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"Ethical Analysis methods."
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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
Methods for Practising Ethics in Research and Innovation: A Literature Review, Critical Analysis and Recommendations
This paper provides a systematic literature review, analysis and discussion of methods that are proposed to practise ethics in research and innovation (R&I). Ethical considerations concerning the impacts of R&I are increasingly important, due to the quickening pace of technological innovation and the ubiquitous use of the outcomes of R&I processes in society. For this reason, several methods for practising ethics have been developed in different fields of R&I. The paper first of all presents a systematic search of academic sources that present and discuss such methods. Secondly, it provides a categorisation of these methods according to three main kinds: (1) ex ante methods, dealing with emerging technologies, (2) intra methods, dealing with technology design, and (3) ex post methods, dealing with ethical analysis of existing technologies. Thirdly, it discusses the methods by considering problems in the way they deal with the uncertainty of technological change, ethical technology design, the identification, analysis and resolving of ethical impacts of technologies and stakeholder participation. The results and discussion of our literature review are valuable for gaining an overview of the state of the art and serve as an outline of a future research agenda of methods for practising ethics in R&I.
Journal Article
Ethical, Legal, and Social Issues Related to the Inclusion of Individuals With Intellectual Disabilities in Electronic Health Record Research: Scoping Review
Data from electronic health records (EHRs) are increasingly used in the field of genetic research to further precision medicine initiatives. However, many of these efforts exclude individuals with intellectual disabilities, which often stem from genetic conditions. To include this important subpopulation in EHR research, important ethical, legal, and social issues should be considered.
The goal of this study was to review prior research to better understand what ethical, legal, and social issues may need further investigation when considering the research use of EHRs for individuals with genetic conditions that may result in intellectual disability. This information will be valuable in developing methods and best practices for involving this group in research given they are considered a vulnerable population that may need special research protections.
We conducted a scoping review to examine issues related to the use of EHRs for research purposes and those more broadly associated with genetic research. The initial search yielded a total of 460 unique citations. We used an evaluative coding process to determine relevancy for inclusion.
This approach resulted in 59 articles in the following areas: informed consent, privacy and security, return of results, and vulnerable populations. The review included several models of garnering informed consent in EHR or genetic research, including tiered or categorical, blanket or general, open, and opt-out models. Second, studies reported on patients' concerns regarding the privacy and security of EHR or genetic data, such as who has access, type of data use in research, identifiability, and risks associated with privacy breach. The literature on return of research results using biospecimens examined the dissension in the field, particularly when sharing individualized genetic results. Finally, work involving vulnerable populations highlighted special considerations when conducting EHR or genetic research.
The results frame important questions for researchers to consider when designing EHR studies, which include individuals with intellectual disabilities, including appropriate safeguards and protections.
Journal Article
A Rubik’s Cube-Inspired Pedagogical Tool for Teaching and Learning Engineering Ethics
To facilitate engineering students’ understanding of engineering ethics and support instructors in developing course content, this study introduces an innovative educational tool drawing inspiration from the Rubik’s Cube metaphor. This Engineering Ethics Knowledge Rubik’s Cube (EEKRC) integrates six key aspects—ethical theories, codes of ethics, ethical issues, engineering disciplines, stakeholders, and life cycle—identified through an analysis of engineering ethics textbooks and courses across the United States, Singapore, and China. This analysis underpins the selection of the six aspects, reflecting the shared and unique elements of engineering ethics education in these regions. In an engineering ethics course, the EEKRC serves multiple functions: it provides visual support for grasping engineering ethics concepts, acts as a pedagogical guide for both experienced and inexperienced educators in course design, offers a complementary assessment method for evaluating students learning outcomes, and assists as a reference for students engaging in ethical analysis.
Journal Article
The Value of Darkness: A Moral Framework for Urban Nighttime Lighting
The adverse effects of artificial nighttime lighting, known as light pollution, are emerging as an important environmental issue. To address these effects, current scientific research focuses mainly on identifying what is bad or undesirable about certain types and uses of lighting at night. This paper adopts a value-sensitive approach, focusing instead on what is good about darkness at night. In doing so, it offers a first comprehensive analysis of the environmental value of darkness at night from within applied ethics. A design for values orientation is utilized to conceptualize, define, and categorize the ways in which value is derived from darkness. Nine values are identified and categorized via their type of good, temporal outlook, and spatial characteristics. Furthermore, these nine values are translated into prima facie moral obligations that should be incorporated into future design choices, policy-making, and innovations to nighttime lighting. Thus, the value of darkness is analyzed with the practical goal of informing future decision-making about urban nighttime lighting.
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
Steps toward improving ethical evaluation in health technology assessment: a proposed framework
Background
While evaluation of ethical aspects in health technology assessment (HTA) has gained much attention during the past years, the integration of ethics in HTA practice still presents many challenges. In response to the increasing demand for expansion of health technology assessment (HTA) methodology to include ethical issues more systematically, this article reports on a multi-stage study that aimed at construction of a framework for improving the integration of ethics in HTA.
Methods
The framework was developed through the following phases: 1) a systematic review and content analysis of guidance documents for ethics in HTA; 2) identification of factors influencing the integration of ethical considerations in HTA; 3) preparation of an action-oriented framework based on the key elements of the existing guidance documents and identified barriers to and facilitators of their implementation; and 4) expert consultation and revision of the framework.
Results
The proposed framework consists of three main components: an algorithmic flowchart, which exhibits the different steps of an ethical inquiry throughout the HTA process, including: defining the objectives and scope of the evaluation, stakeholder analysis, assessing organizational capacity, framing ethical evaluation questions, ethical analysis, deliberation, and knowledge translation; a stepwise guide, which focuses on the task objectives and potential questions that are required to be addressed at each step; and a list of some commonly recommended or used tools to help facilitate the evaluation process.
Conclusions
The proposed framework can be used to support and promote good practice in integration of ethics into HTA. However, further validation of the framework through case studies and expert consultation is required to establish its utility for HTA practice.
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
An Ethical (Descriptive) Framework for Judgment of Actions and Decisions in the Construction Industry and Engineering–Part I
The construction industry is usually characterized as a fragmented system of multiple-organizational entities in which members from different technical backgrounds and moral values join together to develop a particular business or project. The greatest challenge in the construction process for the achievement of a successful practice is the development of an outstanding reputation, which is built on identifying and applying an ethical framework. This framework should reflect a common ethical ground for myriad people involved in this process to survive and compete ethically in today’s turbulent construction market. This study establishes a framework for ethical judgment of behavior and actions conducted in the construction process. The framework was primarily developed based on the essential attributes of business management identified in the literature review and subsequently incorporates additional attributes identified to prevent breaches in the construction industry and common ethical values related to professional engineering. The proposed judgment framework is based primarily on the ethical dimension of professional responsibility. The Ethical Judgment Framework consists of descriptive approaches involving technical, professional, administrative, and miscellaneous terms. The framework provides the basis for judging actions as either ethical or unethical. Furthermore, the framework can be implemented as a form of preventive ethics, which would help avoid ethical dilemmas and moral allegations. The framework can be considered a decision-making model to guide actions and improve the ethical reasoning process that would help individuals think through possible implications and consequences of ethical dilemmas in the construction industry.
Journal Article