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"Ethical Analysis"
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Cluster randomized trial assessing the effects of rapid ethical assessment on informed consent comprehension in a low-resource setting
Background
Maximizing comprehension is a major challenge for informed consent processes in low-literacy and resource-limited settings. Application of rapid qualitative assessments to improve the informed consent process is increasingly considered useful. This study assessed the effects of Rapid Ethical Assessment (REA) on comprehension, retention and quality of the informed consent process.
Methods
A cluster randomized trial was conducted among participants of HPV sero-prevalence study in two districts of Northern Ethiopia, in 2013. A total of 300 study participants, 150 in the intervention and 150 in the control group, were included in the study. For the intervention group, the informed consent process was designed with further revisions based on REA findings. Informed consent comprehension levels and quality of the consent process were measured using the Modular Informed Consent Comprehension Assessment (MICCA) and Quality of Informed Consent (QuIC) process assessment tools, respectively.
Result
Study recruitment rates were 88.7 % and 80.7 % (
p
= 0.05), while study retention rates were 85.7 % and 70.3 % (
p
< 0.005) for the intervention and control groups respectively. Overall, the mean informed consent comprehension scores for the intervention and control groups were 73.1 % and 45.2 %, respectively, with a mean difference in comprehension score of 27.9 % (95 % CI 24.0 % - 33.4 %;
p
< 0.001,). Mean scores for quality of informed consent for the intervention and control groups were 89.1 % and 78.5 %, respectively, with a mean difference of 10.5 % (95 % CI 6.8 -14.2 %;
p
< 0.001).
Conclusion
Levels of informed consent comprehension, quality of the consent process, study recruitment and retention rates were significantly improved in the intervention group. We recommend REA as a potential modality to improve informed consent comprehension and quality of informed consent process in low resource settings.
Journal Article
Theoretical frameworks used to discuss ethical issues in private physiotherapy practice and proposal of a new ethical tool
In the past, several researchers in the field of physiotherapy have asserted that physiotherapy clinicians rarely use ethical knowledge to solve ethical issues raised by their practice. Does this assertion still hold true? Do the theoretical frameworks used by researchers and clinicians allow them to analyze thoroughly the ethical issues they encounter in their everyday practice? In our quest for answers, we conducted a literature review and analyzed the ethical theoretical frameworks used by physiotherapy researchers and clinicians to discuss the ethical issues raised by private physiotherapy practice. Our final analysis corpus consisted of thirty-nine texts. Our main finding is that researchers and clinicians in physiotherapy rarely use ethical knowledge to analyze the ethical issues raised in their practice and that gaps exist in the theoretical frameworks currently used to analyze these issues. Consequently, we developed, for ethical analysis, a four-part prism which we have called the Quadripartite Ethical Tool (QET). This tool can be incorporated into existing theoretical frameworks to enable professionals to integrate ethical knowledge into their ethical analyses. The innovative particularity of the QET is that it encompasses three ethical theories (utilitarism, deontologism, and virtue ethics) and axiological ontology (professional values) and also draws on both deductive and inductive approaches. It is our hope that this new tool will help researchers and clinicians integrate ethical knowledge into their analysis of ethical issues and contribute to fostering ethical analyses that are grounded in relevant philosophical and axiological foundations.
Journal Article
Evaluation of Ethical Analyses in Seven Reports from the European Network for Health Technology Assessment
Ethics has been considered among the core domains of health technology assessment (HTA), but there are still disputes regarding ethical analysis. This study aimed to examine full final reports of the European Network for Health Technology Assessment (EUnetHTA) in terms of their compliance with the ethical methodology and ethical perspective of the HTA Core Model®.
The study examines seven full final HTA reports of EUnetHTA written based on the methodology proposed in the HTA Core Model®. The reports were analyzed using the following parameters: competency of the person/group who conducted ethical analysis, assessment elements, and the methodology of ethical analysis.
The results show that, although the HTA Core Model® helped to standardize the final reports of the assessment, there are still concerns regarding the competency of the ethical analysis team, the perspectives on the purpose of ethical analysis, data sources and viewpoints of various stakeholders, use of ethical analysis methodology, and the evaluation of the ethical appropriateness of the entire HTA process.
The HTA Core Model® helped to standardize the final reports on the HTA; however, not all issues with the content and outcomes were solved. The lack of expertise in ethics and insufficiency of the teams regarding ethical analysis are other existing problems. This study also demonstrated that stakeholder viewpoints in general and patient perspectives, in particular, have been overlooked in the HTA process.
Journal Article
Don’t deploy negative emissions technologies without ethical analysis
Climate policy advice is being undermined by value-laden choices over risky mitigation strategies, warn Dominic Lenzi and colleagues.
Climate policy advice is being undermined by value-laden choices over risky mitigation strategies, warn Dominic Lenzi and colleagues.
Journal Article
Three ethical approaches to expanding newborn screening through genomics: a critical comparative analysis
Background
The expansion of newborn bloodspot screening (NBS) programs through genomic sequencing is proposed as a way to revolutionise infant and lifelong healthcare. But for all its promise, profound ethical challenges arise too. Robust analysis of these ethical challenges, which include technological and commercial imperatives, as well as balancing individual rights with communal goods, first necessitates clarity as to which ethical approach is best suited to considering the use of genomics in NBS.
Methods
We use normative ethical analysis to provide a critical comparison of three ethical approaches to the expansion of NBS that shape debates over the implementation of genomic newborn screening (gNBS): liberal individualism, public health ethics, and genomic healthcare as a human right.
Results
While these approaches often overlap in practice, their distinct priorities illuminate tensions between individual autonomy, collective welfare, and rights-based claims to genomic information and attendant healthcare. We argue that public health ethics should be the primary ethical approach for gNBS. Yet, none of the three approaches are individually sufficient to fully address the ethical complexities involved. This is because each approach sheds useful light on distinct benefits and limitations of gNBS.
Conclusions
While rigorous evidence-gathering to inform the ethical and societal impacts of gNBS is critical, this must be accompanied by – and interpreted through – normative ethical analysis that clearly articulates the values and tensions at stake. Overall, ethical implementation of gNBS requires a policy approach that (i) adopts public health ethics for programme design, (ii) operationalises select human-rights claims in accordance with established screening principles, and (iii) embeds liberal protections against state or parental overreach.
Journal Article