Challenges for ethics committees in biomedical research governance: Illustrations from China and Australia

In this paper, the evolution of the ethics committees for health research, their history, membership, and function in China and Australia is described. Investigators in each country compared the history and governance of their ethical systems based on the published evidence rather than personal opinions. Similarly, examples of challenges were selected from the literature. In both countries, the aim was to maximize the social benefits of research and minimize the risk imposed on the participants. Common challenges include maintaining independence, funding and delivering timely ethical reviews of the research projects. These challenges can be difficult where research ethics committees rely on voluntary contributions and lack a strong resource base. They must adapt to the increasingly rapid pace of research as well as the technological sophistication. Population health research can challenge the conventional views of consent and privacy. The principles of the sound ethical review are common in both countries; governance arrangements and operational procedures, however, can differ, reflecting the cultural values and norms of their host countries and in respect of legal environments. By studying the evolution and function of ethics committees in the two countries, we established the differences in the governance and health systems, while similar ethical objectives helped sustain collaborative research.

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MURAL MELATIH KREATIVITAS VISUAL ANAK USIA DINI (STUDI KASUS TK FAJAR HARAPAN)

PRATAMA WIDYA : JURNAL PENDIDIKAN ANAK USIA DINI ◽

10.25078/pw.v6i1.1796 ◽

2021 ◽

Vol 6 (1) ◽

pp. 1

Author(s):

I Gde Suryawan ◽

Ida Bagus Komang Sindu Putra ◽

I Putu Suyasa Ari Putra

Keyword(s):

Early Childhood ◽

Cultural Values ◽

Visual Art ◽

Communication Theory ◽

Empty Space ◽

Visual Sensitivity ◽

Implicit Function ◽

The Social ◽

New Ideas ◽

And Function

Abstract Murals are one of the alternative media for street visual art / street visual art that functions as a forum for people's aspirations through paintings. The attractiveness of art gives a strong impression, in line with visual communication theory which assumes that the use of art in educational media is very important. One of these forms of art is a mural. The purpose and function of the mural itself is still developing today. The making of murals in early childhood schools is basically a form of utilizing empty space by incorporating educational missions, such as: as a medium for recognizing local cultural values (folklore). Because through folklore, it indirectly represents the social reality that is around us. Thus basically the implicit function of making murals in empty spaces in early childhood schools is to train students' sensitivity.The environment is a factor that can affect a child's imagination. By placing murals on the walls of early childhood schools, apart from functioning as decoration, indirectly has the function of stimulating children's sensitivity to visuals. This visual sensitivity indirectly develops children's imagination. Thus, murals can stimulate the imaginary environment or imaginary world of children that penetrate the developer of their imagination. Art will always develop, which will be the source of ideas in the process of its creation. Like children who are inspired by murals in creating their works. Seeing this, students will be more open and sensitive to the environment around us so that new ideas will emerge fresh and close to us as a source of ideas for creating works.

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Justice: a key consideration in health policy and systems research ethics

BMJ Global Health ◽

10.1136/bmjgh-2019-001942 ◽

2020 ◽

Vol 5 (4) ◽

pp. e001942 ◽

Cited By ~ 2

Author(s):

Bridget Pratt ◽

Verina Wild ◽

Edwine Barasa ◽

Dorcas Kamuya ◽

Lucy Gilson ◽

...

Keyword(s):

Health Policy ◽

Research Ethics ◽

Ethics Committees ◽

Ethical Review ◽

Research Ethics Committees ◽

Systems Research ◽

The Social ◽

Principle Of Justice ◽

The Rich ◽

Health Policy And Systems

Health policy and systems research (HPSR) is increasingly being funded and conducted worldwide. There are currently no specific guidelines or criteria for the ethical review and conduct of HPSR. Academic debates on HPSR ethics in the scholarly literature can inform the development of guidelines. Yet there is a deficiency of academic bioethics work relating to justice in HPSR. This gap is especially problematic for a field like HPSR, which can entail studies that intervene in ways affecting the social and health system delivery structures of society. In this paper, we call for interpreting the principle of justice in a more expansive way in developing and reviewing HPSR studies (relative to biomedical research). The principle requires advancing health equity and social justice at population or systems levels. Drawing on the rich justice literature from political philosophy and public health ethics, we propose a set of essential justice considerations to uphold this principle. These considerations are relevant for research funders, researchers, research ethics committees, policymakers, community organisations and others who are active in the HPSR field.

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Reflections on the social epidemiologic dimension of health technology assessment

International Journal of Technology Assessment in Health Care ◽

10.1017/s0266462304000947 ◽

2004 ◽

Vol 20 (2) ◽

pp. 167-173 ◽

Cited By ~ 5

Author(s):

Arminée Kazanjian

Keyword(s):

Health Technology Assessment ◽

Cultural Values ◽

Social Relations ◽

Technology Assessment ◽

Technological Development ◽

Social Institutions ◽

Health Technology ◽

Sex And Gender ◽

Published Evidence ◽

The Social

Certain key parameters such as safety, efficacy, effectiveness, and cost effectiveness have long been established as key in HTA analysis. Equally important, however, are sociolegal and epidemiologic perspectives. A comprehensive analytic framework will consider the implications of using a technology in the context of societal norms, cultural values, and social institutions and relations. The methodology in which this expanded framework has been developed is termed ‘Strategic HTA’ to denote its power for the decision-making process. In addition to systematic reviews of published evidence, it incorporates analyses of the influence of dominant social relations on technological development and diffusion. This essay discusses the social epidemiologic aspects of health technology assessment, which includes factors such as sex and gender. It seeks to show how it is possible to bring data from wide-ranging disciplinary perspectives within the parameters of a single scientific inquiry; to draw from them scientifically defensible conclusions; and thereby to realize a deeper understanding of technology impact within a health care system. Armed with such an understanding, policy officials will be better prepared to resolve the competitive clamor of stakeholder voices, and to make the most “equitable” use of the available resources.

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Fostering ethical biomedical and health research in India during the COVID-19 pandemic

Research Ethics ◽

10.1177/1747016120941632 ◽

2020 ◽

Vol 16 (3-4) ◽

pp. 1-10 ◽

Cited By ~ 1

Author(s):

Nandini K Kumar ◽

Vasantha Muthuswamy

Keyword(s):

Health Research ◽

Healthcare Workers ◽

Ethics Committees ◽

Health Needs ◽

Ethical Review ◽

Fake News ◽

National Guidelines ◽

The Media ◽

Collaborative Efforts ◽

Indian Perspective

The COVID-19 pandemic has brought unprecedented, major challenges to the ethical conduct of research including challenges for the rapid and robust ethical review of biomedical research. The Indian Council of Medical Research’s “National Guidelines for Ethics Committees Reviewing Biomedical and Health Research during COVID-19 Pandemic” aim to assist ethics committees in this time of crisis, whilst simultaneously protecting researchers and research participants. Whilst ethics committees are encouraged to approve studies rapidly, the Indian guidelines also make clear that no shortcuts will be taken. Informed consent must be obtained innovatively, but cannot be dispensed with. Vulnerable people should only be involved in clinical research that is relevant to their health needs. Approaching communities for research also requires new, trust-building methods, given that healthcare workers and researchers have been assaulted during their COVID-19 research. Importantly, the media must carry their share of responsibility and avoid spreading fake news. From an Indian perspective, the question of whether we are sitting on a volcano that might erupt at any time causing more damage than we ever expected is currently unclear. Only global collaborative efforts will help to tide over in the present crisis.

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OC 8716 ENHANCING RESEARCH ETHICS REVIEW CAPACITY IN SUDAN

BMJ Global Health ◽

10.1136/bmjgh-2019-edc.40 ◽

2019 ◽

Vol 4 (Suppl 3) ◽

pp. A16.3-A17

Author(s):

Shaza Abass ◽

Sara-Lavinia Brair ◽

Shahd Osman ◽

Henry Silverman

Keyword(s):

Research Ethics ◽

Health Research ◽

Human Subjects ◽

Knowledge Score ◽

Ethics Committees ◽

Ethical Review ◽

Human Subjects Research ◽

Review System ◽

Consensus Document ◽

Post Test

BackgroundIn Sudan, there is an increase in health research in a situation of scarce resources and limited counteractive quality assurance in research ethics. The aim of this project was to enhance the ethical review system in Sudan.MethodsOur framework for enhancing the ethical review capacity was based on the context of Sudan with emphasis on governance, coordination, feasibility, efficiency and sustainability. Activities conducted to achieve our goals included reviewing the guidelines that govern human subjects research, enhancing the governance of national authorities (National Health Research Ethics Committee and National Medicine and Poisons Board), improving coordination between the national authorities by developing a consensus clarifying their roles and functions, capacity building for the oversight bodies and institutional ethical review committees (RECs) as well as establishing a network of research ethics committees.ResultsThe guidelines that govern human subjects research in Sudan were reviewed and updated. In addition, a consensus document was endorsed to clarify the roles of the national regulatory authorities creating channels of coordination and cooperation between them and institutional RECs. Thirty-nine RECs from different parts of Sudan have been trained and the results of the pre/post test have shown an increase in the knowledge score among trainees (p<0.05). The project has also provided a platform for sharing experiences and maintaining partnerships with regional and international institutes in addition to provision of technical support for newly established RECs.ConclusionWe believe that the array of activities conducted through this project had enhanced the governance, coordination, feasibility and, efficiency of the ethical review system in Sudan.

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Ethical Characteristics of Research Proposals Related of COVID-19 Pandemic in Nepal: A Retrospective Review

Journal of Nepal Health Research Council ◽

10.33314/jnhrc.v19i1.3373 ◽

2021 ◽

Vol 19 (1) ◽

pp. 148-153

Author(s):

Namita Ghimire ◽

Pawan Kumar Hamal ◽

Asmita Panthee ◽

Anju Vaidya ◽

Mira Khadka ◽

...

Keyword(s):

Informed Consent ◽

Health Research ◽

Ethical Issues ◽

Critical Time ◽

Standard Operating Procedure ◽

Ethics Committees ◽

World Health ◽

Ethical Review ◽

Ethical Guidelines ◽

Related Research

Background: Public health emergency is vulnerable time where maintaining ethical principles is obligatory while doing research, on the other hand, it is the same time when breach in ethics is much likely whenever a researcher is unaware, unprepared or hastens to do research. The aim of this study was to assess ethical issues of the coronavirus disease 2019 (COVID-19) related research proposals submitted during the early stages of pandemic in Nepal.Methods: Retrospective analysis of COVID-19 related research proposals and their informed consent document submitted to the ethical review board at Nepal Health Research Council was done for the study. The analysis was done as per the National Ethical Guidelines, Standard Operating Procedure for Health Research in Nepal and World Health Organization guidelines for infectious disease outbreak, 2016 under ethically relevant headings. Descriptive data were analyzed in SPSS v24.Results: The major issues were observed in the informed consent documents where 55% were lacking principal investigator’s contact information, 68% not having participant selection criteria, 70% without clear informed consent taking process, 57% without explanation of possible risks. Similarly, 68% of the interventional studies’ consent form didn’t mention possible adverse events and mitigation mechanisms.Conclusions: Most of the research proposals related to COVID-19 were devoid of major ethical elements which took longer time for receiving approval and eventually delayed the opportunity for evidence generation in critical time. More attention is needed to increase awareness and to develop capacity of researchers, reviewers, ethics committees and relevant stakeholders at the time of health emergencies.Keywords: COVID-19; ethics pandemic; research proposals

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A review of ethics in developing country in perspective of dental research

Bangladesh Journal of Bioethics ◽

10.3329/bioethics.v5i1.18443 ◽

2014 ◽

Vol 5 (1) ◽

pp. 11-19 ◽

Cited By ~ 1

Author(s):

Md Haider Ali Khan ◽

Shamima Parvin Lasker

Keyword(s):

Developing Countries ◽

Research Ethics ◽

Developing Country ◽

Health Research ◽

Ethical Issues ◽

Ethics Committees ◽

Ethical Review ◽

Ethical Standards ◽

Research Ethics Committees ◽

Dental Research

The objectives of this review were to examine the ethical issues in research in developing country and perspective of dental research. In this review, we performed the systematic literature search, screening process through the web in existing published and unpublished articles and reports that related to our topics between1990 to 2013. In the past few decades, the research and discoveries in the discipline of dentistry have increased dramatically. Recently many dental Institutes in developing country is constantly looking for opportunities to borrow, enhance, and integrate knowledge from biomedical and technological research by using modern technology. The retrieved information in this review reflect that to make any research involving human subjects ethically acceptable, a number of key features have to be considered by the researchers. Those who conduct oral health research are compelled by regulations and convention to follow established ethical standards to protect human rights. Bioethics and in ethical review of research in developing countries reveals many major gaps and have seen that there are indeed many ethical issues to be considered to clinical trials taking place in developing countries. Professional societies have a major influence in shaping the moral tone and ethical climate for research through the adoption of standards, the development of educational programs designed to reinforce those standards. Research ethics committees or institutional ethical review committees is to ensure that studies involving human research participants are designed to conform the relevant ethical standards and that the rights and welfare of participants are protected. Research ethics committees should not function under the influence of others and should ensures the favorable balance of potential benefits and risks. In developing country it is necessary to strengthen local capacity and manpower by developing innovative training models for ethics that are cost-effective and sustainable. The actions required to move ahead in this field include strengthening bioethics capacity, linking health research to community needs in a transparent and participatory process and increasing communication between scientists and ethicists in industrialized and developing countries. DOI: http://dx.doi.org/10.3329/bioethics.v5i1.18443 Bangladesh Journal of Bioethics 2014 Vol.5(1): 11-19

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Fictions of the Human Right to Health: Writing Against the Postcolonial Exotic in Western Medicine

10.3366/edinburgh/9781474400046.003.0030 ◽

2018 ◽

Author(s):

Rosemary J. Jolly

Keyword(s):

Health Research ◽

Western Medicine ◽

Scientific Method ◽

Medical Humanities ◽

Right To Health ◽

The Body ◽

Health And Wellness ◽

Human Right ◽

Cultural Specificity ◽

The Social

The last decade has witnessed far greater attention to the social determinants of health in health research, but literary studies have yet to address, in a sustained way, how narratives addressing issues of health across postcolonial cultural divides depict the meeting – or non-meeting – of radically differing conceptualisations of wellness and disease. This chapter explores representations of illness in which Western narrators and notions of the body are juxtaposed with conceptualisations of health and wellness entirely foreign to them, embedded as the former are in assumptions about Cartesian duality and the superiority of scientific method – itself often conceived of as floating (mysteriously) free from its own processes of enculturation and their attendant limits. In this respect my work joins Volker Scheid’s, in this volume, in using the capacity of critical medical humanities to reassert the cultural specificity of what we have come to know as contemporary biomedicine, often assumed to be

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THE IDENTITY OF JAVANESE WOMEN (The study of Phenomenology Toward Indonesian Migrant Women Workers)

Journal of Academic Research and Sciences (JARES) ◽

10.30957/jares.v1i1.506 ◽

2016 ◽

Vol 1 (1) ◽

pp. 61-72

Author(s):

Anam Miftakhul Huda

Keyword(s):

Women Workers ◽

Cultural Values ◽

Migrant Workers ◽

Homo Sapiens ◽

Formal Sector ◽

Java Language ◽

Cultural Codes ◽

Or Groups ◽

The Social ◽

Opposite Sex

The woman stands for Java language (wani ditoto) term used for Homo sapiens gender and has reproduction. The opposite sex from the woman is a man or a male. The woman is a word commonly used to describe mature women. Awareness of Indonesian women to work very large, although the country must work out to become migrant workers, this is shown by the increasing number of women migrant workers every year.Based BNP2TKI report in 2013 the number of migrants reached 512 168 people, consisting of 285 197 person formal workers (56 %) and 226 871 informal migrant workers (44 %). Whereas in 2012 migrant workers reached 494 609 people consisting of 258 411 formal sector (52 %) and 236 198 informal migrant workers (48 %). (detik.com). This research using phenomenology approach by deep interview (unstructured) observation non participants and study documentation. The subject in this research is Javanese Indonesian women. The informants of this research are six women workers. The purpose of this research is expected to describe the shift in the concept of Javanese women carry out tasks in abroad, there are Indonesian cultural values implied by the instincts of a typical traditional Javanese woman, though the housemaids are located in other countries.Social identity theory is a theory that was originally engaged in the area of Social Psychology, with the language and its ability to find and understand the meaning, has become a meta - theory that is able to bring together many disciplines such as psychology, anthropology, sociology, history, communications, as implications is that reality is always social, and the social contextual character always in a state of local culture and history.The meaning of something can be very different in cultures or groups of people who are different because in each cultural or community groups have own ways to interpret things. Groups of people who have a background of understanding is not the same to certain cultural codes will not be able to understand the meaning produced by other community groups.Research described that diversity nations woman patriarchy, Javanese culture properties characteristic of java women clearly reflected in life with workers Indonesia (TKW) is different from another country.

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ANALISIS UNSUR EKSTRINSIK NOVEL SANG PEMIMPI KARYA ANDREA HIRATA

Jurnal KATA ◽

10.22216/jk.v1i2.2301 ◽

2017 ◽

Vol 1 (2) ◽

pp. 137

Author(s):

Erlina Erlina

Keyword(s):

Cultural Values ◽

Religious Education ◽

Speech Acts ◽

Social Values ◽

The Novel ◽

Political Values ◽

Educational Value ◽

Cultural Rights ◽

The Social ◽

Data Source

This research is motivated by the analysis extrinsic elements novel Sang Pemimpi. This study aimed to describe the social values, cultural values, moral values, and religious values in the novel Sang Pemimpi. The research is a qualitative study using descriptive methods. The data in this study is a form of social values, cultural values, religius values and moral on Sang Pemimpi novel by Andrea Hirata. Data source is Sang Pemimpi novel by Andrea Hirata. Data collection techniques in this study are: (1) to read and understand the Novel Sang Pemimpi by Andrea Hirata, and (2) give coding by underlining sentences containing social values, cultural values and political values in the note of the novel Sang Pemimpi by Andrea Hirata all data regarding speech acts in a novel study. While the steps in analyzing data are: (1) read data that has been recorded, (2) classify or record data for the purpose for researchers based on the novel Sang Pemimpi by Andrea Hirata, (3) interpreting or interpretation of data for the purpose of research is to analyze the novel Sang Pemimpi by Andrea Hirata, and (4) make the conclusion of the study. The results of this study stated that extrinsic elements contained in Sang Pemimpi novel by Andrea Hirata is the value of cultural education, where cultural rights set forth in the novel The Dreamer ie when they are a teenager then it started to work for money. Social educational value, namely the attitude of helping each other like Arai and Mak Cik, and as pastor and Jimbron. the value of religious education that is visible on the pastor and Jimbron, although Jimbron raised by a pastor, but the pastor did not impose his religion on Jimbron. moral and political education value seen in a leader who has no morals and honesty. Penelitian ini dilatarbelakangi oleh analisis unsur ekstrinsik novel Sang Pemimpi. Penelitian ini bertujuan untuk mendeskripsikan nilai sosial, nilai budaya, nilai politik, nilai moral, dan nilai religius dalam novel Sang Pemimpi. Jenis penelitian ini adalah penelitian kualitatif dengan menggunakan metode deskriptif. Data dalampenelitian iniadalah bentuk nilai sosial, nilai budaya, nilai realigi dan moral dalam novel Sang Pemimpi karya Andrea Hirata. Sumber datanya adalah novelSang Pemimpi karya Andrea Hirata.Teknik pengumpulan data dalam penelitian ini adalah: (1) membaca dan memahami Novel Sang Pemimpi karya Andrea Hirata, dan (2) memberi pengkodean dengan menggarisbawahi kalimat-kalimat yang mengandung nilai sosial, nilai budaya, dan nilai politik dalam Mencatat Novel Sang Pemimpi karya Andrea Hirata semua data mengenai tindak tutur dalam novel yang diteliti. Sedangkan langkah-langkah dalam menganalisis datanya adalah: (1) membaca data yang sudah dicatat, (2) mengklasifikasikan atau mencatat data sesuai tujuan peneliti berdasarkan novel Sang Pemimpi karya Andrea Hirata, (3) menginterprestasikan atau penafsiran data dengan tujuan penelitian yaitu menganalisis novel Sang Pemimpi karya Andrea Hirata, dan (4) membuat simpulan penelitian.Hasil penelitian ini menyatakan bahwa unsur ekstrinsik yang dapat dalam novel Sang Pemimpi karya Andrea Hirata adalah nilai pendidikan budaya, di mana budaya yang tercantum dalam novel Sang Pemimpi yaitu apabila sudah beranjak remaja maka sudah mulai bekerja untuk mencari uang. nilai pendidikan sosial, yaitu adanya sikap saling tolong menolong seperti Arai dan Mak Cik, dan seperti pendeta dan Jimbron. nilai pendidikan religius yaitu terlihat pada pendeta dan Jimbron, walaupun Jimbron diasuh oleh seorang Pendeta, tetapi pendeta tersebut tidak memaksakan agamanya pada Jimbron. nilai pendidikan moral dan politik terlihat pada seorang pemimpin yang tidak mempunyai moral dan kejujuran.

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