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  1. (1 other version)Justice and the Human Development Approach to International Research.Alex John London - 2005 - Hastings Center Report 35 (1):24.
    The debate over when medical research may be performed in developing countries has steered clear of the broad issues of social justice in favor of what seem more tractable, practical issues. A better approach will reframe the question of justice in international research in a way that makes explicit the links between medical research, the social determinants of health, and global justice.
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  • Post‐trial obligations in the Declaration of Helsinki 2013: classification, reconstruction and interpretation.Ignacio Mastroleo - 2016 - Developing World Bioethics 16 (2):80-90.
    The general aim of this article is to give a critical interpretation of post-trial obligations towards individual research participants in the Declaration of Helsinki 2013. Transitioning research participants to the appropriate health care when a research study ends is a global problem. The publication of a new version of the Declaration of Helsinki is a great opportunity to discuss it. In my view, the Declaration of Helsinki 2013 identifies at least two clearly different types of post-trial obligations, specifically, access to (...)
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  • 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 (...)
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  • Ethics of medical care and clinical research: a qualitative study of principal investigators in biomedical HIV prevention research.Bridget G. Haire - 2013 - Journal of Medical Ethics 39 (4):231-235.
    In clinical research there is a tension between the role of a doctor, who must serve the best interests of the patient, and the role of the researcher, who must produce knowledge that may not have any immediate benefits for the research participant. This tension is exacerbated in HIV research in low and middle income countries, which frequently uncovers comorbidities other than the condition under study. Some bioethicists argue that as the goals of medicine and those of research are distinct, (...)
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  • Mapping African ethical review committee activity onto capacity needs: The Marc initiative and hrweb's interactive database of recs in Africa.Carel Ijsselmuiden, Debbie Marais, Douglas Wassenaar & Boitumelo Mokgatla-Moipolai - 2012 - Developing World Bioethics 12 (2):74-86.
    Health research initiatives worldwide are growing in scope and complexity, particularly as they move into the developing world. Expanding health research activity in low- and middle-income countries has resulted in a commensurate rise in the need for sound ethical review structures and functions in the form of Research Ethics Committees (RECs). Yet these seem to be lagging behind as a result of the enormous challenges facing these countries, including poor resource availability and lack of capacity. There is thus an urgent (...)
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  • 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 (...)
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  • Justice in international clinical research.Bridget Pratt & Bebe Loff - 2010 - Developing World Bioethics 11 (2):75-81.
    Debates about justice in international clinical research problematically conflate two quite different forms of obligation. International research ethics guidelines were intended to describe how to conduct biomedical research in a just manner at the micro or clinical level (within the researcher-participant interaction) but have come to include requirements that are clearly intended to promote justice at the global level. Ethicists have also made a variety of claims regarding what international research should contribute to global justice. This paper argues that the (...)
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  • Human Dignity and Human Rights as a Common Ground for a Global Bioethics.R. Andorno - 2009 - Journal of Medicine and Philosophy 34 (3):223-240.
    The principle of respect for human dignity plays a crucial role in the emerging global norms relating to bioethics, in particular in the UNESCO Universal Declaration on Bioethics and Human Rights. This instrument, which is a legal, not merely an ethical document, can be regarded as an extension of international human rights law into the field of biomedicine. Although the Declaration does not explicitly define human dignity, it would be a mistake to see the emphasis put on this notion as (...)
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  • Responsibilities in international research: a new look revisited.S. R. Benatar & P. A. Singer - 2010 - Journal of Medical Ethics 36 (4):194-197.
    Following promulgation of the Nuremberg code in 1947, the ethics of research on human subjects has been a challenging and often contentious topic of debate. Escalation in the use of research participants in low-income countries over recent decades , has intensified the debate on the ethics of international research and led to increasing attention both to exploitation of vulnerable subjects and to considerations of how the 10:90 gap in health and medical research could be narrowed. In 2000, prompted by the (...)
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  • HIV prevention research and global inequality: steps towards improved standards of care.K. Shapiro - 2005 - Journal of Medical Ethics 31 (1):39-47.
    Next SectionIntensification of poverty and degradation of health infrastructure over recent decades in countries most affected by HIV/AIDS present formidable challenges to clinical research. This paper addresses the overall standard of health care (SOC) that should be provided to research participants in developing countries, rather than the narrow definition of SOC that has characterised the international debate on standards of health care. It argues that contributing to sustainable improvements in health by progressively ratcheting the standard of care upwards for research (...)
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  • Equitable treatment for HIV/AIDS clinical trial participants: a focus group study of patients, clinician researchers, and administrators in western Kenya.D. N. Shaffer - 2006 - Journal of Medical Ethics 32 (1):55-60.
    Objectives: To describe the concerns and priorities of key stakeholders in a developing country regarding ethical obligations held by researchers and perceptions of equity or “what is fair” for study participants in an HIV/AIDS clinical drug trial. Design: Qualitative study with focus groups. Setting: Teaching and referral hospital and rural health centre in western Kenya. Participants: Potential HIV/AIDS clinical trial participants, clinician researchers, and administrators. Results: Eighty nine individuals participated in a total of 11 focus groups over a four month (...)
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  • Stakeholder perspectives on ethical challenges in hiv vaccine trials in south Africa.Zaynab Essack, Jennifer Koen, Nicola Barsdorf, Catherine Slack, Michael Quayle, Cecilia Milford, Graham Lindegger, Chitra Ranchod & Richard Mukuka - 2009 - Developing World Bioethics 10 (1):11-21.
    There is little published literature on the ethical concerns of stakeholders in HIV vaccine trials. This study explored the ethical challenges identified by various stakeholders, through an open-ended, in-depth approach. While the few previous studies have been largely quantitative, respondents in this study had the opportunity to spontaneously identify the issues that they perceived to be of priority concern in the South African context. Stakeholders spontaneously identified the following as ethical priorities: informed consent, social harms, collaborative relationships between research stakeholders, (...)
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  • Bioethics and the question of human dignity.Adam Schulman - 2008 - In Human dignity and bioethics: essays commissioned by the President's Council on Bioethics. Washington, D.C.: [President's Council on Bioethics.
    Human dignity—is it a useful concept in bioethics, one that sheds important light on the whole range of bioethical issues, from embryo research and assisted reproduction, to biomedical enhancement, to care of the disabled and the dying? Or is it, on the contrary, a useless concept—at best a vague substitute for other, more precise notions, at worst a mere slogan that camouflages unconvincing arguments and unarticulated biases?
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  • 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 (...)
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  • (1 other version)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 (...)
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  • (1 other version)The Balm of Gilead: Is the Provision of Treatment to Those Who Seroconvert in HIV Prevention Trials a Matter of Moral Obligation or Moral Negotiation?Charles Weijer & Guy J. LeBlanc - 2006 - Journal of Law, Medicine and Ethics 34 (4):793-808.
    Is there no balm in Gilead; is there no physician there? Why then is not the health of the daughter of my people recovered?In July of 2004, Cambodian sex workers staged a protest of an HIV prevention trial set to enroll 900 sex workers in Phnom Penh, charging the study planners with exploitation. The Cambodian study was one of a series of international clinical trials sponsored by the U.S. National Institutes of Health, U.S. Centers for Disease Control and Prevention, and (...)
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  • 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.
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  • Because we can: Clashes of perspective over researcher obligation in the failed prep trials.Bridget G. Haire - 2011 - Developing World Bioethics 11 (2):63-74.
    This article examines the relationship between bioethics and the therapeutic standards in HIV prevention research in the developing world, focusing on the closure of the pre-exposure prophylaxis (PrEP) trials in the early 2000s. I situate the PrEP trials in the historical context of the vertical transmission debates of the 1990s, where there was protracted debate over the use of placebos despite the existence of a proven intervention. I then discuss the dramatic improvement in the clinical management of HIV and the (...)
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  • (1 other version)The Balm of Gilead: Is the Provision of Treatment to those Who Seroconvert in HIV Prevention Trials a Matter of Moral Obligation or Moral Negotiation?Charles Weijer & Guy J. LeBlanc - 2006 - Journal of Law, Medicine and Ethics 34 (4):793-808.
    Must treatment be provided to subjects who acquire HIV during the course of a prevention study? An analysis of ethical foundation, regulation, and recent argumentation provides no basis for the obligation. We outline an alternative approach to the problem based on moral negotiation.
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  • (1 other version)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.
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  • Developing Drugs for the Developing World: An Economic, Legal, Moral, and Political Dilemma.David B. Resnik - 2001 - Developing World Bioethics 1 (1):11-32.
    This paper discusses the economic, legal, moral, and political difficulties in developing drugs for the developing world. It argues that large, global pharmaceutical companies have social responsibilities to the developing world, and that they may exercise these responsibilities by investing in research and development related to diseases that affect developing nations, offering discounts on drug prices, and initiating drug giveaways. However, these social responsibilities are not absolute requirements and may be balanced against other obligations and commitments in light of economic, (...)
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  • Legal and Ethical Regulation of Biomedical Research in Developing Countries.Remigius N. Nwabueze - 2013 - Routledge.
    This study argues that whilst ethical regulation of biomedical research in Africa and other developing countries has attracted global attention, legal liability issues, such as the application of common law rules and the development of legally enforceable regulations, have been neglected. It examines some of the major research scandals in Africa and suggests a new ethical framework against which clinical trials could be conducted. The development of research guidelines in Uganda, Tanzania, Malawi and Nigeria are also examined as well as (...)
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  • Post‐Trial Access to Antiretrovirals: Who Owes What to Whom?Joseph Millum - 2011 - Bioethics 25 (3):145-154.
    ABSTRACT Many 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: (...)
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  • The 50th Anniversary of the Declaration of Helsinki: Progress but Many Remaining Challenges.J. Millum - 2013 - Journal of the American Medical Association 310 (20):2143-44.
    Since 1964, through 7 revisions, the World Medical Association’s Declaration of Helsinki has stood as an important statement regarding the ethical principles guiding medical research with human participants. It is consulted by ethics review committees, funders, researchers, and research participants. It has been incorporated into national legislation and is routinely invoked to ascertain the ethical appropriateness of clinical trials. There is much to praise about the revision process and the latest revision, which coincides with the declaration’s 50th anniversary. Nevertheless, the (...)
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  • Attitudes toward Post‐Trial Access to Medical Interventions: A Review of Academic Literature, Legislation, and International Guidelines. [REVIEW]Kori Cook, Jeremy Snyder & John Calvert - 2015 - Developing World Bioethics 16 (2):70-79.
    There is currently no international consensus around post-trial obligations toward research participants, community members, and host countries. This literature review investigates arguments and attitudes toward post-trial access. The literature review found that academic discussions focused on the rights of research participants, but offered few practical recommendations for addressing or improving current practices. Similarly, there are few regulations or legislation pertaining to post-trial access. If regulatory changes are necessary, we need to understand the current arguments, legislation, and attitudes towards post-trial access (...)
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  • (1 other version)Realizing benefit sharing – the case of post-study obligations.Doris Schroeder & Eugenijus Gefenas - 2011 - 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 (...)
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  • Hiv international clinical research: Exploitation and risk.Angela Ballantyne - 2005 - Bioethics 19 (5-6):476-491.
    This paper aims to show that to reduce the level of exploitation present in (some) international clinical trials, research sponsors must aim to provide both an ex-ante expected gain in utility and a fair ex-post distribution of benefits for research subjects. I suggest the following principles of fair risk distribution in international research as the basis of a normative definition of fairness: (a) Persons should not be forced (by circumstance) to gamble in order to achieve or protect basic goods; (b) (...)
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  • Vulnerability: Too Vague and Too Broad?Doris Schroeder & Eugenijus Gefenas - 2009 - Cambridge Quarterly of Healthcare Ethics 18 (2):113.
    Imagine you are walking down a city street. It is windy and raining. Amidst the bustle you see a young woman. She sits under a railway bridge, hardly protected from the rain and holds a woolen hat containing a small number of coins. You can see that she trembles from the cold. Or imagine seeing an old woman walking in the street at dusk, clutching her bag with one hand and a walking stick with the other. A group of male (...)
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  • Corporate Responsibilities for Access to Medicines.Klaus M. Leisinger - 2009 - Journal of Business Ethics 85 (S1):3 - 23.
    Today there is a growing wave of demands being placed upon the pharmaceutical industry to contribute to improved access to medicines for poor patients in the developing countries. 1 This article aims to contribute to the development of a systematic approach and broad consensus about shared benchmarks for good corporate practices in this area. A consensus corridor on what constitutes an appropriate portfolio of corporate responsibilities for access to medicines -especially under conditions of 'failing states' and 'market failure' 2 – (...)
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  • The HIV/aIDS pandemic: A sign of instability in a complex global system.Solomon R. Benatar - 2002 - Journal of Medicine and Philosophy 27 (2):163 – 177.
    Intense scientific work on HIV/AIDS has led to the development of effective combination drug therapies and there is hope that effective vaccines will soon be produced. However, the majority of people with HIV/AIDS in the world are not benefiting from such advances because of extreme poverty. This article focuses on the pandemic as a reflection of a complex trajectory of social and economic forces that create widening global disparities in wealth and health and concomitant ecological niches for the emergence of (...)
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  • (1 other version)'Due' and 'Undue' Inducements: On Pasing Money to Research Subjects.Ruth Macklin - 1981 - IRB: Ethics & Human Research 3 (5):1.
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  • Donating Human Samples: Who Benefits? – Cases from Iceland, Kenya, and Indonesia.J. Lucas, D. Schroeder, G. Arnason, P. Andanda, J. Kimani, V. Fournier & M. Krishnamurthy - 2013 - In Doris Schroeder & Julie Cook Lucas (eds.), Benefit Sharing – From Biodiversity to Human Genetics. Dordrecht, Netherlands: Springer.
    This piece outlines concrete cases of benefit sharing that occur in relation to the sharing of human (biological) samples. For example, it surveys Indonesia’s decision, in 2006, to stop sharing virus samples of H5N1 (avian influenza) with the WHO Global Influenza Surveillance Network (GISN). It also outlines some of the ethical issues that arise in these cases.
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  • (1 other version)Ethics in practice: the state of the debate on promoting the social value of global health research in resource poor settings particularly Africa.Geoffrey M. Lairumbi, Michael Parker, Raymond Fitzpatrick & Michael C. English - 2011 - BMC Medical Ethics 12 (1):22.
    BackgroundPromoting the social value of global health research undertaken in resource poor settings has become a key concern in global research ethics. The consideration for benefit sharing, which concerns the elucidation of what if anything, is owed to participants, their communities and host nations that take part in such research, and the obligations of researchers involved, is one of the main strategies used for promoting social value of research. In the last decade however, there has been intense debate within academic (...)
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  • Reporting of informed consent, standard of care and post-trial obligations in global randomized intervention trials: A systematic survey of registered trials.Emma R. M. Cohen, Jennifer M. O'neill, Michel Joffres, Ross E. G. Upshur & Edward Mills - 2008 - Developing World Bioethics 9 (2):74-80.
    Objective: Ethical guidelines are designed to ensure benefits, protection and respect of participants in clinical research. Clinical trials must now be registered on open-access databases and provide details on ethical considerations. This systematic survey aimed to determine the extent to which recently registered clinical trials report the use of standard of care and post-trial obligations in trial registries, and whether trial characteristics vary according to setting. Methods: We selected global randomized trials registered on http://www.clinicaltrials.gov and http://www.controlled-trials.com. We searched for intervention (...)
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  • 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. (...)
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  • 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 - 2013 - 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 (...)
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  • (1 other version)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 (...)
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  • (1 other version)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 (...)
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  • Reciprocity‐Based Reasons for Benefiting Research Participants: Most Fail, the Most Plausible is Problematic.Neema Sofaer - 2013 - Bioethics 28 (9):456-471.
    A common reason for giving research participants post-trial access to the trial intervention appeals to reciprocity, the principle, stated most generally, that if one person benefits a second, the second should reciprocate: benefit the first in return. Many authors consider it obvious that reciprocity supports PTA. Yet their reciprocity principles differ, with many authors apparently unaware of alternative versions. This article is the first to gather the range of reciprocity principles. It finds that: most are false. The most plausible principle, (...)
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  • 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.
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  • Ethics committees for biomedical research in some African emerging countries: which establishment for which independence? A comparison with the USA and Canada.J. -P. Rwabihama, C. Girre & A. -M. Duguet - 2010 - Journal of Medical Ethics 36 (4):243-249.
    Context The conduct of medical research led by Northern countries in developing countries raises ethical questions. The assessment of research protocols has to be twofold, with a first reading in the country of origin and a second one in the country where the research takes place. This reading should benefit from an independent local ethical review of protocols. Consequently, ethics committees for medical research are evolving in Africa. Objective To investigate the process of establishing ethics committees and their independence. Method (...)
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  • (1 other version)International Research and Just Sharing of Benefits in Mexico.Javier E. GarcÍa De Alba Ricardo PÁez - 2009 - Developing World Bioethics 9 (2):65-73.
    International research enrolling human subjects has raised an ethical concern regarding the just distribution of benefits between the countries that design the research and the host communities. Although several universal declarations have expressed this concern, a gap between theory and practice continues to exist, as well as a significant divergence between the design of the research protocol and the social context where it will be implemented. Although institutional review boards have made a valuable effort to evaluate international research, their sensitivity (...)
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  • Is Ethical Research Feasible in Developed and Developing Countries?Carlos Del R.Ío - 2002 - Bioethics 12 (4):328-330.
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  • Article 6 of the Unesco Universal declaration of bio-ethics and human rights: A moral force in South Africa.Riaan Rheeder - 2014 - South African Journal of Bioethics and Law 7 (2):51.
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  • Global bioethics at UNESCO: in defence of the Universal Declaration on Bioethics and Human Rights.R. Andorno - 2007 - Journal of Medical Ethics 33 (3):150-154.
    The Universal Declaration on Bioethics and Human Rights adopted by the United Nations Educational, Scientific, and Cultural Organisation on 19 October 2005 is an important step in the search for global minimum standards in biomedical research and clinical practice. As a member of UNESCO International Bioethics Committee, I participated in the drafting of this document. Drawing on this experience, the principal features of the Declaration are outlined, before responding to two general charges that have been levelled at UNESCO’s bioethical activities (...)
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  • (1 other version)International research and just sharing of benefits in mexico.Ricardo Páez & Javier E. García de Alba - 2008 - Developing World Bioethics 9 (2):65-73.
    ABSTRACT International research enrolling human subjects has raised an ethical concern regarding the just distribution of benefits between the countries that design the research and the host communities. Although several universal declarations have expressed this concern, a gap between theory and practice continues to exist, as well as a significant divergence between the design of the research protocol and the social context where it will be implemented. Although institutional review boards have made a valuable effort to evaluate international research, their (...)
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  • Informed consent for MRI and fMRI research: Analysis of a sample of Canadian consent documents.Nicole Palmour, William Affleck, Emily Bell, Constance Deslauriers, Bruce Pike, Julien Doyon & Eric Racine - 2011 - BMC Medical Ethics 12 (1):1.
    BackgroundResearch ethics and the measures deployed to ensure ethical oversight of research (e.g., informed consent forms, ethics review) are vested with extremely important ethical and practical goals. Accordingly, these measures need to function effectively in real-world research and to follow high level standards.MethodsWe examined approved consent forms for Magnetic Resonance Imaging (MRI) and functional Magnetic Resonance Imaging (fMRI) studies approved by Canadian research ethics boards (REBs).ResultsWe found evidence of variability in consent forms in matters of physical and psychological risk reporting. (...)
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  • Another Look at Dignity.Matti Häyry - 2004 - Cambridge Quarterly of Healthcare Ethics 13 (1):7-14.
    With the considerable attention given to UNESCO's Universal Declaration on the Human Genome and Human Rights, the time has come to take another look at the concept of dignity, on which this document is morally founded. The term “dignity” now appears in many national constitutions and international bioethical statements. It has also become popular among Continental European ethicists, many of whom wish to challenge the particularly American and overtly individualistic principles of “autonomy,” “justice,” “beneficence,” and “nonmaleficence.” a.
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  • Enhancing capacity of ethics review committees in developing countries: The Kenyan example.Gloria Manyonyi, Walter Jaoko, Kirana Bhatt, Simon Langat, Gaudensia Mutua, Bashir Farah, Jacquelyne Nyange, Joyce Olenja, Julius Oyugi, Sabina Wakasiaka, Maureen Khaniri, Keith Fowke, Rupert Kaul & Omu Anzala - 2014 - South African Journal of Bioethics and Law 7 (2):59.
    Background. The increased number of clinical trials taking place in developing countries and the complexity of trial protocols mandate that local ethics review committees reviewing them have the capacity to ensure that they are conducted to the highest ethical standards.Methods. The Kenya AIDS Vaccine Initiative Institute of Clinical Research and the Kenyan National Council for Science and Technology embarked on an exercise to enhance the capacity of ERCs in Kenya to review such protocols. This process involved conducting an audit of (...)
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  • (1 other version)Research Bioethics in the Ugandan Context II: Procedural and Substantive Reform.Sana Loue & David Okello - 2000 - Journal of Law, Medicine and Ethics 28 (2):165-173.
    In July 1997, the voting representatives at the National Consensus Conference on Bioethics in Health Research voted unanimously to adopt the proposed Guidelines for the Conduct of Health Research Involving Human Subjects in Uganda. This vote represented the culmination of a three-year journey towards the development of a coherent and cohesive framework for the ethical review of health research involving human subjects in Uganda.Attendees at the NCC included both voting representatives and non-voting participants. Voting representatives had been designated by the (...)
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