Contemporary issues such as euthanasia, surrogate motherhood, organ transplantation and gene therapy, which occupy the minds of ethicists in the industrialized countries are, for the moment, irrelevant in most developing countries. There, the ethics of scarcity, sacrifice, cross-cultural research, as well as the activities of multinational companies, are germane. In this article, only the ethics of scarcity and sacrifice will be discussed. Structural adjustment programmes, designed to solve the economic problems of the developing countries, muddied (...) the waters. The dilemma confronting practitioners in developing countries is how to adhere to the basic principles of medical ethics in an atmosphere of hunger, poverty, war and ever-shrinking and often non-existent resources. Nowhere else in the world is the true meaning of scarcity portrayed as vividly as in the developing countries. Consequently, the doctor's clinical freedom may have to be sacrificed by the introduction of an essential drugs list and practice guidelines. The principle of greater good, while appealing, must be carefully interpreted and applied in the developing countries. Thus, while health promotion and disease prevention must be the primary focus, health planners should avoid pushing prevention at the expense of those currently sick. Health care reform in developing countries must not merely re-echo what is being done in the industrialized countries, but must respond to societal needs and be relevant to the community in question. (shrink)

BackgroundBioethics as a field related to the health system and health service delivery has grown in the second half of the 20th century, mainly in North America. This is attributed, the author argues, to mainly three kinds of development that took place in the developed countries at a pace different than the developing countries. They are namely: development of the health system; moral development; and political development.DiscussionThis article discusses the factors that impede the development of the field (...) of bioethics from an academic activity to a living field that is known and practiced by the people in the developing countries. They are quite many; however, the emphasis here is on role of the political structure in the developing countries and how it negatively affects the development of bioethics. It presents an argument that if bioethics is to grow within the system of health service, it should be accompanied by a parallel changes in the political mindsets in these countries.SummaryFor bioethics to flourish in developing countries, it needs an atmosphere of freedom where people can practice free moral reasoning and have full potential to take their life decisions by themselves. Moreover, bioethics could be a tool for political change through the empowerment of people, especially the vulnerable.To achieve that, the article is proposing a practical framework for facilitating the development of the field of bioethics in the developing countries. (shrink)

This book was inspired originally by the debates at the turn of the century about placebo controlled trials of antiretrovirals in HIV positive pregnant women in developing countries. Moving forward from this one limited example, the book includes several additional controversial cases of clinical research conducted in developing countries, and asks probing philosophical questions about the ethics of such trials. All clinical research by its very nature uses people to acquire generalizable knowledge to help future people. (...) But what sorts of "use" are morally permissible? What is it to exploit people? Suppose that a trial conducted in a developing country would not be ethically permissible in the developed world. Can we automatically conclude from this that the trial is unethical, that some sort of morally problematic double standard is in operation? Or might the differences in the two settings justify differences in trial design? This collection of philosophical essays examines these important questions about what exploitation is and when clinical research counts as exploitative. -/- "This is an outstanding contribution to the growing literature on the ethics of research with human subjects and a fine example of what bioethics can offer at its best. Anyone with a serious interest in these issues will need to read this book from start to finish." -Daniel Wikler, Harvard School of Public Health "This book contributes significantly to the literature on exploitation in clinical research conducted in the developing world."--Patricia Marshall, Case Western Reserve University . (shrink)

The aim of this paper is to show that any process of benefit sharing that does not guarantee the representation and participation of women in the decision-making process, as well as in the distribution of benefits, contravenes a central demand of social justice. It is argued that women, particularly in developing countries, can be excluded from benefits derived from genetic research because of existing social structures that promote and maintain discrimination. The paper describes how the structural problem of (...) gender-based inequity can impact on benefit sharing processes. At the same time, examples are given of poor women’s ability to organise themselves and to achieve social benefits for entire communities. Relevant international guidelines (e.g. the Convention on Biodiversity) recognise the importance of women’s contributions to the protection of biodiversity and thereby, implicitly, their right to a share of the benefits, but no mechanism is outlined on how to bring this about. The authors make a clear recommendation to ensure women’s participation in benefit sharing negotiations by demanding seats at the negotiation table. (shrink)

This article examines the problems that research ethics confronts in developing countries and the impact that research in developing countries has had on research ethics. In order to show this it analyzes the first paradigmatic cases that gave rise to the ‘classic’ analysis of research ethics. Hence, in this article, many of the ethical concerns apply wherever research is conducted and are not particular to developing countries. Secondly, the article describes the complex process of (...) research by analyzing different research actors and their interests in the current research process. Thirdly, it sketches some of the recent cases that have prompted fierce ethical debate surrounding research in developing countries. (shrink)

Nigeria is developing country where the practice of euthanasia is not legalized. But a look at the socio-economic conditions of Nigeria calls for the need to legalize the practice in this country. This paper examines the features of this country such as poverty, endemic diseases and a low level of investment in healthcare systems . It argues for the need to legalize euthanasia by justifying it as a policy and practice and identifying factors which are to be taken into (...) account. They include poor standard of living which reduces the life span of many and limited health care resources which prevents access to health care. The paper justifies legalizing euthanasia in Nigeria by responding to some arguments against euthanasia raised by critics emphasizing at the same time ethical issues such as autonomy, dignity and quality of life for euthanasia debate. It concludes by stressing that in Nigeria, a competent person who is terminally ill and undergoing severe pain should be able to determine how and when to end his life; the possibility of this will only depend on the legalization of euthanasia in this country. (shrink)

ABSTRACTGiven its intimate relationship with the human body and its environment, biotechnology innovation, and more particularly stem cell research innovations as a part thereof, implicate diverse social and moral/ethical issues. This paper explores some of the most important and controversial moral concerns raised by human embryonic stem cell research , focusing on concerns relating to the wellbeing of the embryo and the wellbeing of society . It then considers how and whether these concerns are dealt with in regulatory instruments in (...) Argentina, a southern developing country, examining in particular whether the values underlying these concerns have been translated into practical and effective rules reflective of the primary moral positions advanced. It concludes that Argentina's current state of stem cell research governance fails to consistently reflect the moral positions that have formed and is inadequate given Argentina's activity in this field. (shrink)

HIV intervention trials being conducted in developing countries continue to raise questions of ethics in clinical research. Most recently these questions have arisen because of a prospective study reporting the rate of transmission in discordant couples that was conducted in Uganda. The study raises serious questions about the minimum ethical standards required for this kind of research and the responsibilities of the researchers. We re-examine that research particularly focusing on issues of informed consent and duty of care, and (...) place this trial in the context of the broader debate. (shrink)

Evidence suggests a limited contribution to the total research output in leading obstetrics and gynaecology journals by researchers from the developing world. Editorial bias, quality of scientific research produced and language barriers have been attributed as possible causes for this phenomenon. The aim of this study was to understand the prevalence of editorial board members based out of low and lower-middle income countries in leading journals in the field of obstetrics and gynaecology. The top 21 journals in the (...) field of obstetrics and gynaecology were selected based on their impact factor, SCImago ranking and literature search. The composition of the editorial boards of these journals was studied based on World Bank Income Criteria to understand the representation status of researchers from low and lower-middle income countries. A total of 1315 board members make up the editorial composition of leading obstetrics and gynaecology journals. The majority of these editors belong to high-income countries (n = 1148; 87.3%). Low (n = 6; 0.45%) and lower-middle income (n = 55; 4.18%) countries make up for a very minuscule proportion of editorial board members. Only a meagre 9 out of 21 journals have editorial board members from these countries (42.85%). Low and low-middle countries have poor representation in the editorial boards of leading obstetrics and gynaecology journals. Poor representation in research from these countries has grave consequences for a large proportion of the global population and multidisciplinary collaborative efforts must be taken to rapidly change this statistic with immediate effect. (shrink)

Concern about the rapid ageing of all societies reaches alarming proportions as healthcare inequities are steeply rising, prompting the elderly to live longer but subject to insufficient social protection and healthcare in the wake of dwindling public resources. The aged population of developing nations are facing additional hardships due to the growing gap between needs and the financial reductions of public institutions, retirement funds, and the trend towards privatization of essential services turned into commodities. Current approaches to allocation of (...) insufficient resources without ageist discrimination are briefly discussed: individual self‐care aimed at successful, active and healthy ageing based on resourcefulness of the privileged elderly; utilitarian approaches founded on QALY and fair innings, and human rights focused on the plights of the elderly. These approaches cannot apply to resources poor nations, who need to engage in context‐bound bioethics dealing with the realities of their exposed ageing population. A developing world bioethics is needed to face the plights of the elderly in countries with low and middle‐income and insufficient social capital. Suggested are: 1) a phenomenological approach based on the interaction of bioethics and ethnology, furthering grass‐roots input from the elderly; 2) Create small communities –campus‐like boroughs– to simplify accessibility to social services and healthcare facilities, as an alternative to the high‐cost WHO proposal of age‐friendly large cities. (shrink)

Are there any ethical concerns about reproductive technologies that are specific or unique to developing countries? Three ethical concerns often mentioned specifically in regard to developing countries are , the “overpopulation argument”; the limited resources argument; and the ethical problem of poorly trained practitioners offering their services to unsuspecting and uninformed infertile individuals or couples. Each argument is explored in some detail, with the conclusion that ethical problems do, in fact, exist but are not unique to (...) developing countries. Nevertheless, the difficulties relating to reproductive technologies are likely to be greater in developing countries than in developed ones because of limited resources and a larger number of poor people residing there. (shrink)

Are there any ethical concerns about reproductive technologies that are specific or unique to developing countries? Three ethical concerns often mentioned specifically in regard to developing countries are (1), the “overpopulation argument”; (2) the limited resources argument; and (3) the ethical problem of poorly trained practitioners offering their services to unsuspecting and uninformed infertile individuals or couples. Each argument is explored in some detail, with the conclusion that ethical problems do, in fact, exist but are not (...) unique to developing countries. Nevertheless, the difficulties relating to reproductive technologies are likely to be greater in developing countries than in developed ones because of limited resources and a larger number of poor people residing there. (shrink)

This book addresses the problem of how to make democratically-legitimate public policy on issues of contentious bioethical debate. It focuses on ethical contests about research and their legitimate resolution, while addressing questions of political legitimacy. How should states make public policy on issues where there is ethical disagreement, not only about appropriate outcomes, but even what values are at stake? What constitutes justified, democratic policy in such conflicted domains? Case studies from Canada and Australia demonstrate that two countries sharing (...) historical and institutional characteristics can reach different policy responses. This book is of interest to policymakers, bioethicists, and philosophers, and will deepen our understanding of the interactions between large-scale socio-political forces and detailed policy problems in bioethics. (shrink)

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. Ethical principles and practical issues relating to post-trial provision are also discussed. In conclusion, post-trial provision is not necessary in all situations and a set of criteria are proposed to identify the situations that beneficial interventions should be provided beyond the research period. However, mandatory post-trial supply of beneficial experimental interventions should be assured for those who still need and are able to benefit from them but have no alternative access. Mandatory provision is based on universal bioethical principles such as beneficence and justice. Furthermore, difficulties associated with implementation of post-trial provision are not unmanageable. Careful advanced planning and a comprehensive partnership among relevant parties would be very helpful in solving these difficulties in practice, which therefore should not be taken as an excuse to escape post-trial responsibility. (shrink)

The main question explored by the book is: How can cross-border access to human genetic resources, such as blood or DNA samples, be governed in such a way as to achieve equity for vulnerable populations in developing countries? The book situates the field of genomic and genetic research within global health and research frameworks, describing the concerns that have been raised about the potential unfairness in exchanges during recent decades. Access to and sharing in the benefits of human (...) biological resources are aspects not regulated by any international legal framework such as the Convention on Biological Diversity, which applies only to the exchange of plants, animals and microorganisms, as well as to associated traditional knowledge. Examples of genetic research perceived as exploitative are provided in order to illustrate the legal vacuum concerning the global governance of human genetic resources. The main conclusions drawn from the legal and ethical analysis are: - Benefit sharing is crucial in order to avoid the exploitation of developing countries in human genetic research. - With functioning research ethics committees, undue inducement is less of a concern in genetic research than in other areas of medical research (e.g. clinical trials). - Concerns remain over research involving indigenous populations; accordingly, recommendations are provided. In drawing these conclusions, the book addresses in detail a highly pressing topic in global bioethics and international law. In this regard, it combines bioethical arguments with jurisprudence, in particular with reference to the law of equity and the legal concepts of duress (coercion), unconscionable dealing, and undue inducement. (shrink)

Returning research results to participants is recognised as an obligation that researchers should always try to fulfil. But can we ascribe the same obligation to researchers who conduct genomics research producing only aggregated findings? And what about genomics research conducted in developing countries? This paper considers Beskow's et al. argument that aggregated findings should also be returned to research participants. This recommendation is examined in the context of genomics research conducted in developing countries. The risks and (...) benefits of attempting such an exercise are identified, and suggestions on ways to avoid some of the challenges are proposed. I argue that disseminating the findings of genomic research to participating communities should be seen as sharing knowledge rather than returning results. Calling the dissemination of aggregate, population level information returning results can be confusing and misleading as participants might expect to receive individual level information. Talking about sharing knowledge is a more appropriate way of expressing and communicating the outcome of population genomic research. Considering the knowledge produced by genomics research a worthwhile output that should be shared with the participants and approaching the exercise as a ‘sharing of knowledge’, could help mitigate the risks of unrealistic expectations and misunderstanding of findings, whilst promoting trusting and long lasting relationships with the participating communities. (shrink)

(2010). Human Rights: The Normative Engine of Fairness and Research in Developing Countries. The American Journal of Bioethics: Vol. 10, No. 6, pp. 47-49.

The maternal‐fetal HIV transmission trials, conducted in developing countries in the 1990s, undoubtedly generated one of the most intense, high profile controversies in international research ethics. They sparked off a prolonged acrimonious and public debate and deeply divided the scientific community. They also provided an impetus for the revision of the Declaration of Helsinki – the most widely known guideline for international research. In this paper, I provide a brief summary of the context, outline the arguments for and (...) against the controversial use of placebo controls, and focus on particular areas that I believe merit further discussion or clarification. On balance, I argue that the researchers failed in their duties to protect the best interests of their research subjects, and to promote distributive justice. I discuss the difficulties of obtaining valid consent in this research context, and argue that it is unethical to inform women of their HIV status without at least offering them prophylactic treatment for their unborn children. A global view of justice, which endorses international equity, cannot be squared with international research guidelines that allow ‘local conditions’ to define the scope of duty to the control group. Finally, I suggest that the heated debate reflects a tension, if not an outright war, between two conflicting meta‐ethical systems, or incommensurable paradigms, that underpin scientific research involving human subjects. (shrink)

A report by the Nuffield Council on Bioethics, contrary to the Declaration of Helsinki, permits most important research initiatives in developing countries.The Ethics of Research Related to Health Care in Developing Countries by the Nuffield Council on Bioethics makes a number of innovative recommendations that depart from codes such as the Declaration of Helsinki. It recommends that standards of care might be relativised to the standard of that nation. It recommends that very good reasons (...) need to be given for not giving post-trial access to medications but recognises that there may be justifiable instances of this. It is the view of the authors that these and other recommendations of the report are sensible pieces of advice given the complexities of the developing world. (shrink)

Background: Increasing collaboration between industrialised and developing countries in human research studies has led to concerns regarding the potential exploitation of resource deprived countries. This study, commissioned by the former National Bioethics Advisory Commission of the United States, surveyed developing country researchers about their concerns and opinions regarding ethical review processes and the performance of developing country and US international review boards .Methods: Contact lists from four international organisations were used to identify and survey (...) 670 health researchers in developing countries. A questionnaire with 169 questions explored issues of IRB review, informed consent, and recommendations.Results: The majority of the developing country researchers were middle aged males who were physicians and were employed by educational institutions, carrying out research on part time basis. Forty four percent of the respondents reported that their studies were not reviewed by a developing country IRB or Ministry of Health and one third of these studies were funded by the US. During the review process issues such as the need for local language consent forms and letters for approval, and confidentiality protection of participants were raised by US IRBs in significantly higher proportions than by host country IRBs.Conclusion: This survey indicates the need for the ethical review of collaborative research in both US and host countries. It also reflects a desire for focused capacity development in supporting ethical review of research. (shrink)

ABSTRACT Background: The doctrine of informed consent (IC) exists to protect individuals from exploitation or harm. This study into IC was carried out to investigate how different researchers perceived the process whereby researchers obtained consent. It also examined researchers’ perspectives on what constituted IC, and how different settings influenced the process. Methods: The study recorded in‐depth interviews with 12 lecturers and five doctoral students, who had carried out research in developing countries, at a leading school of public health (...) in the United Kingdom. A purposive, snowballing approach was used to identify interviewees. Results: Although the concept and application of the doctrine of IC should have been the same, irrespective of where the research was carried out, the process of obtaining it had to be different. The setting had to be taken into consideration and the autonomy of the subject had to be respected at all times. In areas of high illiteracy, and where understanding of the subject was likely to be a problem, there was an added responsibility placed on the researcher to devise innovative ways of carrying out the study, taking into consideration the peculiarities of the environment. Conclusion: The ethical issues for IC were the same, irrespective of where the research was conducted. However, because the backgrounds, setting, and knowledge of populations differed, there was the need to be similarly sensitive in obtaining consent. The problems of obtaining genuine IC were not limited to developing countries. (shrink)

(2010). For-Profit Clinical Trials in Developing Countries—Those Troublesome Patient Benefits. The American Journal of Bioethics: Vol. 10, No. 6, pp. 52-54.

Dementia accompanies aging in certain susceptible individuals. The chemical function of the brain remains normal, but certain neurotransmitter-selective diseases, such as Parkinson's disease, Huntington's disease, and Alzheimer's disease occur more commonly with age.There are at least two issues troubling researchers of senile dementia at the moment. One is the contribution of cell death, as opposed to selective neuronal atrophy, to the pathology of degenerative disorders. The other is how early the onset of dementia might be detected. The resolution of such (...) issues is important for the design of therapies for the common and most serious chronic, rather than acute, neurodegenerative disease.Alzheimer's disease is one of the most devastating neurological disorders. The ethical debate is often related to when human biological life ceases or when a person ceases to exist. If the elder is still a person, he/she is no more the same person. Huntington's disease is inherited as a highly penetrant, autosomal dominant neuronal disorder. A genetic test can accurately predict a person's risk and that of the children. As the knowledge of the genetic basis is increasing and prenatal diagnosis gets easier, the possibilities to avoid child disorders will become greater, but genetic testing raises problematic ethical issues. Ethical action involves the right to know and the right not to know, it involves freedom of choice and freedom implies knowledge. It is ethical that relatives in age of procreation should be informed. In any case, efficacy and safety of the procedure, the risk-benefit ratio for a particular disease must be judged to be acceptable and understood through informed consent by the patient or the family or both. (shrink)

Dementia accompanies aging in certain susceptible individuals. The chemical function of the brain remains normal, but certain neurotransmitter-selective diseases, such as Parkinson's disease, Huntington's disease, and Alzheimer's disease occur more commonly with age.There are at least two issues troubling researchers of senile dementia at the moment. One is the contribution of cell death, as opposed to selective neuronal atrophy, to the pathology of degenerative disorders. The other is how early the onset of dementia might be detected. The resolution of such (...) issues is important for the design of therapies for the common and most serious chronic, rather than acute, neurodegenerative disease.Alzheimer's disease is one of the most devastating neurological disorders. The ethical debate is often related to when human biological life ceases or when a person ceases to exist. If the elder is still a person, he/she is no more the same person. Huntington's disease is inherited as a highly penetrant, autosomal dominant neuronal disorder. A genetic test can accurately predict a person's risk and that of the children. As the knowledge of the genetic basis is increasing and prenatal diagnosis gets easier, the possibilities to avoid child disorders will become greater, but genetic testing raises problematic ethical issues. Ethical action involves the right to know and the right not to know, it involves freedom of choice and freedom implies knowledge. It is ethical that relatives in age of procreation should be informed. In any case, efficacy and safety of the procedure, the risk-benefit ratio for a particular disease must be judged to be acceptable and understood through informed consent by the patient or the family or both. (shrink)

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. (shrink)

One of the areas of concern raised by cross-border reproductive travel regards the treatment of women who are solicited to provide their ova or surrogacy services to foreign consumers. This is particularly troublesome in the context of developing countries where endemic poverty and low standards for both medical care and informed consent may place these women at risk of exploitation and harm. We explore two contrasting proposals for policy development regarding the industry, both of which seek to promote (...) ethical outcomes and social justice: While one proposal advocates efforts to minimize cross-border demand for female reproductive resources through the pursuit of national self-sufficiency, the other defends cross-border trade as a means for meeting the needs of vulnerable groups. Despite the conflicting objectives of the proposed strategies, the paper identifies common values and points of agreement between the two, including the importance of regulations to safeguard those providing ova or surrogacy services. (shrink)

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. (shrink)

ABSTRACT Background: Explaining technical terms in consent forms prior to seeking informed consent to recruit into trials can be challenging in developing countries, and more so when the studies are randomized controlled trials. This study was carried out to examine the opinions of researchers on ways of dealing with these challenges in developing countries. Methods: Recorded in‐depth interviews with 12 lecturers and five doctoral students, who had carried out research in developing countries, at a (...) leading school of public health in the United Kingdom. A purposive, snowballing approach was used to identify interviewees. Results: Researchers were divided on the feasibility of explaining technical trials in illiterate populations; the majority of them held the view that local analogies could be used to explain these technical terms. Others were of the opinion that this could not be done since it was too difficult to explain technical trials, such as randomized controlled trials, even to people in developed countries. Conclusion: Researchers acknowledged the difficulty in explaining randomized controlled trials but it was also their perception that this was an important part of the ethics of the work of scientific research involving human subjects. These difficulties notwithstanding, efforts should be made to ensure that subjects have sufficient understanding to consent, taking into account the fact that peculiar situations in developing countries might compound this difficulty. (shrink)