The unique status of first-in-human studies: strengthening the social value requirement

For clinical research to be ethical, risks need to be balanced by anticipated benefits. This is challenging for first-in-human (FIH) studies as participants are not expected to benefit directly, and risks are potentially high. We argue that this differentiates FIH studies from other clinical trials to the extent that they should be given unique status in international research ethics guidelines. As there is a general positive attitude regarding the benefits of science, it is important to establish a more systematic method to assess anticipated social value to safeguard participants not only from enrolling in risky, but also in futile trials. Here, we provide some of necessary steps needed to assess the anticipated social value of the intervention

Some Unresolved Ethical Challenges in Healthcare Decision-Making : Navigating Family Involvement

Peer reviewedPublisher PD

How Should the Precautionary Principle Apply to Pregnant Women in Clinical Research?

The precautionary principle is often invoked in relation to pregnant women and may be one of the underlying reasons for their continuous underrepresentation in clinical research. The principle is appealing, because potential fetal harm as a result of research participation is considered to be serious and irreversible. In our paper, we explore through conceptual analysis whether and if so how the precautionary principle should apply to pregnant women. We argue that the principle is a decision-making strategy underlying risk-benefit decisions in clinical research, which can be applied to pregnant women. However, the current application is a strong one, leading to the promotion of absolute exclusion or, less often, absolute inclusion of pregnant women. In order to change this paralyzing situation, a shift toward weak precautionary thinking is necessary. Instead of automatic extreme precaution, a balance will be found between harms and potential benefits of including pregnant women in clinical research

Determinants of successful implementation of population-based cancer screening programmes

Prezentujemy Państwu tłumaczenie artykułu poświęconego organizacji skriningów populacyjnych. Grupa ekspertów uznanych w dziedzinie badań skriningowych zebrała i w syntetycznej formie przedstawiła najważniejsze warunki, których spełnienie jest konieczne, aby można było mówić o dobrze funkcjonującym skriningu. Artykuł wydaje nam się na tyle cenny, że postanowiłyśmy przybliżyć go osobom, które są lub będą włączone w organizację i realizację skriningu w Polsce. Stanowi on rozwinięcie artykułu zatytułowanego Zalecenia komitetu ekspertów działającego w ramach projektu EuSANH dla Ministra Zdrowia w sprawie organizacji skriningów populacyjnych, opublikowanego w „Nowotwory Journal of Oncology” 2014, 64, 5. W celu ułatwienia realizacji populacyjnych programów badań przesiewowych w kierunku nowotworów podsumowano dotychczas zdobyte w Europie doświadczenia w tym zakresie. Wymieniono w punktach najważniejsze kwestie, które obywatele, grupy rzeczników, politycy, osoby organizujące opiekę zdrowotną oraz pracownicy służby zdrowia powinni rozważyć podczas planowania, realizacji i prowadzenia badań przesiewowych w kierunku raka. Lista jest na tyle ogólna, że ma zastosowanie zarówno do skriningu raka piersi, jak i szyjki macicy oraz jelita grubego. Lista powstała na podstawie dowodów przedstawionych w trzech publikacjach Unii Europejskiej, zawierających wytyczne w sprawie kontroli jakości badań przesiewowych i diagnostyki raka. Dodatkowo została wzbogacona piś miennictwem oraz doświadczeniami ekspertów prezentowanymi w czasie warsztatu w ramach European Science Advisory Network. Realizacja programu badań przesiewowych w kierunku raka powinna być podzielona na siedem etapów: 1) przygotowanie do planowania, 2) kompleksowe planowanie, 3) badanie wykonalności, 4) pilotaż i wdrożenie procesu, 5) rozwój serwisu usług skriningowych, 6) uruchomienie programu badań przesiewowych na dużą skalę oraz 7) zapewnienie trwałości. O realizacji każdego etapu można mówić jedynie wtedy, gdy zostanie spełniona określona liczba warunków. Pomyślna realizacja programu badań przesiewowych wymaga akceptacji społecznej oraz użycia najlepszych praktyk opartych na dowodach i weryfi kacji adekwatności wykonania na każdym etapie realizacji

Learning accountable governance: Challenges and perspectives for data-intensive health research networks

Current challenges to sustaining public support for health data research have directed attention to the governance of data-intensive health research networks. Accountability is hailed as an important element of trustworthy governance frameworks for data-intensive health research networks. Yet the extent to which adequate accountability regimes in data-intensive health research networks are currently realized is questionable. Current governance of data-intensive health research networks is dominated by the limitations of a drawing board approach. As a way forward, we propose a stronger focus on accountability as learning to achieve accountable governance. As an important step in that direction, we provide two pathways: (1) developing an integrated structure for decision-making and (2) establishing a dialogue in ongoing deliberative processes. Suitable places for learning accountability to thrive are dedicated governing bodies as well as specialized committees, panels or boards which bear and guide the development of governance in data-intensive health research networks. A continuous accountability process which comprises learning and interaction accommodates the diversity of expectations, responsibilities and tasks in data-intensive health research networks to achieve responsible and effective governance

Experiences and perceptions of continuous deep sedation:An interview study among Dutch patients and relatives

Background: The incidence of continuous deep sedation (CDS) has more than doubled over the last decade in The Netherlands, while reasons for this increase are not fully understood. Patients and relatives have an essential role in deciding on CDS. We hypothesize that the increase in CDS practice is related to the changing role of patients and relatives in deciding on CDS. Objective: To describe perceptions and experiences of patients and relatives with regard to CDS. This insight may help professionals and policymakers to better understand and respond to the evolving practice of CDS. Methods: Qualitative interviews were held with patients and relatives who had either personal experience with CDS as a relative or had contemplated CDS for themselves. Results: The vast majority of respondents appreciated CDS as a palliative care option, and none of the respondents reported (moral) objections to CDS. The majority of respondents prioritized avoiding suffering at the end of life. The patients and families generally considered CDS a palliative care option for which they can choose. Likewise, according to our respondents, the decision to start CDS was made by them, instead of the physician. Negative experiences with CDS care were mostly related to loss of sense of agency, due to insufficient communication or information provision by healthcare professionals. Lack of continuity of care was also a source of distress. We observed a variety in the respondents' understanding of the distinction between CDS and other end-of-life care decisions, including euthanasia. Some perceived CDS as hastening death. Conclusion: The traditional view of CDS as a last resort option for a physician to relieve a patient's suffering at the end of life is not explicit among patients and relatives. Instead, our results show that they perceive CDS as a regular palliative care option. Along with this normalization of CDS, patients and relatives claim a substantial say in the decision-making and are mainly motivated by a wish to avoid suffering and exercise control at the end of life. These distinct views on CDS of patients, their relatives and healthcare providers should be reconciled in guidelines and protocols for CDS. Patient or Public Contribution: One of the authors in our team (G. H.) has experience with CDS as a relative and ensured that the patient/relative viewpoint was adequately reflected in the design and conduct of our study. In the preliminary phase of our study, G. H. adjusted the topic list so it was better adapted to the current practice of CDS. During the data analysis, G. H. read several interviews and took part in the open and critical discussion on central themes and core concepts as an important member of the author team, thereby guaranteeing the central position of the patient/relative perspective in our final research outcome.</p

Overcoming ethical and legal obstacles to data linkage in health research: stakeholder perspectives

Introduction Data linkage for health research purposes enables the answering of countless new research questions, is said to be cost effective and less intrusive than other means of data collection. Nevertheless, health researchers are currently dealing with a complicated, fragmented, and inconsistent regulatory landscape with regard to the processing of data, and progress in health research is hindered. Aim We designed a qualitative study to assess what different stakeholders perceive as ethical and legal obstacles to data linkage for health research purposes, and how these obstacles could be overcome. Methods Two focus groups and eighteen semi-structured in-depth interviews were held to collect opinions and insights of various stakeholders. An inductive thematic analysis approach was used to identify overarching themes. Results This study showed that the ambiguity regarding the `correct' interpretation of the law, the fragmentation of policies governing the processing of personal health data, and the demandingness of legal requirements are experienced as causes for the impediment of data linkage for research purposes by the participating stakeholders. To remove or reduce these obstacles authoritative interpretations of the laws and regulations governing data linkage should be issued. The participants furthermore encouraged the harmonisation of data linkage policies, as well as promoting trust and transparency and the enhancement of technical and organisational measures. Lastly, there is a demand for legislative and regulatory modifications amongst the participants. Conclusions To overcome the obstacles in data linkage for scientific research purposes, perhaps we should shift the focus from adapting the current laws and regulations governing data linkage, or even designing completely new laws, towards creating a more thorough understanding of the law and making better use of the flexibilities within the existing legislation. Important steps in achieving this shift could be clarification of the legal provisions governing data linkage by issuing authoritative interpretations, as well as the strengthening of ethical-legal oversight bodies

Het doel van 'advance care planning'

This commentary reflects on a study to determine the efficacy of an advance care planning (ACP) website in increasing planning documentation. It is interesting to see that ACP is considered to be a regular intervention. ACP thus ceases to be something to believe in or not and becomes a normal intervention, the efficacy of which can be studied. The study also shows that ACP is a concept which can take many forms, that ACP in itself is almost an umbrella term and that physicians need not take the central role in ACP. The main point of critique of the study, however, is that the endpoint of the study is documentation. One can question whether that is the right objective of ACP as the worth of ACP would seem to lie more in the process of enabling a patient to reflect on treatment goals and personal values than in writing a living will

Het doel van 'advance care planning'

This commentary reflects on a study to determine the efficacy of an advance care planning (ACP) website in increasing planning documentation. It is interesting to see that ACP is considered to be a regular intervention. ACP thus ceases to be something to believe in or not and becomes a normal intervention, the efficacy of which can be studied. The study also shows that ACP is a concept which can take many forms, that ACP in itself is almost an umbrella term and that physicians need not take the central role in ACP. The main point of critique of the study, however, is that the endpoint of the study is documentation. One can question whether that is the right objective of ACP as the worth of ACP would seem to lie more in the process of enabling a patient to reflect on treatment goals and personal values than in writing a living will