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result(s) for
"formal bioethics"
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Everyday ethics
2013,2012
This book explores the moral lives of mental health clinicians serving the most marginalized individuals in the US healthcare system. Drawing on years of fieldwork in a community psychiatry outreach team, Brodwin traces the ethical dilemmas and everyday struggles of front line providers. On the street, in staff room debates, or in private confessions, these psychiatrists and social workers confront ongoing challenges to their self-image as competent and compassionate advocates. At times they openly question the coercion and forced-dependency built into the current system of care. At other times they justify their use of extreme power in the face of loud opposition from clients. This in-depth study exposes the fault lines in today's community psychiatry. It shows how people working deep inside the system struggle to maintain their ideals and manage a chronic sense of futility. Their commentaries about the obligatory and the forbidden also suggest ways to bridge formal bioethics and the realities of mental health practice. The experiences of these clinicians pose a single overarching question: how should we bear responsibility for the most vulnerable among us?
Print Me an Organ? Ethical and Regulatory Issues Emerging from 3D Bioprinting in Medicine
by
Gilbert, Frederic
,
Dodds, Susan
,
Mladenovska, Tajanka
in
3-D printers
,
Bioengineering
,
Bioethics
2018
Recent developments of three-dimensional printing of biomaterials (3D bioprinting) in medicine have been portrayed as demonstrating the potential to transform some medical treatments, including providing new responses to organ damage or organ failure. However, beyond the hype and before 3D bioprinted organs are ready to be transplanted into humans, several important ethical concerns and regulatory questions need to be addressed. This article starts by raising general ethical concerns associated with the use of bioprinting in medicine, then it focuses on more particular ethical issues related to experimental testing on humans, and the lack of current international regulatory directives to guide these experiments. Accordingly, this article (1) considers whether there is a limit as to what should be bioprinted in medicine; (2) examines key risks of significant harm associated with testing 3D bioprinting for humans; (3) investigates the clinical trial paradigm used to test 3D bioprinting; (4) analyses ethical questions of irreversibility, loss of treatment opportunity and replicability; (5) explores the current lack of a specific framework for the regulation and testing of 3D bioprinting treatments.
Journal Article
Understanding collective agency in bioethics
by
Jordan, Isabella
,
Beier, Katharina
,
Schicktanz, Silke
in
Bioethical Issues
,
Bioethics
,
Biopolitics
2016
Bioethicists tend to focus on the individual as the relevant moral subject. Yet, in highly complex and socially differentiated healthcare systems a number of social groups, each committed to a common cause, are involved in medical decisions and sometimes even try to influence bioethical discourses according to their own agenda. We argue that the significance of these collective actors is unjustifiably neglected in bioethics. The growing influence of collective actors in the fields of biopolitics and bioethics leads us to pursue the question as to how collective moral claims can be characterized and justified. We pay particular attention to elaborating the circumstances under which collective actors can claim ‘collective agency.’ Specifically, we develop four normative-practical criteria for collective agency in order to determine the conditions that must be given to reasonably speak of ‘collective autonomy’. For this purpose, we analyze patient organizations and families, which represent two quite different kinds of groups and can both be conceived as collective actors of high relevance for bioethical practice. Finally, we discuss some practical implications and explain why the existence of a shared practice of trust is of immediate normative relevance in this respect.
Journal Article
Maturity model for assessing the medical humanities: a Delphi study
2024
Background
Becoming a first-level discipline in China means access to more educational resources. The development of medical humanities in China has been going on for more than 40 years, and some medical schools have set up master’s and doctoral programs in medical humanities. The demand for medical humanities-related knowledge in China is also growing after COVID-19. However, medical humanities is only a second-level discipline and receives limited resources to meet the needs of society. This study aims to establish a system of indicators that can assess whether the medical humanities has a first-level discipline and provide a basis for its upgrading to a first-level.
Methods
A Delphi technique was used, with the panel of expert expressing their views in a series of two questionnaires. A coefficient of variation of less than 0.2 indicates expert agreement.
Result
A total of 25 experts participated in this Delphi study. Consensus was reached on 11 first-grade indices and 48 s-grade indices. The authoritative coefficient(Cr) of the experts was 0.804, which indicates that the experts have a high level of reliability.
Conclusion
This study provides a reliable foundation for the evaluation of medical humanities maturity.
Journal Article
Clinical ethics consultation among Italian ethics committee: A mixed method study
by
Merlo, Domenico Franco
,
Perin, Marta
,
Ghirotto, Luca
in
Bioethics
,
Biology and Life Sciences
,
Clinical medicine
2019
The general purpose for ethics consultations is to deliberate on issues on medical and scientific research and act towards the safeguard of the patient's rights and dignity. With the implementation of European Union (EU) Regulation 536/2014 on clinical trials and cost and time-optimization, the nature of consultations and the bodies they are carried out might be to some extent affected. Accordingly, we sought to gain an updated perspective on the current role and current practices of ethics consultations nationwide in both clinical and research settings.
The study was carried forth by a three-step mixed-method approach: i) review of policies/regulations for ethics committee (EC) nationwide; ii) a structured survey on ethics consultation activity completed by each EC during 2016; iii) incorporated into the third part, a qualitative assessment with a selected sample of 8 key-informants for a semi-structured interview, discussing EC history, the ethics consultation function, and the professional experience of consultants.
Review of the policies/regulations promoted by ECs showed that 72,6% (n = 69) of all the ECs (N = 95) being actually capable of providing ethics consultation service by policy. 71 ECs (74.7%) responded to the survey on ethics consultation requests; among them, 48 (67.6%) provided ethics consultations of which 23 (23/48) actually received requests for this service in the year 2016. Many ECs did not have a structured database in place to provide precise figures of requests received in the last year nor of their contents.
To date, ethics consultation in clinical and research practice is largely underappreciated and not well understood by users. The consultants themselves lack a comprehensive vision of work carried out in their field, and bioethics training programs to keep them updated. Despite clinical ethics consultation services should not necessarily be mandatory, following the recent EU Regulation on clinical trials, institutional ethics consultation bodies should be re-evaluated.
Journal Article
Exploring formal and informal learning opportunities during morning report: a qualitative study
by
Skipper, Mads
,
Balslev, Thomas
,
Sørensen, Anita
in
Clinical education
,
Departments
,
Education
2024
Background
Morning reports are an essential component of physicians’ daily work. Attending morning reports is prioritized by junior doctors as it provides them with an opportunity to learn diagnostic reasoning through discussion of cases. While teaching formats during morning reports have previously been reported, an in-depth analysis of what learning opportunities exist, e.g., how teaching is enacted during morning reports, is lacking. This qualitative study explores learning opportunities during morning reports.
Methods
We used an explorative design based on video-recordings of 23 morning reports from two surgical departments, an internal medicine department and an emergency department. We used thematic analysis combined with and inspired by Eraut’s theoretical framework of workplace learning.
Results
Both formal and informal learning opportunities were identified. Formal learning opportunities had the character of planned teaching activities, and we identified four themes: (1) modes of teaching, (2) structure, (3) presenter role, and (4) participant involvement. Informal learning, on the other hand, was often implicit and reactive, while deliberate learning opportunities were rare. The data showed many missed opportunities for learning.
Conclusion
Both formal and informal learning opportunities are present during morning reports. However, a prevalent focus on medical topics exists, leaving other important aspects of the medical role under-discussed. Pedagogical methods could be employed more optimally, and harnessing the potential of missed opportunities should be encouraged.
Journal Article
The impact of the formal rationalization of healthcare on physician clinical teaching in a United States academic medical center
by
Meese, Katherine A.
,
Rogers, David A.
,
Cain, Cindy L.
in
Academic Medical Centers - organization & administration
,
Adaptation
,
Anesthesiology
2025
Background
Formal rationalization is the process whereby an organization achieves the greatest efficiency through the control of work and is occurring in the United States as an effort to control healthcare costs. This study aimed to explore the McDonaldization thesis’s impact, a contemporary form of formal rationalization, on the academic physicians teaching in a clinical setting where patient care is also being delivered.
Methods
Focus groups of physicians from a single academic medical in the Southeast United States were conducted. Eighteen physicians participated in four groups, representing seven specialties. Session transcripts and field notes served as the data set analyzed.
Results
Four major categories of impact on physicians who teaching in the clinical setting were identified: (1) they hold the view that rationalizing processes will diminish positive features of practicing medicine for learners (2) the compensation plan emphasizes clinical productivity and efficiency at the expense of time to teach (3) the appropriate use of patient cares algorithms embedded in the electronic health care system is an emerging learning need that they are struggling to meet (4) this group of academic physicians is adapting in a number of ways to accommodate to these changes.
Conclusion
Physicians teaching in clinical settings has changed in response to the continued formal rationalization of healthcare. Physicians in this study expressed concern about the immediate and long-term consequences of these changes but also described their strategies for adapting. Despite their distress, they are adapting to try to preserve and enhance their teaching efforts despite the increasing demands of patient care. Our results support the previous recommendation of teaching job crafting and suggest the potential value of team job crafting. However, these group-level approaches must be accompanied by systems changes that address perception of inequity of recognition between clinical work and teaching held by these physicians.
Clinical trial number
Not applicable.
Journal Article
A demonstration of using formal consensus methods within guideline development; a case study
2021
Background
Recommendations within guidelines are developed by synthesising the best available evidence; when limited evidence is identified recommendations are generally based on informal consensus. However, there are potential biases in group decision making, and formal consensus methods may help reduce these.
Methods
We conducted a case study using formal consensus, to develop one set of recommendations within the Neonatal Parenteral Nutrition guideline being produced for the National Institute for Health and Care Excellence. Statements were generated through identification of published guidelines on several topics relating to neonatal parenteral nutrition. Ten high quality guidelines were included, and 28 statements were generated; these statements were rated by the committee via two rounds of voting. The statements which resulted in agreement were then used to develop the recommendations.
Results
The approach was systematic and provided transparency. Additionally, a number of lessons were learnt; including the value of selecting the appropriate topic, giving adequate time to the process, and ensuring methodologies are understood by the committee for their value and relevance.
Conclusion
Formal consensus is a valuable option for use within guideline development when specific criteria are met. The approach provides transparent methodology, ensuring clarity on how recommendations are developed.
Journal Article
Regulation of genomic and biobanking research in Africa: a content analysis of ethics guidelines, policies and procedures from 22 African countries
by
Munung, Syntia Nchangwi
,
Ouwe Missi Oukem-Boyer, Odile
,
Tindana, Paulina
in
Africa
,
Analysis
,
Biological Specimen Banks - ethics
2017
Background
The introduction of genomics and biobanking methodologies to the African research context has also introduced novel ways of doing science, based on values of sharing and reuse of data and samples. This shift raises ethical challenges that need to be considered when research is reviewed by ethics committees, relating for instance to broad consent, the feedback of individual genetic findings, and regulation of secondary sample access and use. Yet existing ethics guidelines and regulations in Africa do not successfully regulate research based on sharing, causing confusion about what is allowed, where and when.
Methods
In order to understand better the ethics regulatory landscape around genomic research and biobanking, we conducted a comprehensive analysis of existing ethics guidelines, policies and other similar sources. We sourced 30 ethics regulatory documents from 22 African countries. We used software that assists with qualitative data analysis to conduct a thematic analysis of these documents.
Results
Surprisingly considering how contentious broad consent is in Africa, we found that most countries allow the use of this consent model, with its use banned in only three of the countries we investigated. In a likely response to fears about exploitation, the export of samples outside of the continent is strictly regulated, sometimes in conjunction with regulations around international collaboration. We also found that whilst an essential and critical component of ensuring ethical best practice in genomics research relates to the governance framework that accompanies sample and data sharing, this was most sparingly covered in the guidelines.
Conclusions
There is a need for ethics guidelines in African countries to be adapted to the changing science policy landscape, which increasingly supports principles of openness, storage, sharing and secondary use. Current guidelines are not pertinent to the ethical challenges that such a new orientation raises, and therefore fail to provide accurate guidance to ethics committees and researchers.
Journal Article
Has the biobank bubble burst? Withstanding the challenges for sustainable biobanking in the digital era
by
Minari, Jusaku
,
Whitton, Tess
,
Nicol, Dianne
in
Bioethical Issues
,
Biological Specimen Banks - economics
,
Biological Specimen Banks - ethics
2016
Biobanks have been heralded as essential tools for translating biomedical research into practice, driving precision medicine to improve pathways for global healthcare treatment and services. Many nations have established specific governance systems to facilitate research and to address the complex ethical, legal and social challenges that they present, but this has not lead to uniformity across the world. Despite significant progress in responding to the ethical, legal and social implications of biobanking, operational, sustainability and funding challenges continue to emerge. No coherent strategy has yet been identified for addressing them. This has brought into question the overall viability and usefulness of biobanks in light of the significant resources required to keep them running. This review sets out the challenges that the biobanking community has had to overcome since their inception in the early 2000s. The first section provides a brief outline of the diversity in biobank and regulatory architecture in seven countries: Australia, Germany, Japan, Singapore, Taiwan, the UK, and the USA. The article then discusses four waves of responses to biobanking challenges. This article had its genesis in a discussion on biobanks during the Centre for Health, Law and Emerging Technologies (HeLEX) conference in Oxford UK, co-sponsored by the Centre for Law and Genetics (University of Tasmania). This article aims to provide a review of the issues associated with biobank practices and governance, with a view to informing the future course of both large-scale and smaller scale biobanks.
Journal Article