As COVID-19 continues to spread, a variety of COVID-19 tracking apps have been introduced to help contain the pandemic. Deployment of this technology poses serious challenges of effectiveness, technological problems and risks to privacy and equity. The ethical use of CTAs depends heavily on the protection of voluntariness. Voluntary use of CTAs implies not only the absence of a legal obligation to employ the app but also the absence of more subtle forms of coercion such as enforced exclusion from certain (...) social and work activities. The protection of individual rights to voluntary use can be enhanced through an ethics by design approach in the development of CTAs that treat the introduction of CTAs for what it is: a complete novelty that is being tested for the first time in democracies. (shrink)
To reduce the global burden of the COVID-19 pandemic, there is an urgent need to develop a safe vaccine. Vaccine development usually takes many years as it goes through several different phases. To hasten COVID-19 vaccine development, it has been suggested that the final stage could be replaced with a human challenge trial. Volunteers would be intentionally infected with SARS-CoV-2 to see how the vaccine candidate works. To intentionally infect a healthy human being with a potentially deadly virus is contrary (...) to the highest ethical standards in medical research. This article highlights the benefits and risks of COVID-19 HCTs and summarises what research ethics committees need to consider during the ethical assessment of such trials including risk reduction, strict containment measures, specific informed consent measures and avoiding high monetary inducements. (shrink)
Universities and other research institutions are increasingly providing additional training in research integrity to improve the quality and reliability of research. Various training courses have been developed, with diverse learning goals and content. Despite the importance of training that focuses on moral character and professional virtues, there remains a lack of training that adopts a virtue ethics approach. To address this, we, a European Commission-funded consortium, have designed a train-the-trainer programme for research integrity. The programme is based on (1) virtue (...) ethics, (2) the ethos of science, (3) learning by doing and (4) learner-centred teaching. The blended learning programme combines e-learning modules with participatory group sessions. Trainers are taught how to guide researchers through a series of structured exercises for fostering reflection on scientific virtues, and how to promote understanding and application of the European Code of Conduct for Research Integrity. Trainers are provided with adaptable tools and resources that can be used and combined in different ways. The programme implementation began in Spring 2020 and 470 trainers have participated to date. When trainers were asked to grade – between 0 (very bad) and 10 (excellent) – the e-learning modules and the participatory exercises, 60% scored a grade 8 or higher (median = 8, IQR = 2) for the e-learning modules, whereas 80% scored a grade 8 or higher (median = 9, IQR = 1) for the participatory exercises. A majority felt that the training helped them as a trainer to learn about ways to organise and teach a research integrity course (82%) and would recommend the interactive exercises to others (92%). Trainers have educated over 3300 researchers in Europe using our virtue-based approach. The VIRT2UE train-the-trainer programme fosters research integrity by providing trainers with exercises and tools which enable them to stimulate the development of good researchers across Europe. (shrink)
Der Band widmet sich der aktuellen Entwicklung in der Humangenomforschung und der Biomedizin. Die neuen Einsichts- und Eingriffsmöglichkeiten nach der Entschlüsselung der menschlichen Gene konfrontieren Forscher und Gesellschaft mit ethischen, rechtlichen und soziokulturellen Fragen in der Genforschung am Menschen. Das Buch bietet einen Überblick über den aktuellen Stand der Forschung und ist zugleich eine hilfreiche Einführung in die gegenwärtige Diskussion. Daneben werden ausgewählte Bereiche vertieft behandelt: genetische Diagnostik, funktionelle Forschung mit therapeutischem Ziel, Pharmakogenetik und die individualisierte Medizin der Zukunft.
The upcoming Regulation No 536/2014 on clinical trials on medicinal products for human use, which will replace the current Clinical Trial Directive at the end of 2021, has triggered a significant reform of research ethics committee systems in Europe. Changes related to ethics review of clinical trials in the EU were considered to be essential to create a more favourable environment to conduct clinical trials in the EU. The concern is, however, that the role of the research ethics committees will (...) weaken in at least some of the Member States because the new Regulation allows narrowing down the scope of ethics review as compared with the currently valid Clinical Trial Directive. Although the new Regulation may lead to faster approval procedures for clinical trials, which is especially relevant in the context of pandemics, high-quality ethics reviews integrating methodological aspects of a clinical trial should nevertheless be ensured. To maintain high research ethics standards as well as to foster measures to mitigate potential negative consequences of the reform, it is therefore of vital importance to start debating and sharing the reflections about the potential consequences of these transformations and trends as soon as possible. (shrink)