Apart from concerns that those most directly affected are insufficiently consulted in the draftin... more Apart from concerns that those most directly affected are insufficiently consulted in the drafting of international guidelines, there are other issues that cause some disquiet in relation to international clinical research. One of these is the issue of corruption that occurs on a national and local level in many developing countries. One commentator suggested recently that corruption “thrived in environments of poor governance, and were exacerbated by poverty.” The same researcher also stated that people were appointed to review ...
Many assumptions are made about public willingness to participate in epidemiological research, ye... more Many assumptions are made about public willingness to participate in epidemiological research, yet few empirical studies have been conducted to ascertain whether such assumptions are correct. Our qualitative study of the public and of expert stakeholders leads us to suggest that people are generally prepared to participate in epidemiological research, particularly if it is conducted by a trusted public institution such as a government health department, charity, or university. However, there is widespread community distrust of research conducted or sponsored by pharmaceutical companies. Individuals are prompted to take part if the study concerns an illness they or a family member or friend have personally experienced or if they believe the research will confer a widespread public benefit. Preferences vary about the mode of contact for the research to be conducted. Willingness to participate in telephone surveys has decreased in recent years, and this may be a consequence of an incre...
Study explanatory forms often state that an ethics committee has approved a research project. To ... more Study explanatory forms often state that an ethics committee has approved a research project. To determine whether the lay community understand the roles of ethics committees in research, we took a cross-sectional national sample from three sampling frames: the general population (n=1532); cohort study participants (n=397); and case-control study participants (n=151). About half (51.3%) of the participants had heard of ethics committees. Those who had were more likely to be those who had participated in previous surveys, older participants, those born in Australia and those with higher education. Almost all participants agreed that the roles of an ethics committee were to protect participants' privacy and ensure no harm came to study participants and most agreed that the committee's role was to ensure that the research was capable of providing answers. Case-control and cohort participants were more likely than the general population to consider that the role of an ethics committee was to design the research and obtain research funding. Overall, we found that about half of the population are aware of ethics committees and that most could correctly identify that ethics committees are there to protect the welfare and rights of research participants, although a substantial minority had some incorrect beliefs about the committees' roles. Increased education, particularly for migrants and older people, might improve understanding of the role of ethics committees in research.
Apart from concerns that those most directly affected are insufficiently consulted in the draftin... more Apart from concerns that those most directly affected are insufficiently consulted in the drafting of international guidelines, there are other issues that cause some disquiet in relation to international clinical research. One of these is the issue of corruption that occurs on a national and local level in many developing countries. One commentator suggested recently that corruption “thrived in environments of poor governance, and were exacerbated by poverty.” The same researcher also stated that people were appointed to review ...
How international research might contribute to justice in global health has not been substantivel... more How international research might contribute to justice in global health has not been substantively addressed by bioethics. This article describes how the provision of ancillary care can link international clinical research to the reduction of global health disparities. It identifies the ancillary care obligations supported by a theory of global justice, showing that Jennifer Ruger's health capability paradigm requires the delivery of ancillary care to trial participants for a limited subset of conditions that cause severe morbidity and mortality. Empirical research on the Shoklo Malaria Research Unit's (SMRU) vivax malaria treatment trial was then undertaken to demonstrate whether and how these obligations might be upheld in a resource-poor setting. Our findings show that fulfilment of the ancillary care obligations is feasible where there is commitment from chief investigators and funders and is strongly facilitated by SMRU's dual role as a research unit and medical non-governmental organization.
In the 2010-11 financial 2013, there was a dramatic reduction in the approvals granted by the Aus... more In the 2010-11 financial 2013, there was a dramatic reduction in the approvals granted by the Australian Electoral Commission for access to samples of the adult population derived from the electoral roll for the purposes of public health research. Much time and effort has been expended in making applications without success. Researchers refused access to electoral roll samples must rely on sampling methods that are not as robust and that may produce less reliable data. We outline a set of recommendations that, if adopted, will result in a fairer system for obtaining access to the electoral roll for public health research.
It has been suggested that community advisory boards (CABs) can play a role in minimising exploit... more It has been suggested that community advisory boards (CABs) can play a role in minimising exploitation in international research. To get a better idea of what this requires and whether it might be achievable, the paper first describes core elements that we suggest must be in place for a CAB to reduce the potential for exploitation. The paper then examines a CAB established by the Shoklo Malaria Research Unit under conditions common in resource-poor settings -namely, where individuals join with a very limited understanding of disease and medical research and where an existing organisational structure is not relied upon to serve as the CAB. Using the Tak Province Border Community Ethics Advisory Board (T-CAB) as a case study, we assess the extent to which it might be able to take on a role minimising exploitation were it to decide to do so. We investigate whether, after two years in operation, T-CAB is capable of assessing clinical trials for exploitative features and addressing those found to have them. The findings show that, although T-CAB members have gained knowledge and developed capacities that are foundational for one-day taking on a role to reduce exploitation, their ability to critically evaluate studies for the presence of exploitative elements has not yet been strongly demonstrated. In light of this example, we argue that CABs may not be able to perform such a role for a number of years after initial formation, making it an unsuitable responsibility for many short-term CABs. We recognise that a lack of responsiveness, appropriate standard of care, and post-trial benefits are not the only features associated with exploitative research and that consensus on the association of these features with exploitation may not be universal. 7 A.
Background: In response to calls to expand the scope of research ethics to address justice in glo... more Background: In response to calls to expand the scope of research ethics to address justice in global health, recent scholarship has sought to clarify how external research actors from high-income countries might discharge their obligation to reduce health disparities between and within countries. An ethical framework-'research for health justice'-was derived from a theory of justice (the health capability paradigm) and specifies how international clinical research might contribute to improved health and research capacity in host communities. This paper examines whether and how external funders, sponsors, and researchers can fulfill their obligations under the framework.
The system of asylum seeker detention in Australia is one in which those seeking refuge are strip... more The system of asylum seeker detention in Australia is one in which those seeking refuge are stripped of many of their rights, including the right to health. This presents serious ethical problems for healthcare providers working within this system. In this article we describe asylum seeker detention and analyse the role of nurses. We discuss how far an ''ethics of care'' and witnessing the suffering of asylum seekers can serve to improve their situation and improve ethical nursing practice.
The system of asylum seeker detention in Australia is one in which those seeking refuge are strip... more The system of asylum seeker detention in Australia is one in which those seeking refuge are stripped of many of their rights, including the right to health. This presents serious ethical problems for healthcare providers working within this system. In this article we describe asylum seeker detention and analyse the role of nurses. We discuss how far an ''ethics of care'' and witnessing the suffering of asylum seekers can serve to improve their situation and improve ethical nursing practice.
Abstract Bioethicists have long debated the content of sponsors and researchers' obligations of j... more Abstract Bioethicists have long debated the content of sponsors and researchers' obligations of justice in international clinical research. However, there has been little empirical investigation as to whether and how obligations of responsiveness, ancillary care, post-trial benefits and research capacity strengthening are upheld in low-and middle-income country settings. In this paper, the authors argue that research ethics guidelines need to be more informed by international research practice.
1. Monash Bioeth Rev. 2007 Oct;26(4):1. The research and life of Rob Barrett. Zion D. PMID: 20433... more 1. Monash Bioeth Rev. 2007 Oct;26(4):1. The research and life of Rob Barrett. Zion D. PMID: 20433092 [PubMed - indexed for MEDLINE]. Publication Types: Editorial; Introductory Journal Article. MeSH Terms. Australia; Bioethics*; Humans; Psychiatry*.
1. Monash Bioeth Rev. 2003 Jul;22(3):23-7. Culture, community and consent: a response to Barrett ... more 1. Monash Bioeth Rev. 2003 Jul;22(3):23-7. Culture, community and consent: a response to Barrett and Parker. Zion D. Centre for Human Bioethics & Centre for the Study of Medicine in Ethics and Society, Department of Medicine, Monash University, Australia. Comment on Monash Bioeth Rev. 2003 Apr;22(2):9-26. PMID: 14682319 [PubMed - indexed for MEDLINE]. Publication Types: Comment. MeSH Terms.
Informit is an online service offering a wide range of database and full content publication prod... more Informit is an online service offering a wide range of database and full content publication products that deliver the vast majority of Australasian scholarly research to the education, research and business sectors. Informit is the brand that encompasses RMIT Publishing's online products: Informit Indexes, Informit Plus Text and Informit Collections.
1. Science. 1998 May 29;280(5368):1329-30; author reply 1330-1. The ethics of AIDS vaccine trials... more 1. Science. 1998 May 29;280(5368):1329-30; author reply 1330-1. The ethics of AIDS vaccine trials. Zion D. Comment on Science. 1998 Jan 9;279(5348):186-8. PMID: 9634405 [PubMed - indexed for MEDLINE]. Publication Types: Comment; Letter. MeSH Terms. AIDS Vaccines*; Acquired Immunodeficiency Syndrome/prevention & control; Clinical Trials as Topic/standards*; Controlled Clinical Trials as Topic/standards*; Developed Countries; Developing Countries; Ethics, Medical*; Humans; Informed Consent. Substances. AIDS Vaccines.
Apart from concerns that those most directly affected are insufficiently consulted in the draftin... more Apart from concerns that those most directly affected are insufficiently consulted in the drafting of international guidelines, there are other issues that cause some disquiet in relation to international clinical research. One of these is the issue of corruption that occurs on a national and local level in many developing countries. One commentator suggested recently that corruption “thrived in environments of poor governance, and were exacerbated by poverty.” The same researcher also stated that people were appointed to review ...
Many assumptions are made about public willingness to participate in epidemiological research, ye... more Many assumptions are made about public willingness to participate in epidemiological research, yet few empirical studies have been conducted to ascertain whether such assumptions are correct. Our qualitative study of the public and of expert stakeholders leads us to suggest that people are generally prepared to participate in epidemiological research, particularly if it is conducted by a trusted public institution such as a government health department, charity, or university. However, there is widespread community distrust of research conducted or sponsored by pharmaceutical companies. Individuals are prompted to take part if the study concerns an illness they or a family member or friend have personally experienced or if they believe the research will confer a widespread public benefit. Preferences vary about the mode of contact for the research to be conducted. Willingness to participate in telephone surveys has decreased in recent years, and this may be a consequence of an incre...
Study explanatory forms often state that an ethics committee has approved a research project. To ... more Study explanatory forms often state that an ethics committee has approved a research project. To determine whether the lay community understand the roles of ethics committees in research, we took a cross-sectional national sample from three sampling frames: the general population (n=1532); cohort study participants (n=397); and case-control study participants (n=151). About half (51.3%) of the participants had heard of ethics committees. Those who had were more likely to be those who had participated in previous surveys, older participants, those born in Australia and those with higher education. Almost all participants agreed that the roles of an ethics committee were to protect participants' privacy and ensure no harm came to study participants and most agreed that the committee's role was to ensure that the research was capable of providing answers. Case-control and cohort participants were more likely than the general population to consider that the role of an ethics committee was to design the research and obtain research funding. Overall, we found that about half of the population are aware of ethics committees and that most could correctly identify that ethics committees are there to protect the welfare and rights of research participants, although a substantial minority had some incorrect beliefs about the committees' roles. Increased education, particularly for migrants and older people, might improve understanding of the role of ethics committees in research.
Apart from concerns that those most directly affected are insufficiently consulted in the draftin... more Apart from concerns that those most directly affected are insufficiently consulted in the drafting of international guidelines, there are other issues that cause some disquiet in relation to international clinical research. One of these is the issue of corruption that occurs on a national and local level in many developing countries. One commentator suggested recently that corruption “thrived in environments of poor governance, and were exacerbated by poverty.” The same researcher also stated that people were appointed to review ...
How international research might contribute to justice in global health has not been substantivel... more How international research might contribute to justice in global health has not been substantively addressed by bioethics. This article describes how the provision of ancillary care can link international clinical research to the reduction of global health disparities. It identifies the ancillary care obligations supported by a theory of global justice, showing that Jennifer Ruger's health capability paradigm requires the delivery of ancillary care to trial participants for a limited subset of conditions that cause severe morbidity and mortality. Empirical research on the Shoklo Malaria Research Unit's (SMRU) vivax malaria treatment trial was then undertaken to demonstrate whether and how these obligations might be upheld in a resource-poor setting. Our findings show that fulfilment of the ancillary care obligations is feasible where there is commitment from chief investigators and funders and is strongly facilitated by SMRU's dual role as a research unit and medical non-governmental organization.
In the 2010-11 financial 2013, there was a dramatic reduction in the approvals granted by the Aus... more In the 2010-11 financial 2013, there was a dramatic reduction in the approvals granted by the Australian Electoral Commission for access to samples of the adult population derived from the electoral roll for the purposes of public health research. Much time and effort has been expended in making applications without success. Researchers refused access to electoral roll samples must rely on sampling methods that are not as robust and that may produce less reliable data. We outline a set of recommendations that, if adopted, will result in a fairer system for obtaining access to the electoral roll for public health research.
It has been suggested that community advisory boards (CABs) can play a role in minimising exploit... more It has been suggested that community advisory boards (CABs) can play a role in minimising exploitation in international research. To get a better idea of what this requires and whether it might be achievable, the paper first describes core elements that we suggest must be in place for a CAB to reduce the potential for exploitation. The paper then examines a CAB established by the Shoklo Malaria Research Unit under conditions common in resource-poor settings -namely, where individuals join with a very limited understanding of disease and medical research and where an existing organisational structure is not relied upon to serve as the CAB. Using the Tak Province Border Community Ethics Advisory Board (T-CAB) as a case study, we assess the extent to which it might be able to take on a role minimising exploitation were it to decide to do so. We investigate whether, after two years in operation, T-CAB is capable of assessing clinical trials for exploitative features and addressing those found to have them. The findings show that, although T-CAB members have gained knowledge and developed capacities that are foundational for one-day taking on a role to reduce exploitation, their ability to critically evaluate studies for the presence of exploitative elements has not yet been strongly demonstrated. In light of this example, we argue that CABs may not be able to perform such a role for a number of years after initial formation, making it an unsuitable responsibility for many short-term CABs. We recognise that a lack of responsiveness, appropriate standard of care, and post-trial benefits are not the only features associated with exploitative research and that consensus on the association of these features with exploitation may not be universal. 7 A.
Background: In response to calls to expand the scope of research ethics to address justice in glo... more Background: In response to calls to expand the scope of research ethics to address justice in global health, recent scholarship has sought to clarify how external research actors from high-income countries might discharge their obligation to reduce health disparities between and within countries. An ethical framework-'research for health justice'-was derived from a theory of justice (the health capability paradigm) and specifies how international clinical research might contribute to improved health and research capacity in host communities. This paper examines whether and how external funders, sponsors, and researchers can fulfill their obligations under the framework.
The system of asylum seeker detention in Australia is one in which those seeking refuge are strip... more The system of asylum seeker detention in Australia is one in which those seeking refuge are stripped of many of their rights, including the right to health. This presents serious ethical problems for healthcare providers working within this system. In this article we describe asylum seeker detention and analyse the role of nurses. We discuss how far an ''ethics of care'' and witnessing the suffering of asylum seekers can serve to improve their situation and improve ethical nursing practice.
The system of asylum seeker detention in Australia is one in which those seeking refuge are strip... more The system of asylum seeker detention in Australia is one in which those seeking refuge are stripped of many of their rights, including the right to health. This presents serious ethical problems for healthcare providers working within this system. In this article we describe asylum seeker detention and analyse the role of nurses. We discuss how far an ''ethics of care'' and witnessing the suffering of asylum seekers can serve to improve their situation and improve ethical nursing practice.
Abstract Bioethicists have long debated the content of sponsors and researchers' obligations of j... more Abstract Bioethicists have long debated the content of sponsors and researchers' obligations of justice in international clinical research. However, there has been little empirical investigation as to whether and how obligations of responsiveness, ancillary care, post-trial benefits and research capacity strengthening are upheld in low-and middle-income country settings. In this paper, the authors argue that research ethics guidelines need to be more informed by international research practice.
1. Monash Bioeth Rev. 2007 Oct;26(4):1. The research and life of Rob Barrett. Zion D. PMID: 20433... more 1. Monash Bioeth Rev. 2007 Oct;26(4):1. The research and life of Rob Barrett. Zion D. PMID: 20433092 [PubMed - indexed for MEDLINE]. Publication Types: Editorial; Introductory Journal Article. MeSH Terms. Australia; Bioethics*; Humans; Psychiatry*.
1. Monash Bioeth Rev. 2003 Jul;22(3):23-7. Culture, community and consent: a response to Barrett ... more 1. Monash Bioeth Rev. 2003 Jul;22(3):23-7. Culture, community and consent: a response to Barrett and Parker. Zion D. Centre for Human Bioethics & Centre for the Study of Medicine in Ethics and Society, Department of Medicine, Monash University, Australia. Comment on Monash Bioeth Rev. 2003 Apr;22(2):9-26. PMID: 14682319 [PubMed - indexed for MEDLINE]. Publication Types: Comment. MeSH Terms.
Informit is an online service offering a wide range of database and full content publication prod... more Informit is an online service offering a wide range of database and full content publication products that deliver the vast majority of Australasian scholarly research to the education, research and business sectors. Informit is the brand that encompasses RMIT Publishing's online products: Informit Indexes, Informit Plus Text and Informit Collections.
1. Science. 1998 May 29;280(5368):1329-30; author reply 1330-1. The ethics of AIDS vaccine trials... more 1. Science. 1998 May 29;280(5368):1329-30; author reply 1330-1. The ethics of AIDS vaccine trials. Zion D. Comment on Science. 1998 Jan 9;279(5348):186-8. PMID: 9634405 [PubMed - indexed for MEDLINE]. Publication Types: Comment; Letter. MeSH Terms. AIDS Vaccines*; Acquired Immunodeficiency Syndrome/prevention & control; Clinical Trials as Topic/standards*; Controlled Clinical Trials as Topic/standards*; Developed Countries; Developing Countries; Ethics, Medical*; Humans; Informed Consent. Substances. AIDS Vaccines.
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Papers by Deborah Zion