scholarly journals Surgical And Medical Error Claims In Ethiopia: Trends Observed From 125 Decisions Made By The Federal Ethics Committee For Health Professionals Ethics Review

2019 ◽  
Vol Volume 9 ◽  
pp. 23-31 ◽  
Author(s):  
Biruk Wamisho ◽  
Mesafint Abeje Tiruneh ◽  
Lidiya Enkubahiry Teklemariam
Keyword(s):  
Medical Error ◽  
Health Professionals ◽  
Ethics Committee ◽  
Ethics Review

Still Not Safe

2019 ◽  
Author(s):  
Robert Wears ◽  
Kathleen Sutcliffe
Keyword(s):  
Patient Safety ◽  
Medical Error ◽  
Health Professionals ◽  
Great Change ◽  
Crowding Out ◽  
Clinical Expertise ◽  
Radical Reform ◽  
Safety Science ◽  
The Future ◽  
Public Consciousness

Patient safety suddenly burst into public consciousness in the late 1990s and became a “celebrated” cause in the 2000s. It has since gradually faltered, and little improvement has been noted over almost 20 years. Both the rise and fall of patient safety demand explanation. Medical harm had been known long before the 1990s, so why did it suddenly become popular? And why were safety efforts ineffective? The authors propose that this rise was due to a discursive shift that reframed “medical harm” into “medical error” in the setting of anxiety about industrialization and great change in healthcare. The “error” framing, with its inherent notion of agency, was useful in advancing the agenda of a technocratic, managerial group of health professionals and diminishing the authority of the old guard based on clinical expertise. The fall was due to this “medicalization” of safety. Health professionals and managers with little knowledge of safety science came to dominate the patient safety field, crowding out expertise from the safety sciences (e.g., psychology, engineering) and thus keeping reform under the control of the healthcare establishment. Operating with a sort of delusional clarity, this scientific-bureaucratic cabal generated a great deal of activity but made little progress because they failed to engage with expertise in the safety sciences. Twenty years after sudden popularity, there is general agreement that little of value has been achieved. The future of patient safety is in doubt, and radical reform in approaches to safety will be required for progress to be made.

Implementation of the EU clinical trial regulation transforms the ethics committee systems and endangers ethical standards

2020 ◽  
pp. medethics-2020-106757
Author(s):  
Vilma Lukaseviciene ◽  
Joerg Hasford ◽  
Dirk Lanzerath ◽  
Eugenijus Gefenas
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Research Ethics ◽  
Ethics Committees ◽  
Ethics Committee ◽  
Negative Consequences ◽  
Ethics Review ◽  
Clinical Trial Directive ◽  
Favourable Environment ◽  
The Eu

The upcoming Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use (Regulation), which will replace the current Clinical Trial Directive at the end of 2021, has triggered a significant reform of research ethics committee systems in Europe. Changes related to ethics review of clinical trials in the EU were considered to be essential to create a more favourable environment to conduct clinical trials in the EU. The concern is, however, that the role of the research ethics committees will weaken in at least some of the Member States because the new Regulation allows narrowing down the scope of ethics review as compared with the currently valid Clinical Trial Directive. Although the new Regulation may lead to faster approval procedures for clinical trials, which is especially relevant in the context of pandemics, high-quality ethics reviews integrating methodological aspects of a clinical trial should nevertheless be ensured. To maintain high research ethics standards as well as to foster measures to mitigate potential negative consequences of the reform, it is therefore of vital importance to start debating and sharing the reflections about the potential consequences of these transformations and trends as soon as possible.

The Psychological Impact of Medical Error on Patients, Family Members, and Health Professionals

2017 ◽  
pp. 171-196
Author(s):  
Mary I. Gouva
Keyword(s):  
Medical Errors ◽  
Medical Error ◽  
Health Professionals ◽  
Psychological Impact ◽  
Psychological Effects ◽  
History Of ◽  
Underlying Causes ◽  
The Individual ◽  
The Impact

The current chapter examines the psychological implications emerging from medical errors. Whilst the psychological effects have studied, nonetheless the consequent impacts and the underlying psychological causes have not been sufficiently analysed and/ or interpreted. The chapter will add to the literate by using a psychodynamic approach in analysing the psychological impact of medical errors and provide interpretations of the underlying causes. The chapter concludes that medical errors lead to a series of implications. For the patient the quality of interactions with health professionals are directly affected and usually have immediate consequences. The impact of these consequences in the patient is mediated by the patient's personality, history of the individual and the psychoanalytic destiny of the patient. For the patient's relatives medical errors create emotional cracks leading to regression and eventual transference of the medical errors as a “bad” object. For health professionals medical errors impact upon the psychological defence mechanisms of the psychic Ego.

scholarly journals Evolving power dynamics in an unconventional, powerless ethics committee

2016 ◽  
Vol 13 (1) ◽  
pp. 42-52 ◽  
Author(s):  
Martin Tolich ◽  
Jay Marlowe
Keyword(s):  
New Brunswick ◽  
Research Ethics ◽  
Ethics Committee ◽  
Power Dynamics ◽  
Government Agencies ◽  
Ethics Review ◽  
Research Areas ◽  
Annual Survey ◽  
Free Service ◽  
One Year

A previous research ethics article by the authors provided evidence to support the claim that the New Zealand Ethics Committee (NZEC) was a powerless ethics committee. Ethics review applicants were not formally obliged to seek ethics review, and any committee recommendations were given on a ‘take it or leave it’ basis. One year later, the capacity of applications has doubled, and NZEC finds its core assumptions challenged as funders and government agencies now compel contracted researchers to make use of this free service. Moreover, NZEC has expanded into research areas inhabited by market researchers, long shy of ethics review. Review requirements and remit expansion challenges some, but not all, aspects of NZEC’s assumption of powerlessness as NZEC remains committed to research ethics, not research governance, and it adheres to the principles of the New Brunswick Declaration to respect applicants the same way it expects applicants to respect participants. This annual survey of applicants makes NZEC accountable to its applicants, providing evidence once more that NZEC’s expeditious and cordial review of applications is considered different from traditional ethics review.

Acidentes de trabalho entre mulheres brasileiras atendidas em uma unidade de emergência

2009 ◽  
Vol 3 (4) ◽  
pp. 908
Author(s):  
Cristiane Aparecida Silveira ◽  
Maria Lúcia Carmo Cruz Robazzi ◽  
Liliana Amorim Alves ◽  
Sandra Verônica Valenzuela Suazo
Keyword(s):  
Data Collection ◽  
Occupational Health ◽  
Health Professionals ◽  
Descriptive Study ◽  
Ethics Committee ◽  
Sao Paulo ◽  
Occupational Accidents ◽  
São Paulo ◽  
Emergency Unit ◽  
Paulo State

Objective: to identify the occurrence of Occupational Accidents among women attended in a hospital in São Paulo city, characterizing them. Methods: observational, non-experimental and descriptive study, from quantitative approach. An instrument has been validated by experts for data collection; it were studied the patients’ charts from 2002 to 2003, in an Emergency Unit of a teaching hospital of the Sao Paulo State, Brazil. The study has been approved by the Research Ethics Committee of Clinics Hospital of the Faculty of Medicine University of São Paulo (4799/2004). Results: 82 women were victims of 117 Occupational Accidents. Most of the 82 female Occupational Accidents victims were between 25-40 years old (52.78%); 47.56% were married. Most of the women were nursing technicians and aides (29,27% each). Most of the Occupational Accidents (32.93%) were caused by falls.  Conclusions: suggestions are presented to minimize these events, in terms of protecting women’s work and train health professionals to enable them to offer better care to these accident victims. Descriptors: occupational health; female work; emergency medical services.

scholarly journals 倫理審查的制度歷史、運行現狀與困境

2010 ◽  
Vol 8 (2) ◽  
pp. 57-72
Author(s):  
Rui DENG
Keyword(s):  
Common Ground ◽  
Conflicts Of Interest ◽  
Human Life ◽  
Scientific Research ◽  
Ethics Committees ◽  
Ethics Committee ◽  
Review System ◽  
International Ethics ◽  
Ethics Review ◽  
History Of

LANGUAGE NOTE | Document text in Chinese; abstract also in English.西方文化和原則主義的生物醫學倫理審查制度大有“普惠全球”之勢，但是從國際文獻的制訂歷史追溯倫理審查要求的修改變化，會發現倫理審查要求的弱化和無窮倒退的現象。本文將結合當前西方倫理審查的運行現狀，對倫理審查制度面臨的理論和實踐困境進行分析。Since the 1970s, the ethics review system has become an important measure to protect human life. International organizations have ceaselessly revised and perfected the rules of several international ethics documents, carried out ability training for ethics reviews on a global scale, helped many countries to set up ethics committees, and attempted to promote the Western ethical culture and principle of “universal ethics.” However, if we investigate the history of the changes in the requirements of ethics reviews coded in the relevant international documents and enactments, we find that the requirements of ethics reviews for medical research have become weakened and have substantially regressed.The Western approach to the ethics review has no means of ensuring that investigators obey the ethics review system. It is also unable to secure common ground and set aside differences when confronted with a pluralist culture. This weakens its ability to review and supervise. The current state of the Western ethics review also displays some negative features, such as a loosely organized structure, commercialization stimulated by conflicts of interest, disagreement over conclusions (especially for research projects involving multiple research centers) due to pluralist cultures and systems of morality, the limited protection of human subjects due to poor review and supervision, and the imposition on researchers of very complex review processes.The system of ethics review is also beset by several dilemmas. The first is the suspicion of ethics imperialism. International documents attempt to provide a universal frame and impose the values of certain moral communities on others. Second, the ethics principles proposed by Beauchamp and Childress seem to be the foundation of many international documents, yet reflect only a small part of American morality, and cannot always be applied to other cultures and customs. They have been attacked by virtue theory, casuistry, feminism, and communitarianism alike. Third, the history of the revision of international ethics documents suggests that ethics reviews often fall into a vicious circle: scientific research must be reviewed by an ethics committee, and the ethics committee must be reviewed by an external institute, but who reviews the external institute?This essay contends that the Western ethics review system is based on Western human rights theory and the religious view of original sin, in that the review process must be enforced to prevent the evil in human nature. This epistemological foundation has caused many problems and dilemmas, as stated. To resolve these problems and dilemmas, we need to re-examine the foundations of ethics reviews. This essay argues that due to the reality of cultural and ethical pluralism, it is difficult, if not impossible, to seek a global or universal ethical theory that will guide all ethics review practices.Finally, this essay puts forward a proposal for reconstructing Chinese ethics reviews by drawing on intellectual and ethical thought in Confucian resources. Confucianism emphasizes the cultivation of virtue and self-improvement, which means that the good of the individual primarily derives from self-discipline. In a scientific research field, this suggests that investigators should do good voluntarily and conscientiously. This idea should be applied in the construction of a harmonious relationship between ethics committees and researchers.DOWNLOAD HISTORY | This article has been downloaded 114 times in Digital Commons before migrating into this platform.

scholarly journals A study to evaluate the effectiveness of Best Beginnings’ Baby Buddy phone app in England: a protocol paper

2018 ◽  
Vol 20 ◽  
Author(s):  
Toity Deave ◽  
Sally Kendal ◽  
Raghu Lingam ◽  
Crispin Day ◽  
Trudy Goodenough ◽  
...  
Keyword(s):  
Cohort Study ◽  
Pregnant Women ◽  
Research Ethics ◽  
Health Professionals ◽  
Self Efficacy ◽  
Well Being ◽  
Ethics Committee ◽  
The West ◽  
Research Ethics Committee ◽  
The Impact

AbstractIntroductionDevelopments in information and communication technologies have enabled electronic health and seen a huge expansion over the last decade. This has increased the possibility of self-management of health issues.PurposeTo assess the effectiveness of the Baby Buddy app on maternal self-efficacy and mental well-being three months post-birth in a sample of mothers recruited antenatally. In addition, to explore when, why and how mothers use the app and consider any benefits the app may offer them in relation to their parenting, health, relationships or communication with their child, friends, family members or health professionals.MethodsWe will use a mixed-methods approach, a cohort study, a qualitative element and analysis of in-app data. Participants will be first-time pregnant women, aged 16 years and over, between 12 and 16 weeks of gestation and recruited from five English study sites.Evaluation planWe will compare maternal self-efficacy and mental health at three months post-delivery in mothers who have downloaded the Baby Buddy app compared with those that have not downloaded the app, controlling for confounding factors. Women will be recruited antenatally between 12 and 16 weeks of gestation. Further follow-ups will take place at 35 weeks of gestation and three months post-birth. Data from the cohort study will be supplemented by in-app data that will include, for example, patterns of usage. Qualitative data will assess the impact of the app on the lives of pregnant women and health professionals using both focus groups and interviews.EthicsApproval from the West Midlands-South Birmingham Research Ethics Committee (NRES) (16/WM/0029) and the University of the West of England, Bristol, Research Ethics Committee (HAS.16.08.001).DisseminationFindings of the study will be published in peer reviewed and professional journals, presented locally, nationally and at international conferences. Participants will receive a summary of the findings and the results will be published on Best Beginnings’ website.

scholarly journals Challenges in the ethics review process of clinical scientific research projects in China

2019 ◽  
Vol 47 (10) ◽  
pp. 4636-4643
Author(s):  
Zhu-Heng Wang ◽  
Guan-Hua Zhou ◽  
Li-Ping Sun ◽  
Jun Gang
Keyword(s):  
Medical Ethics ◽  
Professional Training ◽  
Review Process ◽  
Scientific Research ◽  
Ethics Committees ◽  
Ethics Committee ◽  
Research Projects ◽  
Ethics Review ◽  
Review Criteria

Purpose Ethics review processes have become increasingly complex. The objective of this study was to explore the challenges currently faced in ethics reviews of clinical scientific research projects in China, with the goal of standardizing the structure of medical ethics committees and better protecting the rights and interests of research participants. Methods We reviewed and comprehensively analyzed the available literature discussing standardized ethics reviews of clinical scientific research projects. Results We identified the following problems: incomplete legislation, absence of supervision, vague review criteria, limitations of ethics committee competence, inadequate ethics consciousness, and poor tracking of reviews. In this paper, we suggest strategies for the development of future ethical reviews of clinical scientific research projects. Conclusion To standardize the ethics review process of clinical scientific research projects in China, it is necessary to establish relevant laws and regulations and implement supervisory responsibilities. Professional training of medical ethics committees is suggested as an effective way to improve the quality of ethics reviews.

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