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The growing importance of researching online activities, such as cyber-deviance and cyber-crime, as well as the use of online tools (e.g. questionnaires, games, and other interactive tools) has created new ethical and legal challenges for researchers, which can be even more complicated when researching adolescents. In this article, we highlight the risks emerging from the current European legal and ethical landscape when researching potentially vulnerable groups, with a special focus on online research. It is not always clear how to differentiate research ethics consent from consent for data processing activities: when can an adolescent independently consent to research, or when is parental consent needed? Additional problems emerge when parents do not consent to research activities, but their adolescent children do. A serious ethical challenge can arise when the parents do not communicate with researchers, but the adolescent wishes to participate, especially when weak parental oversight is coupled with research on sensitive topics. We offer some guidance on what to keep in mind when conducting online research with adolescents and highlight possible ways that these issues can be dealt with in pan-European projects.

While many strategies for protecting personal privacy rely on regulatory frameworks, consent, and anonymizing data, they are not always effective. Terms and Conditions often lag behind advances in technology, software, and user behaviours, and consent to use data for a range of unclear purposes may be provided unwittingly. As the commercial market for (student) data expands, so does the number of brokers who move, share and sell data across continents and legislative environments. This paper reviews four Massive Open Online Course (MOOC) providers from different geopolitical and regulatory contexts. It explores how consent to collect and use data is described to potential users, and how that consent applies at micro, meso, and macro levels. This paper proposes a need for greater transparency around the implications of users granting consent at the point of registration. Further, it highlights that though MOOC providers have a responsibility to make clear the potential uses and sharing of user data, users themselves should also be more aware and consider how meaningful student agency can be achieved.

To find a balance between learning analytics research and individual privacy, learning analytics initiatives need to appropriately address ethical, privacy, and data protection issues. A range of general guidelines, model codes, and principles for handling ethical issues and for appropriate data and privacy protection are available, which may serve the consideration of these topics in a learning analytics context. The importance and significance of data security and protection are also reflected in national and international laws and directives, where data protection is usually considered as a fundamental right. Existing guidelines, approaches, and regulations served as a basis for elaborating a comprehensive privacy and data protection framework for the LEA's BOX project. It comprises a set of eight principles to derive implications for ensuring ethical treatment of personal data in a learning analytics platform and its services. The privacy and data protection policy set out in the framework is translated into the learning analytics technologies and tools that were developed in the project and may be used as best practice for other learning analytics projects.

Aim: (1) To determine the repartition of criteria which can be considered as marks of lack of assent by the child with intellectual disabilities from the dentist's point of view and whether that influences the decision to examine the patient or not. (2) To explain the decision of practitioners and determine the ethical implications of these practices. Methods: An anonymous and structured questionnaire was distributed online using the scenario of a 9‐year‐old child with moderate cognitive impairment with eight different oppositional behaviours. The practitioners were asked about their perception of the patient's lack of assent and about their decision to perform the dental examination or not. Results: The proportion of them who performed a dental examination despite the patient's refusal represented between 13% and 28.8% of the population of respondents. Conclusion: There was an ambivalence among the practitioners who carried out a dental consultation when children were uncooperative. They adopted a teleological point of view. It calls for us to reflect on the ethical principles of autonomy and beneficence. [ABSTRACT FROM AUTHOR]

Palliative sedation aims to relieve refractory suffering in patients with life-limiting disease. The 2009 framework on palliative sedation of the European Association for Palliative Care (EAPC) has recently been updated. Recommendations have also been formulated by the research group SedPall in Germany. This article describes the social and ethical complexity of decision-making and summarises the recommendations. Patient autonomy is emphasised. Refractoriness of the suffering should be determined jointly by physician and patient. Sedation should be proportional, that is to say, its form and duration should be adapted to the patient's individual situation. The decision on palliative sedation and that on hydration involve two separate decision-making processes. Midazolam should be used as first choice. Particular attention should be paid to the patient's relatives/significant others and the treating team., (© 2024. The Author(s).)

Digital farming technologies promise to help farmers make well-informed decisions that improve the quality and quantity of their production, with less labour and less impact on the environment. This future, however, can only become a reality if farmers are willing to share their data with agribusinesses that develop digital technologies. To foster trust in data sharing, in Europe the EU Code of Conduct for agricultural data sharing by contractual agreement was launched in 2018 which encourages transparency about data use. This article looks at the EU Code through the lens of literature on trust and contract agreements. We agree with the makers of the EU Code that a contract can make an important contribution to trust relationships as it is needed to mitigate the detrimental effects of power relationships between experts and non-experts. Building on Onora O'Neills perspective to trust, however, we argued that a contract can only be successful in fostering trust when (a) information is comprehended by the more vulnerable party in this relationship who has to sign the contract, (b) the more powerful partner takes responsibility to provide that information, and (c) information is tailored to the information needs of the party signing the contract, even when data are re-used over a longer period. In addition, we think that differences between trust relationships and relationships of accountability, give reason to add to informed consent other more substantive ethical components in a more encompassing code of conduct. [ABSTRACT FROM AUTHOR]

The information and subsequent expression of will, so-called informed consent, have become the essential element of health right, understood as the right to autonomous choice in health, based on the fiduciary relationship between physician and patient. This gradually leads European Countries to adopt special legislations and to issue frequent judgments on the subject. However, new challenges in daily clinical practice call for further study of legal solutions. The authors analyse and compare the regulations on informed consent in health care of Italy, France, the United Kingdom, the Nordic Countries, Germany, and Spain. The health and legal contexts, existence of special regulations on informed consent and their characteristics are discussed. Informed consent resulted a mandatory requirement. Clear communication about treatment, therapeutic alternatives, and major risks, discussed in conversation, but preferably documented in writing, are agreed upon. The possibility of dissent and withdrawal of consent are also included. There is a growing interest in involving and regulating the entire health team in information and consent. Lowering the age of consent for minors or analysing the maturity of minors are attempts to increase their participation in health decisions. On another side, the protection of adult incapables persons requires greater involvement of family and fiduciaries to better adapt to changing health needs. Health policy must take responsibility for training health professionals and citizens about the value of health information and communication as a shared choice in care planning, to strengthen the bond of trust with the healthcare system and users., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Background: Medical data from family doctors are of great importance to health care researchers but seem to be locked in German practices and, thus, are underused in research. The RADAR project (Routine Anonymized Data for Advanced Health Services Research) aims at designing, implementing and piloting a generic research architecture, technical software solutions as well as procedures and workflows to unlock data from family doctor's practices. A long-term medical data repository for research taking legal requirements into account is established. Thereby, RADAR helps closing the gap between the European countries and to contribute data from primary care in Germany.Methods: The RADAR project comprises three phases: (1) analysis phase, (2) design phase, and (3) pilot. First, interdisciplinary workshops were held to list prerequisites and requirements. Second, an architecture diagram with building blocks and functions, and an ordered list of process steps (workflow) for data capture and storage were designed. Third, technical components and workflows were piloted. The pilot was extended by a data integration workflow using patient-reported outcomes (paper-based questionnaires).Results: The analysis phase resulted in listing 17 essential prerequisites and guiding requirements for data management compliant with the General Data Protection Regulation (GDPR). Based on this list existing approaches to fulfil the RADAR tasks were evaluated-for example, re-using BDT interface for data exchange and Trusted Third Party-approach for consent management and record linkage. Consented data sets of 100 patients were successfully exported, separated into person-identifying and medical data, pseudonymised and saved. Record linkage and data integration workflows for patient-reported outcomes in the RADAR research database were successfully piloted for 63 responders.Conclusion: The RADAR project successfully developed a generic architecture together with a technical framework of tools, interfaces, and workflows for a complete infrastructure for practicable and secure processing of patient data from family doctors. All technical components and workflows can be reused for further research projects. Additionally, a Trusted Third Party-approach can be used as core element to implement data privacy protection in such heterogeneous family doctor's settings. Optimisations identified comprise a fully-electronic consent recording using tablet computers, which is part of the project's extension phase. [ABSTRACT FROM AUTHOR]

We consent to many things in life, but sometimes we do not know what we consent to. When discussing data protection in Europe, consent has been associated with permission under the GDPR, and health data are highly sensitive. Patients cannot make an informed decision without being provided with the information they need upfront: no informed decision, no informed consent. This paper presents a consent management system for patient-generated health data stored with HL7 FHIR specification, tested on Type 1 diabetes synthetic data. This architecture, based on using FHIR as an unequivocal data exchange format, can lead to individuals (patients) taking control of their data, enabling potential data exchange and reuse of health data across countries and organisations, in line with the European Commission proposal of a European Health Data Space.

Background Pandemics of new and emerging infectious diseases are unpredictable, recurrent events that rapidly threaten global health and security. We aimed to identify public views regarding provision of information and consent to participate in primary and critical care clinical research during a future influenza-like illness pandemic. Methods Descriptive-interpretive qualitative study, using focus groups (n = 10) and semi-structured interviews (n = 16), with 80 members of the public (>18 years) in Belgium, Spain, Poland and the UK. Local qualitative researchers followed a scenario-based topic guide to collect data. Data were transcribed verbatim, translated into English and subject to framework analysis. Results Public understandings of pandemics were shaped by personal factors (illness during the previous H1N1 pandemic, experience of life-threatening illness) and social factors (historical references, media, public health information). Informants appreciated safeguards provided by ethically robust research procedures, but current enrolment procedures were seen as a barrier. They proposed simplified enrolment processes for higher risk research and consent waiver for certain types of low-risk research. Decision making about research participation was influenced by contextual, research and personal factors. Informants generally either carefully weighed up various approaches to research participation or responded instinctively. They supported the principle of using routinely collected, anonymized clinical biological samples for research without explicit consent, but regarded this as less acceptable if researchers were motivated primarily by commercial gain. Conclusions This bottom-up approach to ascertaining public views on pandemic clinical research has identified support for more proportionate research protection procedures for publically funded, low-risk studies. [ABSTRACT FROM AUTHOR]

Several Central and Eastern European countries have recently enacted retrogressive laws and policies introducing new preconditions that women must fulfill before they can obtain legal abortion services. Mandatory waiting periods and biased counseling and information requirements are particularly common examples of these new prerequisites. The present article considers these requirements in light of international human rights standards and public health guidelines, and outlines the manner in which, by imposing regressive barriers on women's access to legal abortion services, these new laws and policies undermine women's health and well-being, fail to respect women's human rights, and reinforce harmful gender stereotypes and abortion stigma. [ABSTRACT FROM AUTHOR]

The objective of this study was to gather health professionals' perceptions about gaining informed consent and delivering HIV pre-test information. An online self-report survey was completed by 338 respondents involved in HIV testing in 55 countries in the WHO European Region. Nearly two thirds (61.5%) of respondents thought that HIV testing guidelines used in their country of work included recommendations about pre-test information; 83% thought they included recommendations regarding obtaining informed consent. One third (34%) of respondents thought that written informed consent was required; respondents from Eastern Europe and Central Asia were more likely to perceive this as required. Respondents from Western Europe thought pre-test information about the following aspects was significantly less likely to be addressed than respondents in other regions: the right to decline a test; services available after a positive test; laws/regulations impacting someone being tested and receiving a positive test result; potential risks for a client taking an HIV test; the possible need for partner notification after a positive test result. Results offer insight into perceived HIV pre-test practices in all but two national settings across the WHO European Region, and can be used in the development and evaluation of future HIV testing guidelines in the WHO European Region. Findings highlight that practices of obtaining written informed consent depart from current guidelines in some HIV testing settings. Furthermore, findings underscore that it is uncommon for pre-test information to address legal and social risks and harms that people testing HIV-positive may incur. This differs from the most recent global WHO guidelines emphasising the importance of such information, and raises important questions regarding the implications and appropriateness of the currently dominant focus of recommendations on streamlining the HIV testing process. [ABSTRACT FROM AUTHOR]

An increasing number of European research projects return, or plan to return, individual genomic research results (IRR) to participants. While data access is a data subject's right under the General Data Protection Regulation (GDPR), and many legal and ethical guidelines allow or require participants to receive personal data generated in research, the practice of returning results is not straightforward and raises several practical and ethical issues. Existing guidelines focusing on return of IRR are mostly project-specific, only discuss which results to return, or were developed outside Europe. To address this gap, we analysed existing normative documents identified online using inductive content analysis. We used this analysis to develop a checklist of steps to assist European researchers considering whether to return IRR to participants. We then sought feedback on the checklist from an interdisciplinary panel of European experts (clinicians, clinical researchers, population-based researchers, biobank managers, ethicists, lawyers and policy makers) to refine the checklist. The checklist outlines seven major components researchers should consider when determining whether, and how, to return results to adult research participants: 1) Decide which results to return; 2) Develop a plan for return of results; 3) Obtain participant informed consent; 4) Collect and analyse data; 5) Confirm results; 6) Disclose research results; 7) Follow-up and monitor. Our checklist provides a clear outline of the steps European researchers can follow to develop ethical and sustainable result return pathways within their own research projects. Further legal analysis is required to ensure this checklist complies with relevant domestic laws., (© 2023. The Author(s).)

Several COVID-19 vaccinations have been authorised worldwide. Whilst some vaccines are contraindicated for certain age groups or health conditions, there are often multiple clinically suitable authorised vaccine brands available. Few states have allowed recipients to choose amongst them, though there are multiple reasons why choice would be valued. We consider the policy justifications for state controls on recipient choice amongst COVID-19 vaccine brands, focusing on European countries and drawing on the UK context as an example. We contrast justifications for not offering choice at the height of the early pandemic crisis, and as some states seek to de-escalate their response and transition towards living with COVID-19. We argue that in the latter context public expectations of choice between available vaccine brands and platforms may rise, but that several considerations may justify continued restrictions on choice. A key factor which states should continue to take into consideration is the global nature of the pandemic. Insofar as offering recipient choice at a national level might exacerbate global inequity in vaccine distribution, states retain a normative and legal justification for restricting choice amongst available and clinically suitable vaccine brands., (© The Author(s) 2022. Published by Oxford University Press.)

This article examines the relevant international law relating to informed consent to treatment for individuals with psychosocial disabilities and reflects on the protection offered in this respect by the European Convention on Human Rights (ECHR) and the Council of Europe Convention on Human Rights and Biomedicine. The article argues that while the UN Convention on the Rights of Persons with Disabilities is beginning to influence case law of the European Court of Human Rights, only 'weak' protection has been afforded to people with psychosocial disabilities by the ECHR and the Court in relation to informed consent for medical treatment. [ABSTRACT FROM AUTHOR]

In the context of a shift from exceptionalism to normalisation, this study examines recommendations/evidence in current pan-European/global guidelines regarding pre-test HIV testing and counselling practices in health care settings. It also reviews new research not yet included in guidelines. There is consensus that verbal informed consent must be gained prior to testing, individually, in private, confidentially, in the presence of a health care provider. All guidelines recommend pre-test information/discussion delivered verbally or via other methods (information sheet). There is agreement about a minimum standard of information to be provided before a test, but guidelines differ regarding discussion about issues encouraging patients to think about implications of the result. There is heavy reliance on expert consultation in guideline development. Referenced scientific evidence is often more than ten years old and based on US/UK research. Eight new papers are reviewed. Current HIV testing and counselling guidelines have inconsistencies regarding the extent and type of information that is recommended during pre-test discussions. The lack of new research underscores a need for new evidence from a range of European settings to support the process of expert consultation in guideline development. [ABSTRACT FROM AUTHOR]

The challenges of conducting hyperacute stroke research and obtaining informed consent have been increasingly recognized within the stroke research community in recent years. Deferral of consent, in which a patient is enrolled in a trial and then provides consent at some point thereafter, is increasingly used to enroll patients into hyperacute stroke trials in Canada and Europe, although it is not permitted in the United States. Deferral of consent offers several potential advantages-quicker door-to-randomization, increased enrolment, decreased selection bias-but these must be balanced against the risk of enrolling patients against their wishes. We seek to minimize the attendant risks of deferral of consent by offering practical guidance regarding how to conduct acute stroke trials using deferral of consent. Building on existing guidelines and recent experiences with deferral of consent in acute stroke trials, we have developed a protocol for the use of deferral of consent that aims to maximize patient involvement while minimizing ethical and scientific risks., (Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology.)

Research utilizing human tissue and its removal at post-mortem has given rise to many controversies in the media and posed many dilemmas in the fields of law and ethics. The law often lacks clear instructions and unambiguous guidelines. The absence of a harmonized international legislation with regard to post-mortem medical procedures and donation of tissue and organs contributes to the complexity of the issue. Therefore, within the BrainNet Europe (BNE) consortium, a consortium of 19 European brain banks, we drafted an ethical Code of Conduct for brain banking that covers basic legal rules and bioethical principles involved in brain banking. Sources include laws, regulations and guidelines (Declarations, Conventions, Recommendations, Guidelines and Directives) issued by international key organizations, such as the Council of Europe, European Commission, World Medical Association and World Health Organization. The Code of Conduct addresses fundamental topics as the rights of the persons donating their tissue, the obligations of the brain bank with regard to respect and observance of such rights, informed consent, confidentiality, protection of personal data, collections of human biological material and their management, and transparency and accountability within the organization of a brain bank. The Code of Conduct for brain banking is being adopted by the BNE network prior to being enshrined in official legislation for brain banking in Europe and beyond. [ABSTRACT FROM AUTHOR]

Off-label use of medication refers to prescribing a registered medicine outside its approved marketing authorization, purpose, target group, or indication. Off-label prescription is a widely accepted practice. However, no or little regulation can be found. In this article, the legal status of off-label prescription will be examined. Does off-label prescription fall under the therapeutical freedom and is it free from regulation? Or should we equalize off-label prescription with a therapeutical experimentation and should it follow the rules of experimentation? I will also examine whether the patient can give an informed consent. Whether or not this is possible leads to intense discussions. Finally, the potential liability of the prescribing physician is of great importance. [ABSTRACT FROM AUTHOR]

The reviewed ePrivacy Directive aims at ensuring internet users' online privacy by requiring users to give informed consent to the gathering, storing, and processing of their data by internet service providers, e.g., through the cookies' use. However, it is hardly possible to talk about an 'informed' consent if internet users are not aware of cookies or do not understand when and how they work. Currently, European rules require internet service providers to provide internet users with a 'clear and comprehensive' information on the cookies' use without further specifying what kind of disclosure would be seen as compliant therewith. This paper assesses the need for harmonized European guidelines on transparent and readable disclosure on the cookies' use and suggests the way forward based on comparative legal research and findings from consumer behaviour research. [ABSTRACT FROM AUTHOR]

Highlights: [•] In response to new EU regulations, new Dutch cookie legislation requires prior informed consent. [•] Dutch Internet users have insufficient knowledge when confronted with targeted advertising. [•] Older and less-educated groups were most concerned about their privacy. [•] Most users intended to protect their online privacy but not by reading privacy statements. [•] Government should not only focus on enhancing OBA knowledge but also on reducing concerns. [Copyright &y& Elsevier]

Introduction: Informed consent for any surgical intervention is necessary, as only well-informed patients can actively participate in the decision-making process about their care, and better understand the likely or potential outcomes of their treatment. No consensus exists on informed consent for suspension microlaryngoscopy (SML)., Materials and Methods: Informed consent procedures in nine countries on five continents were studied., Results: Several risks can be discerned: risks of SML as procedure, anesthesiologic risks of SML, specific risks of phonosurgery, risks of inadequate glottic exposure or unexpected findings, risks of not treating. SML has recognized potential complications, that can be divided in temporary (minor) complications, and lasting (major) complications., Conclusion: SML is a safe procedure with low morbidity, and virtually no mortality. Eleven recommendations are provided., (© 2022. The Author(s).)

Aims and objectives To assess women's attitudes towards the mechanisms of action of birth control methods. Background When addressing women's knowledge of and attitudes towards birth control methods, researchers frequently focus on side effects, effectiveness or correct use. Women's opinions about mechanisms of action have been much less investigated, and research is usually concentrated on the EC pill. Design Cross-sectional study. Methods Women, aged 18-49, from Germany, France, the UK, Sweden and Romania were randomly selected ( n = 1137). They were asked whether they would use a method that may work after fertilisation or after implantation and whether they would continue using it after learning it may have such effects. Logistic regression was performed to evaluate the influence of certain characteristics on women's attitudes. Results Almost half of women in Romania and Germany would not use methods with postfertilisation effects, while the lowest percentages were found in Sweden and in France. Regarding methods with postimplantation effects, higher percentages were found in all the countries. Highly educated women and those using a highly effective method were more likely to use methods with postfertilisation effects. On the contrary, married women, those who stated that human life begins at fertilisation and women with middle/high religiosity were less likely to consider using methods that may act after fertilisation. Conclusions One-third of European women reported that they would not consider using a method that may have postfertilisation effects. Relevance to clinical practice Given that postfertilisation effects may not be acceptable to some women, informing them of which methods may have these effects is essential to obtaining complete informed consent and to promoting women's autonomy. [ABSTRACT FROM AUTHOR]

CLSR welcomes occasional comment pieces on issues of current importance in the law and technology field. The current debate on the Commission's proposal for a new data pro-tection framework includes a plethora of very specific issues. As important as these may be, it should not be overlooked that the very principles of data protection are at stake at the moment. Given the lobby efforts to exclude large parts of today's data processing from the ambit of the proposed Regulation, to weaken the principle of informed consent, and to broaden the exceptions for "legitimate interests", we want to stress that data protection in Europe needs to be strengthened, and that this can be achieved without threatening innovation and legitimate business models. [ABSTRACT FROM AUTHOR]

Background: 'Assisted dying' is practiced in some European countries and US states. Legislation suggests that there exists an easily prescribed drug which consistently brings about death quickly and painlessly. Evidence from jurisdictions where 'assisted dying' is practiced, however, reveals that hastening patient death is not so simple., Sources of Data: This report is a collation of assisted suicide and euthanasia drug protocols published by the Canadian Association of MAiD Assessors and Providers and the Royal Dutch Medical Association, annual data reports from the USA and Canada and relevant academic publications pertaining to methods of 'assisted dying' in the USA, Belgium, Canada and Switzerland., Areas of Agreement: A wide variety of lethal drug combinations are used for people who want their life ended, and the prevalence of complications and failures in intentionally ending life suggest that 'assisted dying' applicants are at risk of distressing deaths., Areas of Controversy: The efficacy and safety of 'assisted dying' drugs are currently difficult to assess, as clinician reporting is often very low., Growing Points: The findings from this report reveal that little attention has been given to the problem of unmonitored prescribing and administering of lethal drug combinations, whose mode of action is unclear., Areas Timely for Developing Research: In order to properly assess the efficacy and safety of 'assisted dying', a more thorough means of data collection regarding the drugs used must be implemented and research is urgently needed into their mode of action., (© The Author(s) 2022. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.)

Background: The secondary use of deidentified but not anonymized patient data is a promising approach for enabling precision medicine and learning health care systems. In most national jurisdictions (e.g., in Europe), this type of secondary use requires patient consent. While various ethical, legal, and technical analyses have stressed the opportunities and challenges for different types of consent over the past decade, no country has yet established a national consent standard accepted by the relevant authorities., Methods: A working group of the national Medical Informatics Initiative in Germany conducted a requirements analysis and developed a GDPR-compliant broad consent standard. The development included consensus procedures within the Medical Informatics Initiative, a documented consultation process with all relevant stakeholder groups and authorities, and the ultimate submission for approval via the national data protection authorities., Results: This paper presents the broad consent text together with a guidance document on mandatory safeguards for broad consent implementation. The mandatory safeguards comprise i) independent review of individual research projects, ii) organizational measures to protect patients from involuntary disclosure of protected information, and iii) comprehensive information for patients and public transparency. This paper further describes the key issues discussed with the relevant authorities, especially the position on additional or alternative consent approaches such as dynamic consent., Discussion: Both the resulting broad consent text and the national consensus process are relevant for similar activities internationally. A key challenge of aligning consent documents with the various stakeholders was explaining and justifying the decision to use broad consent and the decision against using alternative models such as dynamic consent. Public transparency for all secondary use projects and their results emerged as a key factor in this justification. While currently largely limited to academic medicine in Germany, the first steps for extending this broad consent approach to wider areas of application, including smaller institutions and medical practices, are currently under consideration., (Copyright © 2022. Published by Elsevier Inc.)

Objective: Clinical trial sponsors spend considerable resources preparing informed consent (IC) and assent documentation for multinational paediatric clinical trial applications in Europe due to the limited and dispersed patient populations, the variation of national legal and ethical requirements, and the lack of detailed guidance. The aim of this study was to design new easy-to-use guide publicly available on European Medicines Agency's, Enpr-EMA website for all stakeholders., Methods: Current EU legal, ethical and regulatory guidance for paediatric clinical trials were collated, analysed and divided into 30 subject elements in two tables. The European Network of Young Person's Advisory Group reviewed the data and provided specific comments. A three-level recommendation using 'traffic light' symbols was designed for four age groups of children, according to relevance and the requirements., Results: A single guide document includes two tables: (1) general information and (2) trial-specific information. In the age group of 6-9 years old, 92% of the trial-specific subject elements can be or should be included in the IC discussion. Even in the youngest possible age group (2-5 years old children), the number of elements considered was, on average, 52%., Conclusion: The EU Clinical Trial Regulation (2014) does not contain specific requirements exclusively for paediatric clinical trials. This work is the first to extensively collate all the current legal, regulatory and ethical documentation on the IC process, together with input from adolescents. This guide may increase the ethical standards in paediatric clinical trials., Competing Interests: Competing interests: PL is the Chair of the Coordinating Group of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA), and all authors have been members of the ad hoc Enpr-EMA Ethics Working Group during this work., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Within the context of health and insurance law, an important question that arises is 'to what extent is an applicant for private insurance truly capable of giving his/her 'free' and informed consent for a medical examination?'. It should be borne in mind that it is the private insurer who requires a medical examination in order to gather medical information, and, moreover, that the insurer will not be inclined to conclude or carry out an insurance contract without this medical information. A distinction has to be made between not being free by legal coercion and not being (completely) free by factual circumstances. Exercising the right to informed consent involves exactly weighing up the consequences of the decision. Hence the applicant must be put in a position of being able to weigh up the consequences and take them into consideration. [ABSTRACT FROM AUTHOR]

For centuries, people of various nationalities from various States have sought asylum for varied reasons. These people seeking asylum can need medical care in the host country. In this article I would like to discuss to what extent informed consent is needed, and to what extent informed consent must be sought. The problem is discussed from the perspective of European international documents, mainly on those of the Council of Europe. [ABSTRACT FROM AUTHOR]

Family-based research in genetically isolated populations is an effective approach for identifying loci influencing variation in disease traits. In common with all studies in humans, those in genetically isolated populations need ethical approval; however, existing ethical frameworks may be inadequate to protect participant privacy and confidentiality and to address participants’ information needs in such populations. Using the ethical–legal guidelines of the Council for International Organizations of Medical Sciences (CIOMS) as a template, we compared the participant information leaflets and consent forms of studies in five European genetically isolated populations to identify additional information that should be incorporated into information leaflets and consent forms to guarantee satisfactorily informed consent. We highlight the additional information that participants require on the research purpose and the reasons why their population was chosen; on the potential risks and benefits of participation; on the opportunities for benefit sharing; on privacy; on the withdrawal of consent and on the disclosure of genetic data. This research raises some important issues that should be addressed properly and identifies relevant types of information that should be incorporated into information leaflets for this type of study. [ABSTRACT FROM AUTHOR]

The ageing society poses significant challenges to Europe’s economy and society. In coming to grips with these issues, we must be aware of their ethical dimensions. Values are the heart of the European Union, as Article 1a of the Lisbon Treaty makes clear: “The Union is founded on the values of respect for human dignity...”. The notion of Europe as a community of values has various important implications, including the development of inclusion policies. A special case of exclusion concerns the gap between those people with effective access to digital and information technology and those without access to it, the “digital divide”, which in Europe is chiefly age-related. Policies to overcome the digital divide and, more generally speaking, e-inclusion policies addressing the ageing population raise some ethical problems. Among younger senior citizens, say those between 65 and 80 years old, the main issues are likely to be universal access to ICT and e-participation. Among the older senior citizens, say those more than 80 years old, the main issues are mental and physical deterioration and assistive technology. An approach geared towards the protection of human rights could match the different needs of senior citizens and provide concrete guidance to evaluate information technologies for them. [ABSTRACT FROM AUTHOR]

The article analyses the relationship of international and national law regulating and ensuring the protection of biomedical research subjects as well as factors determining the actual effectiveness of this protection. For this purpose the article reveals reasons affecting legislation initiatives at international and European level; shows circumstances of adopting specific legal acts, their wording and compatibility. Analysing whether harmonized standards in this area ensure the actual protection of the research subjects the authors assessed the role of national legal norms and the level of legal consciousness and legal culture. Authors pursued the objectives of the article by analysing the main areas of biomedical research directly determining the protection of the research subjects' rights and the effectiveness of their protection such as operation of Research Ethics Committees, biomedical research liability and liability insurance. The analysis was carried out on the basis of national examples of the Baltic countries (Lithuania, Latvia, and Estonia) which were also compared to the situation in Western European countries. The article also assesses issues of the scope and effectiveness of biomedical research regulation related to the ratio of legal, ethical, and deontological norms in biomedical research. [ABSTRACT FROM AUTHOR]

The rights and well-being of children involved in clinical research in Europe should be assured by the respect of ethical considerations and legal rules. Specific provisions are included in the Directive 2001/20/EC (CT-Dir) aimed at providing a homogeneous ethical and legal context to perform clinical trials in Europe. The TEDDY Network of Excellence carried out a "Survey on the ethical and legal frameworks existing in Europe for paediatric clinical trials" to examine the measures enforced by Member States to implement the CT-Dir and other relevant ethical norms. The results showed that many differences exist in the protection of children enrolled in clinical trials. Such differences are especially due to a non-coordinated implementation of the Directive's Article 4 and a lack of public awareness on ethical issues in this field. The recently approved 'Ethical considerations for clinical trials on medicinal products conducted with the paediatric population' should speed up the implementation of an 'ad hoc set of ethical rules' and increase the level of minors' protection. Nevertheless, in lack of 'binding rules', a coordination at European level is still needed. Public initiatives aiming at promoting in-depth debates have to be supported in order to encourage this process of coordination. [ABSTRACT FROM AUTHOR]

The European Convention on Human Rights and Biomedicine of the Council of Europe provides in article 6 for special protection of persons who are not able to give free and informed consent to an intervention in the health field, e.g. minors. According to the second paragraph of this article it is up to domestic law to decide whether and under which conditions a minor is capable of taking autonomous decisions in the health field. In the present article an overview is given of the legal regulations in place regarding the position of minors in a health care setting in the EU Member States that have ratified the European Convention on Human Rights and Biomedicine namely Cyprus, Czech Republic, Denmark, Estonia, Greece, Hungary, Lithuania, Portugal, Slovakia, Slovenia and Spain. As the overview will show, the legal position of minor patients in a health care setting varies from country to country. This in view of the system they have opted for as well as the age and circumstances under which minors are allowed to take health care decisions autonomously. [ABSTRACT FROM AUTHOR]

The ethics of research, audit and publication have developed mainly within the last fifty years. The Declaration of Helsinki is the universally accepted code of conduct for researchers worldwide. All research has to be approved by an ethics committee, all of which are governed by a centralised structure which is the Central Office for Research Ethics Committees (COREC) in the UK. This standardised system has been developed to oversee all research activity across the whole of Europe and every European county will have an equivalent organisation. The committees concern themselves with research but the differences between audit and research are difficult to discern in many places. If there is any doubt then the advice of the local research ethics committee should be sought. Only the individual him/herself can give consent. This may produce difficulties in cases of certain groups especially unconscious patients and children. The outcome of every study should be published whatever the results and the ongoing development of centralised (national) research trial databases will promote this philosophy. Publication of results thought to be of lesser importance may prove difficult, however, and so there is a temptation to falsify or modify data to make it more attractive. This, together with other activities such as the fabrication of data, plagiarism, dual publication, salami publication, conflicts of interest and irregularities in authorship, have given Editors of journals a number of problems. Many of these issues around publication ethics may prove difficult to detect but the fear of sanctions from employers and professional organisations is a useful deterrent. [Copyright &y& Elsevier]

Objectives: To determine the effect of a change in the "Dutch Directive on Medical Research Involving Human Subjects" (DD) on the number of eligible intensive care unit (ICU) patients for medical research. In addition, we determined how family members experience their role as acting representative for giving informed consent, and in turn whether patients feel their representatives would do well representing them.Design and Setting: Prospective observational study in three Dutch ICUs.Participants: 714 consecutive ICU patients. Analysis was restricted to 211 patients who were incapacitated for more than 24h after ICU admission.Measurements and Results: The old DD left 45.5% of patients without a legal representative; with the new DD this figure declines to 8.1%. Older age was significantly associated with the impossibility of obtaining informed consent in the old DD; after the change there was no effect of age. The median grade of confidence that representatives had in giving informed consent for incapacitated patients was 8.0 (IQR 7.0-9.0) on a scale from 0 to 10. Patients gave an equal median grade to their representatives.Conclusion: When patients' adult children are not legally allowed to give informed consent, older patients are excluded from medical research, causing selection bias. The change in the DD has increased the number of surrogates allowed to give informed consent. Representatives felt very confident in their ability to represent the patients. In turn patients were equally confident that their representatives were able to represent them. [ABSTRACT FROM AUTHOR]

Informed consent means approval of the legal representative of the child and/or of the competent child for medical interventions following appropriate information. National legal regulations differ in regard to the question when a child has the full right to give his or her autonomous consent. Informed assent means a child's agreement to medical procedures in circumstances where he or she is not legally authorised or lacks sufficient understanding for giving consent competently. Doctors should carefully listen to the opinion and wishes of children who are not able to give full consent and should strive to obtain their assent. Doctors have the responsibility to determine the ability and competence of the child for giving his or her consent or assent. All children, even those not judged as competent, have a right to receive information given in a way that they can understand and give their assent or dissent. This consent/assent process must promote and protect the dignity, privacy and confidentiality of the child and his or her family. Consent or assent is required for all aspects of medical care, for preventive, diagnostic or therapeutic measures and research. Children may effectively refuse treatment or procedures which are not necessary to save their lives or prevent serious harm. Where treatment is necessary to save a life or prevent serious harm, the doctor has the duty to act in the best interest of the child. However, parents may also refuse to consent and in this case national laws and legal mechanisms for resolving disputes may be used. [ABSTRACT FROM AUTHOR]

The contribution of laboratory medicine in delivering value-based care depends on active cooperation and trust between pathologist and clinician. The effectiveness of medicine more in general depends in turn on active cooperation and trust between clinician and patient. From the second half of the 20th century, the art of medicine is challenged by the spread of artificial intelligence (AI) technologies, recently showing comparable performances to flesh-and-bone doctors in some diagnostic specialties. Being the principle source of data in medicine, the laboratory is a natural ground where AI technologies can disclose the best of their potential. In order to maximize the expected outcomes and minimize risks, it is crucial to define ethical requirements for data collection and interpretation by-design, clarify whether they are enhanced or challenged by specific uses of AI technologies, and preserve these data under rigorous but feasible norms. From 2018 onwards, the European Commission (EC) is making efforts to lay the foundations of sustainable AI development among European countries and partners, both from a cultural and a normative perspective. Alongside with the work of the EC, the United Kingdom provided worthy-considering complementary advice in order to put science and technology at the service of patients and doctors. In this paper we discuss the main ethical challenges associated with the use of AI technologies in pathology and laboratory medicine, and summarize the most pertaining key-points from the guidelines and frameworks before-mentioned., (© 2022 Walter de Gruyter GmbH, Berlin/Boston.)

Analysis and comparison of genetic screening programs shows that the extent of development of programs varies widely across Europe. Regional variations are due not only to genetic disease patterns but also reflect the novelty of genetic services. In most countries, the focus for genetic screening programs has been pregnant women and newborn children. Newborn children are screened only for disorders which are treatable. Prenatal screening when provided is for conditions for which termination may be offered. The only population screening programs for adults are those for thalassaemia carrier status in Cyprus, Greece and Italy. Social responses to genetic screening range from acceptance to hostility. There is a fundamental tension between individual and communi ty in the debates in various European countries about implementation of screening programs. Opposition to genetic screening is frequently expressed in terms of arguments about "eugenics" with insufficient regard to the meaning of the term and its implications. Only a few countries have introduced explicit legislation on genetic screening. Legislation to address discrimination may provide more safeguards than legislation protecting genetic information itself. [ABSTRACT FROM AUTHOR]

A questionnaire was sent to the 590 members of the European Society of Intensive Care Medicine to define both the current practices and the opinions of these specialists on various ethical issues. The answers from 242 (41%) European members were collected and analysed. The first part of the questionnaire was designed to define the criteria for admission to Intensive Care throughout Europe. Admissions to the ICU were generally or commonly limited by the number of available beds according to 57% of the respondents and sometimes or almost never according to 41% (100/242). Bed availability in the ICU was especially limited in Spain, Portugal, Italy and the United Kingdom. Despite limited bed availability, two thirds of the respondents did admit patients who were thought to have little or no hope of survival other than for a few weeks. When asked about what ought to be done in these circumstances, the number of respondents who supported the admission of such terminal patients to ICU was halved. These data illustrate the heterogeneity of admission practices in Europe and stress the need for all ICUs to define a policy for admission. The second part was designed to assess the information given to patients in the ICU. Only 24 (10%) of the respondents stated that they always delivered complete information to their patients and only 31 (13%) thought they should do so. When an iatrogenic incident occurred, only 39 (16%) claimed to relate exactly what had happened, to the patient or their relatives but 121 (50%) thought they should. Informed consent was usually required for surgery or gastroscopy and the administration of a new medication. [ABSTRACT FROM AUTHOR]

Background: The landscape of clinical research has evolved over the past decade. With technological advances, the practice of using electronic informed consent (eIC) has emerged. However, a number of challenges hinder the successful and widespread deployment of eIC in clinical research. Therefore, we aimed to investigate the views of various stakeholders on the potential advantages and challenges of eIC., Methods: Semi-structured interviews were conducted with 39 participants from 5 stakeholder groups from across 11 European countries. The stakeholder groups included physicians, patient organization representatives, regulator representatives, ethics committee members, and pharmaceutical industry representatives, and all were involved in clinical research. Interviews were analyzed using the framework method., Results: Interviewees identified that a powerful feature of eIC is its personalized approach as it may increase participant empowerment. However, they identified several ethical and practical challenges, such as ensuring research participants are not overloaded with information and offering the same options to research participants who would prefer a paper-based informed consent rather than eIC. According to the interviewees, eIC has the potential to establish efficient long-term interactions between the research participants and the research team in order to keep the participants informed during and after the study. Interviewees emphasized that a personal interaction with the research team is of utmost importance and this cannot be replaced by an electronic platform. In addition, interviewees across the stakeholder groups supported the idea of having a harmonized eIC approach across the European Member States., Conclusions: Interviewees reported a range of design and implementation challenges which needs to be overcome to foster innovation in informing research participants and obtaining their consent electronically. It was considered important that the implementation of eIC runs alongside the face-to-face contact between research participants and the research team. Moreover, interviewees expect that eIC could offer the opportunity to enable a personalized approach and to strengthen continuous communication over time. If successfully implemented, eIC may facilitate the engagement of research participants in clinical research., (© 2021. The Author(s).)

Unrelated cord blood (CB) units, already manufactured, fully tested and stored, are high-quality products for haematopoietic stem cell transplantation and cell therapies, as well as an optimal starting material for cell expansion, cell engineering or cell re-programming technologies. CB banks have been pioneers in the development and implementation of Current Good Manufacturing Practices for cell-therapy products. Sharing their technological and regulatory experience will help advance all cell therapies, CB-derived or not, particularly as they transition from autologous, individually manufactured products to stored, 'off-the shelf' treatments. Such strategies will allow broader patient access and wide product utilisation., (© 2021 British Society for Haematology and John Wiley & Sons Ltd.)

The General Data Protection Regulation (GDPR) became binding law in the European Union Member States in 2018, as a step toward harmonizing personal data protection legislation in the European Union. The Regulation governs almost all types of personal data processing, hence, also, those pertaining to biomedical research. The purpose of this article is to highlight the main practical issues related to data and biological sample sharing that biomedical researchers face regularly, and to specify how these are addressed in the context of GDPR, after consulting with ethics/legal experts. We identify areas in which clarifications of the GDPR are needed, particularly those related to consent requirements by study participants. Amendments should target the following: (1) restricting exceptions based on national laws and increasing harmonization, (2) confirming the concept of broad consent, and (3) defining a roadmap for secondary use of data. These changes will be achieved by acknowledged learned societies in the field taking the lead in preparing a document giving guidance for the optimal interpretation of the GDPR, which will be finalized following a period of commenting by a broad multistakeholder audience. In parallel, promoting engagement and education of the public in the relevant issues (such as different consent types or residual risk for re-identification), on both local/national and international levels, is considered critical for advancement. We hope that this article will open this broad discussion involving all major stakeholders, toward optimizing the GDPR and allowing a harmonized transnational research approach.

In the context of the increasing spread of cardiac active implantable heart devices (CIEDs) in the population and of the wide diagnostic/therapeutic utility of magnetic resonance (MRI) examinations, the goal of this paper is to provide the experience of the Santa Maria Nuova Hospital of the USL Tuscany Center in Florence and to report an organizational proposal to perform, in the hospital settings, MRI examinations on patients carrying CIED. This report is intended to show the operational choices of a Radiology Department which organizes this activity in accordance with the new Italian regulatory framework in the field of safety of MR sites (Ministero della Salute in Decreto Ministeriale 10 agosto 2018 Determinazione degli standard di sicurezza e impiego per le apparecchiature a risonanza magnetica, 2018).

Introduction: Telemedicine provides remote clinical support through technology tools. It can facilitate medical care delivery while reducing unnecessary office visits. The COVID-19 outbreak has caused an abrupt change in our daily urological practice, where teleconsultations play a crucial role., Objective: To provide practical recommendations for the effective use of technological tools in telemedicine., Materials and Methods: A literature search was conducted on Medline until April 2020. We selected the most relevant articles related to «telemedicine» and «smart working» that could provide valuable information., Results: Telemedicine refers to the use of electronic information and telecommunication tools to provide remote clinical health care support. Smart working is a working approach that uses new or existing technologies to improve performance. Telemedicine is becoming a useful and fundamental tool during the COVID-19 pandemic and will be even more in the future. It is time for us to officially give telemedicine the place it deserves in clinical practice, and it is our responsibility to adapt and familiarize with all the tools and possible strategies for its optimal implementation. We must guarantee that the quality of care received by patients and perceived by them and their families is of the highest standard., Conclusions: Telemedicine facilitates remote specialized urological clinical support and solves problems caused by limited patient mobility or transfer, reduces unnecessary visits to clinics and is useful to reduce the risk of COVID-19 viral transmission., (Copyright © 2020 AEU. Publicado por Elsevier España, S.L.U. All rights reserved.)

Purpose: Enrolling traumatic brain injury (TBI) patients with an inability to provide informed consent in research is challenging. Alternatives to patient consent are not sufficiently embedded in European and national legislation, which allows procedural variation and bias. We aimed to quantify variations in informed consent policy and practice., Methods: Variation was explored in the CENTER-TBI study. Policies were reported by using a questionnaire and national legislation. Data on used informed consent procedures were available for 4498 patients from 57 centres across 17 European countries., Results: Variation in the use of informed consent procedures was found between and within EU member states. Proxy informed consent (N = 1377;64%) was the most frequently used type of consent in the ICU, followed by patient informed consent (N = 426;20%) and deferred consent (N = 334;16%). Deferred consent was only actively used in 15 centres (26%), although it was considered valid in 47 centres (82%)., Conclusions: Alternatives to patient consent are essential for TBI research. While there seems to be concordance amongst national legislations, there is regional variability in institutional practices with respect to the use of different informed consent procedures. Variation could be caused by several reasons, including inconsistencies in clear legislation or knowledge of such legislation amongst researchers., Competing Interests: Declaration of Competing Interest The authors declare that they have no competing interests., (Copyright © 2020. Published by Elsevier Inc.)

Background: Many of the important elements of a valid informed consent - comprehension, voluntariness, and capacity - can be compromised or unmet in the context of psychiatric research. The inability to protect their own interests puts mentally ill subjects at an increased likelihood of being wronged or harmed and makes them particularly vulnerable in the context of clinical research. Therefore, they are due extra protection. Sometimes, these additional safeguards can significantly limit the possibilities for research involving subjects deemed unable to consent due to their mental illness. Montenegro, a middle-income country in Southern-Eastern Europe, goes so far in their policy to protect these subjects from harms of research, as to ban all biomedical research on mentally ill persons who are unable to provide consent., Main Body: Mental health research is often neglected and very low on the list of health research priorities, especially in low- and middle-income countries. Despite the fact that mental health disorders are among leading causes of disability, the need for evidence-based services and interventions for those affected remains unmet. To exclude all members of a certain group of subjects seems extremely restrictive and unnecessary. Such a policy is discriminatory and unethical, because it inflicts further harms and exclusion of those patients from participation in society. This unjust exclusion policy obstructs research of certain psychiatric disorders and implies that new treatments for conditions that directly affect these incapacitated subjects will not be developed., Conclusions: Scientific and clinical development must not be precluded by overly restrictive, discriminatory and unjust practices, such as the normative ban on research on decisionally-impaired mentally ill subjects. Rather, there should be a regulative framework that ensures that those who cannot consent for themselves are respected and protected in research, the anticipated benefits maximized, risks minimized, their autonomy recognized and extended. These patient-subjects must be appropriately included unless there is a clear and compelling rationale and justification that inclusion is inappropriate with respect to the health of the participants or the purpose of the research.

Background: Novel rationales for randomizing clusters rather than individuals appear to be emerging from the push for more pragmatic trials, for example, to facilitate trial recruitment, reduce the costs of research, and improve external validity. Such rationales may be driven by a mistaken perception that choosing cluster randomization lessens the need for informed consent. We reviewed a random sample of published cluster randomized trials involving only individual-level health care interventions to determine (a) the prevalence of reporting a rationale for the choice of cluster randomization; (b) the types of explicit, or if absent, apparent rationales for the use of cluster randomization; (c) the prevalence of reporting patient informed consent for study interventions; and (d) the types of justifications provided for waivers of consent. We considered cluster randomized trials for evaluating exclusively the individual-level health care interventions to focus on clinical trials where individual randomization is only theoretically possible and where there is a general expectation of informed consent., Methods: A random sample of 40 cluster randomized trials were identified by implementing a validated electronic search filter in two electronic databases (Ovid MEDLINE and Embase), with two reviewers independently extracting information from each trial. Inclusion criteria were the following: primary report of a cluster randomized trial, evaluating exclusively an individual-level health care intervention, published between 2007 and 2016, and conducted in Canada, the United States, European Union, Australia, or low- and middle-income country settings., Results: Twenty-five trials (62.5%, 95% confidence interval = 47.5%-77.5%) reported an explicit rationale for the use of cluster randomization. The most commonly reported rationales were those with logistical or administrative convenience (15 trials, 60%) and those that need to avoid contamination (13 trials, 52%); five trials (20%) were cited rationales related to the push for more pragmatic trials. Twenty-one trials (52.5%, 95% confidence interval = 37%-68%) reported written informed consent for the intervention, two (5%) reported verbal consent, and eight (20%) reported waivers of consent, while in nine trials (22.5%) consent was unclear or not mentioned. Reported justifications for waivers of consent included that study interventions were already used in clinical practice, patients were not randomized individually, and the need to facilitate the pragmatic nature of the trial. Only one trial reported an explicit and appropriate justification for waiver of consent based on minimum criteria in international research ethics guidelines, namely, infeasibility and minimal risk., Conclusion: Rationales for adopting cluster over individual randomization and for adopting consent waivers are emerging, related to the need to facilitate pragmatic trials. Greater attention to clear reporting of study design rationales, informed consent procedures, as well as justification for waivers is needed to ensure that such trials meet appropriate ethical standards.