Should the Regulation of Research Misconduct Be Integrated with the Ethics Framework Promulgated in The Belmont Report ?

2021 ◽  
Vol 43 (1) ◽  
pp. 37-41
Author(s):  
Barbara K. Redman ◽  
Arthur L. Caplan
2018 ◽  
Vol 44 (12) ◽  
pp. 843-850 ◽  
Author(s):  
Lainie F Ross ◽  
J Richard Thistlethwaite

Both living donor transplantation and human subjects research expose one set of individuals to clinical risks for the clinical benefits of others. In the Belmont Report, the National Commission for the Protection of Human Subjects of Biomedical and Behavior Research (National Commission) articulated three principles to serve as the basis for a research ethics framework: respect for persons, beneficence and justice. In contrast, living donor transplantation lacks a framework. In this manuscript, we adapt the three principles articulated in the Belmont Report to serve as the foundation for an ethics framework for living donor transplantation which we supplement with the principles of vulnerability and responsibility. The National Commission supported additional protections for vulnerable groups of potential research participants. In 2001, Kenneth Kipnis effectively argued that the concept of vulnerable groups failed to explore in what ways particular groups of people were vulnerable, thereby risking unnecessary protections for some and inadequate protections for others. He proposed a taxonomy that explored different types of vulnerabilities that all research participants may experience to provide a more robust framework for human subjects protections, which we adapt to living donors. Robert Goodin claims that health professionals, who stand in special relationship with patients, are responsible for promoting and protecting their well-being. In living donor transplantation, the donor transplant team is responsible for empowering prospective donors to address their vulnerabilities and/or for protecting those who cannot by disqualifying them from donation.


10.2196/16249 ◽  
2020 ◽  
Vol 22 (1) ◽  
pp. e16249
Author(s):  
Joanna Sleigh ◽  
Manuel Schneider ◽  
Julia Amann ◽  
Effy Vayena

Background Data have become an essential factor in driving health research and are key to the development of personalized and precision medicine. Primary and secondary use of personal data holds significant potential for research; however, it also introduces a new set of challenges around consent processes, privacy, and data sharing. Research institutions have issued ethical guidelines to address challenges and ensure responsible data processing and data sharing. However, ethical guidelines directed at researchers and medical professionals are often complex; require readers who are familiar with specific terminology; and can be hard to understand for people without sufficient background knowledge in legislation, research, and data processing practices. Objective This study aimed to visually represent an ethics framework to make its content more accessible to its stakeholders. More generally, we wanted to explore the potential of visualizing policy documents to combat and prevent research misconduct by improving the capacity of actors in health research to handle data responsibly. Methods We used a mixed methods approach based on knowledge visualization with 3 sequential steps: qualitative content analysis (open and axial coding, among others); visualizing the knowledge structure, which resulted from the previous step; and adding interactive functionality to access information using rapid prototyping. Results Through our iterative methodology, we developed a tool that allows users to explore an ethics framework for data sharing through an interactive visualization. Our results represent an approach that can make policy documents easier to understand and, therefore, more applicable in practice. Conclusions Meaningful communication and understanding each other remain a challenge in various areas of health care and medicine. We contribute to advancing communication practices through the introduction of knowledge visualization to bioethics to offer a novel way to tackle this relevant issue.


Author(s):  
Sandra Carvalho ◽  
Gustavo Rivara ◽  
Andre Brunoni ◽  
Felipe Fregni

This chapter discusses authorship, ethics in research, plagiarism, and misconduct. It summarizes the general criteria for scientific report authorship according to the International Committee of Medical Journal Editors (ICMJE) and Ethics in Research. It discusses ethics in research, based on the famous Tuskegee syphilis study, and the Belmont Report that followed it. Three basic ethical principles derived from the Belmont Report—respect for persons, beneficence, and justice—and their impact on research with human subjects are discussed, along with the direct applications of these three ethical principles: informed consent, risk/benefit ratio, and subject selection. Finally, the chapter reviews the main aspects of research misconduct and presents some examples. Research integrity requires that the research process is governed by honesty, objectivity, and verifiable methods, instead of preconceived ideas and expectations. It is an important topic to be reviewed and discussed before anyone decides to pursue the field of clinical research.


2021 ◽  
pp. 53-80
Author(s):  
Lainie Friedman ◽  
J. Richard Thistlethwaite, Jr

This chapter advances an ethical framework for living donor transplantation. Given the analogies between living donor transplantation and human subjects research, the three principles enumerated in the National Commission’s Belmont Report are adopted as the starting point: respect for persons, beneficence, and justice. Two additional principles are also adopted: the principle of vulnerability and the principle that special relationships create special obligations. Whereas the Belmont Report discussed vulnerable groups, vulnerability is more aptly understood as an assortment of vulnerabilities that may apply to different people in different circumstances at different times of their lives. Eight distinct but overlapping vulnerabilities are described: capacitational, juridic, deferential, social, medical, situational, allocational, and infrastructural. The living donor advocate team (LDAT) stands in special relationship with the potential living donor and supports living organ donation provided that the living donor successfully addresses the challenges to autonomy and voluntariness that these vulnerabilities pose.


2020 ◽  
Vol 30 (Supplement_5) ◽  
Author(s):  
P Schröder-Bäck ◽  
T Schloemer ◽  
K Martakis ◽  
C Brall

Abstract Background The outbreak of SARS in 2002 lead to a public health ethics discourse. The crisis management of that time was ethically analysed and lessons to be learned discussed. Scholarship and WHO, among others, developed an ethics of pandemic preparedness. The current “corona crisis” also faces us with ethical challenges. This presentation is comparing the two crises from an ethical point of view and a focus on Europe. Methods An ethics framework for pandemic preparedness (Schröder et al. 2006 and Schröder-Bäck 2014) is used to make a synopsis of ethical issues. Ethical aspects of 2002 and 2020 that were discussed in the literature and in the media are compared. For 2020, the focus is on interventions in Italy, Germany, Switzerland, and the Netherlands. Results Topics that emerged from the 2002 crisis were, among others, revolving around aspects of stigmatisation and fair distribution of scarce resources (esp. vaccines, antivirals). Currently, most urgent and ethically challenging aspects relate to social distancing vs. autonomy: Isolation and quarantine are handled differently across Europe and the EU. Questions of transferability of such interventions prevail. Contexts vary vertically over time (2002 vs. 2020) and horizontally (e.g. between Italy and Germany at the same time). Furthermore, trust in authorities, media and health information is a key issue. Conclusions Ethical aspects are key for good pandemic preparedness and management. The context of the crises between 2002 and 2020 has slightly changed, also based on “lessons learned” from 2002. This has implications on ethical issues that are being discussed. New lessons will have to be learned from the 2020 crisis. Key messages Pandemic preparedness and outbreak management entail many ethical tensions that need to be addressed. Currently, questions of trust and transferability are key to the crisis management, further ethical issues could still emerge.


2021 ◽  
Vol 6 (1) ◽  
Author(s):  
Noémie Aubert Bonn ◽  
Wim Pinxten

Abstract Background Research misconduct and questionable research practices have been the subject of increasing attention in the past few years. But despite the rich body of research available, few empirical works also include the perspectives of non-researcher stakeholders. Methods We conducted semi-structured interviews and focus groups with policy makers, funders, institution leaders, editors or publishers, research integrity office members, research integrity community members, laboratory technicians, researchers, research students, and former-researchers who changed career to inquire on the topics of success, integrity, and responsibilities in science. We used the Flemish biomedical landscape as a baseline to be able to grasp the views of interacting and complementary actors in a system setting. Results Given the breadth of our results, we divided our findings in a two-paper series with the current paper focusing on the problems that affect the integrity and research culture. We first found that different actors have different perspectives on the problems that affect the integrity and culture of research. Problems were either linked to personalities and attitudes, or to the climates in which researchers operate. Elements that were described as essential for success (in the associate paper) were often thought to accentuate the problems of research climates by disrupting research culture and research integrity. Even though all participants agreed that current research climates need to be addressed, participants generally did not feel responsible nor capable of initiating change. Instead, respondents revealed a circle of blame and mistrust between actor groups. Conclusions Our findings resonate with recent debates, and extrapolate a few action points which might help advance the discussion. First, the research integrity debate must revisit and tackle the way in which researchers are assessed. Second, approaches to promote better science need to address the impact that research climates have on research integrity and research culture rather than to capitalize on individual researchers’ compliance. Finally, inter-actor dialogues and shared decision making must be given priority to ensure that the perspectives of the full research system are captured. Understanding the relations and interdependency between these perspectives is key to be able to address the problems of science. Study registration https://osf.io/33v3m


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