Digital Health Solutions to Reduce the Burden of Atherosclerotic Cardiovascular Disease Proposed by the CARRIER Consortium.

Digital health is a promising tool to support people with an elevated risk for atherosclerotic cardiovascular disease (ASCVD) and patients with an established disease to improve cardiovascular outcomes. Many digital health initiatives have been developed and employed. However, barriers to their large-scale implementation have remained.

The European Union and Public Health Emergencies: Expert Opinions on the Management of the First Wave of the COVID-19 Pandemic and Suggestions for Future Emergencies.

The first wave of the coronavirus SARS-COV-2 pandemic has revealed a fragmented governance within the European Union (EU) to tackle public health emergencies. This qualitative study aims: 1) to understand the current EU position within the field of public health emergencies taking the case of the COVID-19 as an example by comparing and contrasting experiences from EU institutions and experts from various EU Member States at the beginning of the pandemic; and, 2) to identify and to formulate future EU pandemic strategies and actions based on experts' opinions. Eighteen semi-structured interviews were conducted with public health experts from various European Member States and European Commission officials from May 2020 until August 2020.

Ethics of ECPR research.

The design of emergency medicine trials can raise several ethical concerns - risks may be greater, and randomisation may have to occur before consent. Research in emergency medicine is thus an illuminating context to explore the interplay between risk and randomisation, and the consequences for consent. Using a currently running trial, we describe possible concerns, considerations, and solutions to reconcile the conflicting interests of scientific inquiry, ethical principles, and clinical reality in emergency medicine research.

Examining the power of the social imaginary through competing narratives of data ownership in health research.

This article explores the social imaginary in the context of data ownership and the (non-)delivery of the data sharing revolution in biomedicine. We contribute to this special issue on imaginaries by developing a method and paradigm of 'competing narratives'. Despite multiple initiatives to encourage health data sharing, and a strong 'open access' agenda, the data sharing revolution is not yet delivered.

Allonymous science: the politics of placing and shifting credit in public-private nutrition research.

Ideally, guidelines reflect an accepted position with respect to matters of concern, ranging from clinical practices to researcher behaviour. Upon close reading, authorship guidelines reserve authorship attribution to individuals fully or almost fully embedded in particular studies, including design or execution as well as significant involvement in the writing process. These requirements prescribe an organisation of scientific work in which this embedding is specifically enabled.

Systematic Review of Privacy-Preserving Distributed Machine Learning From Federated Databases in Health Care.

Big data for health care is one of the potential solutions to deal with the numerous challenges of health care, such as rising cost, aging population, precision medicine, universal health coverage, and the increase of noncommunicable diseases. However, data centralization for big data raises privacy and regulatory concerns.Covered topics include (1) an introduction to privacy of patient data and distributed learning as a potential solution to preserving these data, a description of the legal context for patient data research, and a definition of machine/deep learning concepts; (2) a presentation of the adopted review protocol; (3) a presentation of the search results; and (4) a discussion of the findings, limitations of the review, and future perspectives.

A Privacy-Preserving Infrastructure for Analyzing Personal Health Data in a Vertically Partitioned Scenario.

It is widely anticipated that the use and analysis of health-related big data will enable further understanding and improvements in human health and wellbeing. Here, we propose an innovative infrastructure, which supports secure and privacy-preserving analysis of personal health data from multiple providers with different governance policies. Our objective is to use this infrastructure to explore the relation between Type 2 Diabetes Mellitus status and healthcare costs.

Systematic literature review on which maternal alcohol behaviours are related to fetal alcohol spectrum disorders (FASD).

Objectives: Fetal alcohol spectrum disorders (FASD) is a worldwide problem. Maternal alcohol consumption is an important risk factor for FASD. It remains unknown which alcohol consumption patterns most strongly predict FASD.

Conclusion: harmonisation in genomic and health data sharing for research: an impossible dream?

There are clear benefits from genomics and health data sharing in research and in therapy for individuals across societies. At the same time, citizens have different expectations and fears about that data sharing. International legislation in relation with research ethics and practice and, particularly, data protection create a particular environment that, as is seen in the articles in part two of this special issue, are crying out for harmonisation both at a procedural but at fundamental conceptual levels.

When can the Child Speak for Herself? The Limits of Parental Consent in Data Protection Law for Health Research.

Draft regulatory guidance suggests that if the processing of a child's personal data begins with the consent of a parent, then there is a need to find and defend an enduring consent through the child's growing capacity and on to their maturity. We consider the implications for health research of the UK Information Commissioner's Office's (ICO) suggestion that the relevant test for maturity is the Gillick test, originally developed in the context of medical treatment. Noting the significance of the welfare principle to this test, we examine the implications for the responsibilities of a parent to act as proxy for their child.

Permitting patients to pay for participation in clinical trials: the advent of the P4 trial.

In this article we explore the ethical issues raised by permitting patients to pay for participation (P4) in clinical trials, and discuss whether there are any categorical objections to this practice. We address key considerations concerning payment for participation in trials, including patient autonomy, risk/benefit and justice, taking account of two previous critiques of the ethics of P4. We conclude that such trials could be ethical under certain strict conditions, but only if other potential sources of funding have first been explored or are unavailable.

Division and discord in the Clinical Trials Regulation.

The Clinical Trials Regulation is intended to harmonise and streamline the review and conduct of clinical trials in the European Union. In this paper, we identify and analyse several serious issues concerning the division imposed by the Regulation between scientific review and ethical review. We conclude that these problems may compromise the objectives of the Regulation.

EU Laws on Privacy in Genomic Databases and Biobanking.

Both the European Union and the Council of Europe have a bearing on privacy in genomic databases and biobanking. In terms of legislation, the processing of personal data as it relates to the right to privacy is currently largely regulated in Europe by Directive 95/46/EC, which requires that processing be "fair and lawful" and follow a set of principles, meaning that the data be processed only for stated purposes, be sufficient for the purposes of the processing, be kept only for so long as is necessary to achieve those purposes, and be kept securely and only in an identifiable state for such time as is necessary for the processing. The European privacy regime does not require the de-identification (anonymization) of personal data used in genomic databases or biobanks, and alongside this practice informed consent as well as governance and oversight mechanisms provide for the protection of genomic data.

Protecting Animals and Enabling Research in the European Union: An Overview of Development and Implementation of Directive 2010/63/EU.

In 1986, European Directive 86/609/EEC, regulating the use of animals in research, was one of the first examples of common legislation to set standards for animal protection across the Member States of the former European Economic Community, now the European Union, with the aim of securing a level European playing field. Starting in 2002, a process of revising European animal experimentation legislation was undertaken, with one of its key aims being to ensure high standards of welfare for laboratory animals across Europe. This resulted in Directive 2010/63/EU, which has regulated this activity in Europe since 2013.

Worldwide Prevalence of Fetal Alcohol Spectrum Disorders: A Systematic Literature Review Including Meta-Analysis.

Background: Although fetal alcohol spectrum disorders (FASD) affect communities worldwide, little is known about its prevalence. The objective of this study was to provide an overview of the global FASD prevalence.

Methods: We performed a search in multiple electronic bibliographic databases up to August 2015, supplemented with the ascendancy and descendancy approach.

Reflections on different governance styles in regulating science: a contribution to 'Responsible Research and Innovation'.

In European science and technology policy, various styles have been developed and institutionalised to govern the ethical challenges of science and technology innovations. In this paper, we give an account of the most dominant styles of the past 30 years, particularly in Europe, seeking to show their specific merits and problems. We focus on three styles of governance: a technocratic style, an applied ethics style, and a public participation style.

Multicenter randomized trial of centralized nurse-led telephone-based care coordination to improve outcomes after surgical resection for colorectal cancer: the CONNECT intervention.

Purpose: To investigate the effectiveness of a centralized, nurse-delivered telephone-based service to improve care coordination and patient-reported outcomes after surgery for colorectal cancer.

Patients And Methods: Patients with a newly diagnosed colorectal cancer were randomly assigned to the CONNECT intervention or usual care. Intervention-group patients received standardized calls from the centrally based nurse 3 and 10 days and 1, 3, and 6 months after discharge from hospital.

Health inequalities and regional specific scarcity in primary care physicians: ethical issues and criteria.

Objectives: A substantial body of evidence supports the beneficial health impact of an increase in primary care physicians for underserved populations. However, given that in many countries primary care physician shortages persist, what options are available to distribute physicians and how can these be seen from an ethical perspective?

Methods: A literature review was performed on the topic of primary care physician distribution. An ethical discussion of conceivable options for decision makers that applied prominent theories of ethics was held.

Issues in networking and research funding for the European Association of Health Law.

All academics, perhaps with the exception of those who are hermits with independent private means, are concerned with questions of networking and research funding. The nature of academic life is to search out new ideas and revisit old ones, and to discuss these ideas with others. This requires networks of colleagues and funding to provide the basic resources of time and literature.