In this paper we will describe the arguments to adopt a jurisprudence platform for scientific misconduct, we argue that this will increase the principle of legal certainty, improve procedures, and... Show moreIn this paper we will describe the arguments to adopt a jurisprudence platform for scientific misconduct, we argue that this will increase the principle of legal certainty, improve procedures, and will promote scientific integrity in other, indirect ways. With the platform that we are currently setting up in the Netherlands as a motivating example, we finally also describe the prerequisites for such a platform, its contents as well as its value in the international context. Show less
Verweij, E.J.; Proost, L. de; Laar, J.O.E.H. van; Frank, L.; Obermann-Borstn, S.A.; Vermeulen, M.J.; ... ; Kingma, E. 2021
In this paper we present an initial roadmap for the ethical development and eventual implementation of artificial amniotic sac and placenta technology in clinical practice. We consider four... Show moreIn this paper we present an initial roadmap for the ethical development and eventual implementation of artificial amniotic sac and placenta technology in clinical practice. We consider four elements of attention: (1) framing and societal dialogue; (2) value sensitive design, (3) research ethics and (4) ethical and legal research resulting in the development of an adequate moral and legal framework. Attention to all elements is a necessary requirement for ethically responsible development of this technology. The first element concerns the importance of framing and societal dialogue. This should involve all relevant stakeholders as well as the general public. We also identify the need to consider carefully the use of terminology and how this influences the understanding of the technology. Second, we elaborate on value sensitive design: the technology should be designed based upon the principles and values that emerge in the first step: societal dialogue. Third, research ethics deserves attention: for proceeding with first-in-human research with the technology, the process of recruiting and counseling eventual study participants and assuring their informed consent deserves careful attention. Fourth, ethical and legal research should concern the status of the subject in the AAPT. An eventual robust moral and legal framework for developing and implementing the technology in a research setting should combine all previous elements. With this roadmap, we emphasize the importance of stakeholder engagement throughout the process of developing and implementing the technology; this will contribute to ethically and responsibly innovating health care. Show less
Aim: To explore the perspectives of patients and laymen with regard to the development, use and storage of cerebral organoids, in order to contribute to the ethical debate about this technology.... Show moreAim: To explore the perspectives of patients and laymen with regard to the development, use and storage of cerebral organoids, in order to contribute to the ethical debate about this technology. Materials & methods: In depth semi-structured interviews with 28 patients and laymen were conducted. A qualitative thematic analysis was undertaken using a constant comparative method. Results: Three interrelated themes emerged from the empirical material: moral value; willingness to donate; and elements of good governance. Conclusion: Patients and laymen are most concerned about cerebral organoids potentially developing consciousness and potential misuse. They support the use of cerebral organoids under the conditions that donors are adequately informed and that there will be good governance. Perspectives of patients and laymen are helpful to enable responsible development and use of cerebral organoids in practice.Lay abstractIn this study, we asked patients and laymen for their perspectives and opinions on the development, use and storage of so-called 'brain organoids'. Brain organoids are 3D cell structures that resemble parts of the human brain. These can be used as a model to study the development of the human brain and brain diseases. It is a promising technology that also raises ethical questions. For example, what kind of entity is a brain organoid and what should (and should not) be done with it? Our interview-study shows that patients and laymen are concerned that brain organoids might develop consciousness. They are also concerned about potential misuse of brain organoids. Overall, patients and laymen support the development of brain organoids if donors are well-informed and if responsible use is guaranteed by good governance. For them, good governance involves safety measures, well-defined boundaries to research and ethical oversight. The perspectives of these patients and laymen contribute to further development of brain organoids in a morally justifiable and socially acceptable way. Show less
Hoogerwerf, M.A.; Vries, M. de; Roestenberg, M. 2020
Objective To quantitatively investigate the motivations, decision-making and experience of participants in controlled human infection (CHI) studies.Design Cross-sectional descriptive survey study.S...Show moreObjective To quantitatively investigate the motivations, decision-making and experience of participants in controlled human infection (CHI) studies.Design Cross-sectional descriptive survey study.Setting Previous participants of CHI studies at the Leiden Controlled Human Infection Center, control group of students from Leiden University.Participants 61 previous participants and 156 controls.Measurements Ranking of motivational and decisional factors, risk propensity score and multiple-choice questions on experience of trial participation and ethical aspects of CHI studies.Results Motivating factors for participants were contributing to science (81%), contributing to research that may benefit developing countries (72%) and the financial compensation (63%). For 51% of participants, a reason other than financial compensation was the most important motivational factor. Participants considered trust in the study team (70%), time investment (63%), severity of symptoms (54%), chance of developing symptoms (54%) and whether it is an easy way to make money (54%) in their decision to participate. Most CHI participants (84%) were proud of their participation, would advise others to participate (89%) and would participate in a similar trial again (85%). CHI participants had a higher risk propensity score than students (estimated difference 0.9, p<0.001).Conclusion Although financial compensation is important, the motivations for participants in a CHI study are diverse and participants make a balanced appraisal of risks and burden before participating. Show less
The chapter reflects on the unintended consequences of fieldwork in polarised societies, which may affect the autonomy of both the researcher and the researched. In a context of past violence and... Show moreThe chapter reflects on the unintended consequences of fieldwork in polarised societies, which may affect the autonomy of both the researcher and the researched. In a context of past violence and intractable conflict, research participants often have concerns about how the research impacts the autonomy of their daily life by potentially compromising their safety. On the other hand, research participants may try to make use of the researcher for their own political and economic objectives, compromising the autonomy of the project. In analysing the simultaneous empowerment and disempowerment of research participants, the chapter builds on fieldwork conducted in rural Mozambique on community mobilization against insurgent violence during the country’s civil war (1976-1992). The chapter discusses the methodological and ethical challenges of power and neutrality during fieldwork and joins others in showing that conflict research needs to be understood as a form of intervention in local affairs. Show less
Dekking, S.A.S.; Graaf, R. van der; Kars, M.C.; Beishuizen, A.; Vries, M.C. de; Delden, J.J.M. van 2015
