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. The law of data sharing is pulling in different directions. This paper poses the question, ‘harmonisation, an impossible dream?’ and the answer is a qualified ‘no’. The paper reflects on what can be seen in the papers in part two of the special issue. It then identifies three major areas of conceptual uncertainty in the new EU General Data Protection Regulation (not because it has superiority over other jurisdictions, but because it is a recent revision of data protection law that leaves universal conceptual questions unclear). Thereafter, the potential for Artificial Intelligence to meet some of the shortcomings is discussed. The paper ends with a consideration of the conditions under which data sharing harmonisation might be achieved: an understanding of a human rights approach and citizen sensitivities in considering the ‘public interest’; social liberalism as a basis of solidarity; and the profession of ‘researcher’.
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. Drawing from interviews with nutrition scientists at universities and in the food industry, we demonstrate that the organisation of research labour can deviate significantly from such prescriptions. The organisation of labour, regardless of its content, then, has consequences for who qualifies as an author. The fact that fewer food industry employees qualify is actively used by the food industry to manage the credibility and ownership of their knowledge claims as allonymous science: the attribution of science assisted by authorship guidelines blind to all but one organisational frame.
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 ...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. Unmet supportive care needs, experience of care coordination, unplanned readmissions, emergency department presentations, distress, and quality of life (QOL) were assessed by questionnaire at 1, 3, and 6 months.
Of 775 patients treated at 23 public and private hospitals in Australia, 387 were randomly assigned to the intervention group and 369 to the control group. There were no significant differences between groups in unmet supportive care needs, but these were consistently low in both groups at both follow-up time points. There were no differences between the groups in emergency department presentations (10.8% v 13.8%; P = .2) or unplanned hospital readmissions (8.6% v 10.5%; P = .4) at 1 month. By 6 months, 25.6% of intervention-group patients had reported an unplanned readmission compared with 27.9% of controls (P = .5). There were no significant differences in experience of care coordination, distress, or QOL between groups at any follow-up time point.
This trial failed to demonstrate substantial benefit of a centralized system to provide standardized, telephone follow-up for postoperative patients with colorectal cancer. Future interventions could investigate a more tailored approach.
Objective:
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.
Methods:
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. The transcripts were analyzed by Thematic Content Analysis (TCA), mainly a manifest content analysis.
Results:
This study demonstrated that the limited EU mandate in health hinders proper actions to prevent and tackle infectious disease outbreaks, such as the COVID-19 pandemic. The results showed that this limitation significantly impacted the ECDC, as the Member States' competence did not allow the agency to have more capacity. The European Commission has fulfilled its role of coordinating and supporting the Member States by facilitating networks and information exchange. However, EU intra- and inter-communication need further improvement. Although diverse EU instruments and mechanisms were found valid, their implementation needed to be faster and more efficient. The results pointed out that underlying political challenges in EU decision-making regarding health emergencies hinder the aligned response. It was stated that the Member States were not prepared, and due to the restriction of their mandate, EU institutions could not enforce binding guidelines. Additionally, the study explored future EU pandemic strategies and actions. Both, EU institutions and national experts suggested similar and clear recommendations regarding the ECDC, the investment, and future harmonized preparedness tools.
Conclusion:
The complex politics of public health at the EU level have led to the fragmentation of its governance for effective pandemic responses. This ongoing pandemic has shed light on the fragility of the political and structural systems in Europe in public health emergencies. Health should be of high importance in the political agenda, and robust health reforms at the local, regional, national, and EU levels are highly recommended.
Abstract
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. We argue, contrary to draft ICO guidance, that a data controller might legitimately continue to rely upon parental consent as a legal basis for processing after a child is old enough to provide her own consent. Nevertheless, we conclude that data controllers should develop strategies to seek fresh consent from children as soon as practicable after the data controller has reason to believe they are mature enough to consent independently. Techniques for effective communication, recommended to address challenges associated with Big Data analytics, might have a role here in addressing the dynamic relationship between data subject and processing. Ultimately, we suggest that fair and lawful processing of a child’s data will be dependent upon data controllers taking seriously the truism that consent is ongoing, rather than a one-time event: the core associated responsibility is to continue to communicate with a data subject regarding the processing of personal data.
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.
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.
This paper focuses on these barriers and presents solutions as proposed by the Dutch CARRIER (ie, Coronary ARtery disease: Risk estimations and Interventions for prevention and EaRly detection) consortium. We will focus in 4 sections on the following: (1) the development process of an eHealth solution that will include design thinking and cocreation with relevant stakeholders; (2) the modeling approach for two clinical prediction models (CPMs) to identify people at risk of developing ASCVD and to guide interventions; (3) description of a federated data infrastructure to train the CPMs and to provide the eHealth solution with relevant data; and (4) discussion of an ethical and legal framework for responsible data handling in health care.
The Dutch CARRIER consortium consists of a collaboration between experts in the fields of eHealth development, ASCVD, public health, big data, as well as ethics and law. The consortium focuses on reducing the burden of ASCVD. We believe the future of health care is data driven and supported by digital health. Therefore, we hope that our research will not only facilitate CARRIER consortium but may also facilitate other future health care initiatives.
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. Studies were considered when published in English, included human participants, and reported empirical data on prevalence or incidence estimates of FASD. Raw prevalence estimates were transformed using the Freeman–Tukey double arcsine transformation so that the data followed an approximately normal distribution. Once the pooled prevalence estimates, 95% confidence intervals and prediction intervals were calculated based on multiple meta‐analyses with transformed proportions using random effects models, these estimates were transformed back to regular prevalence rates. Heterogeneity was tested using Cochran's Q and described using the I2 statistic.
Results
Among studies that estimated prevalence in general population samples, considerable differences in prevalence rates between countries were found and therefore separate meta‐analyses for country were conducted. Particularly high‐prevalence rates were observed in South Africa for fetal alcohol syndrome (55.42 per 1,000), for alcohol‐related neurodevelopmental disorder (20.25 per 1,000), and FASD (113.22 per 1,000), For partial fetal alcohol syndrome high rates were found in Croatia (43.01 per 1,000), Italy (36.89 per 1,000), and South Africa (28.29 per 1,000). In the case of alcohol‐related birth defects, a prevalence of 10.82 per 1,000 was found in Australia. However, studies into FASD exhibited substantial heterogeneity, which could only partly be explained by moderators, most notably geography and descent, in meta‐regressions. In addition, the moderators were confounded, making conclusions as to each moderator's relevance tentative at best.
Conclusions
The worldwide pooled prevalence estimates are higher than assumed so far, but this was largely explained by geography and descent. Furthermore, prevalence studies varied considerably in terms of used methodology and methodological quality. The pooled estimates must therefore be interpreted with caution and for future research it is highly recommended to report methodology in a more comprehensive way. Finally, clear guidelines on assessing FASD prevalence are urgently needed, and a first step toward these guidelines is presented.
Fetal Alcohol Spectrum Disorders form a considerable burden to every society. Although FASD affect communities worldwide, until now our knowledge about its prevalence is limited. A clear overview of FASD prevalence is not available. This is the first study providing an overview of this problem worldwide. Meta‐analysis reveals that cautious interpretation is warranted and guidelines on assessing FASD prevalence are urgently needed.
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.
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