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Showing papers in "Developing World Bioethics in 2009"


Journal ArticleDOI
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


Journal ArticleDOI
TL;DR: It is concluded that international surrogacy must be regulated, and the proposed regulatory mechanism is termed Fair Trade Surrogacy, focusing on minimizing potential harms to all parties and ensuring fair compensation for surrogate mothers.
Abstract: Since the development of assisted reproductive technologies, infertile individuals have crossed borders to obtain treatments unavailable or unaffordable in their own country. Recent media coverage has focused on the outsourcing of surrogacy to developing countries, where the cost for surrogacy is significantly less than the equivalent cost in a more developed country. This paper discusses the ethical arguments against international surrogacy. The major opposition viewpoints can be broadly divided into arguments about welfare, commodification and exploitation. It is argued that the only valid objection to international surrogacy is that surrogate mothers may be exploited by being given too little compensation. However, the possibility of exploitation is a weak argument for prohibition, as employment alternatives for potential surrogate mothers may be more exploitative or more harmful than surrogacy. It is concluded that international surrogacy must be regulated, and the proposed regulatory mechanism is termed Fair Trade Surrogacy. The guidelines of Fair Trade Surrogacy focus on minimizing potential harms to all parties and ensuring fair compensation for surrogate mothers.

77 citations


Journal ArticleDOI
TL;DR: It is argued that basic national regulatory mechanisms are required in countries such as Argentina that are marketing fertility services to local and international publics and that regular oversight of all fertility clinics is essential to ensure that consumer information is accurate and that marketed services are safe and effective.
Abstract: Elise Smith was supported by a COPSE studentship from the Faculty of Medicine (Universite de Montreal), Carolina Martin by a Bioethics scholarship from the Faculty of Graduate Studies (Universite de Montreal), and Jason Behrmann by scholarships from the Fonds de la recherche en sante du Quebec (FRSQ), the Universite de Montreal and the APOGEE-Net Network of Canada. This project, part of larger program of research, was supported by grants to Bryn Williams-Jones from the Faculty of Medicine of the Universite de Montreal (start-up grant, 2006), the Social Sciences and Humanities Research Council of Canada (SSHRC Institutional pilot grant, 2007), and the International Institute of Research in EthicsandBiomedicine (IIREB travel award to visit Argentina, 2008).

51 citations


Journal ArticleDOI
TL;DR: This review presents a composite picture of informed consent in Nigeria using empirical studies and legal and regulatory prescriptions, as well as clinical experience, which shows that Nigeria, like most other nations in Africa, is a mixture of sociocultural entities, and, notwithstanding the multitude of factors affecting it, informed consent is evolving along a purely Western model.
Abstract: Most writing on informed consent in Africa highlights different cultural and social attributes that influence informed consent practices, especially in research settings. This review presents a composite picture of informed consent in Nigeria using empirical studies and legal and regulatory prescriptions, as well as clinical experience. It shows that Nigeria, like most other nations in Africa, is a mixture of sociocultural entities, and, notwithstanding the multitude of factors affecting it, informed consent is evolving along a purely Western model. Empirical studies show that 70-95% of Nigerian patients report giving consent for their surgical treatments. Regulatory prescriptions and adjudicated cases in Nigeria follow the Western model of informed consent. However, adversarial legal proceedings, for a multiplicity of reasons, do not play significant roles in enforcing good medical practice in Nigeria. Gender prejudices are evident, but not a norm. Individual autonomy is recognized even when decisions are made within the family. Consent practices are influenced by the level of education, extended family system, urbanization, religious practices, and health care financing options available. All limitations notwithstanding, consent discussions improved with increasing level of education of the patients, suggesting that improved physician's knowledge and increasing awareness and education of patients can override other influences. Nigerian medical schools should restructure their teaching of medical ethics to improve the knowledge and practices of physicians. More research is needed on the preferences of the Nigerian people regarding informed consent so as to adequately train physicians and positively influence physicians' behaviors.

48 citations


Journal ArticleDOI
TL;DR: The need for physicians to update their knowledge on the process of informed consent through the attendance of biomedical ethics courses is addressed, which should highlight socio-cultural practices that may make this process different from the Western concept, but perfectly acceptable in this setting.
Abstract: The process of obtaining informed consent in a teaching hospital in a developing country (e.g. Nigeria) is shaped by factors which, to the Western world, may be seen to be anti-autonomomous: autonomy being one of the pillars of an ideal informed consent. However, the mix of cultural bioethics and local moral obligation in the face of communal tradition ensures a mutually acceptable informed consent process. Paternalism is indeed encouraged by the patients who prefer to see the doctor as all-powerful and all-knowing, and this is buttressed by the cultural practice of customary obedience to those ‘above you’: either in age or social rank. The local moral obligation reassures the patients that those in authority will always look after others placed in their care without recourse to lengthy discussions or signed documentation, while the communal traditions ensure that the designated head of a family unit has the honor and sole responsibility of assenting and consenting to an operation to be carried out on a younger, or female, member of the family. Indeed it is to only a few educated patients that the informed consent process is deemed a shield against litigation by the doctors. This paper later addresses the need for physicians to update their knowledge on the process of informed consent through the attendance of biomedical ethics courses, which should highlight socio-cultural practices that may make this process different from the Western concept, but perfectly acceptable in this setting.

47 citations


Journal ArticleDOI
TL;DR: A large discrepancy in the quality of reporting and approaches used in trials in developing settings compared to wealthier settings is found.
Abstract: 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 trials of HIV/AIDS, malaria, and tuberculosis from 9 October 2004, the date of the most recent version of the Helsinki Declaration, to 10 April 2007. Results: We collected data from 312 trials. Fifty-eight percent (58%, 95% CI = 53 to 64) of trial protocols report informed consent. Fifty-eight percent (58%, 95% CI = 53 to 64) of trials report active controls. Almost no trials (1%, 95% CI = 0.5 to 3) mention post-trial provisions. Most trials measure surrogate outcomes. Twenty percent (20%, 95% CI = 16 to 25) of trials measure patient-important outcomes, such as death; and the odds that these outcomes are in a low income country are five times greater than for a developed country (odds ratio (OR) 5.03, 95% CI = 2.70 to 9.35, p = < 0.001). Pharmaceutical companies are involved in 28% (CI = 23 to 33) of trials and measure surrogate outcomes more often than nonpharmaceutical companies (OR 2.45, 95% CI = 1.18 to 5.09, p = 0.31). Conclusion: We found a large discrepancy in the quality of reporting and approaches used in trials in developing settings compared to wealthier settings.

32 citations


Journal ArticleDOI
TL;DR: The results demonstrate a steady increase in global participation in neuroethics from 1989 to 2005, characterized by an increase in numbers of articles published specifically on neuroethic, journals publishing these articles, and countries contributing to the literature.
Abstract: Neuroethics, in its modern form, investigates the impact of brain science in four basic dimensions: the self, social policy, practice and discourse. In this study, we analyzed a set of 461 peer-reviewed articles with neuroethics content, published by authors from 32 countries. We analyzed the data for: (1) trends in the development of international neuroethics over time, and (2) how challenges at the intersection of ethics and neuroscience are viewed in countries that are considered developed by International Monetary Fund (IMF) standards, and in those that are developing. Our results demonstrate a steady increase in global participation in neuroethics from 1989 to 2005, characterized by an increase in numbers of articles published specifically on neuroethics, journals publishing these articles, and countries contributing to the literature. The focus from all countries was on the practice of brain science and the amelioration of neurological disease. Indicators of technology creation and diffusion in developing countries were specifically correlated with increases in publications concerning policy implications of brain science. Neuroethics is an international endeavor and, as such, should be sensitive to the impact that context has on acceptance and use of technological innovation.

30 citations


Journal ArticleDOI
TL;DR: The survey identified the major constraints on ERCs as lack of office equipment, outdated or lack of SOPs, lack of electronic data management systems, inadequate resources, Lack of or insufficient expertise on the committees, and poor recognition of the importance of the role of the committees.
Abstract: A needs assessment survey of ethics review committees (ERCs) across Africa was conducted in order to establish their major needs and areas of weaknesses in terms of ethical review capacity. The response rate was 84% (31 of 37 targeted committees), and committees surveyed were located in 18 African countries. The majority of the responding committees (61%) have been in existence between 5 and 10 years; approximately 74% of the respondents were institutional committees, with the remainder being either national (6/31) or regional (2/31). In terms of the ethical review process, nine of the 31 committees that responded did not have standard operating procedures (SOPs), and seven of the 22 that did have SOPs had never revised them after their initial development (an average period of three years). Of the 31 committees, 10 operated without any ethical guidelines. Many of the committees (13/30) met once per month, and the number of proposals reviewed annually varied, ranging from five to over 100. All respondents relied on paper-based data management and archiving systems. Overall, the survey identified the major constraints on ERCs as lack of office equipment, outdated or lack of SOPs, lack of electronic data management systems, inadequate resources, lack of or insufficient expertise on the committees, and poor recognition of the importance of the role of the committees. Consequently, the authors are addressing the identified needs and weaknesses through the Bill and Melinda Gates Foundation-funded capacity building project. The impact of the intervention project will be assessed during and at the end of the four-year longitudinal project.

29 citations


Journal ArticleDOI
TL;DR: Although the majority of REC members in the targeted African countries had received training in ethics, they expressed a need for additional training, which has been used to design a training program in research ethics evaluation that meets this need.
Abstract: Background: As actors with the key responsibility for the protection of human research participants, Research Ethics Committees (RECs) need to be competent and well-resourced in order to fulfil their roles. Despite recent programs designed to strengthen RECs in Africa, much more needs to be accomplished before these committees can function optimally. Objective: To assess training needs for biomedical research ethics evaluation among targeted countries. Methods: Members of RECs operating in three targeted African countries were surveyed between August and November 2007. Before implementing the survey, ethical approvals were obtained from RECs in Switzerland, Cameroon, Mali and Tanzania. Data were collected using a semi-structured questionnaire in English and in French. Results: A total of 74 respondents participated in the study. The participation rate was 68%. Seventy one percent of respondents reported having received some training in research ethics evaluation. This training was given by national institutions (31%) and international institutions (69%). Researchers and REC members were ranked as the top target audiences to be trained. Of 32 topics, the top five training priorities were: basic ethical principles, coverage of applicable laws and regulations, how to conduct ethics review, evaluating informed consent processes and the role of the REC. Conclusion: Although the majority of REC members in the targeted African countries had received training in ethics, they expressed a need for additional training. The results of this survey have been used to design a training program in research ethics evaluation that meets this need.

28 citations


Journal ArticleDOI
TL;DR: The major components, key strengths and weaknesses of this law, which became effective in 2001, and the suggestion that new amendments should be considered for future revisions of the Clinical Research Law in Jordan are discussed.
Abstract: An ethical analysis of Jordan's Clinical Research Law, which became effective in 2001, was performed. Accordingly, this paper discusses the major components, key strengths and weaknesses of this law. As an initial effort, the Law addresses important aspects of research ethics and, hence, should serve as an example for other Arab Countries in the Middle East. Unique aspects of the Law include the requirement that those conducting any study have insurance that can compensate for research injuries and a system of fines and punishments for noncompliance with the Law. There are, however, some key items missing in the Jordanian Law. For example, the Law does not mention the requirement of a favourable assessment of risks and benefits, the fair selection of subjects, or articles regarding the protection of the rights and welfare of children and other vulnerable subjects participating in research. The paper concludes with the suggestion that new amendments should be considered for future revisions of the Clinical Research Law in Jordan.

21 citations


Journal ArticleDOI
TL;DR: The paper emphasizes the importance of genetic screening for Africa, by assessing the current level of burden of diseases in the continent and shows its role in reducing disease prevalence and highlights the ethical considerations of doing genetic screening on the continent.
Abstract: Africa is a continent in transition amidst a revival of cultural practices. Over previous years the continent was robbed of the benefits of medical advances by unfounded cultural practices surrounding its cultural heritage. In a fast moving field like genetic screening, discussions of social and policy aspects frequently need to take place at an early stage to avoid the dilemma encountered by Western medicine. This paper, examines the potential challenges to genetic screening in Africa. It discusses how cultural practices may affect genetic screening. It views genomics science as a culture which is trying to diffuse into another one. It argues that understanding the existing culture will help the diffusion process. The paper emphasizes the importance of genetic screening for Africa, by assessing the current level of burden of diseases in the continent and shows its role in reducing disease prevalence. The paper identifies and discusses the cultural challenges that are likely to confront genetic screening on the continent, such as the worldview, rituals and taboos, polygyny, culture of son preference and so on. It also discusses cultural practices that may promote the science such as inheritance practices, spouse selection practices and naming patterns. Factors driving the cultural challenges are identified and discussed, such as socialization process, patriarchy, gender, belief system and so on. Finally, the paper discusses the way forward and highlights the ethical considerations of doing genetic screening on the continent. However, the paper also recognizes that African culture is not monolithic and therefore makes a case for exceptions.

Journal ArticleDOI
TL;DR: A South African community's perceptions of who should provide what to HVT participants as well as how and why this should be done are explored, highlighting a series of implications for researchers in HVTs, including the need to be aware of prospective participants' considerable trust in and respect for researchers and the need for clear communication with communities so as not to erode community trust.
Abstract: Access to treatment, in HIV vaccine trials (HVTs), remains ethically controversial. In most prevention trials, including in South Africa, participants who seroconvert are referred to publicly funded programmes for treatment. This strategy is problematic when there is inadequate and uneven access to public sector antiretroviral therapy (ART) and support resources. The responsibilities, if any, of researchers, sponsors and public health authorities involved in HVTs has been hotly debated among academics, scholars, representatives of international organizations and sponsors. However, there is little published on community perceptions. Recent guidance asserts that communities should make inputs into treatment and care decisions. This qualitative study explored a South African community’s perceptions of who should provide what to HVT participants as well as how and why this should be done. Twenty-nine adults working at or attending five primary health care clinics in two rural areas in KwaZulu-Natal participated in in-depth interviews. Respondents expressed that researchers should ‘help participants to access’ treatment and care ‘because they are in a position to do so’ and ‘are in a relationship with’ trial participants. Respondents suggested that researchers could help by ‘facilitating referral’ until such time that participants can access care and treatment on their own. We highlight a series of implications for researchers in HVTs, including their need to be aware of prospective participants’ considerable trust in and respect for researchers, the responsibility that this places on them, and the need for clear communication with communities so as not to erode community trust.

Journal ArticleDOI
TL;DR: It is concluded that health research ethics committees have an important role to play nationally and locally in overseeing research, and in avoiding future occurrences in avoiding ethical issues.
Abstract: To participate in health research, there is a need for well-administered informed consent. Understanding of informed consent, especially in international health research, is influenced by the participants' understanding of information and the meaning attached to the information communicated to them regarding the purpose and procedure of the research. Incorrect information and the power differential between researcher and participants may lead to participants becoming victims of harmful research procedures. Meningitis epidemics in Kano in early 1996 led to a response from drug companies, especially Pfizer, as well as humanitarian workers from Medecins Sans Frontiers, which resulted in an unethical trial. Pfizer's drug trial during the epidemics has left a lasting controversy, which has yet to be resolved. This paper examines the key issues surrounding the controversy, discusses the context of informed decision-making, the ethical issues and implications of the incident, and concludes with some recommendations. Relevant texts, journals, Internet materials, newspaper articles and documentary materials on the conduct of the Pfizer's Trovan trial have been consulted. Four types of action (act intuitively, act rationally, act ignorantly, and act contextually - based on information provided) are identified as possible options for decision making. Participants most likely acted in ignorance due to poor understanding of the information contained in the verbal informed consent administered, thereby raising ethical issues. It is concluded that health research ethics committees have an important role to play nationally and locally in overseeing research, and in avoiding future occurrences.

Journal ArticleDOI
TL;DR: A multidisciplinary meeting held to discuss ethical issues in medical research in the developing world, providing a forum for consultation and debate between different ethics actors and finding ethical and pragmatic solutions to these issues.
Abstract: This paper reports on a multidisciplinary meeting held to discuss ethical issues in medical research in the developing world. Many studies, including clinical trials, are conducted in developing countries with a high burden of disease. Conditions under which this research is conducted vary because of differences in culture, public health, political, legal and social contexts specific to these countries. Research practices, including standards of care for participants, may vary as a result. It is therefore not surprising that ethical issues emerge. This meeting sought to identify and discuss these issues from the perspectives of the many actors in such research, including community representatives, with a view to finding ethical and pragmatic solutions to these issues. Dialogue between these actors was also promoted, with a view to identifying the need to develop such dialogue in future. Drawing from the experiences of the speakers, the colloquium attempted to outline some answers to several key questions characterising the field today. Experiences related to epidemiologic research, vaccine trials, drug trials, diagnostic tests and to some fundamental ethical issues in health research. Speakers were from different countries, disciplines and professions. The meeting provided a forum for consultation and debate between different ethics actors. Both encouraging findings and challenges emerged.

Journal ArticleDOI
TL;DR: Analysis of pain and pain relief in the Caribbean finds barriers to pain relief include patient and family attitudes, inadequate knowledge among health professionals and unduly restrictive regulations on the medical use of opioids.
Abstract: This paper examines pain and pain relief in the Caribbean, where pain is widely perceived as an unavoidable part of life, and where unnecessary suffering results from untreated and under treated pain. Barriers to pain relief in the Caribbean include patient and family attitudes, inadequate knowledge among health professionals and unduly restrictive regulations on the medical use of opioids. Similar barriers exist all over the world. This paper urges medical, nursing and public health professionals, and educators to examine attitudes towards pain and pain relief and to work towards making effective pain relief and palliation more accessible. It recommends that i) health professionals and officials be better educated about pain, palliation and opioids, ii) regulatory restrictions be updated in light of clinical and scientific evidence, iii) opioid procurement policies be adjusted to facilitate increased medical use, iv) medical charts and records be modified to routinely elicit and document patients levels of pain, and v) educational campaigns be developed to inform the public that moderate and severe pain can be safely relieved at the end of life and other stages of life. The professional, respectful, and beneficent response to patients in pain is to provide rapid and aggressive pain relief or to urgently consult a pain or palliative specialist. When a health system hinders such efforts the ethical response is to identify, facilitate and advocate for overcoming barriers to improvement.

Journal ArticleDOI
TL;DR: In this article, the authors argue that this requirement places greater obstacles in the path of ethical xenotransplantation than has previously been recognised, arguing that the community is global and there are no existing institutions with demo- cratic credentials sufficient to establish this consent.
Abstract: Keywords ethics, consent, justice, Xenotransplatation, Xenozoonosis, risk ABSTRACT The risk posed to the community by possible xenozoonosis after xenotrans- plantation suggests that some form of 'community consent' is required before whole organ animal-to-human xenotransplantation should take place. I argue that this requirement places greater obstacles in the path of ethical xenotransplantation than has previously been recognised. The rel- evant community is global and there are no existing institutions with demo- cratic credentials sufficient to establish this consent. The distribution of the risks and benefits from xenotransplantation also means that consent is unlikely to be forthcoming. Proceeding on the basis of hypothetical consent to a package of global health measures that includes xenotransplantation, as Rothblatt has recently advocated, is more problematic than she acknowl- edges. Given that it may place the lives of citizens of poor nations at risk to benefit the citizens of wealthy nations, xenotransplantation raises signifi- cant questions of international justice.

Journal ArticleDOI
TL;DR: Buddhists, from at least certain traditions - particularly Mahāyāna Buddhist traditions - should advocate the development or use of pharmaceutical enhancements if a consequence of their use is further insight into the authors' self-nature or the reduction or alleviation of duhkha.
Abstract: This paper integrates some Buddhist moral values, attitudes and self-cultivation techniques into a discussion of the ethics of cognitive enhancement technologies - in particular, pharmaceutical enhancements. Many Buddhists utilize meditation techniques that are both integral to their practice and are believed to enhance the cognitive and affective states of experienced practitioners. Additionally, Mahāyāna Buddhism's teaching on skillful means permits a liberal use of methods or techniques in Buddhist practice that yield insight into our selfnature or aid in alleviating or eliminating duhkha (i.e. dissatisfaction). These features of many, if not most, Buddhist traditions will inform much of the Buddhist assessment of pharmaceutical enhancements offered in this paper. Some Buddhist concerns about the effects and context of the use of pharmaceutical enhancements will be canvassed in the discussion. Also, the author will consider Buddhist views of the possible harms that may befall human and nonhuman research subjects, interference with a recipient's karma, the artificiality of pharmaceutical enhancements, and the possible motivations or intentions of healthy individuals pursuing pharmacological enhancement. Perhaps surprisingly, none of these concerns will adequately ground a reflective Buddhist opposition to the further development and continued use of pharmaceutical enhancements, either in principle or in practice. The author argues that Buddhists, from at least certain traditions - particularly Mahāyāna Buddhist traditions - should advocate the development or use of pharmaceutical enhancements if a consequence of their use is further insight into our self-nature or the reduction or alleviation of duhkha.

Journal ArticleDOI
TL;DR: The moral framework for considering palliative care as a public health priority in resource-poor countries and a fair deliberation process is necessary to allow these strong moral commitments to serve as reasons when setting priorities in resource poor countries.
Abstract: Many countries have not considered palliative care a public health problem. With limited resources, disease-oriented therapies and prevention measures take priority. In this paper, I intend to describe the moral framework for considering palliative care as a public health priority in resource-poor countries. A distributive theory of justice for health care should consider integrative palliative care as morally required as it contributes to improving normal functioning and preserving opportunities for the individual. For patients requiring terminal care, we are guided less by principles of justice and more by the duty to relieve suffering and society's commitment to protecting the professional's obligation to uphold principles of beneficence, compassion and non-abandonment. A fair deliberation process is necessary to allow these strong moral commitments to serve as reasons when setting priorities in resource poor countries.

Journal ArticleDOI
TL;DR: The development of a curriculum guide, core competencies and associated learning objectives and activities to help educators organize research ethics workshops in their respective institutions represents a sustainable educational resource to enhance research ethics capacity in the Middle East.
Abstract: To help ensure the ethical conduct of research, many have recommended educational efforts in research ethics to investigators and members of research ethics committees (RECs). One type of education activity involves multi-day workshops in research ethics. To be effective, such workshops should contain the appropriate content and teaching techniques geared towards the learning styles of the targeted audiences. To ensure consistency in content and quality, we describe the development of a curriculum guide, core competencies and associated learning objectives and activities to help educators organize research ethics workshops in their respective institutions. The curriculum guide is divided into modular units to enable planners to develop workshops of different lengths and choose content materials that match the needs, abilities, and prior experiences of the target audiences. The content material in the curriculum guide is relevant for audiences in the Middle East, because individuals from the Middle East who participated in a Certificate Program in research ethics selected and developed the training materials (e.g., articles, powerpoint slides, case studies, protocols). Also, many of the activities incorporate active-learning methods, consisting of group work activities analyzing case studies and reviewing protocols. The development of such a workshop training curriculum guide represents a sustainable educational resource to enhance research ethics capacity in the Middle East.

Journal ArticleDOI
TL;DR: Research ethics committees in El Salvador possess a basic knowledge of locally relevant ethical principles, though they need more training to optimize the application of bioethical principles and models to their particular contexts.
Abstract: Objective: To identify perceived barriers to capacity building for local research ethics oversight in El Salvador, and to set an agenda for international collaborative capacity building. Methods: Focus groups were formed in El Salvador which included 17 local clinical investigators and members of newly formed research ethics committees. Information about the proposed research was presented to participants during an international bioethics colloquium sponsored and organized by the St. Jude Children's Research Hospital in collaboration with the National Ethics Committee of El Salvador and the University of El Salvador. Interviews with the focus group participants were qualitatively analyzed. Results: Participants expressed the need to tailor the informed consent process and documentation to the local culture; for example, allowing family members to participate in decision-making, and employing shorter consent forms. Participants indicated that economic barriers often impede efforts in local capacity building. Participants valued international collaboration for mutual capacity building in research ethics oversight. Conclusions: Research ethics committees in El Salvador possess a basic knowledge of locally relevant ethical principles, though they need more training to optimize the application of bioethical principles and models to their particular contexts. Challenges increase the value of collaborative exchanges with ethics committee members in the United States. Further research on facilitating communication between host country and sponsor country ethics committees can maximize local research ethics expertise, and thus raise the standard of protecting human participants involved in international research.

Journal ArticleDOI
TL;DR: It is argued that more debate is required to define the role and responsibilities of witnesses in the consent process, their training requirements and whether a universal legal requirement for witnessed consent, regardless of the type of research, is desirable.
Abstract: Various mechanisms to ensure the protection of subjects in human research have been suggested, including the presence of witnesses during the informed consent process. For our commentary on the use of witnesses and their potential role and responsibility during the consent process, we start by addressing current guidelines for human subjects research in four Latin American countries. By using examples from public health research, we highlight some of the practical difficulties of using witnessed consent, from becoming a meaningless ritual at one end of the spectrum to the research subject feeling intimidated or coerced to participate at the other. Apart from these practical difficulties, it is unclear what responsibility the witness could and should have. We argue that there are important ethical questions about the role of witnesses that have not been adequately addressed in national and international regulations. This work addresses these gaps and argues that more debate is required to define the role and responsibilities of witnesses in the consent process, their training requirements and whether a universal legal requirement for witnessed consent, regardless of the type of research, is desirable.

Journal ArticleDOI
TL;DR: This paper examines the case of a recent H5N1virus (avian influenza) outbreak in West Bengal, an eastern state of India, and argues that poorly executed pandemic management may be viewed as a moral lapse, and views the West Bengal case as a learning opportunity.
Abstract: This paper examines the case of a recent H5N1virus (avian influenza) outbreak in West Bengal, an eastern state of India, and argues that poorly executed pandemic management may be viewed as a moral lapse. It further argues that pandemic management initiatives are intimately related to the concept of health as a social ‘good’ and to the moral responsibility of protection from foreseeable social harm from an infectious disease. The initiatives, therefore, have to be guided by special moral obligations towards biorisk reduction, obligations which remain unfulfilled when a public body entrusted with the responsibility fails to manage satisfactorily the prevention and control of the infection. The overall conclusion is that pandemic management has a moral dimension. The gravity of the threat that fatal infectious diseases pose for public health creates special moral obligations for public bodies in pandemic situations. However, the paper views the West Bengal case as a learning opportunity, and considers the lapses cited as challenges that better, more effectively conducted pandemic management can prepare for. It is hoped that this paper will provoke constructive bioethical deliberations, particularly pertinent to the developing world, on how to ensure that the obligations towards health are fulfilled ethically and more effectively.

Journal ArticleDOI
TL;DR: The distribution of benefits in a review of international research in Mexico is analyzed and an ethical reflection is produced based on the results.
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 sensitivity to the just sharing of research benefits as well as their attention to the social context must be evaluated. This article analyzes the distribution of benefits in a review of international research in Mexico and produces an ethical reflection based on the results.

Journal ArticleDOI
TL;DR: The World Health Organization’s Code of Practice addresses ethical concerns regarding recruitment practices, highlights the principle of mutuality of benefits, and underscores the need for national workforce sustainability, data gathering and research, monitoring, and global collaboration but is only a modest beginning.
Abstract: When the World Health Organization (WHO) issued its draft Code of Practice on the International Recruitment of Health Personnel on September 1, 2008, it took an important step in responding to a growing global health concern. Aimed at protecting the health systems of so-called ‘source’ countries – and ultimately the health of their populations – and shielding workers from unethical recruitment and employment practices, the WHO code joins a host of others promulgated in recent years by governments, non-governmental organizations, and health professional associations. Beyond the fact that the transnational flow of health workers has never been higher, especially troubling is that they are increasingly likely to migrate from low-income countries with a low supply of health personnel to high income countries. And the recruitment industry, involved in a range of activities related to recruitment, testing, credentialing, and immigration, is booming. Not only has the size of the industry surged in the last decade, so too has the number of countries in which recruiters operate, including those with high burdens of disease and low health worker-to-population ratios. Unique in its global scope, the WHO Code of Practice addresses ethical concerns regarding recruitment practices, highlights the principle of mutuality of benefits, and underscores the need for national workforce sustainability, data gathering and research, monitoring, and global collaboration. But despite its seeming comprehensiveness, it is only a modest beginning, and one that may be focusing on the least problematic element of the global flow of health workers. First, ethics codes can be useful in offering guidance, in addition to their importance as declarative and aspirational documents. But as voluntary instruments, their efficacy is uncertain. A surer strategy for managing health worker migration in a manner that respects health workers, regards the health of those persons remaining in ‘source’ countries as a moral concern (many would express these concerns in terms of the rights to migrate and to health), and helps to uphold ethical ideals across countries and institutions would be to issue a stronger call for Member States to develop binding bilateral or multilateral agreements between countries, and to set a deadline for their implementation. Moreover, both the WHO’s code and the agreements it will hopefully encourage should be explicit regarding the different responsibilities of so-called ‘source’ and ‘destination’ countries, especially given the profound inequalities of power and resources between many of them. Second, in addition to the force it fails to carry with its voluntary nature, the code seems strangely focused. It emphasizes the right of workers to migrate and to be treated fairly, yet gives inadequate attention to the root causes of the migration and the threat it poses for global health equity. While it acknowledges that poor health workforce planning 1 M. Dayrit et al. Code of Practice on the International Recruitment of Health Personnel. Bulletin of the World Health Organization (WHO) 2008; 86: 737–816. Available at: http://www.who.int/bulletin/volumes/ 86/10/08-058578/en/index.html [Accessed 4 Feb 2009]. 2 J.C. Dumont & P. Zurn. 2007. Immigrant Health Workers in OECD Countries in the Broader Context of Highly Skilled Migration. In International Migration Outlook. Paris: OECD; D. Polsky et al. Trends in characteristics and country of origin among foreign-trained nurses in the United States, 1990 and 2000. Am J Public Health 2007; 97: 895– 899. 3 P. Pittman et al. 2007. U.S.-Based International Nurse Recruitment: Structure and Practices of a Burgeoning Industry. Washington, DC: Academy Health; M. Kingma. 2006. Nurses on the Move: Migration and the Global Health Care Economy. Ithaca, NY: ILR Press.

Journal ArticleDOI
TL;DR: Ethical issues related to these kinds of studies related to the hazards and risks of becoming infected by Leishmania (Leishmania) mexicana through the bite of naturally infected sand flies are identified and some guidelines for conducting them are proposed.
Abstract: Occupational health remains neglected in developing countries because of competing social, economic and political challenges. Ethical issues in the workplace related to the hazards and risks of becoming infected by Leishmania (Leishmania) mexicana, through the bite of naturally infected sand flies, is another area of concern that has been neglected as well. We report here the results of reviewing two entomological field studies carried out in our research center from 2003 to 2006. Eight students from our School of Biology were invited to catch sand flies. A total of six of the eight (75%) developed a typical clinical picture of Localized Cutaneous Leishmaniasis (LCL) caused by L. (L.) mexicana. In this article we identify the ethical issues related to these kinds of studies and propose some guidelines for conducting them.


Journal ArticleDOI
TL;DR: This is a new ethical and political challenge for developing countries with universal and free healthcare systems, such as Brazil, Colombia, India or Turkey confronting the issue of how to allocate healthcare resources fairly, particularly access to highcost medicines.
Abstract: The phenomenon of judicial review, to guarantee access to high cost medicines, has been ongoing for more than 20 years in developed countries with universal and public healthcare. In some countries, such as the United Kingdom, the national variation in access to treatment was tremendous, depending on the provision of the healthcare services or on the willingness of the courts to overturn the decisions denying treatments. It was known as the ‘postcode lottery’. This is a new ethical and political challenge for developing countries with universal and free healthcare systems, such as Brazil, Colombia, India or Turkey. There are now supreme court cases in most of these countries confronting the issue of how to allocate healthcare resources fairly, particularly access to highcost medicines.dewb_260 2..2