IntroductionInternational sharing of health data opens the door to the study of the so-called ‘Big Data’, which holds great promise for improving patient-centred care. Failure of recent data sharing initiatives indicates an urgent need to invest in societal trust in researchers and institutions. Key to an informed understanding of such a ‘social license’ is identifying the views patients and the public may hold with regard to data sharing for health research.MethodsWe performed a narrative review of the empirical evidence addressing patients’ (...) and public views and attitudes towards the use of health data for research purposes. The literature databases PubMed, Embase, Scopus and Google Scholar were searched in April 2019 to identify relevant publications. Patients’ and public attitudes were extracted from selected references and thematically categorised.ResultsTwenty-seven papers were included for review, including both qualitative and quantitative studies and systematic reviews. Results suggest widespread—though conditional—support among patients and the public for data sharing for health research. Despite the fact that participants recognise actual or potential benefits of data research, they expressed concerns about breaches of confidentiality and potential abuses of the data. Studies showed agreement on the following conditions: value, privacy, risk minimisation, data security, transparency, control, information, trust, responsibility and accountability.ConclusionsOur results indicate that a social license for data-intensive health research cannot simply be presumed. To strengthen the social license, identified conditions ought to be operationalised in a governance framework that incorporates the diverse patient and public values, needs and interests. (shrink)

Pragmatic trials aim to directly inform health care decision-making through the collection of so-called ‘real world data’ from observations of comparative treatment effects in clinical practice. In order to ensure the applicability and feasibility of a pragmatic trial, design features may be necessary that deviate from standard research ethics requirements. Examples are traditional requirements to seek written informed consent and to perform extensive data and safety monitoring. Proposals for deviations from standard research ethics practice have resulted in controversy about their (...) ethical acceptability. One of the justifications for altered procedures is the allegedly high social value of pragmatic trials. In order to properly operationalize the concept in the ethical assessment of pragmatic trial designs, specification is warranted. We identified three determinants from common claims about a pragmatic trial's social value: the extent to which the research question has real world relevance, the trial design's ability to generate a real world answer and the probability of direct uptake of the results by decision-makers in practice. Subsequently, we discuss how these determinants should be applied to the practice of pragmatic trials, and to what extent they might be applicable to explanatory trials. (shrink)

BackgroundAn important principle underlying the Dutch Euthanasia Act is physicians' responsibility to alleviate patients' suffering. The Dutch Act states that euthanasia and physician-assisted suicide are not punishable if the attending physician acts in accordance with criteria of due care. These criteria concern the patient's request, the patient's suffering (unbearable and hopeless), the information provided to the patient, the presence of reasonable alternatives, consultation of another physician and the applied method of ending life. To demonstrate their compliance, the Act requires physicians (...) to report euthanasia to a review committee. We studied which arguments Dutch physicians use to substantiate their adherence to the criteria and which aspects attract review committees' attention.MethodsWe examined 158 files of reported euthanasia and physician-assisted suicide cases that were approved by the review committees. We studied the physicians' reports and the verdicts of the review committees by using a checklist.ResultsPhysicians reported that the patient's request had been well-considered because the patient was clear-headed (65%) and/or had repeated the request several times (23%). Unbearable suffering was often substantiated with physical symptoms (62%), function loss (33%), dependency (28%) or deterioration (15%). In 35%, physicians reported that there had been alternatives to relieve patients' suffering which were refused by the majority. The nature of the relationship with the consultant was sometimes unclear: the consultant was reported to have been an unknown colleague (39%), a known colleague (21%), otherwise (25%), or not clearly specified in the report (24%). Review committees relatively often scrutinized the consultation (41%) and the patient's (unbearable) suffering (32%); they had few questions about possible alternatives (1%).ConclusionDutch physicians substantiate their adherence to the criteria in a variable way with an emphasis on physical symptoms. The information they provide is in most cases sufficient to enable adequate review. Review committees' control seems to focus on (unbearable) suffering and on procedural issues. (shrink)

Context In some cases, physicians estimate that continuous sedation until death may have a life-shortening effect. The accuracy of these estimations can be questioned.Aim The aim of this study is to compare two approaches to estimate the potential life-shortening effect of continuous sedation until death.Methods In 2008, 370 Dutch physicians filled out a questionnaire and reported on their last patient who received continuous sedation until death. The potential life-shortening effect of continuous sedation was estimated through a direct approach and an (...) indirect approach . The intrarater agreement between both approaches was determined with a weighted κ.Results According to the direct approach, sedation might have had a life-shortening effect in 51% of the cases and according to the indirect approach in 84%. The intrarater agreement between both approaches was fair . In 10% of all cases, the direct approach yielded higher estimates of the extent to which life had been shortened; in 58% of the cases, the indirect approach yielded higher estimates.Conclusions The results show a discrepancy between different approaches to estimate the potential life-shortening effect of continuous sedation until death. (shrink)

In this article ethical issues are discussed which play a role in pharmacogenetics. Developments in pharmacogenetics have a large impact on many different practices such as clinical trials, the practice of medicine and society at large. In clinical trials, questions rise regarding the exclusion of genetic subgroups that may be non- or poor-responders to the experimental drug. Also, the question is asked how pharmaceutical companies should deal with their growing knowledge about the relations between genetic variation and adverse effects. Moreover, (...) pharmacogenetics may provide disease-specific predictive information which may have a significant impact on the relations between physicians, patients and their relatives in the practice of medicine. Here, issues also arise regarding responsibility of patients and physicians for health and disease. In the society at large, the high costs of new pharmacogenetic possibilities lead to questions concerning solidarity and fair distribution on a national as well as an international level. It is concluded that in the near future, ethical research should be focused on the themes responsibility, inclusion and exclusion and global justice. (shrink)