The devil is in the details: an analysis of patient rights in Swiss cancer registries.

Cancer registries are an important part of the public health infrastructure, since they allow to monitor the temporal trends of this illness as well as facilitate epidemiological research. In order to effectively set up such registries, it is necessary to create a system of data collection that permits to record health-related information from patients who are diagnosed with cancer. Given the sensitive nature of such data, it is debated whether their recording should be based on consent or whether alternative arrangements are possible (eg, opt-out systems where information is automatically collected but patients can later withdraw). In the recent reform of the Swiss cancer registration legislation, the lawmaker set out to implement rules about the recording of data in cancer registries that would allegedly go beyond a consent-based model, in order to balance accurate registration with respect of patient rights. However, by analysing the operational norms of the new legislation and comparing them with those of other systems, it emerges that the Swiss rules de facto closely resemble a system of registration based on informed consent-in partial contradiction with the objective pursued by the lawmaker. In this paper, we show how the details of a policy are crucial to determine its true nature and we highlight some critical elements-from an ethical standpoint-of the recently reformed Swiss policy on cancer registration.

Digital pills: a scoping review of the empirical literature and analysis of the ethical aspects.

BACKGROUND: Digital Pills (DP) are an innovative drug-device technology that permits to combine traditional medications with a monitoring system that automatically records data about medication adherence as well as patients' physiological data. Although DP are a promising innovation in the field of digital medicine, their use has also raised a number of ethical concerns. These ethical concerns, however, have been expressed principally from a theoretical perspective, whereas an ethical analysis with a more empirically oriented approach is lacking. There is also a lack of clarity about the empirical evidence available concerning the application of this innovative digital medicine. METHODS: To map the studies where DP have been tested on patients and discuss the ethically relevant issues evident therein, we performed a scoping review of the empirical literature concerning DP. RESULTS: Our search allowed us to identify 18 papers reporting on studies where DP were tested on patients. These included studies with different designs and involving patients with a variety of conditions. In the empirical literature, a number of issues with ethical relevance were evident. At the patient level, the ethical issues include users' interaction with DP, personal sphere, health-related risks and patients' benefits. At the provider level, ethically relevant issues touch upon the doctor-patient relationship and the question of data access. At the societal level, they concern the benefits to society, the quality of evidence and the dichotomy device-medicine. CONCLUSIONS: We conclude that evidence concerning DP is not robust and that more research should be performed and study results made available to evaluate this digital medicine. Moreover, our analysis of the ethically relevant aspects within empirical literature underscores that there are concrete and specific open questions that should be tackled in the ethical discussion about this new technological solution.

Working with Research Integrity-Guidance for Research Performing Organisations: The Bonn PRINTEGER Statement.

This document presents the Bonn PRINTEGER Consensus Statement: Working with Research Integrity-Guidance for research performing organisations. The aim of the statement is to complement existing instruments by focusing specifically on institutional responsibilities for strengthening integrity. It takes into account the daily challenges and organisational contexts of most researchers. The statement intends to make research integrity challenges recognisable from the work-floor perspective, providing concrete advice on organisational measures to strengthen integrity. The statement, which was concluded February 7th 2018, provides guidance on the following key issues: § 1. Providing information about research integrity § 2. Providing education, training and mentoring § 3. Strengthening a research integrity culture § 4. Facilitating open dialogue § 5. Wise incentive management § 6. Implementing quality assurance procedures § 7. Improving the work environment and work satisfaction § 8. Increasing transparency of misconduct cases § 9. Opening up research § 10. Implementing safe and effective whistle-blowing channels § 11. Protecting the alleged perpetrators § 12. Establishing a research integrity committee and appointing an ombudsperson § 13. Making explicit the applicable standards for research integrity.

[Parte III. Ethical and juridical aspects in end-stage chronic organ failures. A position paper on a shared care planning]. / Parte III. Aspetti etici e giuridici nelle insufficienze croniche d'organo "end-stage". Documento di consenso per una pianificazione condivisa delle scelte di cura.

The specific target of an experts panel was to assess in terms of law and ethics the compliance of a new specific decision making algorithm described in the position paper proposed by the Gruppo di Lavoro Insufficienze Croniche d'Organo, with the main goal of the position paper consisting in the shared care planning process. The following specific aspects were assessed by the experts: a) the impact on case law and statute law of a new clinical pathway shared by scientific societies in light of good clinical practice and scientific evidence; b) the relevance of all tools useful to identify the appropriateness of care pathways, recognizing responsibilities and decision-making skills related to the end of life choices made by all stakeholders involved (healthcare professionals, patients and their beloved ones); c) the consistency of the healthcare professionals duties proposed in the position paper with the Italian legal order; d) the opportunity to take into account the role of all healthcare providers involved in care relationship; e) the consistency of the definition of patient rights at the end of life as proposed in the position paper with the Italian legal order and the relevance in this context of simultaneous palliative care; f) the relevance of shared care planning and its consistency with the proposed operative tools; g) the relevance of the conscientious objection issue and the compliance of management tools proposed in the position paper with the results of ethical and legal considerations; h) considerations about available resources allocation.