What Makes Clinical Research in Developing Countries Ethical? The Benchmarks of Ethical Research
01 Mar 2004-The Journal of Infectious Diseases (Oxford University Press)-Vol. 189, Iss: 5, pp 930-937
TL;DR: This work applies a previously proposed ethical framework for clinical research within developed countries to developing countries explicating a previously implicit requirement for collaboration and proposes specific and practical benchmarks to guide researchers and research-ethics committees in assessing how well the enumerated ethical principles have been fulfilled in particular cases.
Abstract: In recent years there has been substantial debate about the ethics of research in developing countries. In general the controversies have centered on 3 issues: first the standard of care that should be used in research in developing countries; second the “reasonable availability” of interventions that are proven to be useful during the course of research trials; and third the quality of informed consent. The persistence of controversies on such issues reflects in part the fact that existing ethical guidelines can be interpreted in multiple ways are sometimes contradictory or rely on unstated yet controversial ethical principles. To provide unified and consistent ethical guidance we apply a previously proposed ethical framework for clinical research within developed countries to developing countries explicating a previously implicit requirement for collaboration. More importantly we propose specific and practical benchmarks to guide researchers and research-ethics committees in assessing how well the enumerated ethical principles have been fulfilled in particular cases. (excerpt)
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TL;DR: The authors argue that there have been few systematic attempts to determine the effectiveness of community engagement in research.
Abstract: Health (GCGH) initiative, discussed in the fi rst article in this series [3], we are exploring a range of ESC issues identifi ed by the GCGH investigators and developing world key informants, discussed in the second article in this series [4]. The investigators and key informants placed particular emphasis upon the importance of community engagement, and therefore we prepared a conceptual paper on this topic, which we distributed as a working paper to GCGH investigators and program staff at the 2nd Annual GCGH Meeting. In this article, we summarize this conceptual paper. We fi rst examine the concept of CE in research in developing countries, then we describe published models of CE, and fi nally we discuss two relevant examples of CE in research from Africa. What Is a Community?
340 citations
Cites background or methods from "What Makes Clinical Research in Dev..."
...Multinational Clinical Research What Makes Clinical Research in Developing Countries Ethical? The Benchmarks of Ethical Research [14]...
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...The Benchmarks of Ethical Research [14] HIV Prevention Trial Network (HPTN) HPTN Approach to Ensuring Community Involvement in Research: HPTN Year One (http://www.hptn.org/ Web%20Documents/CommunityProgram/HPTNYear_One_Guidance_for_Community_Participation.pdf) doi:10.1371/journal.pmed.0040273.t002 PLoS Medicine | www.plosmedicine.org 1454 September 2007 | Volume 4 | Issue 9 | e273 on issues such as study participant recruitment and retention strategies, cultural factors that might affect the research initiative, and development of study-specifi c communication strategies in Zulu, the indigenous language of the area....
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...In the context of international research, such partnership has been proposed as an ethical requirement [14]....
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TL;DR: It is suggested that key methodologic and contextual issues have contributed to this state of affairs and a major shift is proposed to produce research with more rapid clinical, public health, and policy impact.
324 citations
TL;DR: It is argued that collaborative partnership, including democratic deliberation, offers the context and process by which many of the ethical challenges in international herbal medicine research can be resolved and should be resolved.
Abstract: Governments, international agencies and corporations are increasingly investing in traditional herbal medicine research. Yet little literature addresses ethical challenges in this research. In this paper, we apply concepts in a comprehensive ethical framework for clinical research to international traditional herbal medicine research. We examine in detail three key, underappreciated dimensions of the ethical framework in which particularly difficult questions arise for international herbal medicine research: social value, scientific validity and favourable risk-benefit ratio. Significant challenges exist in determining shared concepts of social value, scientific validity and favourable risk-benefit ratio across international research collaborations. However, we argue that collaborative partnership, including democratic deliberation, offers the context and process by which many of the ethical challenges in international herbal medicine research can, and should be, resolved. By "cross-training" investigators, and investing in safety-monitoring infrastructure, the issues identified by this comprehensive framework can promote ethically sound international herbal medicine research that contributes to global health.
298 citations
Journal Article•
TL;DR: In this paper, the authors apply a practical, comprehensive and widely accepted ethical framework to international traditional herbal medicine research and examine in detail difficult questions related to social value, scientific validity and favorable risk-benefit ratio.
Abstract: Introduction Traditional herbal medicines are naturally occurring, plant-derived substances with minimal or no industrial processing that have been used to treat illness within local or regional healing practices Traditional herbal medicines are getting significant attention in global health debates In China, traditional herbal medicine played a prominent role in the strategy to contain and treat severe acute respiratory syndrome (SARS) (1) Eighty per cent of African populations use some form of traditional herbal medicine, (2,3) and the worldwide annual market for these products approaches US$ 60 billion (2) Many hope traditional herbal medicine research will play a critical role in global health China, India, Nigeria, the United States of America (USA) and WHO have all made substantial research investments in traditional herbal medicines (2) Industry has also invested millions of US dollars looking for promising medicinal herbs and novel chemical compounds (4,5) This is still a relatively modest investment compared to the overall pharmaceutical industry; however, it raises interesting ethical questions, some of which are not faced in more conventional drug development As attention and public funding for international traditional herbal medicine research collaborations grows, more detailed analysis of ethical issues in this research is warranted Scant literature has addressed selected issues such as informed consent and independent review related to traditional herbal medicine research (6,7) Here we apply a practical, comprehensive and widely accepted ethical framework to international traditional herbal medicine research (80 We examine in detail difficult questions related to social value, scientific validity and favourable risk--benefit ratio We conclude with implications for future research in this area, focusing on the importance of collaborative partnership Case A government agency from a developed country is conducting an HIV-treatment trial in Africa A traditional herbal medicine, Africa Flower, has been used for decades to treat wasting symptoms associated with HIV Local traditional medicine healers believe Africa Flower is an effective antiviral It is already widely used for immune boosting in AIDS In vitro pharmacokinetic studies suggest potential interference with vaccines, and animal models show liver toxicity at very high doses There are no systemic side-effects reported for humans in the literature A few case series have shown mixed results Local leaders are requesting the government agency conduct a large, randomized controlled trial (RCT) of Africa Flower to test its efficacy as a novel adjunctive therapy to slow progression to MDS Ethical framework Cases like these present challenging questions related to the role of traditional herbal medicines in public health In general, international research on traditional herbal medicines should be subject to the same ethical requirements as all research related to human subjects (9) An ethical framework previously outlined by Emanuel et al and revised for international research (8) offers a useful starting point for thinking about the ethics of international traditional herbal medicine research This framework includes eight ethical requirements for clinical research (Table 1) (8) These ethical requirements are universal and comprehensive but must be adapted to the particular social context in which the research is implemented (8) Of these, fair subject selection, independent review, informed consent, and respect for enrolled subjects have been discussed previously in the literature on the ethics of global health research and raise few issues unique to international traditional herbal medicine research (8) However, social value, scientific validity, and favourable risk--benefit ratio raise specific challenges in international herbal medicine research that have not been adequately discussed …
260 citations
TL;DR: A review of major ethical issues is presented, how they pertain to students, and a framework is outlined to help guide students in their work.
Abstract: As a result of increased interest in global health, more and more medical students and trainees from the ‘developed world’ are working and studying in the ‘developing world’. However, while opportunities to do this important work increase, there has been insufficient development of ethical guidelines for students. It is often assumed that ethics training in developed world situations is applicable to health experiences globally. However, fundamental differences in both clinical and research settings necessitate an alternative paradigm of analysis. This article is intended for teachers who are responsible for preparing students prior to such experiences. A review of major ethical issues is presented, how they pertain to students, and a framework is outlined to help guide students in their work.
177 citations
References
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Book•
24 Sep 1984
TL;DR: In this paper, complex equality, membership, security and welfare, money and commodities, office, hard work, free time, education, kinship and love, recognition, political power, Tyrannies and just societies.
Abstract: * Complex Equality * Membership * Security and Welfare * Money and Commodities * Office * Hard Work * Free Time * Education * Kinship and Love * Divine Grace * Recognition * Political Power * Tyrannies and Just Societies
2,529 citations
Book•
01 Jan 1996
TL;DR: In this paper, the authors discuss the persistence of moral disagreement, the sense of reciprocity, the scope of accountability, and the promise of Utilitarianism in Deliberative Democracy.
Abstract: Acknowledgments Introduction The Persistence of Moral Disagreement The Sense of Reciprocity The Value of Publicity The Scope of Accountability The Promise of Utilitarianism The Constitution of Deliberative Democracy The Latitude of Liberty The Obligations of Welfare The Ambiguity of Fair Opportunity Conclusion Notes Index
2,421 citations
TL;DR: 7 requirements are proposed that systematically elucidate a coherent framework for evaluating the ethics of clinical research studies and are universal, although they must be adapted to the health, economic, cultural, and technological conditions in which clinical research is conducted.
Abstract: Many believe that informed consent makes clinical research ethical. However, informed consent is neither necessary nor sufficient for ethical clinical research. Drawing on the basic philosophies underlying major codes, declarations, and other documents relevant to research with human subjects, we propose 7 requirements that systematically elucidate a coherent framework for evaluating the ethics of clinical research studies: (1) value-enhancements of health or knowledge must be derived from the research; (2) scientific validity-the research must be methodologically rigorous; (3) fair subject selection-scientific objectives, not vulnerability or privilege, and the potential for and distribution of risks and benefits, should determine communities selected as study sites and the inclusion criteria for individual subjects; (4) favorable risk-benefit ratio-within the context of standard clinical practice and the research protocol, risks must be minimized, potential benefits enhanced, and the potential benefits to individuals and knowledge gained for society must outweigh the risks; (5) independent review-unaffiliated individuals must review the research and approve, amend, or terminate it; (6) informed consent-individuals should be informed about the research and provide their voluntary consent; and (7) respect for enrolled subjects-subjects should have their privacy protected, the opportunity to withdraw, and their well-being monitored. Fulfilling all 7 requirements is necessary and sufficient to make clinical research ethical. These requirements are universal, although they must be adapted to the health, economic, cultural, and technological conditions in which clinical research is conducted. JAMA. 2000;283:2701-2711.
2,183 citations
"What Makes Clinical Research in Dev..." refers background in this paper
...Science and ethics do not conflict; valid science is an ethical requirement [25, 37]....
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...An ethical framework for multinational research should minimize the possibilities of exploitation [25]....
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...Finally, review must be independent and competent [25]....
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...The ethical conduct of clinical research does not end when informed consent is obtained [25]....
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...Previously, we delineated a framework for ethical research that included 7 principles [25]....
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01 Jan 1991
TL;DR: The main aim of the conference, as expressed in its title, is to improve drug safety through the joint efforts of all those who are partners in this very complicated but crucial task of ensuring progress in medicine.
Abstract: It is an honor and a great pleasure for me to welcome you, on behalf of the Council for International Organizations of Medical Sciences (CIOMS), to this international dialogue conference organized in the framework of the RAD-AR initiative. The main aim of the conference, as expressed in its title, is to improve drug safety through the joint efforts of all those who are partners in this very complicated but crucial task of ensuring progress in medicine. I am particularly pleased by the presence of all major constituencies responsible for drug safety, namely, representatives of the national drug regulatory authorities, drug manufacturers, and health professions, as well as scientists, journalists, and representatives of consumer organizations.
1,458 citations
TL;DR: This is a very seriously written book which is, incidentally, beautifully edited and well produced and it is essentially for educationists and community physicians who will follow the discussions with interest and benefit.
Abstract: served and the difficulty for this reviewer is to understand how this contract is to be developed. By and large, it must be through the individual to do otherwise must be, as Hamilton points out, to change the medical ethic. Several of the participants share these doubts. Dr McWhinney, for example, points out that we must not make too much of a distinction between clinical and population competency for the latter will be applied through the former. Put another way by Sir Douglas Black: 'The ideal curriculum should recognise that population problems are aggregations of individual problems'. Moreover, while doctors must know about and understand the effect of the environment, both natural and manmade, on the distribution of ill-health, the resolution of such problems is not within the power of the medical school whose essential function, as Inui puts it, is to educate physicians. How we are educating them is another matter. It may well be that the 'humanitarian dimensions' of doctoring are being sacrificed to the rote of science and it is certain that the undergraduate medical curriculum is too crowded. Perhaps we should avoid the concept of the five or sixyear undergraduate training programme and think more in terms of a ten-year graduate curriculum. In any event, the sweeping re-orientation suggested throughout the book is probably unattainable. The major difficulty is that the majority of, at least UK, hospitals are not community-based and the graduates go out to serve disparate populations not excluding those of developing countries whose needs may be completely different. The paper by Marmot and Zwi, 'A model exercise in public health', demonstrates this only too well. Several contributors come from medical schools which claim that population-based education of the type envisaged can be achieved but one suspects that Newcastle, NSW, for example, is, by reason of geography, the classic community-based medical school. In fact, the contributions from discussants are, in many ways, more readable than the primary papers insofar as they bring us back from Utopia to Camberwell. This is a very seriously written book which is, incidentally, beautifully edited and well produced. In so far as medical ethics are founded in the medical school, it has an interest for readers of this journal but it takes a long time to make a relatively narrow point. It is essentially for educationists and community physicians who will follow the discussions with interest and benefit.
1,269 citations