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Background: During recent decades, providing patients with access to their electronic health records (EHRs) has advanced in healthcare. In the European Union (EU), the General Data Protection Regulation provides individuals with the right to check their data in registries such as EHRs. A proposal for a European Health Data Space has been launched, which will further strengthen patients' right to have online access to their EHRs throughout Europe. Against these policy changes, scant attention has been paid to the ethical question about whether adolescents and parents should access the adolescent's EHR, and if so, under what conditions., Methods: In this paper, we apply biomedical ethical principles to explore key questions about adolescents' and parents' access to adolescents' EHRs, with the aim of informing future discussions about the development of ethical and policy practice guidelines., Results: Drawing on current empirical research, we find preliminary evidence that in some contexts, patient online record access (ORA) could help to facilitate autonomy for adolescents and parents as well as offering support in managing appointments and medications. Notably, however, we find contrasting perspectives between adolescents' and parents' experienced benefits and healthcare professionals' (HCPs) perceived potential harm, with the latter worried about decreased documentation quality after access. Concerns about capacity to understand their health information, and increased anxiety among adolescents obstruct the support of adolescent autonomy among parents and HCPs. Still, research is limited, particularly with respect to adolescents' experiences of reading their EHRs, and differences across settings have not been closely examined., Conclusions: To advance more comprehensive understanding of the effects of ORA, and to inspire greater attention to, and development of, evidence-informed ethical guidance in this domain of clinical practice, we outline a range of empirical questions regarding adolescents' and parents' experiences that now warrant further study., Competing Interests: Declarations. Ethics approval and consent to participate: Not applicable. Consent for publication: Not applicable. Competing interests: The authors declare no competing interests., (© 2025. The Author(s).)

The lack of paediatric medicines, including innovative and advanced ones, is a long-lasting and well-known problem at European and international levels. Despite the existing legal frameworks and incentives, children remain deprived of many kinds of therapy because of challenges faced in appropriately study and tailoring medicinal and other products for them. In this context, the necessity to foster paediatric research addressing unsolved and uncovered issues within a 'translational approach' has appeared. This article, after having clarified the concept of translational research in the perspective of the establishment of a European paediatric research infrastructure (RI), will identify and point out ethical, legal and regulatory issues particularly relevant in a children's rights perspective. It concludes asking for the setting up of an adequate model of governance within a future RI, including adequate and independent ethical oversight and a pluridisciplinary common service dealing with ethical, legal and societal issues relevant for children.

Background: As Next Generation Sequencing technologies are increasingly implemented in biomedical research and (translational) care, the number of study participants and patients who ask for release of their genomic raw data is set to increase. This raises the question whether research participants and patients have a legal and moral right to receive their genomic raw data and, if so, how this right should be implemented into practice., Methods: In a first step we clarify some central concepts such as "raw data"; in a second step we sketch the international legal framework. The third step provides an extensive ethical analysis which comprehends two parts: an evaluation of whether there is a prima facie moral right to receive one's raw data, and a contextualization and discussion of the right in light of potentially conflicting interests and rights of the data subject herself and third parties; in a last fourth step we emphasize the main practical consequences of the ethical analyses and propose recommendations for the release of raw data., Results: In several legislations like the new European General Data Protection Regulation, patients do in principle have the right to receive their raw data. However, the procedural implementation of this right and whether it involves genetic counselling is at the discretion of the Member States. Even more questions remain with respect to the research context. The ethical analysis suggests that patients and research subjects have a moral right to receive their genomic raw data and addresses aspects which are also of relevance for the legal discussion such as the costs of release of raw data and its impact on academic freedom., Conclusion: Taking into account the specific nature and implications of genomic raw data and the contexts of research and health care, several concerns and potentially conflicting interests of the data subjects themselves and involved researchers, physicians, biomedical institutions and relatives arise. Instead of using them to argue in favor of restrictions of the data subjects' legal and moral right to genomic raw data, the concerns should be addressed through provision of information and other measures. To this end, we propose relevant recommendations.

Background: During the set-up phase of an international study of genetic influences on outcomes from sepsis, we aimed to characterise potential differences in ethics approval processes and outcomes in participating European countries., Methods: Between 2005 and 2007 of the FP6-funded international Genetics Of Sepsis and Septic Shock (GenOSept) project, we asked national coordinators to complete a structured survey of research ethic committee (REC) approval structures and processes in their countries, and linked these data to outcomes. Survey findings were reconfirmed or modified in 2017., Results: Eighteen countries participated in the study, recruiting 2257 patients from 160 ICUs. National practices differed widely in terms of composition of RECs, procedures and duration of the ethics approval process. Eight (44.4%) countries used a single centralised process for approval, seven (38.9%) required approval by an ethics committee in each participating hospital, and three (16.7%) required both. Outcomes of the application process differed widely between countries because of differences in national legislation, and differed within countries because of interpretation of the ethics of conducting research in patients lacking capacity. The RECs in four countries had no lay representation. The median time from submission to final decision was 1.5 (interquartile range 1-7) months; in nine (50%) approval was received within 1 month; six took over 6 months, and in one 24 months; had all countries been able to match the most efficient approvals processes, an additional 74 months of country or institution-level recruitment would have been available. In three countries, rejection of the application by some local RECs resulted in loss of centres; and one country rejected the application outright., Conclusions: The potential benefits of the single application portal offered by the European Clinical Trials Regulation will not be realised without harmonisation of research ethics committee practices as well as national legislation.

The regulatory framework of clinical research is necessary to ensure the protection of participants and to define the actors and their responsibilities. Although main principles have been set up in 1947 with the Nuremberg Code, this regulatory framework is relatively recent in Europe: development of national regulations in the years 1980-1990, first European Directive regarding clinical trials in 2001. In France, as 2006 was marked by the implementation of this first "Clinical trials Directive", the end of the year 2016 and the following months were marked by the enforcement of the Jardé law (previously modified in order to reinforce the regulatory requirements following the death of an healthy volunteer in a clinical trial). As clinical researches involve processing of personal data, the entry into force, on 25 May 2018, of the General Data Protection Regulation (GDPR) had also consequences on their implementation. Finally, regarding clinical trials on drugs, the "Clinical trials Regulation" repealing the Directive, voted in 2014, should come into force in the coming months., (Copyright © 2019 Société Française du Cancer. Published by Elsevier Masson SAS. All rights reserved.)

Background: Medical data are gold mines for deriving the knowledge that could change the course of a single patient's life or even the health of the entire population. A data analyst needs to have full access to relevant data, but full access may be denied by privacy and confidentiality of medical data legal regulations, especially when the data analyst is not affiliated with the data owner., Objective: Our first objective was to analyze the privacy and confidentiality issues and the associated regulations pertaining to medical data, and to identify technologies to properly address these issues. Our second objective was to develop a procedure to protect medical data in such a way that the outsourced analyst would be capable of doing analyses on protected data and the results would be comparable, if not the same, as if they had been done on the original data. Specifically, our hypothesis was there would not be a difference between the outsourced decision trees built on encrypted data and the ones built on original data., Methods: Using formal definitions, we developed an algorithm to protect medical data for outsourced analyses. The algorithm was applied to publicly available datasets (N=30) from the medical and life sciences fields. The analyses were performed on the original and the protected datasets and the results of the analyses were compared. Bootstrapped paired t tests for 2 dependent samples were used to test whether the mean differences in size, number of leaves, and the accuracy of the original and the encrypted decision trees were significantly different., Results: The decision trees built on encrypted data were virtually the same as those built on original data. Out of 30 datasets, 100% of the trees had identical accuracy. The size of a tree and the number of leaves was different only once (1/30, 3%, P=.19)., Conclusions: The proposed algorithm encrypts a file with plain text medical data into an encrypted file with the data protected in such a way that external data analyses are still possible. The results show that the results of analyses on original and on protected data are identical or comparably similar. The approach addresses the privacy and confidentiality issues that arise with medical data and is adherent to strict legal rules in the United States and Europe regarding the processing of the medical data.

In France, since the approval of the first bioethics laws in 1994, the principle of the anonymity of sperm donors has prevailed. This choice is regularly challenged, namely by children who have been conceived under these conditions and have now reached adulthood. In this paper, we will briefly describe the reasons that led practitioners of assisted reproduction to endorse the anonymity principle in 1994. Secondly, we will elaborate on the reasons why this principle is becoming so controversial today. Finally, we shall examine two possible outcomes of the debate, highlighting their respective legitimacy as well as their consequences, as far as the rights of children, the notion of the family, and medical practice are concerned.

The aim of this paper is to focus on the ethical issues raised by the removal of anonymity from sperm donors. The increasing currency of a 'right to genetic truth' is clearly visible in the drive to revise the legislation on donor anonymity in Western and European countries. The ethical debate is polarized between the 'right to privacy' of the donor or parent and the 'right to know' of the prospective child. However, it is evident that religious, social and cultural attitudes have an overarching impact on attitudes towards sperm donation generally and anonymity specifically. In Asian countries, the social and cultural heritage is hugely diverse and different from those of the West. This review considers the research exploring the complexity of ethical issues informing this debate, and argues that parent's decisions to reveal donor insemination origins to their children are highly complex and relate to a range of social and cultural attitudes that have not been addressed within the policy to remove anonymity from sperm donors.

The scope of the Medical Exposure Directive (MED), 97/43/Euratom (Council Directive 97/43/EURATOM, on the health protection of individuals against the dangers of ionising radiation in relation to medical exposures. OJ L 180 of 09.07.1997), is such that it includes not only those exposures which are part of the normal diagnosis and treatment of patients but also exposures for occupational health surveillance, health-screening programmes, research and medico-legal exposures. This is the first time that radiation protection legislation has tried to deal explicitly with the issue of medico-legal exposures in a European Directive. However, it has done so in the context of a Directive whose primary focus is the protection of patients undergoing diagnostic or therapeutic medical exposures. This may not be an appropriate framework for medico-legal exposures. In considering medico-legal exposures, a significant number of ethical considerations arise. The MED may not adequately take account of these matters and in fact may not be a suitable legal instrument for dealing with them. This paper looks specifically at the issues surrounding medico-legal exposures and considers whether or not the current system provides adequate protection for the individuals exposed.

A main identifying factor of professions is professionals' willingness to comply with ethical and professional standards, often defined in a code of ethics and conduct. In a period of intense nursing mobility, if the public are aware that health professionals have committed themselves to the drawing up of a code of ethics and conduct, they will have more trust in the health professional they choose, especially if this person comes from another European Member State. The Code of Ethics and Conduct for European Nursing is a programmatic document for the nursing profession constructed by the FEPI (European Federation of Nursing Regulators) according to Directive 2005/36/EC On recognition of professional qualifications , and Directive 2006/123/EC On services in the internal market, set out by the European Commission. This article describes the construction of the Code and gives an overview of some specific areas of importance. The main text of the Code is reproduced in Appendix 1.

Since the mid-1990s most EU Member States have established a national forensic DNA database. These mass repositories of DNA profiles enable the police to identify DNA stains which are found at crime scenes and are invaluable in criminal investigation. Governments have always brushed aside privacy objections by stressing that the stored DNA profiles do not contain sensitive genetic information on the included individuals and that they reside under the statutory privacy protection regulations. However, it has been generally overlooked that the police also store the DNA samples from which the DNA profiles are derived. Although these DNA samples are actually a potential source of genetic information, they have so far scarcely been the subject of discussion. In this article we will show that both European and national regulations offer inadequate protection to completely prevent function creep, that is, the use of these forensic DNA samples for purposes beyond those envisaged at the time of collection.

The sharing of samples and data stored in biobanks for research has implications for donor privacy, but also raises questions on the regulation of research within Europe. Many legal documents and principles within Europe, with a direct impact on biobanking, have not been developed specifically to support this activity. Moreover, while some new regulations have been set up at national level, there are many variations in the definitions, scope and purpose of these legal instruments. This has resulted in unnecessary hurdles for genome-based research, particularly if samples are shared across national borders. The question is also raised on whether new, specific legislative and governance frameworks designed for biobanking are needed, or whether it is sufficient to modify current general law and to develop specific guidelines, or to accommodate issues raised by biobanking in the current regulation. A workshop with experts from academia and industry, lawyers, national data protection authorities, representatives from the European Commission and the European Data Protection Supervisor was held to review the existing legal bottlenecks and future needs of biobanking, with special regard to the collection, exchange and linkage of samples and data. This report presents highlights of the presentations and discussions from the workshop held in Sevilla, Spain, in March 2007 and the conclusions that followed. The workshop focused on the internal linkage of data and samples stored in a biobank, and the external linkage of biobanks with secondary information resources, such as cancer registries.

In this article, the authors describe how the European Dementia Consensus Network developed a consensus on research ethics in dementia, taking into account the questions posed by the era of genetic research and its new research methods. The consensus process started with a Delphi procedure to analyze relevant stakeholders' positions by describing their statements on the possibilities and limitations of research into genetic determinants of Alzheimer disease and to describe and analyze the moral desirability of genetic research on Alzheimer disease. The conclusions drawn from the Delphi procedure fuelled the development of the consensus statement, which is presented in this paper. The consensus statement aims to stimulate ethically acceptable research in the field of dementia and the protection of vulnerable elderly patients with dementia from application of inadequate research methods or designs.

There are many issues of concern regarding the legal and ethical aspects of telemedicine. These include the responsibilities and potential liabilities of the health professional, the duty to maintain the confidentiality and privacy of patient records, and the jurisdictional problems associated with cross-border consultations. There is also the issue of reimbursement for care provided using a telemedicine service. Telemedicine allows the transmission of health information across the borders of nation states. Cross-border telemedicine services have begun, particularly in specialties such as teleradiology, but questions of jurisdiction and registration have yet to be answered definitively. While this may be true of many of the legal and ethical aspects of telemedicine generally, it is also the case that health-care professionals who undertake telemedicine in a prudent manner will minimize the possibility of medicolegal complications.

A Directive of the European Union was first published in 2000, which dealt with telemedicine as part of its provisions. This E-Commerce Directive, as it became known, was subjected to further study which revealed some problems relative to the practice of telemedicine. Among the subjects discussed in this paper are those of privacy, data protection, free movement of services, the impact of electronic communication and ethical issues.