I region (SWIR-I: 1000–1200 nm) and SWIR-II (1200–1300 nm) and because of the wide range of TSM concentrations from 48 up to 1400 mg L−1. The ASD measurements were gathered using a detailed measurement protocol and were subjected to a strict quality control. The SeaSWIR marine reflectance is characterized by low reflectance at short wavelengths ( The SeaSWIR dataset has been made publicly available (https://doi.org/10.1594/PANGAEA.886287).

Image correction for atmospheric effects (iCOR) is an atmospheric correction tool that can process satellite data collected over coastal, inland or transitional waters and land. The tool is adaptable with minimal effort to hyper- or multi-spectral radiometric sensors. By using a single atmospheric correction implementation for land and water, discontinuities in reflectance within one scene are reduced. iCOR derives aerosol optical thickness from the image and allows for adjacency correction, which is SIMilarity Environmental Correction (SIMEC) over water. This paper illustrates the performance of iCOR for Landsat-8 OLI and Sentinel-2 MSI data acquired over water. An intercomparison of water leaving reflectance between iCOR and Aerosol Robotic Network – Ocean Color provided a quantitative assessment of performance and produced coefficient of determination (R2) higher than 0.88 in all wavebands except the 865 nm band. For inland waters, the SIMEC adjacency correction improved results in the red-edge and near-infrared region in relation to optical in situ measurements collected during field campaigns.

Earth surfaces, such as deserts, salt lakes, and playas, have been widely used in the vicarious radiometric calibration of optical earth observation satellites. In 2009, the Infrared and Visible Optical Sensors (IVOS) sub-group of the Committee of Earth Observation Satellites (CEOS) Working Group on Calibration and Validation (WGCV) designated eight LANDNET reference sites to focus international efforts, facilitate traceability and enable the establishment of measurement "best practices." With support from the European Space Agency (ESA), one of the LANDNET sites, the Tuz Gölü salt lake located in central Turkey, was selected to host a cross-comparison of measurement instrumentation and methodologies conducted by 11 different ground teams across the globe. This paper provides an overview of the preliminary results of the cross-comparison of the ground-based spectral measurements made during the CEOS Land Comparison 13-27 August, 2010 with the simultaneous satellite image data acquisitions of the same site.

Background: In Belgium, termination of pregnancy after the first trimester is exclusively allowed on medical grounds. When faced with fetal or maternal health complications during pregnancy, patients typically turn to obstetricians for guidance on the diagnosis, prognosis, and available options. Patients' decisions and their actual access to termination of pregnancy can be profoundly influenced by the quality of this counselling and the willingness of professionals to present termination as an acceptable option. This paper aims to explore the factors influencing obstetricians' acceptance of TOP requests after the first trimester of pregnancy. We subsequently analyze these acceptance dynamics from a multidisciplinary angle, incorporating ethical perspectives and a socio-legal exploration into how the interviewed health professionals experience, interpret, and apply the law., Methods: We conducted an interview study with 23 hospital obstetricians who had prior experience with termination of pregnancy decision-making beyond the first trimester in Flanders, Belgium. Interviews, on average, lasted 1h30 and followed a semi-structured format guided by a topic guide. The transcripts were coded with NVivo software and subsequently thematically analyzed by a multidisciplinary research team to provide a comprehensive understanding of obstetricians' acceptance of termination of pregnancy after the first trimester., Results: Obstetricians' acceptance of termination of pregnancy after the first trimester mainly depends on the presence of compelling clinical factors. Secondary factors, including patient/couple preferences, institutional and collegial processes, timing and viability, technical considerations, obstetricians' ethical and professional values, the wider background of the patient/couple, and perception of alternatives, could sway decisions in the absence of compelling clinical factors., Conclusions: Secondary factors help sway obstetricians' decisions in favor of or against termination of pregnancy after 12 weeks when a request is characterized by inconclusive clinical factors. The multifactorial acceptance dynamics of obstetricians illustrate the limits of a strong emphasis on fetal interest argumentation. Moreover, they exhibit a degree of divergence and complexity absent from the Belgian Abortion Law. The presented typology of factors could stimulate and guide debates on legal reform and the importance that should be attributed to various factors in professional decision-making on termination of pregnancy., Competing Interests: Declarations. Ethics approval and consent to participate: We obtained each participant’s written informed consent and ethical approval to conduct this study from the Ethics Committee of the University Hospital of Ghent (UZ) and the University Hospital of Antwerp (UZA). The study adheres to the Helsinki Declaration regarding ‘Ethical Principles for Medical Research Involving Human Participants’. Consent for publication: Not applicable. Competing interests: The authors declare no competing interests., (© 2025. The Author(s).)

Background: Hepato-Pancreato-Biliary (HPB) surgery is a complex specialty and Artificial Intelligence (AI) applications have the potential to improve pre- intra- and postoperative outcomes of HPB surgery. While ethics guidelines have been developed for the use of AI in clinical surgery, the ethical implications and reliability of AI in HPB surgery remain specifically unexplored., Methods: An online survey was developed by the Innovation Committee of the E-AHPBA to investigate the current perspectives on the ethical principles and trustworthiness of AI in HPB Surgery among E-AHPBA membership. The survey consisted of 22 questions, based on guidelines outlined by the Artificial Intelligence Surgery Journal Task Force on AI Ethics in clinical surgery and was disseminated via email to all E-AHPBA members., Results: A total of 84 members of the E-AHPBA participated in the survey. Seventeen out of 22 questions achieved more than 80 % agreement, with nine of those exceeding 90 %. Five questions had agreement levels between 70 % and 80 %., Conclusion: While HPB surgeons are aware of the need to regulate the use of AI devices, robots, and to protect patient data, consensus appears to be heterogeneous regarding AI's role in mitigating gender-related and minority biases, as well as ensuring fairness and equity., (Copyright © 2024 International Hepato-Pancreato-Biliary Association Inc. Published by Elsevier Ltd. All rights reserved.)

This paper explores recently emerging challenges in Medical Assistance in Dying on Psychiatric Grounds (MAID-PG), focusing on ethical, clinical, and societal perspectives. Two themes are explored. First, the growing number of young MAID-PG requestors and the public platform given to MAID-PG requests. Ethically, media portrayal, particularly of young patients' testimonials, requires scrutiny for oversimplification, acknowledging the potential for a Werther effect alongside the absence of a Papageno effect. This highlights the need for better communication policies for media purposes. Second, cautionary considerations regarding psychiatric care adequacy are addressed. In MAID-PG this includes reasons underlying psychiatrist reluctance to engage in MAID-PG trajectories, leading to growing waiting lists at end-of-life-care centers. Addressing current shortages in psychiatric care adequacy is crucial, necessitating less narrow focus on short-term care trajectories and recovery beside transdiagnostic treatment approaches, expanded palliative care strategies, and integrated MAID-PG care., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Verhofstadt, Marijnissen, Creemers, Rasing, Schweren, Sterckx, Titeca, van Veen and Pronk.)

Background and Objectives: Defining the optimal moment to start renal replacement therapy (RRT) in acute kidney injury (AKI) remains challenging. Multiple randomized controlled trials (RCTs) addressed this question whilst using absolute criteria such as pH or serum potassium. However, there is a need for identification of the most optimal cut-offs of these criteria. We conducted a causal analysis on routinely collected data (RCD) to compare the impact of different pre-specified dynamic treatment regimes (DTRs) for RRT initiation based on time-updated levels of potassium, pH, and urinary output on 30-day ICU mortality., Design, Setting, Participants, and Measurements: Patients in the ICU of Ghent University Hospital were included at the time they met KDIGO-AKI-stage ≥ 2. We applied inverse-probability-of-censoring-weighted Aalen-Johansen estimators to evaluate 30-day survival under 81 DTRs prescribing RRT initiation under different thresholds of potassium, pH, or persisting oliguria., Results: Out of 13,403 eligible patients (60.8 ± 16.8 years, SOFA 7.0 ± 4.1), 5622 (63.4 ± 15.3 years, SOFA 8.2 ± 4.2) met KDIGO-AKI-stage ≥ 2. The DTR that delayed RRT until potassium ≥ 7 mmol/l, persisting oliguria for 24-36 h, and/or pH < 7.0 (non-oliguric) or < 7.2 (oliguric) despite maximal conservative treatment resulted in a reduced 30-day ICU mortality (from 12.7% [95% CI 11.9-13.6%] under current standard of care to 10.5% [95% CI 9.5-11.7%]; risk difference 2.2% [95% CI 1.3-3.8%]) with no increase in patients starting RRT (from 471 [95% CI 430-511] to 475 [95% CI 342-572]). The fivefold cross-validation benchmark for the optimal DTR resulted in 30-day ICU mortality of 10.7%., Conclusions: Our causal analysis of RCD to compare RRT initiation at different thresholds of refractory low pH, high potassium, and persisting oliguria identified a DTR that resulted in a decrease in 30-day ICU mortality without increase in number of RRTs. Our results suggest that the current criteria to start RRT as implemented in most RCTs may be suboptimal. However, as our analysis is hypothesis generating, this optimal DTR should ideally be validated in a multicentric RCT., (© 2022. The Author(s).)

This article explores whether 'digital pills' that track medication intake should be used to enhance adherence. We concentrate on psychiatric conditions since these pose unique challenges. We analyze two public policies that potentially encourage the development of systems for remote monitoring of intake, namely the granting of patents and marketing authorization, and identify key stakeholders and their main interests so as to discuss whether these policies provide disproportionate benefits to some. The stakeholders identified are patients, system providers, drug manufacturers, insurers or healthcare systems, physicians, data users, and society at large. We discuss relevant industry reports, regulatory data, patent documents, and academic literature, and argue that there is concern that the drivers for these tracking systems are revenue and the monitoring of 'compliance' rather than 'adherence'. While accepting that the use of these systems can be justified in some circumstances, in our view these systems pose risks to patient autonomy, Shared Decision-Making, and privacy. We also find that policies on granting patents and marketing authorization overly favor the commercial actors and put patients' interests at risk. Accordingly, we propose that additional safeguards are required., (© The Author(s) 2022. Published by Oxford University Press on behalf of Duke University School of Law, Harvard Law School, Oxford University Press, and Stanford Law School. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

The combination of "Big Data" and Artificial Intelligence (AI) is frequently promoted as having the potential to deliver valuable health benefits when applied to medical decision-making. However, the responsible adoption of AI-based clinical decision support systems faces several challenges at both the individual and societal level. One of the features that has given rise to particular concern is the issue of explainability, since, if the way an algorithm arrived at a particular output is not known (or knowable) to a physician, this may lead to multiple challenges, including an inability to evaluate the merits of the output. This "opacity" problem has led to questions about whether physicians are justified in relying on the algorithmic output, with some scholars insisting on the centrality of explainability, while others see no reason to require of AI that which is not required of physicians. We consider that there is merit in both views but find that greater nuance is necessary in order to elucidate the underlying function of explainability in clinical practice and, therefore, its relevance in the context of AI for clinical use. In this paper, we explore explainability by examining what it requires in clinical medicine and draw a distinction between the function of explainability for the current patient versus the future patient. This distinction has implications for what explainability requires in the short and long term. We highlight the role of transparency in explainability, and identify semantic transparency as fundamental to the issue of explainability itself. We argue that, in day-to-day clinical practice, accuracy is sufficient as an "epistemic warrant" for clinical decision-making, and that the most compelling reason for requiring explainability in the sense of scientific or causal explanation is the potential for improving future care by building a more robust model of the world. We identify the goal of clinical decision-making as being to deliver the best possible outcome as often as possible, and find-that accuracy is sufficient justification for intervention for today's patient, as long as efforts to uncover scientific explanations continue to improve healthcare for future patients., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Pierce, Van Biesen, Van Cauwenberge, Decruyenaere and Sterckx.)

Background: Belgium is one of very few countries that legally allow euthanasia for suffering caused by psychiatric illness. In the first criminal trial in Belgium of physicians involved in euthanasia, three physicians recently faced the accusation of "murder by poisoning," for allegedly having failed to comply with several requirements of the Belgian Euthanasia Law in granting the euthanasia request a woman suffering from psychiatric illness. Although all three physicians were acquitted, the case generated much debate among policy makers, medical professionals, and the general public., Method: We use this trial as the starting point for a critical analysis of the adequacy of the three-level control system established in the Euthanasia Law, as it is applied in the evaluation of euthanasia requests from persons who suffer unbearably from a psychiatric illness. This analysis is based on information presented during the criminal trial as well as information on the euthanasia that was published in the press., Results: Our analysis highlights substantial problems in the assessment and granting of the euthanasia request. The patient was euthanized without it having been substantiated that her psychiatric illness had no prospect of improvement and that her suffering could not be alleviated. The three-step control system enshrined in the Law and promoted by the Federal Control and Evaluation Commission for Euthanasia appears to have failed at each level., Conclusion: To evaluate requests for euthanasia for mental suffering caused by psychiatric illness, the requirements of the Belgian Euthanasia Law should be complemented by mandating the advice of two psychiatrists, and face-to-face discussions between all physicians involved. In parallel with the process of evaluating the euthanasia request, a treatment track should be guaranteed where reasonable evidence-based treatments and recovery-oriented options are tried., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 De Hert, Loos, Sterckx, Thys and Van Assche.)

Background: There is increasing interest in incorporating clinical decision support (CDS) into electronic healthcare records (EHR). Successful implementation of CDS systems depends on acceptance of them by healthcare workers. We used a mix of quantitative and qualitative methods starting from Qsort methodology to explore expectations and perceptions of practicing physicians on the use of CDS incorporated in EHR., Methods: The study was performed in a large tertiary care academic hospital. We used a mixed approach with a Q-sort based classification of pre-defined reactions to clinical case vignettes combined with a thinking-aloud approach, taking into account COREQ recommendations The open source software of Ken-Q Analysis version 1.0.6. was used for the quantitative analysis, using principal components and a Varimax rotation. For the qualitative analysis, a thematic analysis based on the four main themes was performed based on the audiotapes and field notes., Results: Thirty physicians were interviewed (7 in training, 8 junior staff and 15 senior staff; 16 females). Nearly all respondents were strongly averse towards interruptive messages, especially when these also were obstructive. Obstructive interruption was considered to be acceptable only when it increases safety, is adjustable to user expertise level and/or allows deviations when the end-user explains why a deviation is desirable in the case at issue. Transparency was deemed an essential feature, which seems to boil down to providing sufficient clarification on the factors underlying the recommendations of the CDS, so that these can be compared against the physicians' existing knowledge, beliefs and convictions., Conclusion: Avoidance of disruptive workflows and transparency of the underlying decision processes are important points to consider when developing CDS systems incorporated in EHR., (© 2022. The Author(s).)

Research regarding the drivers of acceptance of clinical decision support systems (CDSS) by physicians is still rather limited. The literature that does exist, however, tends to focus on problems regarding the user-friendliness of CDSS. We have performed a thematic analysis of 24 interviews with physicians concerning specific clinical case vignettes, in order to explore their underlying opinions and attitudes regarding the introduction of CDSS in clinical practice, to allow a more in-depth analysis of factors underlying (non-)acceptance of CDSS. We identified three general themes from the results. First, 'the perceived role of the AI', including items referring to the tasks that may properly be assigned to the CDSS according to the respondents. Second, 'the perceived role of the physician', referring to the aspects of clinical practice that were seen as being fundamentally 'human' or non-automatable. Third, 'concerns regarding AI', including items referring to more general issues that were raised by the respondents regarding the introduction of CDSS in general and/or in clinical medicine in particular. Apart from the overall concerns expressed by the respondents regarding user-friendliness, we will explain how our results indicate that our respondents were primarily occupied by distinguishing between parts of their job that should be automated and aspects that should be kept in human hands. We refer to this distinction as 'the division of clinical labor.' This division is not based on knowledge regarding AI or medicine, but rather on which parts of a physician's job were seen by the respondents as being central to who they are as physicians and as human beings. Often the respondents' view that certain core parts of their job ought to be shielded from automation was closely linked to claims concerning the uniqueness of medicine as a domain. Finally, although almost all respondents claimed that they highly value their final responsibility, a closer investigation of this concept suggests that their view of 'final responsibility' was not that demanding after all., (© 2022. The Author(s).)

The use of artificial intelligence (AI) in healthcare comes with opportunities but also numerous challenges. A specific challenge that remains underexplored is the lack of clear and distinct definitions of the concepts used in and/or produced by these algorithms, and how their real world meaning is translated into machine language and vice versa, how their output is understood by the end user. This "semantic" black box adds to the "mathematical" black box present in many AI systems in which the underlying "reasoning" process is often opaque. In this way, whereas it is often claimed that the use of AI in medical applications will deliver "objective" information, the true relevance or meaning to the end-user is frequently obscured. This is highly problematic as AI devices are used not only for diagnostic and decision support by healthcare professionals, but also can be used to deliver information to patients, for example to create visual aids for use in shared decision-making. This paper provides an examination of the range and extent of this problem and its implications, on the basis of cases from the field of intensive care nephrology. We explore how the problematic terminology used in human communication about the detection, diagnosis, treatment, and prognosis of concepts of intensive care nephrology becomes a much more complicated affair when deployed in the form of algorithmic automation, with implications extending throughout clinical care, affecting norms and practices long considered fundamental to good clinical care., (© 2021 The Authors. Bioethics published by John Wiley & Sons Ltd.)

In 2017, regulatory approval was given in the US for a 'digital pill', a pill for which actual ingestion could be remotely monitored. The pill, Abilify Mycite is marketed by Otsuka but the monitoring system derives from Proteus Digital Health. In this paper, we focus on this digital pill and another equivalent system from AiCure which relies on facial recognition. Both systems not only remind the patient to take a pill but also verify the actual intake. In this process, patient-related data beyond the fact that the pill has been taken are also collected and sent to a remote computer system of the system-providing company and possibly to third parties.Although marketed as 'innovative', the introduction of such systems raises questions as to the limitation of patient autonomy, secondary uses of patient data, impact on the physician's liability, and artificial inflation of drug prices. Whereas incorrect medication taking can be problematic, it can be questioned whether remote intake-monitoring systems are, from an ethical, legal and social perspective, the ideal way to address this. In this paper, we will reflect on this question from the position of the different potential stakeholders involved.

While at least 8 million tons of plastic litter are ending up in our oceans every year and research on marine litter detection is increasing, the spectral properties of wet as well as submerged plastics in natural marine environments are still largely unknown. Scientific evidence-based knowledge about these spectral characteristics has relevance especially to the research and development of future remote sensing technologies for plastic litter detection. In an effort to bridge this gap, we present one of the first studies about the hyperspectral reflectances of virgin and naturally weathered plastics submerged in water at varying suspended sediment concentrations and depth. We also conducted further analyses on the different polymer types such as Polyethylene terephthalate (PET), Polypropylene (PP), Polyester (PEST) and Low-density polyethylene (PE-LD) to better understand the effect of water absorption on their spectral reflectance. Results show the importance of using spectral wavebands in both the visible and shortwave infrared (SWIR) spectrum for litter detection, especially when plastics are wet or slightly submerged which is often the case in natural aquatic environments. Finally, we demonstrate in an example how to use the open access data set driven from this research as a reference for the development of marine litter detection algorithms.

Over the last decades, the face of health care has changed dramatically, with big improvements in what is technically feasible. However, there are indicators that the current approach to evaluating evidence in health care is not holistic and hence in the long run, health care will not be sustainable. New conceptual and normative frameworks for the evaluation of health care need to be developed and investigated. The current paper presents a novel framework of justifiable health care and explores how the use of artificial intelligence and big data can contribute to achieving the goals of this framework.

In 2002 with the passing of the Euthanasia Law, Belgium became one of the few countries worldwide to legalize euthanasia. In the 18 years since the passing of the law, much has changed. We argue that in Belgium a widening of the use of euthanasia is occurring and that this can be ethically and legally problematic. This is in part related to the fact that several legal requirements intended to operate as safeguards and procedural guarantees in reality often fail to operate as such. We focus on three kinds of safeguards or procedural guarantees: (1) the legally defined due care criteria for eligibility for euthanasia; (2) the consultation of a second (and sometimes third) physician; and (3) the reporting of euthanasia cases to the Federal Control and Evaluation Commission for Euthanasia. We will show how each of these three safeguards can exhibit shortcomings in theory and practice., (© The Author(s) 2021. Published by Oxford University Press, on behalf of the Journal of Medicine and Philosophy Inc. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Euthanasia and physician assisted suicide (E/PAS) in the context of unbearable psychological or emotional suffering related to psychiatric disorders (psychiatric E/PAS) is ahighly debated topic. In Belgium and The Netherlands, the law allows for psychiatric E/PAS since 2002. The aim of this article is to give an overview of the Belgian and Dutch experiences and the questions raised during the last decade of real-life experiences with psychiatric E/PAS. We use the available national data on psychiatric E/PAS to present a quantitative overview of the current situation. In addition, we identified different challenges; i.e. ethical, medicalpsychiatric and legal, that increasingly impact and change the attitudes within the medical and psychiatric professional community towards psychiatric E/PAS.

In 2014, the Belgian Euthanasia Law was amended so as to extend the possibility of obtaining euthanasia to minors who have the capacity for discernment. The amendment led to considerable debate among Belgian legal experts, health care professionals and ethicists, in large part due to concerns about the scope and assessment of the minor's 'capacity for discernment', a concept first introduced in Belgian medical law by the amendment. This article offers a critical legal analysis of the concept of 'capacity for discernment' and its implications for euthanasia practice in Belgium. We do so by focusing on a ruling of the Belgian Constitutional Court of 29 October 2015, where the concept figured prominently in the examination of the constitutionality of the amendment. This approach also allows us to shed light on the interpretation of several core aspects of the original 2002 Euthanasia Law and its 2014 amendment., (© The Author(s) 2018. Published by Oxford University Press; All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Background: Since Belgium legalised euthanasia, the number of performed euthanasia cases for psychological suffering in psychiatric patients has significantly increased, as well as the number of media reports on controversial cases. This has prompted several healthcare organisations and committees to develop policies on the management of these requests., Method: Five recent initiatives that offer guidance on euthanasia requests by psychiatric patients in Flanders were analysed: the protocol of Ghent University Hospital and advisory texts of the Flemish Federation of Psychiatry, the Brothers of Charity, the Belgian Advisory Committee on Bioethics, and Zorgnet-Icuro. These were examined via critical point-by-point reflection, focusing on all legal due care criteria in order to identify: 1) proposed measures to operationalise the evaluation of the legal criteria; 2) suggestions of additional safeguards going beyond these criteria; and 3) remaining fields of tension., Results: The initiatives are well in keeping with the legal requirements but are often more stringent. Additional safeguards that are formulated include the need for at least two positive advices from at least two psychiatrists; an a priori evaluation system; and a two-track approach, focusing simultaneously on the assessment of the patient's euthanasia request and on that person's continuing treatment. Although the initiatives are similar in intent, some differences in approach were found, reflecting different ethical stances towards euthanasia and an emphasis on practical clinical assessment versus broad ethical reflection., Conclusions: All initiatives offer useful guidance for the management of euthanasia requests by psychiatric patients. By providing information on, and proper operationalisations of, the legal due care criteria, these initiatives are important instruments to prevent potential abuses. Apart from the additional safeguards suggested, the importance of a decision-making policy that includes many actors (e.g. the patient's relatives and other care providers) and of good aftercare for the bereaved are rightly stressed. Shortcomings of the initiatives relate to the aftercare of patients whose euthanasia request is rejected, and to uncertainty regarding the way in which attending physicians should manage negative or conflicting advices, or patients' suicide threats in case of refusal. Given the scarcity of data on how thoroughly and uniformly requests are handled in practice, it is unclear to what extent the recommendations made in these guidelines are currently being implemented., (Copyright © 2019 The Authors. Published by Elsevier Ltd.. All rights reserved.)

In 2012, a new and promising gene manipulation technique, CRISPR-Cas9, was announced that seems likely to be a foundational technique in health care and agriculture. However, patents have been granted. As with other technological developments, there are concerns of social justice regarding inequalities in access. Given the technologies' "foundational" nature and societal impact, it is vital for such concerns to be translated into workable recommendations for policymakers and legislators. Colin Farrelly has proposed a moral justification for the use of patents to speed up the arrival of technology by encouraging innovation and investment. While sympathetic to his argument, this article highlights a number of problems. By examining the role of patents in CRISPR and in two previous foundational technologies, we make some recommendations for realistic and workable guidelines for patenting and licensing.

Advancements in the field of biotechnology have accelerated the development of drugs that are manufactured from cultures of living cells, commonly referred to as "biologics." Due to the complexity of the production process, generic biologics are unlikely to be chemically identical to the reference product, and accordingly are referred to as "biosimilars." Encouraging the development of biosimilars has been presented as the key solution to decrease prices and increase access to biologics, but the development and use of biosimilars continues to raise problems, none of which can easily be addressed. Developing a biosimilar requires considerable time and financial resources, and legitimate safety concerns necessitate elaborate clinical testing of biosimilars. As a consequence, the introduction of biosimilars onto the market has not resulted in significant price reductions, and concerns regarding the substitution and interchangeability of original biologics with biosimilars persist. This article will explain how the biologics production process distorts the trade-offs that traditionally guided both patent protection and regulatory exclusivities: disclosure as a key condition for benefiting from the corresponding monopoly position. Hence, we propose establishing a mechanism of mandatory deposit of the original biologic's cell line at the stage of the regulatory approval as the most effective remedy.

Rapid advances in microarray and sequencing technologies are making genotyping and genome sequencing more affordable and readily available. There is an expectation that genomic sequencing technologies improve personalized diagnosis and personalized drug therapy. Concurrently, provision of direct-to-consumer genetic testing by commercial providers has enabled individuals' direct access to their genomic data. The expanded availability of genomic data is perceived as influencing the relationship between the various parties involved including healthcare professionals, researchers, patients, individuals, families, industry, and government. This results in a need to revisit their roles and responsibilities. In a 1-day agenda-setting meeting organized by the COST Action IS1303 "Citizen's Health through public-private Initiatives: Public health, Market and Ethical perspectives," participants discussed the main challenges associated with the expanded availability of genomic information, with a specific focus on public-private partnerships, and provided an outline from which to discuss in detail the identified challenges. This paper summarizes the points raised at this meeting in five main parts and highlights the key cross-cutting themes. In light of the increasing availability of genomic information, it is expected that this paper will provide timely direction for future research and policy making in this area.

The introduction of Web 2.0 technology, along with a population increasingly proficient in Information and Communications Technology (ICT), coupled with the rapid advancements in genetic testing methods, has seen an increase in the presence of participant-centred research initiatives. Such initiatives, aided by the centrality of ICT interconnections, and the ethos they propound seem to further embody the ideal of increasing the participatory nature of research, beyond what might be possible in non-ICT contexts alone. However, the majority of such research seems to actualise a much narrower definition of 'participation'-where it is merely the case that such research initiatives have increased contact with participants through ICT but are otherwise non-participatory in any important normative sense. Furthermore, the rhetoric of participant-centred initiatives tends to inflate this minimalist form of participation into something that it is not, i.e. something genuinely participatory, with greater connections with both the ICT-facilitated political contexts and the largely non-ICT participatory initiatives that have expanded in contemporary health and research contexts. In this paper, we highlight that genuine (ICT-based) 'participation' should enable a reasonable minimum threshold of participatory engagement through, at least, three central participatory elements: educative, sense of being involved and degree of control. While we agree with criticisms that, at present, genuine participation seems more rhetoric than reality, we believe that there is clear potential for a greater ICT-facilitated participatory engagement on all three participatory elements. We outline some practical steps such initiatives could take to further develop these elements and thereby their level of ICT-facilitated participatory engagement.

Since the adoption of the WTO-TRIPS Agreement in 1994, there has been significant controversy over the impact of pharmaceutical patent protection on the access to medicines in the developing world. In addition to the market exclusivity provided by patents, the pharmaceutical industry has also sought to further extend their monopolies by advocating the need for additional 'regulatory' protection for new medicines, known as data exclusivity. Data exclusivity limits the use of clinical trial data that need to be submitted to the regulatory authorities before a new drug can enter the market. For a specified period, generic competitors cannot apply for regulatory approval for equivalent drugs relying on the originator's data. As a consequence, data exclusivity lengthens the monopoly for the original drug, impairing the availability of generic drugs. This article illustrates how the pharmaceutical industry has convinced the US and the EU to impose data exclusivity on their trade partners, many of them developing countries. The key arguments formulated by the pharmaceutical industry in favor of adopting data exclusivity and their underlying ethical assumptions are described in this article, analyzed, and found to be unconvincing. Contrary to industry's arguments, it is unlikely that data exclusivity will promote innovation, especially in developing countries. Moreover, the industry's appeal to a property rights claim over clinical test data and the idea that data exclusivity can prevent the generic competitors from 'free-riding' encounters some important problems: Neither legitimize excluding all others., (© 2016 The Authors Developing World Bioethics Published by John Wiley & Sons Ltd.)

In this piece, we comment on the article by Pearce earlier in this journal. As Pearce correctly points out, what is fundamentally at issue in ESHRE et al's opposition to Stanford University's European patent on time-lapse microscopy is whether an exclusion from patentability, here of methods of medical diagnosis, should be interpreted narrowly or not. In the present case, the dominant piece of case law from the European Patent Office (EPO) gives a narrow interpretation of what a method of diagnosis must be in order not to be patentable. In their submissions to the EPO, ESHRE et al. have argued that this narrow interpretation is unfounded and incorrect., (Copyright © 2016 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.)

In 2013, a European Patent for the technique of time-lapse microscopy was granted by the European Patent Office (EPO) to Stanford University and was subsequently opposed by Unisense FertiliTech A/S and by the European Society for Human Reproduction and Embryology (ESHRE), Sigrid Sterckx, Julian Cockbain and Guido Pennings. ESHRE et al.'s opposition was based on the argument that Stanford's patent was directed to a method of medical diagnosis, methods that are excluded from patentability by Article 53(c) of the European Patent Convention. The Opposition Division of the EPO rejected the oppositions in November 2015, and both opponents have now filed their appeals. In this paper, we comment on the Opposition Division decision and the grounds of appeal put forward by ESHRE et al., (Copyright © 2016 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.)

Living organ donation (LD) is an increasingly established practice. Whereas in the United States and Canada LD by minors has occasionally been reported, LD by minors seems to be largely absent in the European Union (EU). It is currently unclear whether this is the result of a different legal approach. This study is the first to systematically analyze the regulations of EU member states, Norway, and Iceland toward LD by minors. Relevant regulations were identified by searching government websites, translated, compared, and sent for verification to national legal experts. We identified five countries where LD by minors is allowed. In two of these (Belgium and the United Kingdom), some minors may be deemed sufficiently mature to make an autonomous decision regarding LD. In contrast, in the three other countries (Luxembourg, Norway, and Sweden), LD by minors is only allowed subject to parental permission and the assent (or absence of objection) of the donor. Where allowed, regulations differ significantly with regard to the substantive and procedural safeguards in place. In view of the controversial nature of the procedure, as illustrated by recent reports and surveys, we argue for a very cautious approach and greater harmonization in countries where LD by minors is allowed., (© Copyright 2016 The American Society of Transplantation and the American Society of Transplant Surgeons.)

Background: Continuous deep sedation at the end of life is a practice that has been the topic of considerable ethical debate, for example surrounding its perceived similarity or dissimilarity with physician-assisted dying. The practice is generally considered to be legal as a form of symptom control, although this is mostly only assumed. France has passed an amendment to the Public Health Act that would grant certain terminally ill patients an explicit right to continuous deep sedation until they pass away. Such a framework would be unique in the world., Discussion: In this paper we will highlight and reflect on four relevant aspects and shortcomings of the proposed bill. First, that the bill suggests that continuous deeps sedation should be considered as a sui generis practice. Second, that it requires that sedation should always be accompanied by the withholding of all artificial nutrition and hydration. In the most recently amended version of the legal proposal it is stated that life sustaining treatments are withheld unless the patient objects. Third, that the French bill would not require that the suffering for which continuous deep sedation is initiated is unbearable. Fourth, the question as to whether the proposal should be considered as a way to avoid having to decriminalise euthanasia and/or PAS or, on the contrary, as a veiled way to decriminalise these practices. The French proposal to amend the Public Health Act to include a right to continuous deep sedation for some patients is a unique opportunity to clarify the legality of continuous deep sedation as an end-of-life practice. Moreover, it would recognize that the practice of continuous deep sedation raises ethical and legal issues that are different from those raised by symptom control on the one hand and assisted dying on the other hand. Nevertheless, there are still various issues of significant ethical concern in the French legislative proposal.

Background: The language of "participant-driven research," "crowdsourcing" and "citizen science" is increasingly being used to encourage the public to become involved in research ventures as both subjects and scientists. Originally, these labels were invoked by volunteer research efforts propelled by amateurs outside of traditional research institutions and aimed at appealing to those looking for more "democratic," "patient-centric," or "lay" alternatives to the professional science establishment. As mainstream translational biomedical research requires increasingly larger participant pools, however, corporate, academic and governmental research programs are embracing this populist rhetoric to encourage wider public participation., Discussion: We examine the ethical and social implications of this recruitment strategy. We begin by surveying examples of "citizen science" outside of biomedicine, as paradigmatic of the aspirations this democratizing rhetoric was originally meant to embody. Next, we discuss the ways these aspirations become articulated in the biomedical context, with a view to drawing out the multiple and potentially conflicting meanings of "public engagement" when citizens are also the subjects of the science. We then illustrate two uses of public engagement rhetoric to gain public support for national biomedical research efforts: its post-hoc use in the "care.data" project of the National Health Service in England, and its proactive uses in the "Precision Medicine Initiative" of the United States White House. These examples will serve as the basis for a normative analysis, discussing the potential ethical and social ramifications of this rhetoric. We pay particular attention to the implications of government strategies that cultivate the idea that members of the public have a civic duty to participate in government-sponsored research initiatives. We argue that such initiatives should draw from policy frameworks that support normative analysis of the role of citizenry. And, we conclude it is imperative to make visible and clear the full spectrum of meanings of "citizen science," the contexts in which it is used, and its demands with respect to participation, engagement, and governance.

An 'Information Centre' has recently been established by law which has the power to collect, collate and provide access to the medical information for all patients treated by the National Health Service in England, whether in hospitals or by General Practitioners. This so-called 'care.data' scheme has given rise to major and ongoing controversies. We will sketch the background of the scheme and look at the responses it has elicited from citizens and medical professionals. In Autumn 2013, NHS England set up a care.data website where citizens could record their concerns regarding the collection of health-related data by the Information Centre. We have reviewed all the comments on this website up until June 2015. We have also analysed the readers' comments on the coverage of the care.data scheme in one of the main national UK newspapers. When discussing the responses of citizens, we will make a distinction between the problems that citizens detect and the solutions they propose. The solutions that are being perceived as the most relevant ones can be summarized as follows: citizens wish to further the common good without being manipulated into doing it, while at the same time being safeguarded against various abuses. The issue of trust turns out to figure prominently. Our analysis of reactions to the scheme in no way pretends to be exhaustive, yet it provides various relevant insights into the concerns identified by citizens as well as medical professionals. These concerns, moreover, have a more general relevance in relation to other contexts of medical data-mining as well as biobank research. Our analysis also offers important pointers as to how those concerns might be addressed.

Rationale, Aims and Objectives: Continuous sedation at the end of life is an end-of-life practice that has gained considerable attention in the international literature. Nevertheless, significant confusion persists, even on how to label or define the practice. Several different terms and definitions exist, and these are often non-neutral and indicative of one's normative position on sedation at the end of life. This is problematic for two reasons. First, the use of such value-laden terms or definitions of continuous sedation may make it difficult, if not impossible, to agree on the facts surrounding continuous sedation. Second, including normative criteria in a definition can lead one to make disguised circular or tautological statements., Methods: This paper identifies commonly used terms and definitions and demonstrates how particular elements present in these are value-laden and can influence the ethical evaluation of continuous sedation at the end of life., Results: Two commonly used terms, 'palliative sedation' and 'terminal sedation', have been strongly criticized. We propose to use another, more descriptive term, namely 'continuous sedation at the end of life'. As regards the different definitions of sedation, some are general, but most contain very specific elements, thereby clearly limiting the number of cases that are covered by the definition. Some definitions of sedation include the intention one should (not) have, the possible indications for the practice, and the type of patients the practice should be reserved for., Conclusion: Including value-laden elements in the very definition of a clinical practice runs the risk of pre-empting a proper normative debate about the practice. We explain why this is the case and why it is problematic, and we propose an alternative, descriptive, definition that seeks to avoid these problems., (© 2015 John Wiley & Sons, Ltd.)

Although transplant professionals have initially been reluctant to perform transplants after public solicitation of organs from living donors, nowadays these transplants are increasingly being performed and reported. After clarifying the existing terminology, we elaborate an operational definition of public solicitation that is consistent with the Ethical, Legal, and Psychosocial Aspects of Transplantation classification for living organ donation. Our aim is to critically assess this phenomenon, from a legal, moral, and practical perspective, and to offer some recommendations. From a legal point of view, we analyze the current situation in the Europe and the United States. From a moral perspective, we evaluate the various arguments used in the literature, both in favor and against. Finally, we offer a set of recommendations aimed at maximizing the organ donor pool while safeguarding the interests of potential living donors.

With the recent transposition of Directive 2010/53/EU into the transplant regulation of EU Member States, the time is right to have a closer look at its implications for living organ donation practice. We first discuss the relevance of the Action Plan which forms the basis for the policy of the European Commission in the field of organ donation and transplantation. We then analyze the impact of Directive 2010/53/EU which was adopted to support the implementation of the Priority Actions set out in the Action Plan. We more specifically focus on the obligations of transplant centers engaged in living organ donation and highlight their significance for clinical practice. Finally, we point out some strengths and weaknesses of the Directive in addressing living organ donation.

The application of ethically controversial medical procedures may differ from one place to another. Drawing on a keyword and text-mining analysis of 156 interviews with doctors and nurses involved in end-of-life care ('care providers'), differences between countries in care providers' ethical rationales for the use of sedation are reported. In the United Kingdom, an emphasis on titrating doses proportionately against symptoms is more likely, maintaining consciousness where possible. The potential harms of sedation are perceived to be the potential hastening of social as well as biological death. In Belgium and the Netherlands, although there is concern to distinguish the practice from euthanasia, rapid inducement of deep unconsciousness is more acceptable to care providers. This is often perceived to be a proportionate response to unbearable suffering in a context where there is also greater pressure to hasten dying from relatives and others. This means that sedation is more likely to be organised like euthanasia, as the end 'moment' is reached, and family farewells are organised before the patient is made unconscious for ever. Medical and nursing practices are partly responses to factors outside the place of care, such as legislation and public sentiment. Dutch guidelines for sedation largely tally with the practices prevalent in the Netherlands and Belgium, in contrast with those produced by the more international European Association for Palliative Care whose authors describe an ethical framework closer to that reportedly used by UK care providers., (© The Author(s) 2014.)

Human body material removed post mortem is a particularly valuable resource for research. Considering the efforts that are currently being made to study the biochemical processes and possible genetic causes that underlie cancer and cardiovascular and neurodegenerative diseases, it is likely that this type of research will continue to gain in importance. However, post mortem procurement of human body material for research raises specific ethical concerns, more in particular with regard to the consent of the research participant. In this paper, we attempt to determine which consent regime should govern the post mortem procurement of body material for research. In order to do so, we assess the various arguments that could be put forward in support of a duty to make body material available for research purposes after death. We argue that this duty does in practice not support conscription but is sufficiently strong to defend a policy of presumed rather than explicit consent.

Background: Extensive debate surrounds the practice of continuous sedation until death to control refractory symptoms in terminal cancer care. We examined reported practice of United Kingdom, Belgian and Dutch physicians and nurses., Methods: Qualitative case studies using interviews., Setting: Hospitals, the domestic home and hospices or palliative care units., Participants: In all, 57 Physicians and 73 nurses involved in the care of 84 cancer patients., Results: UK respondents reported a continuum of practice from the provision of low doses of sedatives to control terminal restlessness to rarely encountered deep sedation. In contrast, Belgian respondents predominantly described the use of deep sedation, emphasizing the importance of responding to the patient's request. Dutch respondents emphasized making an official medical decision informed by the patient's wish and establishing that a refractory symptom was present. Respondents employed rationales that showed different stances towards four key issues: the preservation of consciousness, concerns about the potential hastening of death, whether they perceived continuous sedation until death as an 'alternative' to euthanasia and whether they sought to follow guidelines or frameworks for practice., Conclusion: This qualitative analysis suggests that there is systematic variation in end-of-life care sedation practice and its conceptualization in the United Kingdom, Belgium and the Netherlands., (© The Author(s) 2014.)