Switch to: Citations

Add references

You must login to add references.
  1. Pharmaceutical Companies Vs. The State: Who Is Responsible for Post-Trial Provision of Drugs in Brazil?Daniel Wei L. Wang & Octavio Luiz Motta Ferraz - 2012 - Journal of Law, Medicine and Ethics 40 (2):188-196.
    This paper discusses the post-trial access to drugs for patients who participated in clinical trials in Brazil. The ethical guidance for clinical trials in Brazil is arguably one of the clearest in the world in attributing to research sponsors the responsibility for providing post-trial drugs to patients who participated in their experiments. The Federal Constitution recognizes health as a fundamental right to be fulfilled by the State. Based on the Brazilian constitution and on the National Health Council resolutions, courts have (...)
    Download  
     
    Export citation  
     
    Bookmark   5 citations  
  • Pharmaceutical Companies Vs. The State: Who is Responsible for Post-Trial Provision of Drugs in Brazil?Daniel Wei L. Wang & Octavio Luiz Motta Ferraz - 2012 - Journal of Law, Medicine and Ethics 40 (2):188-196.
    This paper discusses so-called post-trial access to drugs for patients who participated in clinical trials in Brazil. Brazil is currently a relevant country for the pharmaceutical industry due to the dimensions of its actual and potential market. As a consequence, the number of pharmaceutical trials has been rising. It is the largest market for pharmaceutical companies in Latin America, the 8th biggest in the world and second only to China among the so-called BRICS’s emerging countries. The demand for pharmaceutical products (...)
    Download  
     
    Export citation  
     
    Bookmark   4 citations  
  • Exploitation and Developing Countries: The Ethics of Clinical Research.Jennifer S. Hawkins & Ezekiel J. Emanuel - 2008 - Princeton, NJ, USA: Princeton Univ Pr.
    This book was inspired originally by the debates at the turn of the century about placebo controlled trials of antiretrovirals in HIV positive pregnant women in developing countries. Moving forward from this one limited example, the book includes several additional controversial cases of clinical research conducted in developing countries, and asks probing philosophical questions about the ethics of such trials. All clinical research by its very nature uses people to acquire generalizable knowledge to help future people. But what sorts of (...)
    Download  
     
    Export citation  
     
    Bookmark   16 citations  
  • Forthcoming Practical Framework for Ethics Committees and Researchers on Post-Trial Access to the Trial Intervention and Healthcare.Neema Sofaer, Penney Lewis & Hugh Davies - 2014 - Journal of Medical Ethics 40 (4):217-218.
    When research concludes, post-trial access to the trial intervention or standard healthcare can be crucial for participants who are ill such as those in resource-poor countries with inadequate healthcare, British participants testing ‘last-chance drugs’ unavailable on the National Health Service and underinsured US participants. Yet, many researchers are unclear about their obligations regarding the post-trial period, and many research ethics committees do not know what to require of researchers. Consequences include participants who reasonably expect but lack PTA to the trial (...)
    Download  
     
    Export citation  
     
    Bookmark   2 citations  
  • International Ethical Guidelines for Biomedical Research Involving Human Subjects.C. G. Foster - 1994 - Journal of Medical Ethics 20 (2):123-124.
    Download  
     
    Export citation  
     
    Bookmark   93 citations  
  • Should Post-Trial Provision of Beneficial Experimental Interventions Be Mandatory in Developing Countries?Z. Zong - 2008 - Journal of Medical Ethics 34 (3):188-192.
    The need for continuing provision of beneficial experimental interventions after research is concluded remains a controversial topic in bioethics for research. Based on the principle of beneficence, justice as reciprocity, concerns about exploitation and fair benefits, participants should be able to have continuing access to benefits beyond the research period. However, there is no consensus about whether or not post-trial provision of beneficial interventions should be mandatory for participants from developing countries. This paper summarises recommendations from international and national guidelines. (...)
    Download  
     
    Export citation  
     
    Bookmark   15 citations  
  • Just Health: Meeting Health Needs Fairly.Norman Daniels - 2007 - Cambridge University Press.
    In this book by the award-winning author of Just Healthcare, Norman Daniels develops a comprehensive theory of justice for health that answers three key questions: what is the special moral importance of health? When are health inequalities unjust? How can we meet health needs fairly when we cannot meet them all? Daniels' theory has implications for national and global health policy: can we meet health needs fairly in ageing societies? Or protect health in the workplace while respecting individual liberty? Or (...)
    Download  
     
    Export citation  
     
    Bookmark   233 citations  
  • A Framework to Link International Clinical Research to the Promotion of Justice in Global Health.Bridget Pratt & Bebe Loff - 2013 - Bioethics 27 (3):387-396.
    How international research might contribute to justice in global health has not been substantively addressed by bioethics. Theories of justice from political philosophy establish obligations for parties from high-income countries owed to parties from low and middle-income countries. We have developed a new framework that is based on Jennifer Ruger's health capability paradigm to strengthen the link between international clinical research and justice in global health. The ‘research for health justice’ framework provides direction on three aspects of international clinical research: (...)
    Download  
     
    Export citation  
     
    Bookmark   18 citations  
  • Political Liberalism by John Rawls. [REVIEW]Philip Pettit - 1994 - Journal of Philosophy 91 (4):215-220.
    Download  
     
    Export citation  
     
    Bookmark   525 citations  
  • Post-Trial Access to Treatment: Corporate Best Practices.Irene Schipper & Silvia Colona - 2015 - SOMO Centre for Research on Multinational Corporations.
    The paper Post-Trial Acces To Treatment (PTA) offers an insight into current corporate policies and corporate best practices relating to the provision of PTA in low and middle income countries based on company sources. In these countries there is a greater appeal for pharmaceutical companies to take responsibility for providing PTA. However, the practice of providing PTA is the exception rather than the rule.
    Download  
     
    Export citation  
     
    Bookmark   2 citations  
  • Reasons Why Post-Trial Access to Trial Drugs Should, or Need Not Be Ensured to Research Participants: A Systematic Review.N. Sofaer & D. Strech - 2011 - Public Health Ethics 4 (2):160-184.
    Background : researchers and sponsors increasingly confront the issue of whether participants in a clinical trial should have post-trial access (PTA) to the trial drug. Legislation and guidelines are inconsistent, ambiguous or silent about many aspects of PTA. Recent research highlights the potential importance of systematic reviews (SRs) of reason-based literatures in informing decision-making in medicine, medical research and health policy. Purpose: to systematically review reasons why drug trial participants should, or need not be ensured PTA to the trial drug (...)
    Download  
     
    Export citation  
     
    Bookmark   21 citations  
  • How to Do Research Fairly in an Unjust World.Angela J. Ballantyne - 2010 - American Journal of Bioethics 10 (6):26-35.
    International research, sponsored by for-profit companies, is regularly criticised as unethical on the grounds that it exploits research subjects in developing countries. Many commentators agree that exploitation occurs when the benefits of cooperative activity are unfairly distributed between the parties. To determine whether international research is exploitative we therefore need an account of fair distribution. Procedural accounts of fair bargaining have been popular solutions to this problem, but I argue that they are insufficient to protect against exploitation. I argue instead (...)
    Download  
     
    Export citation  
     
    Bookmark   34 citations  
  • Realizing Benefit Sharing - the Case of Post-Study Obligations.Doris Schroeder & Eugenijus Gefenas - 2012 - Bioethics 26 (6).
    In 2006, the Indonesian government decided to withhold avian flu samples from the World Health Organization. They argued that even though Indonesian samples were crucial to the development of vaccines, the results of vaccine research would be unaffordable for its citizens. Commentaries on the case varied from alleging blackmail to welcoming this strong stance against alleged exploitation. What is clear is that the concern expressed is related to benefit sharing. Benefit sharing requires resource users to return benefits to resource providers (...)
    Download  
     
    Export citation  
     
    Bookmark   4 citations  
  • EI principio de acceso posinvestigación en la revisión 2008 de la Declaración de Helsinki.Ignacio Mastroleo - 2008 - Perspectivas Bioéticas 13 (24-25):140-157.
    El objetivo del presente trabajo es analizar la nueva formulación del principio de acceso posinvestigación en la más reciente (2008) revisión de la Declaración de Helsinki. Se identifican los artículos relevantes de la Declaración y se presentan dos interpretaciones posibles del principio de acceso posinvestigación: una interpretación robusta y otra permisiva, inspiradas cada una por modelos de justicia distintos. Luego, se hace una evaluación crítica de dichas interpretaciones y se intenta avanzar argumentos en contra de la interpretación permisiva. [The objective (...)
    Download  
    Translate
     
     
    Export citation  
     
    Bookmark   2 citations  
  • Post‐Trial Access to Antiretrovirals: Who Owes What to Whom?Joseph Millum - 2011 - Bioethics 25 (3):145-154.
    ABSTRACTMany recent articles argue that participants who seroconvert during HIV prevention trials deserve treatment when they develop AIDS, and there is a general consensus that the participants in HIV/AIDS treatment trials should have continuing post‐trial access. As a result, the primary concern of many ethicists and activists has shifted from justifying an obligation to treat trial participants, to working out mechanisms through which treatment could be provided. In this paper I argue that this shift frequently conceals an important assumption: that (...)
    Download  
     
    Export citation  
     
    Bookmark   15 citations  
  • Care After Research: A Framework for NHS RECs.Neema Sofaer, Penney Lewis & Hugh Davies - 2012 - Health Research Authority.
    Care after research is for participants after they have finished the study. Often it is NHS-provided healthcare for the medical condition that the study addresses. Sometimes it includes the study intervention, whether funded and supplied by the study sponsor, NHS or other party. The NHS has the primary responsibility for care after research. However, researchers are responsible at least for explaining and justifying what will happen to participants once they have finished. RECs are responsible for considering the arrangements. There are (...)
    Download  
     
    Export citation  
     
    Bookmark   3 citations  
  • Subjects' Views of Obligations to Ensure Post-Trial Access to Drugs, Care and Information: Qualitative Results From the Experiences of Participants in Clinical Trials (EPIC) Study.N. Sofaer, C. Thiessen, S. D. Goold, J. Ballou, K. A. Getz, G. Koski, R. A. Krueger & J. S. Weissman - 2009 - Journal of Medical Ethics 35 (3):183-188.
    Objectives: To report the attitudes and opinions of subjects in US clinical trials about whether or not, and why, they should receive post-trial access (PTA) to the trial drug, care and information. Design: Focus groups, short self-administered questionnaires. Setting: Boston, Dallas, Detroit, Oklahoma City. Participants: Current and recent subjects in clinical trials, primarily for chronic diseases. Results: 93 individuals participated in 10 focus groups. Many thought researchers, sponsors, health insurers and others share obligations to facilitate PTA to the trial drug, (...)
    Download  
     
    Export citation  
     
    Bookmark   6 citations  
  • Engaging Diverse Social and Cultural Worlds: Perspectives on Benefits in International Clinical Research From South African Communities.Olga Zvonareva, Nora Engel, Eleanor Ross, Ron Berghmans, Ames Dhai & Anja Krumeich - 2015 - Developing World Bioethics 15 (1):8-17.
    The issue of benefits in international clinical research is highly controversial. Against the background of wide recognition of the need to share benefits of research, the nature of benefits remains strongly contested. Little is known about the perspectives of research populations on this issue and the extent to which research ethics discourses and guidelines are salient to the expectations and aspirations existing on the ground. This exploratory study contributes to filling this void by examining perspectives of people in low-income South (...)
    Download  
     
    Export citation  
     
    Bookmark   4 citations  
  • The Fair Benefits Approach Revisited.Reidar K. Lie - 2010 - Hastings Center Report 40 (4):3-3.
    In this issue, Alex London and Kevin Zollman provide an analysis of an influential approach to the ethics of international research, known as the “fair benefits” approach. According to them, the fair benefits approach suffers from a fatal flaw: it is either too vague to be useful, or worse, is internally inconsistent. The fair benefits approach was developed based on a presentation I gave at a workshop organized in Malawi in March 2001 by the National Institutes of Health Clinical Center’s (...)
    Download  
     
    Export citation  
     
    Bookmark   3 citations  
  • Justifying Community Benefit Requirements in International Research.Robert C. Hughes - 2014 - Bioethics 28 (8):397-404.
    It is widely agreed that foreign sponsors of research in low- and middle-income countries (LMICs) are morally required to ensure that their research benefits the broader host community. There is no agreement, however, about how much benefit or what type of benefit research sponsors must provide, nor is there agreement about what group of people is entitled to benefit. To settle these questions, it is necessary to examine why research sponsors have an obligation to benefit the broader host community, not (...)
    Download  
     
    Export citation  
     
    Bookmark   6 citations  
  • Taking Benefits Seriously in Developing Countries.Leonard H. Glantz, George J. Annas, Michael A. Grodin & Wendy K. Mariner - 1998 - Hastings Center Report 28 (6):38-42.
    Download  
     
    Export citation  
     
    Bookmark   11 citations  
  • Moral Standards for Research in Developing Countries From "Reasonable Availability" to "Fair Benefits".Maged El Setouhy, Tsiri Agbenyega, Francis Anto, Christine Alexandra Clerk, Kwadwo A. Koram, Michael English, Rashid Juma, Catherine Molyneux, Norbert Peshu, Newton Kumwenda, Joseph Mfutso-Bengu, Malcolm Molyneux, Terrie Taylor, Doumbia Aissata Diarra, Saibou Maiga, Mamadou Sylla, Dione Youssouf, Catherine Olufunke Falade, Segun Gbadegesin, Reidar Lie, Ferdinand Mugusi, David Ngassapa, Julius Ecuru, Ambrose Talisuna, Ezekiel Emanuel, Christine Grady, Elizabeth Higgs, Christopher Plowe, Jeremy Sugarman & David Wendler - 2004 - Hastings Center Report 34 (3):17.
    Download  
     
    Export citation  
     
    Bookmark   37 citations  
  • Realizing Benefit Sharing – the Case of Post-Study Obligations.Doris Schroeder & Eugenijus Gefenas - 2012 - Bioethics 26 (6):305-314.
    In 2006, the Indonesian government decided to withhold avian flu samples from the World Health Organization. They argued that even though Indonesian samples were crucial to the development of vaccines, the results of vaccine research would be unaffordable for its citizens. Commentaries on the case varied from alleging blackmail to welcoming this strong stance against alleged exploitation. What is clear is that the concern expressed is related to benefit sharing.Benefit sharing requires resource users to return benefits to resource providers in (...)
    Download  
     
    Export citation  
     
    Bookmark   11 citations  
  • ""Research in Developing Countries: Taking" Benefit" Seriously.Leonard H. Glantz, George J. Annas, Michael A. Grodin & Wendy K. Mariner - 1998 - Hastings Center Report 28 (6):38.
    Download  
     
    Export citation  
     
    Bookmark   20 citations  
  • Pharmaceutical Companies Vs. The State: Who Is Responsible for Post-Trial Provision of Drugs in Brazil?Daniel Wei Wang & Octavio Motta Ferraz - 2012 - Journal of Law, Medicine and Ethics 40 (2):188-196.
    This paper discusses the post-trial access to drugs for patients who participated in clinical trials in Brazil. The ethical guidance for clinical trials in Brazil is arguably one of the clearest in the world in attributing to research sponsors the responsibility for providing post-trial drugs to patients who participated in their experiments. The Federal Constitution recognizes health as a fundamental right to be fulfilled by the State. Based on the Brazilian constitution and on the National Health Council resolutions, courts have (...)
    Download  
     
    Export citation  
     
    Bookmark   3 citations  
  • Justicia global e investigación biomédica: La obligación post investigación hacia la comunidad anfitriona.Ignacio Mastroleo - 2007 - Perspectivas Bioéticas 12 (23):76-92.
    Este artículo considera el problema de justicia en la investigación biomédica en países en desarrollo. En particular se hace foco en la discusión de si el requisito de poner a disposición toda intervención probada efectiva puede ser considerado como una obligación post investigación de los patrocinadores hacia la comunidad anfitriona. Primero, se discuten las concepciones de la Comisión Nacional de Asesoramiento sobre Bioética (NBAC) de los Estados Unidos y de las guías éticas internacionales sobre la obligación post investigación hacia la (...)
    Download  
    Translate
     
     
    Export citation  
     
    Bookmark   2 citations  
  • Responsiveness to Host Community Health Needs.Alex John London - unknown
    There is near universal agreement within the scientific and ethics communities that a necessary condition for the moral permissibility of cross-national, collaborative research is that it be responsive to the health needs of the host community. It has proven difficult, however, to leverage or capitalize on this consensus in order to resolve lingering disputes about the ethics of international medical research. This is largely because different sides in these debates have sometimes provided different interpretations of what this requirement amounts to (...)
    Download  
     
    Export citation  
     
    Bookmark   9 citations  
  • Political Liberalism.J. Rawls - 1995 - Tijdschrift Voor Filosofie 57 (3):596-598.
    Download  
    Translate
     
     
    Export citation  
     
    Bookmark   1550 citations  
  • International Ethical Guidelines for Biomedical Research Involving Human Subjects CIOMS.Udo Schuklenk - 1994 - Bioethics 8 (2):189-189.
    Download  
     
    Export citation  
     
    Bookmark   35 citations  
  • Research at the Auction Block: Problems for the Fair Benefits Approach to International Research.Alex John London & Kevin J. S. Zollman - 2010 - Hastings Center Report 40 (4):34-45.
    Download  
     
    Export citation  
     
    Bookmark   23 citations