Pub Date : 2018-05-31eCollection Date: 2018-01-01DOI: 10.1080/11287462.2018.1480253
Joeva Rock
The recent increase in research and commercialization of genetically modified (GM) crops in Africa has resulted in considerable and understandable interest from farmers, scholars, and practitioners. However, messy situations are often hard to critically engage in from afar, and the recent article published by Braimah et al. [(2017). Debated agronomy: Public discourse and the future of biotechnology policy in Ghana. Global Bioethics. doi:10.1080/11287462.2016.1261604] presents certain claims that further obfuscate - rather than clarify - an already complex landscape. In this commentary I first seek to clarify particular details of the Ghanaian "GMO" (as GM crops are colloquially called in Ghana) story with particular focus on certain actors and their stances. Next, I highlight some methodological shortcomings of Debated Agronomy and correct certain dubious quotations and claims. Finally, I suggest a more ethnographically and discourse-focused methodology to gain much needed insight into how Ghanaians are actively molding, contesting, and questioning GM discourse, funding, and use.
{"title":"Complex mediascapes, complex realities: critically engaging with biotechnology debates in Ghana.","authors":"Joeva Rock","doi":"10.1080/11287462.2018.1480253","DOIUrl":"10.1080/11287462.2018.1480253","url":null,"abstract":"<p><p>The recent increase in research and commercialization of genetically modified (GM) crops in Africa has resulted in considerable and understandable interest from farmers, scholars, and practitioners. However, messy situations are often hard to critically engage in from afar, and the recent article published by Braimah et al. [(2017). Debated agronomy: Public discourse and the future of biotechnology policy in Ghana. <i>Global Bioethics</i>. doi:10.1080/11287462.2016.1261604] presents certain claims that further obfuscate - rather than clarify - an already complex landscape. In this commentary I first seek to clarify particular details of the Ghanaian \"GMO\" (as GM crops are colloquially called in Ghana) story with particular focus on certain actors and their stances. Next, I highlight some methodological shortcomings of <i>Debated Agronomy</i> and correct certain dubious quotations and claims. Finally, I suggest a more ethnographically and discourse-focused methodology to gain much needed insight into how Ghanaians are actively molding, contesting, and questioning GM discourse, funding, and use.</p>","PeriodicalId":36835,"journal":{"name":"Global Bioethics","volume":" ","pages":"55-64"},"PeriodicalIF":0.0,"publicationDate":"2018-05-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5990936/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"36209833","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2018-02-26eCollection Date: 2018-01-01DOI: 10.1080/11287462.2018.1441780
Louise Bezuidenhout, Ereck Chakauya
There has considerable interest in bringing low/middle-income countries (LMIC) scientists into discussions on Open Data - both as contributors and users. The establishment of in situ data sharing practices within LMIC research institutions is vital for the development of an Open Data landscape in the Global South. Nonetheless, many LMICs have significant challenges - resource provision, research support and extra-laboratory infrastructures. These low-resourced environments shape data sharing activities, but are rarely examined within Open Data discourse. In particular, little attention is given to how these research environments shape scientists' perceptions of data sharing (dis)incentives. This paper expands on these issues of incentivizing data sharing, using data from a quantitative survey disseminated to life scientists in 13 countries in sub-Saharan Africa. This interrogated not only perceptions of data sharing amongst LMIC scientists, but also how these are connected to the research environments and daily challenges experienced by them. The paper offers a series of analysis around commonly cited (dis)incentives such as data sharing as a means of improving research visibility; sharing and funding; and online connectivity. It identifies key areas that the Open Data community need to consider if true openness in research is to be established in the Global South.
{"title":"Hidden concerns of sharing research data by low/middle-income country scientists.","authors":"Louise Bezuidenhout, Ereck Chakauya","doi":"10.1080/11287462.2018.1441780","DOIUrl":"10.1080/11287462.2018.1441780","url":null,"abstract":"<p><p>There has considerable interest in bringing low/middle-income countries (LMIC) scientists into discussions on Open Data - both as contributors and users. The establishment of <i>in situ</i> data sharing practices within LMIC research institutions is vital for the development of an Open Data landscape in the Global South. Nonetheless, many LMICs have significant challenges - resource provision, research support and extra-laboratory infrastructures. These low-resourced environments shape data sharing activities, but are rarely examined within Open Data discourse. In particular, little attention is given to how these research environments shape scientists' perceptions of data sharing (dis)incentives. This paper expands on these issues of incentivizing data sharing, using data from a quantitative survey disseminated to life scientists in 13 countries in sub-Saharan Africa. This interrogated not only perceptions of data sharing amongst LMIC scientists, but also how these are connected to the research environments and daily challenges experienced by them. The paper offers a series of analysis around commonly cited (dis)incentives such as data sharing as a means of improving research visibility; sharing and funding; and online connectivity. It identifies key areas that the Open Data community need to consider if true openness in research is to be established in the Global South.</p>","PeriodicalId":36835,"journal":{"name":"Global Bioethics","volume":"29 1","pages":"39-54"},"PeriodicalIF":0.0,"publicationDate":"2018-02-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5827722/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10335358","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2017-12-20eCollection Date: 2018-01-01DOI: 10.1080/11287462.2017.1415722
Gillian F Black, Alun Davies, Dalia Iskander, Mary Chambers
There is a growing body of literature describing conceptual frameworks for working with participatory visual methods (PVM). Through a global health lens, this paper examines some key themes within these frameworks. We reflect on our experiences of working with with an array of PVM to engage community members in Vietnam, Kenya, the Philippines and South Africa in biomedical research and public health. The participants that we have engaged in these processes live in under-resourced areas with high prevalence of communicable and non-communicable diseases. Our paper describes some of the challenges that we have encountered while using PVM to foster knowledge exchange, build relationships and facilitate change among individuals and families, community members, health workers, biomedical scientists and researchers. We consider multiple ethical situations that have arisen through our work and discuss the ways in which we have navigated and negotiated them. We offer our reflections and learning from facilitating these processes and in doing so we add novel contributions to ethical framework concepts.
{"title":"Reflections on the ethics of participatory visual methods to engage communities in global health research.","authors":"Gillian F Black, Alun Davies, Dalia Iskander, Mary Chambers","doi":"10.1080/11287462.2017.1415722","DOIUrl":"https://doi.org/10.1080/11287462.2017.1415722","url":null,"abstract":"<p><p>There is a growing body of literature describing conceptual frameworks for working with participatory visual methods (PVM). Through a global health lens, this paper examines some key themes within these frameworks. We reflect on our experiences of working with with an array of PVM to engage community members in Vietnam, Kenya, the Philippines and South Africa in biomedical research and public health. The participants that we have engaged in these processes live in under-resourced areas with high prevalence of communicable and non-communicable diseases. Our paper describes some of the challenges that we have encountered while using PVM to foster knowledge exchange, build relationships and facilitate change among individuals and families, community members, health workers, biomedical scientists and researchers. We consider multiple ethical situations that have arisen through our work and discuss the ways in which we have navigated and negotiated them. We offer our reflections and learning from facilitating these processes and in doing so we add novel contributions to ethical framework concepts.</p>","PeriodicalId":36835,"journal":{"name":"Global Bioethics","volume":" ","pages":"22-38"},"PeriodicalIF":0.0,"publicationDate":"2017-12-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/11287462.2017.1415722","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"35822811","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2017-12-08eCollection Date: 2018-01-01DOI: 10.1080/11287462.2017.1411224
Gustavo Ortiz-Millán
Since 2007, when Mexico City decriminalized abortion during the first trimester, a debate has been taking place regarding abortion and the right to conscientious objection (CO). Many people argue that, since the provision of abortions (or "legal terminations of pregnancy" as they are called under Mexico City's law) is now a statutory duty of healthcare personnel there can be no place for "conscientious objection." Others claim that, even if such an objection were to be allowed, it should not be seen as a right, since talk about a right to CO may lead to a slippery slope where we may end up recognizing a right to disobey the law. In this paper, I argue that there is a right to CO and that this may be justified through the notions of autonomy and integrity, which a liberal democracy should respect. However, it cannot be an absolute right, and in the case of abortion, it conflicts with women's reproductive rights. Therefore, CO should be carefully regulated so that it does not obstruct the exercise of women's reproductive rights. Regulation should address questions about who is entitled to object, how such objection should take place, and what can legitimately be objected to.
{"title":"Abortion and conscientious objection: rethinking conflicting rights in the Mexican context.","authors":"Gustavo Ortiz-Millán","doi":"10.1080/11287462.2017.1411224","DOIUrl":"10.1080/11287462.2017.1411224","url":null,"abstract":"<p><p>Since 2007, when Mexico City decriminalized abortion during the first trimester, a debate has been taking place regarding abortion and the right to conscientious objection (CO). Many people argue that, since the provision of abortions (or \"legal terminations of pregnancy\" as they are called under Mexico City's law) is now a statutory duty of healthcare personnel there can be no place for \"conscientious objection.\" Others claim that, even if such an objection were to be allowed, it should not be seen as a right, since talk about a right to CO may lead to a slippery slope where we may end up recognizing a right to disobey the law. In this paper, I argue that there <i>is</i> a right to CO and that this may be justified through the notions of autonomy and integrity, which a liberal democracy should respect. However, it cannot be an absolute right, and in the case of abortion, it conflicts with women's reproductive rights. Therefore, CO should be carefully regulated so that it does not obstruct the exercise of women's reproductive rights. Regulation should address questions about who is entitled to object, how such objection should take place, and what can legitimately be objected to.</p>","PeriodicalId":36835,"journal":{"name":"Global Bioethics","volume":" ","pages":"1-15"},"PeriodicalIF":0.0,"publicationDate":"2017-12-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5727449/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"35664217","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2017-12-07eCollection Date: 2018-01-01DOI: 10.1080/11287462.2017.1411762
Chea Nguon, Lek Dysoley, Chan Davoeung, Yok Sovann, Nou Sanann, Ma Sareth, Pich Kunthea, San Vuth, Kem Sovann, Kayna Kol, Chhouen Heng, Rouen Sary, Thomas J Peto, Rupam Tripura, Renly Lim, Phaik Yeong Cheah
This article describes our experience using art and theatre to engage rural communities in western Cambodia to understand malaria and support malaria control and elimination. The project was a pilot science-arts initiative to supplement existing engagement activities conducted by local authorities. In 2016, the project was conducted in 20 villages, involved 300 community members and was attended by more than 8000 people. Key health messages were to use insecticide-treated bed-nets and repellents, febrile people should attend village malaria workers, and to raise awareness about the risk of forest-acquired malaria. Building on the experience and lessons learnt in the year prior, the 2017 project which was conducted in 15 villages involved 600 community members and attracted more than 12,000 people. In addition to the malaria theme, upon discussion with local health authorities, secondary theme (infant vaccination) was added to the 2017 project. We learnt the following lessons from our experience in Cambodia: involving local people including children from the beginning of the project and throughout the process is important; messages should be kept simple; it is necessary to take into consideration practical issues such as location and timing of the activities; and that the project should offer something unique to communities.
{"title":"Art and theatre for health in rural Cambodia.","authors":"Chea Nguon, Lek Dysoley, Chan Davoeung, Yok Sovann, Nou Sanann, Ma Sareth, Pich Kunthea, San Vuth, Kem Sovann, Kayna Kol, Chhouen Heng, Rouen Sary, Thomas J Peto, Rupam Tripura, Renly Lim, Phaik Yeong Cheah","doi":"10.1080/11287462.2017.1411762","DOIUrl":"https://doi.org/10.1080/11287462.2017.1411762","url":null,"abstract":"<p><p>This article describes our experience using art and theatre to engage rural communities in western Cambodia to understand malaria and support malaria control and elimination. The project was a pilot science-arts initiative to supplement existing engagement activities conducted by local authorities. In 2016, the project was conducted in 20 villages, involved 300 community members and was attended by more than 8000 people. Key health messages were to use insecticide-treated bed-nets and repellents, febrile people should attend village malaria workers, and to raise awareness about the risk of forest-acquired malaria. Building on the experience and lessons learnt in the year prior, the 2017 project which was conducted in 15 villages involved 600 community members and attracted more than 12,000 people. In addition to the malaria theme, upon discussion with local health authorities, secondary theme (infant vaccination) was added to the 2017 project. We learnt the following lessons from our experience in Cambodia: involving local people including children from the beginning of the project and throughout the process is important; messages should be kept simple; it is necessary to take into consideration practical issues such as location and timing of the activities; and that the project should offer something unique to communities.</p>","PeriodicalId":36835,"journal":{"name":"Global Bioethics","volume":" ","pages":"16-21"},"PeriodicalIF":0.0,"publicationDate":"2017-12-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/11287462.2017.1411762","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"35664218","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2017-02-22eCollection Date: 2017-01-01DOI: 10.1080/11287462.2016.1261604
Joseph A Braimah, Kilian N Atuoye, Siera Vercillo, Carrie Warring, Isaac Luginaah
This paper examines the highly contested and ongoing biotechnology (Bt) policy-making process in Ghana. We analyse media content on how Bt is viewed in the context of Ghana's parliamentary debate on the Plant Breeders Bill and within the broader public policy-making literature. This paper does not seek to take a position on Bt or the Bill, but to understand how policy actors influence the debate with political and scientific rhetoric in Ghana. The study reveals that in the midst of scientific uncertainties of Bt's potential for sustainable agriculture production and food security, policy decisions that encourage its future adoption are heavily influenced by health, scientific, economic, environmental and political factors dictated by different ideologies, values and norms. While locally pioneered plant breeding is visible and common in the Ghanaian food chain, plant breeding/GMOs/Bt from international corporations is strongly resisted by anti-GMO coalitions. Understanding the complex and messy nature of Bt policy-making is critical for future development of agricultural technology in Ghana and elsewhere.
{"title":"Debated agronomy: public discourse and the future of biotechnology policy in Ghana.","authors":"Joseph A Braimah, Kilian N Atuoye, Siera Vercillo, Carrie Warring, Isaac Luginaah","doi":"10.1080/11287462.2016.1261604","DOIUrl":"https://doi.org/10.1080/11287462.2016.1261604","url":null,"abstract":"<p><p>This paper examines the highly contested and ongoing biotechnology (Bt) policy-making process in Ghana. We analyse media content on how Bt is viewed in the context of Ghana's parliamentary debate on the Plant Breeders Bill and within the broader public policy-making literature. This paper does not seek to take a position on Bt or the Bill, but to understand how policy actors influence the debate with political and scientific rhetoric in Ghana. The study reveals that in the midst of scientific uncertainties of Bt's potential for sustainable agriculture production and food security, policy decisions that encourage its future adoption are heavily influenced by health, scientific, economic, environmental and political factors dictated by different ideologies, values and norms. While locally pioneered plant breeding is visible and common in the Ghanaian food chain, plant breeding/GMOs/Bt from international corporations is strongly resisted by anti-GMO coalitions. Understanding the complex and messy nature of Bt policy-making is critical for future development of agricultural technology in Ghana and elsewhere.</p>","PeriodicalId":36835,"journal":{"name":"Global Bioethics","volume":"28 1","pages":"3-18"},"PeriodicalIF":0.0,"publicationDate":"2017-02-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/11287462.2016.1261604","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"35618099","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2016-09-27DOI: 10.1080/11287462.2016.1230989
M. Pratarelli
ABSTRACT Belief in human exceptionalism—the idea that humans are not bound by the same evolutionary constraints and biophysical limitations as other organisms—is rampant in society. To ignore human nature in favor of such a constructivist perspective is foolhardy because it compromises prospects for achieving sustainability. Human activity already exceeds Earth's long-term carrying-capacity, yet many governments and ordinary citizens alike are focused on fostering a new round of material growth. Few academics pay more than lip service to the causal drivers behind such unsustainable behavior. In particular, the sociological model for dealing with overshoot focuses on the shortcomings of social institutions, effectively decoupling the problem from H.sapiens' innate expansionist tendencies and such instinctive drives as competition for social status, mates, territory, and other resources. Understanding human unsustainability depends as much on insights from the behavioral and biological sciences as from the social sciences. Merging bioevolutionary, psychological, and sociological explanations into a unified framework is an essential step in moderating human (over)consumption. Humanity is now dangerously close to global collapse; as academics we have the obligation to investigate humanity's unsustainability conundrum through an interdisciplinary lens and apply our new understanding to solving global and local problems before solutions become moot.
{"title":"The failure to achieve sustainability may be in our genes","authors":"M. Pratarelli","doi":"10.1080/11287462.2016.1230989","DOIUrl":"https://doi.org/10.1080/11287462.2016.1230989","url":null,"abstract":"ABSTRACT Belief in human exceptionalism—the idea that humans are not bound by the same evolutionary constraints and biophysical limitations as other organisms—is rampant in society. To ignore human nature in favor of such a constructivist perspective is foolhardy because it compromises prospects for achieving sustainability. Human activity already exceeds Earth's long-term carrying-capacity, yet many governments and ordinary citizens alike are focused on fostering a new round of material growth. Few academics pay more than lip service to the causal drivers behind such unsustainable behavior. In particular, the sociological model for dealing with overshoot focuses on the shortcomings of social institutions, effectively decoupling the problem from H.sapiens' innate expansionist tendencies and such instinctive drives as competition for social status, mates, territory, and other resources. Understanding human unsustainability depends as much on insights from the behavioral and biological sciences as from the social sciences. Merging bioevolutionary, psychological, and sociological explanations into a unified framework is an essential step in moderating human (over)consumption. Humanity is now dangerously close to global collapse; as academics we have the obligation to investigate humanity's unsustainability conundrum through an interdisciplinary lens and apply our new understanding to solving global and local problems before solutions become moot.","PeriodicalId":36835,"journal":{"name":"Global Bioethics","volume":"47 1","pages":"61 - 75"},"PeriodicalIF":0.0,"publicationDate":"2016-09-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/11287462.2016.1230989","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"59807726","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2016-08-10DOI: 10.1080/11287462.2016.1212608
Alexander Angsongna, Frederick Ato Armah, Sheila A. Boamah, H. Hambati, I. Luginaah, R. Chuenpagdee, Gwyn Campbell
ABSTRACT The dependence of humans on the ecosystem services that natural resources provide is absolute. The need for social taboos as frameworks for governing natural resource abstraction is gaining widespread recognition especially within the context of climate change. However, the complex relationship between resource and habitat taboos (RHTs) and human health is not entirely understood. We conducted a systematic review of existing studies of the association between RHTs and human health outcomes, focusing on the best evidence available. We searched JSTOR, SocINDEX, Greenfile and Academic Search Complete databases from 1970 to July 2015; and also searched the reference lists of reviews and relevant articles. About 779 studies and data from 26 studies were eligible for the analysis. Only 9 out of 26 studies clearly linked RHTs to human health. Overall, nine taboos, spatial, temporal, gear, method, effort, catch, species-specific, life history and segment, were covered by the empirical studies. This systematic review provides new evidence of relationships between RHTs and human health outcomes. Several methodological limitations were identified in the empirical material. The findings suggest the need for context-specific conservation policies to reduce erosion of RHTs in order to sustain human health in the face of climate change.
{"title":"A systematic review of resource habitat taboos and human health outcomes in the context of global environmental change","authors":"Alexander Angsongna, Frederick Ato Armah, Sheila A. Boamah, H. Hambati, I. Luginaah, R. Chuenpagdee, Gwyn Campbell","doi":"10.1080/11287462.2016.1212608","DOIUrl":"https://doi.org/10.1080/11287462.2016.1212608","url":null,"abstract":"ABSTRACT The dependence of humans on the ecosystem services that natural resources provide is absolute. The need for social taboos as frameworks for governing natural resource abstraction is gaining widespread recognition especially within the context of climate change. However, the complex relationship between resource and habitat taboos (RHTs) and human health is not entirely understood. We conducted a systematic review of existing studies of the association between RHTs and human health outcomes, focusing on the best evidence available. We searched JSTOR, SocINDEX, Greenfile and Academic Search Complete databases from 1970 to July 2015; and also searched the reference lists of reviews and relevant articles. About 779 studies and data from 26 studies were eligible for the analysis. Only 9 out of 26 studies clearly linked RHTs to human health. Overall, nine taboos, spatial, temporal, gear, method, effort, catch, species-specific, life history and segment, were covered by the empirical studies. This systematic review provides new evidence of relationships between RHTs and human health outcomes. Several methodological limitations were identified in the empirical material. The findings suggest the need for context-specific conservation policies to reduce erosion of RHTs in order to sustain human health in the face of climate change.","PeriodicalId":36835,"journal":{"name":"Global Bioethics","volume":"27 1","pages":"111 - 91"},"PeriodicalIF":0.0,"publicationDate":"2016-08-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/11287462.2016.1212608","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"59807681","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2016-06-30DOI: 10.1080/11287462.2016.1192979
I. R. Pavone
ABSTRACT The conduct of clinical trials involving placebo in developing countries in the presence of an existing effective treatment triggered an intense debate on the standard of care to be provided to those populations. Charges of exploitation of vulnerable groups and double standards have been raised by several scholars. In response to these concerns, the Declaration of Helsinki (DoH) was revised in 2000, 2008 and 2013, eventually endorsing the golden standard instead of the local standard of care. The European Union (EU) adopted a strategy on the Marketing Authorization of medicinal products tested in third countries, improved with Regulation 536/2014 on clinical trials on medicinal products for human use. Additional rules have been enacted by other international organizations (UNESCO, Council of Europe). The present paper has the aim of analyzing scope and content of existing international and regional standards on placebo.
{"title":"Legal responses to placebo-controlled trials in developing countries","authors":"I. R. Pavone","doi":"10.1080/11287462.2016.1192979","DOIUrl":"https://doi.org/10.1080/11287462.2016.1192979","url":null,"abstract":"ABSTRACT The conduct of clinical trials involving placebo in developing countries in the presence of an existing effective treatment triggered an intense debate on the standard of care to be provided to those populations. Charges of exploitation of vulnerable groups and double standards have been raised by several scholars. In response to these concerns, the Declaration of Helsinki (DoH) was revised in 2000, 2008 and 2013, eventually endorsing the golden standard instead of the local standard of care. The European Union (EU) adopted a strategy on the Marketing Authorization of medicinal products tested in third countries, improved with Regulation 536/2014 on clinical trials on medicinal products for human use. Additional rules have been enacted by other international organizations (UNESCO, Council of Europe). The present paper has the aim of analyzing scope and content of existing international and regional standards on placebo.","PeriodicalId":36835,"journal":{"name":"Global Bioethics","volume":"27 1","pages":"76 - 90"},"PeriodicalIF":0.0,"publicationDate":"2016-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/11287462.2016.1192979","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"59807667","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}