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 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.

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.

PROBLEMS OF PROFESSIONAL TRAINING OF INFORMATICS FUTURE TEACHERS IN THE CONDITIONS OF DIGITALIZATION OF EDUCATION

2021 ◽  
Vol 69 (1) ◽  
pp. 66-73
Author(s):  
G.S. Saudabayeva ◽  
◽  
G.K. Sholpankulova ◽  
A.D Toleukhanova ◽  
◽  
...  
Keyword(s):  
Professional Training ◽  
Human Life ◽  
Scientific Research ◽  
Spiritual Values ◽  
Diagnostic Competence ◽  
Educational Psychologists ◽  
Theoretical Approaches ◽  
National Values ◽  
History Of ◽  
Interdisciplinary Study

The article is devoted to the formation of diagnostic competence of future teacherspsychologists. Some aspects of the prerequisites for the formation of diagnostic competence are considered. Diagnostic competence is characterized as a new environment of human life and a factor of social change. The concepts related to diagnostic competence are analyzed on the basis of the analysis of scientific research of foreign, Russian and domestic scientists. Of particular importance in the education system is the issue of studying the experience of implementing the diagnostic competence of future educational psychologists . The article analyzes the main theoretical approaches in scientific research on the issues of diagnostic competence of future educational psychologists in the context of cultural and national values. An excursion into the history of the problems of diagnostic competence of future educational psychologists was conducted . Based on the analysis of scientific studies of Russian and domestic scientists, it was decided to determine the main methodological approaches to the diagnostic competence of future educational psychologists. When considering this issue, it is necessary to pay special attention to the historical, cultural and spiritual values of the ethnic group, along with modern socio-cultural realities. There is an urgent need for an interdisciplinary study of the problems of diagnostic competence of future educational psychologists

scholarly journals When patient advocacy organizations meet industry: a novel approach to dealing with financial conflicts of interest

2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Orna Ehrlich ◽  
Laura Wingate ◽  
Caren Heller ◽  
Inmaculada de Melo-Martin
Keyword(s):  
Conflicts Of Interest ◽  
Ethics Committees ◽  
Patient Advocacy ◽  
Ethics Committee ◽  
Main Body ◽  
Advocacy Organizations ◽  
Academic Context ◽  
Novel Approach ◽  
Financial Conflicts Of Interest ◽  
The Creation

Abstract Background Much like academic-industry partnerships, industry financial support of patient advocacy organizations (PAOs) has become very common in recent years. While financial conflicts of interest (FCOI) between PAOs and industry have received more attention in recent years, robust efforts to mitigate these conflicts are still limited. Main body The authors outline the possible benefits and ethical concerns that can result from financial interactions between biomedical companies and PAOs. They argue that the use of novel strategies, such as the creation of a standing ethics committee, could be helpful in managing FCOIs and ensuring the warranted trust of PAO’s constituents. Although ethics committees to address FCOIs are common in the academic context, its use by PAOs is still limited. The authors conclude by describing the process of development and implementation of such an ethics committee at the Crohn’s & Colitis Foundation. Conclusions While collaborations with industry can result in conflicts of interest, PAOs can develop strategies to address those conflicts. One such strategy is the creation of a standing independent ethics committee to guide PAOs on new and/or existing programs and protocols as they pertain to their industry relationships.

scholarly journals POTENTIALITIES AND LIMITS OF THE CLINICAL ETHICS COMMITTEE AND NURSE PARTICIPATION: REFLECTIONS

2020 ◽  
Vol 29 ◽  
Author(s):  
Luciana Neves da Silva Bampi ◽  
Lydia Feito Grande
Keyword(s):  
Clinical Ethics ◽  
Ethics Committees ◽  
Well Being ◽  
Ethics Committee ◽  
Care Practice ◽  
Clinical Ethics Committee ◽  
School Of Medicine ◽  
Ethical Conflicts ◽  
History Of ◽  
Key Participants

ABSTRACT Objective: to reflect on the importance of the participation of nurses in the Clinical Ethics Committee in Brazil and the knowledge required for this performance. Method: reflection based on experience of a postdoctoral internship carried out within the Department of Preventive Medicine, Public Health and History of Science of the School of Medicine of Universidad Complutense de Madrid, Madrid, Spain. Results: the Clinical Ethics Committee contributes to the improvement of health care provided by professionals and health institutions. The nurses are key participants, not only because they are professionals involved in the clinical practice, committed to the decision-making and the patient's performance, but also because they vision is necessary and irreplaceable in an environment of deliberation in which different perspectives and approximations for prudent resolution of ethical conflicts. Conclusion: if the nurses want to assume a strategic position, positively influencing the quality of care provided, protecting interests and ensuring the well-being of the users, they should assume as an urgent basis the need to develop the skills required to deal with ethical problems in the day-to-day of their care practice, accepting the responsibility to participate in the Clinical Ethics Committees, promoting their creation and inserting themselves into their activities.

SEJARAH KONFLIK KEBANGKITAN ISLAM DI MINANGKABAU: Sebuah Tinjauan Awal Terhadap Proses Kemunculannya

2018 ◽  
pp. 33-48
Author(s):  
Ihsan Sanusi
Keyword(s):  
Human Life ◽  
Initial Period ◽  
Analysis Model ◽  
Islamic Revival ◽  
Religious Texts ◽  
Interactive Analysis ◽  
The Past ◽  
The Reformation ◽  
History Of ◽  
Correct Understanding

This article in principle wants to examine the history of the emergence of the conflict of Islamic revival in Minangkabau starting from the Paderi Movement to the Youth in Minangkabau. Especially in the initial period, namely the Padri movement, there was a tragedy of violence (radicalism) that accompanied it. This study becomes important, because after all the reformation of Islam began to be realized by reforming human life in the world. Both in terms of thought with the effort to restore the correct understanding of religion as it should, from the side of the practice of religion, namely by reforming deviant practices and adapted to the instructions of the religious texts (al-Qur'an and sunnah), and also from the side of strengthening power religion. In this case the research will be directed to the efforts of renewal by the Padri to the Youth towards the Islamic community in Minangkabau. To discuss this problem used historical research methods. Through this method, it is tested and analyzed critically the records and relics of the past. In analyzing the data in this research basically used approach or interactive analysis model by Miles and Huberman. In this analysis model, the three components of the analysis are data reduction, data presentation, and conclusion drawing or verification, the activity is carried out in an interactive form with the process of collecting data as a process that continues, repeats, and continues to form acycle.

Kedudukan dan Fungsi Bahasa dalam Permuseuman

Metahumaniora ◽  
2019 ◽  
Vol 9 (1) ◽  
pp. 54
Author(s):  
Erlina Zulkifli Mahmud ◽  
Taufik Ampera ◽  
Yuyu Yohana Risagarniwa ◽  
Inu Isnaeni Sidiq
Keyword(s):  
Human Life ◽  
Field Research ◽  
Communicative Function ◽  
Language Functions ◽  
The Past ◽  
Library Research ◽  
History Of ◽  
And Function ◽  
Museum Guides ◽  
Bahasa Indonesia

Kedudukan dan fungsi bahasa sebagai alat komunikasi manusia mencakup seluruh bidang kehidupan termasuk ilmu pengetahuan antara lain terkait sejarah peradaban manusia; bagaimana manusia mempertahankan hidupnya, bagaimana manusia memperlakukan alam, bagaimana alam menyediakan segala kebutuhan manusia. Apa yang dilakukan manusia saat ini, saat lampau, dan apa yang dilakukan manusia jauh di masa prasejarah, bagaimana kondisi alam di masa-masa tersebut, apa perubahan dan perkembangannya, dapat didokumentasikan melalui bahasa, divisualisasikan kembali, lalu dipajang sebagai salah satu upaya konversai dan preservasi dalam satu institusi yang disebut museum. Penelitian ini membahas kedudukan dan fungsi bahasa dalam permuseuman. Bagaimana kedudukan dan fungsi bahasa dalam permuseuman baik dalam informasi yang disampaikan oleh pemandu wisata museumnya maupun yang terpajang menyertai benda-benda dan gambar-gambar merupakan tujuan dari penelitian ini. Metode penelitian yang digunakan adalah gabungan antara metode lapangan dan metode literatur. Hasil penelitian menunjukkan bahwa secara umum kedudukan bahasa Indonesia berada pada urutan pertama setelah Bahasa Inggris dan keberadaan kedua bahasa dalam permuseuman ini melibatkan dua fungsi utama bahasa, yakni fungsi komunikatif dan fungsi informatif.The existence and function of language  as a medium of communication covers all fields of human life including knowledge, one of them is the history of human civilization; how humans survived, how human utilized nature for their lives, and how nature provides all the necessities for humans. What humans have been doing now, what they have done in the past and far before that in the pre-history time, how the conditions of the nature at those times were and what changes as well as progresses occurred are documented using language, then re-visualized,  displayed as one of conservation and preservation acts in an institution called museum. This research discusess the existence and function of language in museums. How important the existence of a language in museums and what language functions used in museums both in informations given by the museum guides and on the displays accompanying objects and pictures are the aims of this research. The methods used are the combination between field research and library research. The results show that generally the existence of Indonesian language plays more important role than English and both languages have two main functions; communicative function and informative function.     

Thanato-Laboratorien. Theorien von Tod und Sterben und Elias Canettis Buch gegen den Tod

2020 ◽  
Vol 4 (1) ◽  
pp. 67-86
Author(s):  
Elisabeth Heyne
Keyword(s):  
Human Life ◽  
Death And Dying ◽  
Point Of View ◽  
Visual Images ◽  
Elias Canetti ◽  
History Of ◽  
Series Of Experiments ◽  
First Time ◽  
Textual Form ◽  
Or History

AbstractAlthough visual culture of the 21th century increasingly focuses on representation of death and dying, contemporary discourses still lack a language of death adequate to the event shown by pictures and visual images from an outside point of view. Following this observation, this article suggests a re-reading of 20th century author Elias Canetti. His lifelong notes have been edited and published posthumously for the first time in 2014. Thanks to this edition Canetti's short texts and aphorisms can be focused as a textual laboratory in which he tries to model a language of death on experimental practices of natural sciences. The miniature series of experiments address the problem of death, not representable in discourses of cultural studies, system theory or history of knowledge, and in doing so, Canetti creates liminal texts at the margins of western concepts of (human) life, science and established textual form.

INTER AKSI AGAMA DAN BUDAYA

EMPIRISMA ◽  
2018 ◽  
Vol 27 (1) ◽  
Author(s):  
Mohammad Arif Dan Yuli Darwati
Keyword(s):  
Human Life ◽  
Belief System ◽  
Cultural Interaction ◽  
Cultural Economic ◽  
Modern Period ◽  
Or Groups ◽  
Close Relationship ◽  
History Of ◽  
The Relationship ◽  
Determining Factor

This paper will try to explain the relationship between religion and culture. These two topics are the most important items that are inseparable in the history of human civilization from the classical to the modern period. Religion is ahuman belief system that is related to God. If the rule comes from God, then it cannot be said to be a culture, because it is not human creation, but God’s creation that is absolute. Religion is interpreted as part of the life (culture) ofindividuals or groups, each of which has the authority to understand religion and apply it. With the characteristics as indicated by Fazlur Rahman, wherever religion is located, it is hoped that it can provide guidance on values or moralsfor all activities of human life, whether social, cultural, economic or political. Not infrequently also religion becomes a determining factor in the adhesive process of social cultural interaction of the community as well as unifying thenation. Culture and religion are something different but can influence each other so that new cultures or mixing of cultures emerge. The opinion of Endang Saifudin Anshari who said in his writing that religion and culture do notinclude each other, in principle one is not part of the other and each consists of itself. Between them, of course, they are closely related like us, we see in everyday life and human life. As also seen in the close relationship between husband and wife who can give birth to a son but the husband is not part of the wife, and vice versa. Religion and culture are two different things but cannot be separated. The existence of a religion will be greatly influenced and affect thepractice of a religion in question. And conversely, a culture will be greatly influenced by the beliefs of the society in which culture develops. Therefore religion is not only an individual problem but religion is also a social affair whichultimately religious people are not only able to give birth to individual piety but also must be able to give birth to social piety.Key words: Interaction, Religion, Culture,

Sign in / Sign up

Export Citation Format

Share Document