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Background: Electronic informed consent (eIC) may offer various advantages compared to paper-based informed consent. However, the regulatory and legal landscape related to eIC provides a diffuse image. By drawing from the perspectives of key stakeholders in the field, this study aims to inform the creation of a European guidance framework on eIC in clinical research. Methods: Focus group discussions and semi-structured interviews were conducted with 20 participants from six stakeholder groups. The stakeholder groups included representatives of ethics committees, data infrastructure organizations, patient organizations, and the pharmaceutical industry as well as investigators and regulators. All were involved in or knowledgeable about clinical research and were active in one of the European Union Member States or at a pan-European or global level. The framework method was used for data analysis. Results: Stakeholders underwrote the need for a multi-stakeholder guidance framework addressing practical elements related to eIC. According to the stakeholders, a European guidance framework should describe consistent requirements and procedures for implementing eIC on a pan-European level. Generally, stakeholders agreed with the definitions of eIC issued by the European Medicines Agency and the US Food and Drug Administration. Nevertheless, it was raised that, in a European guidance framework, it should be emphasized that eIC aims to support rather than replace the personal interaction between research participants and the research team. In addition, it was believed that a European guidance framework should include details on the legality of eIC across European Union Member States and the responsibilities of an ethics committee in the eIC assessment process. Although stakeholders supported the idea to include detailed information on the type of eIC-related materials to be submitted to an ethics committee, opinions varied on this regard. Conclusion: The creation of a European guidance framework is a much needed factor to advance eIC implementation in clinical research. By collecting the views of multiple stakeholder groups, this study advances recommendations that may facilitate the development of such a framework. Particular consideration should go to harmonizing requirements and providing practical details related to eIC implementation on a European Union-wide level. [ABSTRACT FROM AUTHOR]

Background: Over the years, there has been increasing interest in electronic informed consent (eIC) in clinical research. The user-friendliness of an eIC application and its acceptance by stakeholders plays a central role in achieving successful implementation. Objective: This study aims to identify insights for the design and implementation of a user-friendly, personalized, and long-term eIC application based on a usability study with (potential) research participants and semistructured interviews with stakeholders on the practical integration of such an application into their daily practice. Methods: An eIC prototype was evaluated and refined through usability testing among Belgian citizens and iterative redesign. On the basis of a digital literacy questionnaire, a heterogeneous sample of participants was established. Participants needed to complete a series of usability tasks related to personalization and long-term interaction with the research team while using the "think aloud" technique. In addition, usability tests involved completing the System Usability Scale questionnaire and taking part in a semistructured feedback interview. Furthermore, semistructured interviews were conducted with ethics committee members, health care professionals, and pharmaceutical industry representatives active in Belgium and involved in clinical research. Thematic analysis was undertaken using the NVivo software (Lumivero). Results: In total, 3 iterations of usability tests were conducted with 10 participants each. Each cycle involved some participants who reported having low digital skills. The System Usability Scale scores related to the tasks on personalization and long-term interaction increased after each iteration and reached 69.5 (SD 8.35) and 71.3 (SD 16.1) out of 100, respectively, which represents above-average usability. Semistructured interviews conducted with health care professionals (n=4), ethics committee members (n=8), and pharmaceutical industry representatives (n=5) identified the need for an eIC system that can be easily set up. For example, a library could be established enabling stakeholders to easily provide background information about a clinical study, presented in the second layer of the interface. In contrast, some functionalities, such as informing participants about new studies through an eIC system, were not considered useful by stakeholders. Conclusions: This study provides insights for the implementation of a user-friendly personalized and long-term eIC application. The study findings showed that usability testing is key to assessing and increasing the user-friendliness of an eIC application. Although this eIC system has the potential to be usable by a wide audience, participants with low digital literacy may not be able to use it successfully, highlighting the need for additional support for participants or other alternatives to an eIC system. In addition, key lessons emerging from the interviews included ensuring that the application is easy to implement in practice and is interoperable with other established systems. [ABSTRACT FROM AUTHOR]

Background: Current preimplantation genetic testing (PGT) technologies enable embryo genotyping across the whole genome. This has led to the development of polygenic risk scoring of human embryos (PGT-P). Recent implementation of PGT-P, including screening for intelligence, has been extensively covered by media reports, raising major controversy. Considering the increasing demand for assisted reproduction, we evaluated how information about PGT-P is communicated in press media and explored the diversity of ethical themes present in the public debate.Methods: LexisNexis Academic database and Google News were searched to identify articles about polygenic embryo screening. This led to 535 news articles. 59 original articles met the inclusion criteria. Inductive content analysis was used to analyse these articles.Results: 8.8% of articles gave embryo polygenic scoring a positive portrayal, while 36.8% expressed a negative attitude. 54.4% were neutral, mostly highlighting limited practical value of the technology in in vitro fertilization settings. We identified five main ethical themes that are also present in academic literature and the broader debate on reproductive technologies: a slippery slope towards designer babies, well-being of the child and parents, impact on society, deliberate choice and societal readiness.Conclusions: Implementation of embryo polygenic profiling engenders a need for specific recommendations. Current media analysis discloses important ethical themes to consider when creating future guidelines for PGT-P. [ABSTRACT FROM AUTHOR]

Background: Infrastructures are being developed to enhance and facilitate the sharing of cohort data internationally. However, empirical studies show that many barriers impede sharing data broadly. Purpose: Therefore, our aim is to describe the barriers and concerns for the sharing of cohort data, and the implications for data sharing platforms. Methods: Seventeen participants involved in developing data sharing platforms or tied to cohorts that are to be submitted to platforms were recruited for semi-structured interviews to share views and experiences regarding data sharing. Results: Credit and recognition, the potential misuse of data, loss of control, lack of resources, socio-cultural factors and ethical and legal barriers are elements that influence decisions on data sharing. Core values underlying these reasons are equality, reciprocity, trust, transparency, gratification and beneficence. Conclusions: Data generators might use data sharing platforms primarily for collaborative modes of working and network building. Data generators might be unwilling to contribute and share for non-collaborative work, or if no financial resources are provided for sharing data. [ABSTRACT FROM AUTHOR]

Background. The World Anti-Doping Agency is the international body coordinating anti-doping efforts, with the mandate of harmonizing anti-doping policy worldwide. With novel performance-enhancing compounds continuously entering the market, research is necessary to develop appropriate methods for their detection. WADA-accredited laboratories are required to spend 7% of their annual budget on this research and need to obtain ethics approval for studies involving human participants. Nevertheless, these labs may face difficulties in obtaining ethics approval for anti-doping research due to its distinct differences from traditional biomedical research. Therefore, our aim was to investigate potential difficulties in obtaining ethics approval for anti-doping research. Methods. Semi-structured interviews were conducted with stakeholders in anti-doping research to investigate their experiences toward the ethics review process of their research proposals. Interviews were transcribed, de-identified, coded and analyzed. Results. The interviews indicated that large discrepancies in the evaluation of anti-doping research proposals exist. A majority of the laboratories could not acquire ethics approval for the administration of substances not approved for medical use. Some laboratories faced obstacles to obtain ethics approval for substances approved for clinical use. Respondents communicated that ethics committees often lack background knowledge about the anti-doping context. Conclusions. Disapproval of research proposals may originate from concerns over the safety of the study, the fact that there is seldom a direct benefit to the participant, the consideration that volunteers may be incentivized to use prohibited substances, a lack of background knowledge about anti-doping, or the focus of research ethics committees on health research. [ABSTRACT FROM AUTHOR]

Aim: Direct-to-consumer (DTC) genetic tests (GT) have created controversy regarding their risks and benefits. In view of recent regulatory developments, this article aims to explore the attitudes of European clinical geneticists toward the oversight of DTC GT. Materials & methods: Fifteen semi-structured interviews were performed with clinical geneticists based in ten European countries. The transcripts were thematically analysized in an iterative process. Results & conclusion: Respondents strongly supported quality standards for DTC GT equal to those applied within the healthcare setting. Despite participants unanimously considering the involvement of healthcare professionals to be important, mandatory medical supervision was controversial. In this regard, promoting education and truth-in-advertising was considered as being key in maintaining a balance between protecting consumers and promoting their autonomy. [ABSTRACT FROM AUTHOR]

Direct-to-consumer (DTC) genetic tests (GT) enable consumers to access a wide range of GT, without involving a healthcare professional, promoting an increasing disassociation of genetics from the clinical context. This study explores, through semi-structured interviews, the experiences and attitudes of European clinical geneticists towards DTCGT. Our results indicate that the participants have limited experience of consultations with patients regarding such tests. The majority of participants stated that consumers purchased tests out of curiosity and sought a general interpretation of test results by a healthcare professional. Most respondents were skeptical of the quality of tests, especially regarding their clinical utility. The participants supported the importance of medical supervision and genetic counseling in this context. Finally, most respondents considered it their duty to accept consultations concerning DTCGT results. However, due to concerns over limited time and potential downstream costs, some participants supported that a prioritization system based on guidelines would be necessary. [ABSTRACT FROM AUTHOR]

Background: The European Commission is funding projects that aim to establish data-sharing platforms. These platforms are envisioned to enhance and facilitate the international sharing of cohort data. Nevertheless, broad data sharing may be restricted by the lack of adequate recognition for those who share data.Objective: The aim of this study is to describe in depth the concerns about acquiring credit for data sharing within epidemiological research.Methods: A total of 17 participants linked to European Union-funded data-sharing platforms were recruited for a semistructured interview. Transcripts were analyzed using inductive content analysis.Results: Interviewees argued that data sharing within international projects could challenge authorship guidelines in multiple ways. Some respondents considered that the acquisition of credit for articles with extensive author lists could be problematic in some instances, such as for junior researchers. In addition, universities may be critical of researchers who share data more often than leading research. Some considered that the evaluation system undervalues data generators and specialists. Respondents generally looked favorably upon alternatives to the current evaluation system to potentially ameliorate these issues.Conclusions: The evaluation system might impede data sharing because it mainly focuses on first and last authorship and undervalues the contributor's work. Further movement of crediting models toward contributorship could potentially address this issue. Appropriate crediting mechanisms that are better aligned with the way science ought to be conducted in the future need to be developed. [ABSTRACT FROM AUTHOR]

Background: Informed consent is one of the key elements in biomedical research. The introduction of electronic informed consent can be a way to overcome many challenges related to paper-based informed consent; however, its novel opportunities remain largely unfulfilled due to several barriers.Objective: We aimed to provide an overview of the ethical, legal, regulatory, and user interface perspectives of multiple stakeholder groups in order to assist responsible implementation of electronic informed consent in biomedical research.Methods: We conducted a systematic literature search using Web of Science (Core collection), PubMed, EMBASE, ACM Digital Library, and PsycARTICLES. PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines were used for reporting this work. We included empirical full-text studies focusing on the concept of electronic informed consent in biomedical research covering the ethical, legal, regulatory, and user interface domains. Studies written in English and published from January 2010 onward were selected. We explored perspectives of different stakeholder groups, in particular researchers, research participants, health authorities, and ethics committees. We critically appraised literature included in the systematic review using the Newcastle-Ottawa scale for cohort and cross-sectional studies, Critical Appraisal Skills Programme for qualitative studies, Mixed Methods Appraisal Tool for mixed methods studies, and Jadad tool for randomized controlled trials.Results: A total of 40 studies met our inclusion criteria. Overall, the studies were heterogeneous in the type of study design, population, intervention, research context, and the tools used. Most of the studies' populations were research participants (ie, patients and healthy volunteers). The majority of studies addressed barriers to achieving adequate understanding when using electronic informed consent. Concerns shared by multiple stakeholder groups were related to the security and legal validity of an electronic informed consent platform and usability for specific groups of research participants.Conclusions: Electronic informed consent has the potential to improve the informed consent process in biomedical research compared to the current paper-based consent. The ethical, legal, regulatory, and user interface perspectives outlined in this review might serve to enhance the future implementation of electronic informed consent.Trial Registration: PROSPERO International Prospective Register of Systematic Reviews CRD42020158979; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=158979. [ABSTRACT FROM AUTHOR]

Although live kidney donation (LD) has become an increasingly common procedure, European and US transplant centres disagree as to whether minors and young adults should qualify as donor candidates. Therefore, we aimed to better understand the attitudes and viewpoints of transplant professionals. We conducted fourteen in‐depth interviews with a purposive sample of international transplant professionals from various professional backgrounds. Data analysis was guided by QUAGOL, a systematic approach based on the constant‐comparative method. Professionals expressed a cautionary view, worrying about the uncertain long‐term medical and psychosocial consequences of LD at a young age. They also worried that young individuals' decisions are more likely to be influenced by their psychosocial developmental stage or family pressure. As these concerns were more significant for minors as compared to young adults, minors were deemed ineligible for LD except for in highly exceptional circumstances. Professionals' attitudes were also influenced by the expected benefits for the recipient and the availability of therapeutic alternatives, as well as the strength of the donor‐recipient relationship. More prospective research on the long‐term medical and psychological outcomes in young adult donors is likely to shed more light on the acceptability of LD by adolescents and young adults. [ABSTRACT FROM AUTHOR]

• The use of polygenic risk scores for embryo selection is ethically contentious • Patients in Belgium undergoing PGT for monogenic/single-gene disorders or structural rearrangements were largely negative about polygenic embryo screening • They emphasized the difficulties of PGT/IVF treatment • Worries were expressed about knowing risk information and difficult choices • Polygenic embryo screening was associated with increasing responsibility and control related to parenthood and health What are the perspectives of preimplantation genetic testing (PGT) patients in Belgium on the ethics of PGT for polygenic risk scoring (PGT-P)? In-depth interviews (18 in total, 10 couples, 8 women, n = 28) were performed with patients who had undergone treatment with PGT for monogenic/single-gene defects (PGT-M) or chromosomal structural rearrangements (PGT-SR) between 2017 and 2019 in Belgium. Participants were asked about their own experiences with PGT-M/SR and about their viewpoints on PGT-P, including their own interest and their ideas on its desirability, scope and consequences. Inductive content analysis was used to analyse the interviews. Participants stated that their experiences with PGT-M/SR had been physically, psychologically and practically difficult. Most participants stated that, partly because of these difficulties, they did not see the added value of knowing the risk scores of embryos via PGT-P. Many participants worried that PGT-P could lead to additional anxieties, responsibilities and complex choices in reproduction and parenthood. They argued that not everything should be controlled and felt that PGT-P, especially non-medical and broad screening, was going too far. With regards to the clinical implementation of PGT-P, participants in general preferred PGT-P to be limited to people with a serious polygenic family history and wanted embryo selection decisions to be made by healthcare professionals. This study shows that individuals with experience of PGT-M/SR saw PGT-P as different from PGT-M/SR. They had various ethical concerns with regards to PGT-P, especially regarding broadly offering PGT-P. These stakeholder viewpoints need to be considered regarding potential PGT-P implementation and guidelines. [ABSTRACT FROM AUTHOR]

The recent introduction of polygenic risk scores within preimplantation genetic testing (PGT-P) has been met with many concerns. To get more insights into the perspectives of relevant stakeholders on the socio-ethical aspects of PGT-P, an interview study with 31 healthcare professionals involved in reproductive medicine and genetics in Europe and North-America was performed. Healthcare professionals in our study were concerned that PGT-P was going too far in terms of selection, with regards to both medical conditions and non-medical traits. Healthcare professionals were worried about the ethical 'slippery slope' of PGT-P, the increasing medicalization of reproductive health, the commercial context of PGT-P, and potential stigmatization and discrimination. There were also concerns that the availability and the 'technological imperative' of PGT-P could lead to pressure and a sense of responsibility for parents to use PGT-P. Additionally, it could cause new anxieties about the child's health before the child has even been born. Since PGT-P provides polygenic risk scores before birth, the autonomy of the child has to be considered. These socio-ethical concerns heighten existing debates regarding reproductive genetic technologies and show that the specifics of PGT-P make this screening option especially ethically controversial. • Introduction of polygenic risk scores in preimplantation genetic testing. • Healthcare professionals concerned about socio-ethical implications. • Associated with 'slippery slope', going too far, discrimination and stigmatization. • Increased sense of medicalization and commercialization of reproduction and health. • Worries about effects on prospective parents and on the future child's autonomy. [ABSTRACT FROM AUTHOR]