Proper conduct of an AIDS vaccine trial in Africa must be informed not only by the epidemiology and biology of HIV infection in African settings, but also by the ethical norms and cultural constraints prevailing in African settings.

BackgroundAfrica continues to bear a disproportionate share of the global HIV/AIDS, tuberculosis (TB) and malaria burden. The development and distribution of safe, effective and affordable vaccines is critical to reduce these epidemics. However, conducting HIV/AIDS, TB, and/or malaria vaccine trials simultaneously in developing countries, or in populations affected by all three diseases, is likely to result in numerous ethical challenges.MethodsIn order to explore convergent ethical issues in HIV/AIDS, TB and malaria vaccine trials in Africa, the Ethics, (...) Law and Human Rights Collaborating Centre of the WHO/UNAIDS African AIDS Vaccine Programme hosted a consultation on the Convergent Ethical Issues in HIV/AIDS, TB and Malaria Vaccine Trials in Africa in Durban, South Africa on the 10-11 February 2009.ResultsKey cross cutting ethical issues were prioritized during the consultation as community engagement; ancillary care obligations; care and treatment; informed consent; and resource sharing.ConclusionThe consultation revealed that while there have been few attempts to find convergence on ethical issues between HIV/AIDS, TB and malaria vaccine trial fields to date, there is much common ground and scope for convergence work between stakeholders in the three fields. (shrink)

The response to the HIV/AIDS pandemic in Africa has so far ignored important traditional African values and attitudes toward disease and commerce. These values and attitudes are significantly different from the libertarian, market-driven, profit-oriented values and practices of important sectors of the Western world. To deal with this epidemic, the world should consider respect for, and possibly even adoption of those African values, which provide for people in genuine need, irrespective of their ability to pay. HIV/AIDS vaccine research (...) indigenous to Africa is also not always taken seriously, and struggles to find adequate funding for such research within or outside of the continent have been extremely difficult. A better appreciation of knowledge systems and values indigenous to the African experience is important in the fight against the HIV/AIDS pandemic. (shrink)

Research that is initiated, designed or funded by sponsor agencies based in countries with relatively high social and economic development, and conducted in countries that are relatively less developed, gives rise to many important ethical challenges. Although clinical trials of HIV vaccines began ten years ago in the US and Europe, an increasing number of trials are now being conducted or planned in other countries, including several that are considered “developing” countries. Safeguarding the rights and welfare of individuals participating (...) as research subjects in developing countries is a priority. In September, 1997, the Joint United Nations Programme on HIV/AIDS embarked on a process of international consultation; its purpose was further to define the important ethical issues and to formulate guidance that might facilitate the ethical design and conduct of HIV vaccine trials in international contexts. This paper summarises the major outcomes of the UNAIDS consultative process. (shrink)

This paper addresses the just distribution of vaccines against the SARS-CoV-2 virus and sets forth an ethical framework that prioritises frontline and essential workers, people at high risk of severe disease or death, and people at high risk of infection. Section I makes the case that vaccine distribution should occur at a global level in order to accelerate development and fair, efficient vaccine allocation. Section II puts forth ethical values to guide vaccine distribution including helping people with the greatest (...) need, reducing health disparity, saving the most lives and promoting narrow social utility. It also responds to objections which claim that earlier years have more value than later years. Section III puts forth a practical ethical framework to aid decision-makers and compares it with alternatives. (shrink)

This chapter contains sections titled: HIV Testing HIV Infection: Harm to Self or Harm to Others Access to Experimental Drugs and the Ethics of Research Clinical Trials Developing Preventive Vaccines Affordable Access to Life‐preserving Medication HIV Infection in Health‐care Professionals and Patients Final Remarks References Further reading.

The debate around vaccine passports has been polarising and controversial. Although the measure allows businesses to resume in-person operations and enables transitioning out of lockdown due to the COVID-19 pandemic, some have expressed concerns about liberty violations and discrimination. Understanding the splintered viewpoints can aid businesses in communicating such measures to employees and consumers. We conceptualise the business implementation of vaccine passports as a moral decision rooted in individual values that influence reasoning and emotional reaction. We surveyed support for vaccine (...) passports on a nationally representative sample in the United Kingdom in 2021: April (n = 349), May (n = 328), and July (n = 311). Drawing on the Moral Foundations Theory—binding (loyalty, authority, and sanctity), individualising (fairness and harm), and liberty values—we find that individualising values are a positive predictor and liberty values a negative predictor of support for passports, suggesting adoption hinges on addressing liberty concerns. Longitudinal analysis examining the trajectory of change in support over time finds that individualising foundations positively predict changes in utilitarian and deontological reasoning over time. In contrast, a fall in anger over time predicts increased support towards vaccine passports. Our study can inform business and policy communication strategies of existing vaccine passports, general vaccine mandates, and similar measures in future pandemics. (shrink)

ABSTRACTGiven the ethical controversies concerning HIV vaccine trials , we aimed to understand through an exploratory study how members of institutional review boards in the United States and research ethics committees in South Africa view issues concerning the process and content of reviews of these studies. We mailed packets of 20 questionnaires to 12 US IRB chairs and administrators and seven REC chairs to distribute to their members. We received 113 questionnaires . In both countries, members tended to be white (...) males with advanced academic degrees. Compared to the US, SA members called for ‘major changes’ in HVT protocols more frequently , and were less likely to think that HVT participants understood risks and benefits or informed consent forms . In both countries, members were divided on several critical issues , but agreed that they needed more training. Of the SA respondents, 40% reported that they were ‘self‐taught’ in ethics. This study, the first we know of to offer quantitative data comparing US vs. non‐US IRBs/RECs, thus suggests key similarities and differences , along with needs for education. These initial exploratory data in this area have important implications for IRBs, RECs, policy‐makers and scholars concerning future practice, training, policy, and investigations in research ethics, and prevention and treatment of HIV and other diseases in the developing world and elsewhere. (shrink)

Introduction Future HIV vaccine efficacy trials with adolescents will need to ensure that participants comprehend study concepts in order to confer true informed assent. A Hepatitis B vaccine trial with adolescents offers valuable opportunity to test youth understanding of vaccine trial requirements in general. Methods Youth reviewed a simplified assent form with study investigators and then completed a comprehension questionnaire. Once enrolled, all youth were tested for HIV and confirmed to be HIV-negative. Results 123 youth completed the questionnaire (mean age=15 (...) years; 63% male; 70% Hispanic). Overall, only 69 (56%) youth answered all six questions correctly. Conclusions Youth enrolled in a Hepatitis B vaccine trial demonstrated variable comprehension of the study design and various methodological concepts, such as treatment group masking. (shrink)

In few other areas of bioethical inquiry exists as close a connection between bioethical professional advice and policy development as is the case with HIV and AIDS. Historically, the reasons for this have much to do with one of the groups initially affected most severely by HIV and AIDS, namely well-educated middle-class gay men in developed countries. This particular group of people, highly sophisticated and used to political activism in its pursuit of civil rights-related objectives, engaged the medical (...) profession as well as regulatory agencies such as the US Food and Drug Administration, and legislators (more so in the USA than in other countries) in a number of bioethically interesting policy areas. Many of the controversies of the times were framed as civil rights and/or ethical disputes. The initial areas of concern and inquiry focused on: informed consent to HIV testing and trial participation, the confidentiality of HIV test results, access to trials as a means of access to experimental drugs, the length of time it took to get an experimental drug to the market approval stage, and end-of-life decision-making. This line-up of issues explains why AIDS has become such an interesting topic for bioethicists. Bioethicists concerned about the traditional breadand- butter themes of medical ethics themes of the doctor - patient relationship (e.g., Daniels, 1991; Boyd, 1992), as well as bioethicists more concerned about policy and regulatory issues in the drug research and approval process (e.g., Edgar & Rothman, 1990; Salisbury & Schechter, 1990), found research topics worthy of vigorous pursuit. No surprise, then, that HIV/AIDS led to a probably unprecedented number of books and articles in professional journals (Manuel et al., 1990). HIV/AIDS has become a permanent fixture in all major mainstream bioethics textbooks (e.g., Kuhse & Singer, 1998; Arras & Steinbock, 1999). Reference series in medicine, ethics and law provide for dedicated volumes on AIDS.1 Even specialist bioethics textbooks, for instance those directed at dentistry students, carry chapters on HIV/AIDS (Ozar & Sokol, 2002). 128 Udo Schuklenk AIDS, designated by the medical profession a pandemic lives up to its classification. It did not stop at the borders of developed countries. As one would expect of a primarily sexually transmitted illness in the age of globalisation, it spread rapidly across the globe. Indeed, in many countries it has become one of the main causes of death, as in sub- Saharan Africa (Shisana & Simbayi, 2002). Dramatic increases in the number of AIDS cases are predicted for many Eastern European countries as well as for the two most populous nations on earth, India and China. Some of the HIV/AIDS-related bioethical and policy issues of concern to developed countries remain the same for developing countries. However, in ethically important ways they are dwarfed by concerns over drug prices, intellectual property rights, and affordable access to essential AIDS drugs for the impoverished masses of infected people in such countries. Of increasing importance have become ethical issues pertaining to the ever-growing research industry associated with clinical trials undertaken in developing countries. Indeed, major funding initiatives both in the USA and UK have brought clinical research in developing countries into focus. Some have questioned whether this attention is appropriate, considering other bioethical problems of arguably greater importance to developing countries (Chadwick & Schuklenk, 2003). Standards of clinical care in a study, and after a trial has concluded, as well as community benefits and access to the trial regime after the trial’s conclusion remain contentious issues. It is worth noting that more often than not it was an AIDS-related trial or policy decision that led to a great deal of bioethical analysis, yet the issues discussed almost always have ramifications far beyond AIDS. For instance, decisions about the question of what (if any) standards of care failures in preventive trials (of HIV vaccines or microbicides) ought to receive have important implications for non-AIDS prevention trials. (shrink)

BackgroundFor over 35 years, Africa has continued to host HIV vaccine trials geared towards overturning the HIV/aids pandemic in the continent. However, the methods of sharing the vaccines, when available remain less certain. Therefore, the study aims to explore stakeholders’ perspectives in the global South, in this case, Tanzania, on how HIV vaccines ought to be fairly shared.MethodsThe study deployed a qualitative case study design. Data were collected through in-depth interviews and focus group discussions with a total (...) of 37 purposively selected participants. This included researchers, institutional review board members, a policymaker, HIV/aids advocates, and community advisory board members. The data obtained were inductively and deductively analyzed.Results Findings indicate that HIV vaccines can be shared fairly under the principles of distributive justice (contribution, need and equality). Thus, contribution-based sharing ought to be utilized upon the necessity to prioritize vaccine access or subsidized trial benefits to host communities. Need-based sharing ought to be considered for non-host communities that are at an increased risk of HIV infection. Lastly, equal-based sharing would be useful at later stages of vaccine distribution or when the aforementioned principles are deemed morally inappropriate. However, none of the benefit-sharing approaches is free of limitations and a counterbalancing sense of unfairness.ConclusionFair sharing of HIV vaccines, when available, ought to be informed by the contribution, need and equality principles of distributive justice. Countries in the global south including Tanzania are likely to be prioritized during the distribution of the HIV vaccines due to their participation in HIV vaccine trials and due to the disproportionate HIV burden evident in the region. (shrink)

Problems posed by HIV/AIDS differ from those ofpast epidemics by virtue of unique propertiesof the causative agent, dramatic societalchanges of the late 20th century, and thetransition of medical practice from aprofessional ethic to a technology-dependentbusiness ethic. HIV/AIDS struck during thecoming-of-age of molecular biology and also ofbioethics, and the epidemic stimulated thegrowth of both disciplines. The number ofarticles published about AIDS and ethics (asidentified by a MEDLINE search) peaked in 1990,just before the peak incidence of AIDS in (...) theUnited States. The character of ethicaldialogue has now shifted from familiar moralquandaries such as civil liberty versus publicwelfare to concerns about vaccine trials andpublic policy toward the developing world.Physicians and other health care workers whowere involved from the onset endured somethingof an emotional roller coaster. Theircompassion-based work ethic was to a largeextent replaced by a competence-based workethic after the introduction in 1996 of highlyactive antiretroviral therapy. The abundantrecent literature on ``professionalism'' inmedicine makes scant mention of AIDS/HIV. Thedisruptive effect of AIDS/HIV on society wouldhave been substantially greater had relevanttechnology such as the ability to isolateretroviruses and potent therapy againsttuberculosis not been in place. This soberingconsideration, along with such recent events asthe use of bioterrorism against civilianpopulations, suggests new relevance forPotter's definition of ``bioethics'' as a scienceof survival in which the biology of ecosystemsmust be taken into account. (shrink)

Debates about what constitutes benefits in human research continue to be less informed due to a lack of empirical evidence from the developing world. This study aimed to explore what constitutes benefits in HIV vaccine trials in Tanzania and examine inherent ethical implications. A qualitative case study design was deployed and a total of 29 purposively selected study participants comprising of experienced researchers, institutional review board members and community advisory board members were included. Collected data were analyzed by thematic analysis (...) aided by computer software: MAXQDA version 20.4.0. The study findings indicate that there is a growing appreciation of benefits beyond actual vaccines to include 1) capacity building at individual, community, institutional and regulatory levels; and 2) non‐capacity building related benefits such as strengthened collaborations, ancillary care and employment opportunities. So, as the struggle for viable HIV vaccines continues, other benefits that have accrued from such trials are not to be blindsided especially for developing countries like Tanzania. (shrink)

The theory that AIDS originated from contaminated polio vaccines raises a number of challenging issues with ethical dimensions. The Journal of Medical Ethics dealt with a submission about the theory a decade ago; subsequent developments have raised further issues. Four areas of contention are addressed: whether the theory should be investigated; whether anyone should be blamed; whether defamation actions are appropriate, and whether the scientific community has a responsibility to examine unorthodox theories.

In the decade following hepatitis B vaccine’s 1981 approval, U.S. health officials issued evolving guidelines on who should receive the vaccine: first, gay men, injection drug users, and healthcare workers; later, hepatitis B-positive women’s children; and later still, all newborns. States laws that mandated the vaccine for all children were quietly accepted in the 1990s; in the 2000s, however, popular anti-vaccine sentiment targeted the shot as an emblem of immunization policy excesses. Shifting attitudes toward the vaccine in this period were (...) informed by hepatitis B’s changing popular image, legible in textual and visual representations of the infection from the 1980s through the 1990s. Notably, the outbreak of AIDS, the advent of genetically engineered pharmaceuticals, and a Democratic push for health reform shaped and reshaped hepatitis B’s public image. Hepatitis B thus became, in turn, an AIDS-like scourge; proof of a new era of pharmaceuticals; a threat from which all American children had a right to be protected; and a cancer-causing infection spread by teenage lifestyles. The metamorphosis of the infection’s image was reflected in evolving policy recommendations regarding who should receive the vaccine in the 1980s, and was key to securing broad uptake of the vaccine in the 1990s. (shrink)

Intense scientific work on HIV/AIDS has led to the development of effective combination drug therapies and there is hope that effective vaccines will soon be produced. However, the majority of people with HIV/AIDS in the world are not benefiting from such advances because of extreme poverty. This article focuses on the pandemic as a reflection of a complex trajectory of social and economic forces that create widening global disparities in wealth and health and concomitant ecological niches for (...) the emergence of new infectious diseases. While the biomedical approach to HIV/AIDS is necessary, has prolonged the lives of many individuals and could offer much at the level of population health, it cannot, in isolation, improve the health of populations. To achieve the latter will require understanding and addressing the deeper social causes of pandemics. Broadening the discourse on ethics to include public health ethics and the ethics of international relations could contribute to reducing the impact of the pandemic and to preventing the emergence of new infectious diseases in the future. (shrink)

Tuberculosis (TB) is one of the world’s leading causes of death due to infection and efforts to control TB would be substantially aided by the availability of an improved TB vaccine. There are currently nine new TB vaccines in clinical development, and the first efficacy trials are due to commence in 2009. There are many complex ethical issues which arise at all stages of TB vaccine development, from the need to conduct trials in developing countries to informed consent and (...) the process of ethical review. While it is important that these issues are discussed, it may also be timely to consider the challenges which may arise if a vaccine in clinical development proves to be highly effective. We examine a number of scenarios where decisions on the deployment of a new TB vaccine may impact on the rights and liberty of the individual. (shrink)

Background A morally sound framework for benefit-sharing is crucial to minimize research exploitation for research conducted in developing countries. However, in practice, it remains uncertain which stakeholders should be involved in the decision-making process regarding benefit-sharing and what the implications might be. Therefore the study aimed to empirically propose a framework for benefit-sharing negotiations in research by taking HIV vaccine trials as a case. Methods The study was conducted in Tanzania using a case study design and qualitative approaches. Data were (...) collected using in-depth interviews (IDI) and focus group discussions (FGD). A total of 37 study participants were selected purposively comprising institutional review board (IRB) members, researchers, community advisory board (CAB) members, a policymaker, and HIV/AIDS advocates. Deductive and inductive thematic analysis approaches were deployed to analyze collected data with the aid of MAXQDA version 20.4.0 software. Results The findings indicate a triangular relationship between the research community, researched community and intermediaries. However, the relationship ought to take into consideration the timing of negotiations, the level of understanding between parties and the phase of the clinical trial. The proposed framework operationalize partnership interactions in community-based participatory research. Conclusion In the context of this study, the suggested framework incorporates the research community, the community being researched, and intermediary parties. The framework would guarantee well-informed and inclusive decision-making regarding benefit-sharing in HIV vaccine trials and other health-related research conducted in resource-limited settings. (shrink)

Background. To inform their health decisions, patients may seek narratives describing other patients' evaluations of their treatment experiences. Narratives can provide anti-treatment or pro-treatment evaluative meaning that low-numerate patients may especially struggle to derive from statistical information. Here, we examined whether anti-vaccine narratives had relatively stronger effects on the perceived informativeness and judged vaccination probabilities reported among recipients with lower numeracy. Methods. Participants from a nationally representative US internet panel were randomly assigned to an anti-vaccine or pro-vaccine narrative, as presented (...) by a patient discussing a personal experience, a physician discussing a patient's experience, or a physician discussing the experiences of 50 patients. Anti-vaccine narratives described flu experiences of patients who got the flu after getting vaccinated; pro-vaccine narratives described flu experiences of patients who got the flu after not getting vaccinated. Participants indicated their probability of getting vaccinated and rated the informativeness of the narratives. Results. Participants with lower numeracy generally perceived narratives as more informative. By comparison, participants with higher numeracy rated especially anti-vaccine narratives as less informative. Anti-vaccine narratives reduced the judged vaccination probabilities as compared with pro-vaccine narratives, especially among participants with lower numeracy. Mediation analyses suggested that low-numerate individuals' vaccination probabilities were reduced by anti-vaccine narratives - and, to a lesser extent, boosted by pro-vaccine narratives - because they perceived narratives to be more informative. These findings were similar for narratives provided by patients and physicians. Conclusions. Patients with lower numeracy may rely more on narrative information when making their decisions. These findings have implications for the development of health communications and decision AIDS. (shrink)

This bibliographical study involved first the exploitation of four data-banks: Medline, CNRS, Bioethics and AIDS, with the following key words (in conjunction with AIDS): ethics, human rights, confidentiality, legislation, jurisprudence. A total of 412 references were listed between 1983 and the end of 1987. Examination of the quantitative increase of articles over these years shows that, while references to AIDS and/or HIV infection--referred to as 'AIDS' for brevity--increased by about one third per year, the number of (...) papers treating ethical problems linked to AIDS doubled each year. This increase makes it clear that these problems are important and pressing, that they are evolving rapidly and can be given no easy solution. After reading and analysis of accessible articles in readily comprehensible languages, the different themes can be classified in two categories: 1: Measures intended to protect society (starting with the most coercive); quarantine and isolation; discriminatory measures concerning specific groups; non-respect of the confidential nature of medical information; application of the penal code; screening; obligatory declaration and registration; testing of blood given by donors; vaccination and medical innovations, therapeutic assays; information, education. 2. Measures intended to protect the individual: fundamental rights of the patient: his/her right to confidentiality, to information and to treatment; civil rights: civil liberty, right to education, right to work, etc...; rights of the healthy individual: right of those in contact with the patients, safety of hospital staff, of those receiving blood-transfusions, etc... The legislation adopted in the various countries and the main opinions to be found in these articles are listed and analysed, and for each particular theme it is possible to refer to a list of the 232 most important articles. While the debate seems to concentrate on the conflict between the right of society to protect itself against the spread of infection and the 'civil' rights of the infected minorities, our conclusion tends to reduce this antagonism, showing that, particularly as far as the confidential nature of medical information is concerned, measures intended to protect the individual also protect society. (shrink)

Here are the 18 guidance points contained in the UNAIDS document on Ethical Considerations in HIV Preventive Vaccine Research, reproduced by kind permission of the Joint United Nations Programme on HIV/AIDS.

In lieu of an abstract, here is a brief excerpt of the content:Closing the Gaps in Pediatric HIV/AIDS Care, One Step at a TimeLisa V. Adams, Helga Naburi, Goodluck Lyatuu, Paul Palumbo, and C. Fordham von ReynFatuma's* doctors were completely perplexed. It was 2003 and she had returned to the DARDAR clinic in her hometown of Dar es Salaam, Tanzania three times that week with vague complaints of various pains and aches. Her doctors were considering whether these symptoms were (...) due to the initiation of her recent treatment with antiretroviral medications for her HIV infection or related to the last administration of the investigational tuberculosis (TB) vaccine that the DARDAR Health Study was evaluating. Fatuma's doctor, Dr. Lillian Mtei, consulted with Dartmouth's chief of Infectious Disease, Dr. Ford von Reyn, who happened to be in Dar that week on a site visit. Neither physician could determine the basis for her symptoms. Dr. Mtei returned to the exam room once more and this time emerged with the answer: Fatuma had just learned that her three year old daughter was HIV-infected, likely contracted from Fatuma during or shortly after she gave birth to her daughter. Fatuma believed that her HIV diagnosis was a death sentence for her daughter since antiretroviral therapy was not widely available for children.Dr. von Reyn, Dartmouth's lead clinical researcher in Africa and a father, knew too well the harsh reality of inequities in a resource-limited country. He turned to Dr. Mtei and said decidedly, "we need to do something about this."Thus the DARDAR Pediatric Program was born.Pediatric HIV: A Neglected DiseaseThe need for HIV treatment among children in Tanzania, as in most of sub-Saharan Africa, is compelling. At the end of 2009, approximately 160,000 children aged zero to fourteen in Tanzania were living with HIV (Joint United Nations Programme on HIV/AIDS [UNAIDS], 2011). Even with successful roll out of prevention of mother to child transmission programs in Tanzania, there were nearly 29,000 perinatal infections in 2009. As of December 2010, only 18% of these were enrolled in HIV treatment programs (UNAIDS, 2011; World Health Organization [WHO], 2011). Without antiretroviral therapy (ART), one-half of HIV-infected children will die before their second birthday. Since clinical research to determine efficacy and safety of new medical treatments is conducted almost exclusively in adults, provision of new medical treatments to [End Page 75] children always lags behind advances for adults. Furthermore, children are often underrepresented in programs for antiretroviral drugs for the following reasons: 1) they are not prioritized for care; 2) facilities lack infant diagnostic capabilities; 3) there is limited pediatric HIV training and consequently, a shortage of pediatric providers; and 4) pediatric antiretroviral formulations are frequently unavailable. The unacceptable delays in pediatric HIV drug development and treatment access led the international organization Drugs for Neglected Diseases initiative to publish an editorial in which they referred to pediatric HIV as a "neglected disease" (Lallemant, Chang, Cohen, & Pecoul, 2011).The Tip of the Iceberg: More than Just MedicinesWith a grant from the New York-based Foundation for the Treatment of Children with AIDS, the DARDAR Pediatric Program, a joint collaboration between Geisel School of Medicine at Dartmouth and Muhimbili University of Health and Allied Sciences, began seeing patients in May 2006. It was the first dedicated pediatric HIV Care and Treatment Center in Tanzania and operates in accordance with Tanzania's National AIDS Control Programme's guidance. Testing for both children and infants (the latter of which requires a more sophisticated assay) is available.The day the clinic opened we celebrated this collaborative effort that would provide HIV-infected children in Dar es Salaam access to antiretroviral treatment. One of our first patients was a six-year-old boy whose mother, like Fatuma, was a participant in our TB vaccine trial. She had been advised to bring her son to us for HIV screening. Her son looked healthy so she was surprised and understandably distraught when his test results indicated that not only was he HIV-infected, but his CD4 percentage was very low. His mother was reluctant to have him started on antiretrovirals given his general appearance and young age—and that he was... (shrink)

This paper surveys the historiography of the global response to HIV/AIDS. Since 1981, when the disease was first identified, there have been great strides in the medical and biological sciences in understanding the impact of the new virus on the human immune system. Although there is still no successful vaccine, antiretroviral (ART) treatment continues to improve the likelihood of HIV-positive people living long and healthy lives. We have also seen a few exciting cases of full recovery, which will allow (...) scientists to explore new avenues towards a cure. Yet the AIDS pandemic is by no means over: 40 million have died and over 35 million individuals still live with HIV. More importantly, as historians and scholars in the humanities and social sciences have been pointing out since the early 1980s, HIV brought to light how non-medical factors play a critical role in a successful disease response. As the global community faces the aftermath of a new pandemic, it is timely to examine how broader social, economic, political, and cultural factors influence individual experiences of disease at local, national, international, and global scales. This essay examines how scholars have written historically about the HIV pandemic, using a variety of methods and approaches: from traditional histories of medicine to anthropologies of development. While HIV has sparked a massive corpus of historical reflection from a variety of disciplines, its contemporaneity means that “global AIDS historiography” cannot yet be described as a cohesive academic conversation. Yet what unites the scholarship, this essay argues, is its use of HIV to examine how and why post-war social and economic systems have achieved health objectives for some populations and not others. (shrink)

Biotechnology and genomic innovation are seen as increasingly important for achieving public health goals in Africa. In particular, vaccines based on advances in genomic technology are deemed vital in the fight against HIV/aids. Public-Private Partnerships (PPPs) provide a collaborative mechanism to ensure these vaccines are developed when the private sector lacks incentives to develop these products. These partnerships provide new mechanisms for transferring the knowledge required to ensure vaccine development occurs as quickly and efficiently as possible. One (...) such accine partnership is the South African AIDS Vaccine Initiative (SAAVI). This has been successful in ensuring 'value added' (benefit gained by taking part) is created for those involved particularly in the area of intangible value added determinants of collaboration and knowledge capacity. This paper outlines the results of a case study of SAAVI and argues that it provides evidence of a need to strengthen our understanding of the linkage between wider conceptual 'systems' of innovation and health. In particular, it espouses the usefulness of 'Systems of Innovation' thinking as a means to ensure that more specific focus is placed on process outputs such as collaboration and knowledge capacity. This will ensure that necessary knowledge flow is transferred between those working in the vaccine project for more efficient and effective operations. The research also raises questions about the possibility of such case studies highlighting areas of attention that need addressing if greater linkage is to occur between innovation and health at a wider health research policy level. (shrink)

Last year there was a heated debate regarding clinical trials with AZT carried out in developing countries. AIDs vaccine trials also posed various dilemmas and ethical problems. In this paper I will consider the possibility of corruption in bioethics, and international multi‐centre research will be taken as an example. International clinical trials will be seen from another perspective. I will try to show that the possibility of systemic corruption should be considered when designing an international multi‐centre research trial which (...) may involve countries in very different situations regarding corruption. I will analyze three different approaches to this problem and suggest some strategies regarding their capacity to exclude the possibility of corruption. (shrink)

Background. The increased number of clinical trials taking place in developing countries and the complexity of trial protocols mandate that local ethics review committees reviewing them have the capacity to ensure that they are conducted to the highest ethical standards.Methods. The Kenya AIDS Vaccine Initiative Institute of Clinical Research and the Kenyan National Council for Science and Technology embarked on an exercise to enhance the capacity of ERCs in Kenya to review such protocols. This process involved conducting an audit (...) of all ERCs in the country, and performing training needs assessments to identify knowledge and capacity gaps. Information obtained was used to develop training materials for ERC members at workshops conducted in different parts of the country.Results. Five accredited and 13 non-accredited ERCs were identified. Four of the accredited ERCs were located in the capital city of Kenya, Nairobi. The most common challenges cited by participants during the needs assessments were excess workload, and a lack of co-ordination and/or communication between the ERCs. Subsequently, 140 ERC members from 17 institutions across the country were trained as follows: 36 from institutions in the western part of Kenya, 38 from institutions in the south-eastern coastal region, 38 from the eastern region and 44 from Nairobi.Conclusion. The KAVI-ICR and the NCST have developed training modules for training ERC members in Kenya and are in the process of developing a manual to train members. The Kenyan experience may be used to enhance the capacity of ERCs in the East African region. (shrink)

This paper recounts the efforts of a Bioethics student to understand the experience of human subjects of medical research in Kenya. Although the endeavor resulted in more questions than answers, it served to highlight areas where the current system of protections has failed to secure the well-being of those involved. It concludes that, in addition to existing considerations, ethical review ought to include another kind of information: that which can be gained only from listening to the feelings and experiences related (...) by subjects themselves. (shrink)

Remaining important tasks in finding and developing new drugs and vaccines for HIV/AIDS, malaria, cancer and other diseases require continued industry research and development. Industry’s research and development pipeline has produced drugs that have saved AIDS victims previously facing certain death, but still no cure nor vaccine is yet available. Experience with the process of research and development indicates that it requires more than a decade of development to produce a new drug with costs in the hundreds (...) of millions of dollars. Intellectual property protection is critically important in assuring that drug development continues. Partnerships between industry and the public sector have increased access to new therapies in developing countries and promise to enhance access to both patented and generic medicines in the future. (shrink)

Two articles in the September–October 2022 issue of the Hastings Center Report discuss health‐related reasons that people might have to actively bring their lives to an end. In one, Brent Kious considers the situation of a person who, because of illness, becomes a burden on loved ones. A person in such a situation might prefer to die, and Kious argues that, while there is no obligation to hasten one's death, the choice to do so could sometimes be reasonable. In a (...) second article, Henri Wijsbek and Thomas Nys discuss a case in the Netherlands in which a woman with severe dementia was euthanized at a point when her advance euthanasia directive did not align with what she said, when asked, about death. Wijsbek and Nys defend the authority of her advance directive against a range of objections.In a third article, Henry Silverman and Patrick Odonkor, physicians at the University of Maryland Medical Center, where the first pig‐to‐human heart transplantation was performed in early 2022, develop recommendations for clinical trials of porcine heart transplantation. And an essay in the issue criticizes the allocation recommendations developed for Covid‐19 vaccines by the U.S. Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices. (shrink)

Next SectionAccess to medicines, vaccination and care in resource-poor settings is threatened by the emigration of physicians and other health workers. In entire regions of the developing world, low physician density exacerbates child and maternal mortality and hinders treatment of HIV/AIDS. This article invites philosophers to help identify ethical and effective responses to medical brain drain. It reviews existing proposals and their limitations. It makes a case that, in resource-poor countries, ’locally relevant medical training’—teaching primarily locally endemic diseases and (...) practice in scarcity conditions, training in rural communities and admitting rural students preferentially—could help improve retention. Locally relevant training would arguably diminish medical brain drain in five ways. It would (i) make graduates less attractive for Western employers, (ii) align graduates’ expectations with actual practice, diminishing ‘burn-out’, (iii) enhance the professional prestige of local practice, (iv) hold rotations in, and recruit applicants from, rural areas, which is known to improve retention there, and (v) create local career development options that attract practitioners to stay. Such educational reform may raise worries about poor-quality care, breach of the freedom of education and occupation, breach of the freedom of movement, unequal distribution of opportunities among students, hypocrisy and resistance from influential actors. We address these worries. (shrink)

Remaining important tasks in finding and developing new drugs and vaccines for HIV/AIDS, malaria, cancer and other diseases require continued industry research and development. Industry’s research and development pipeline has produced drugs that have saved AIDS victims previously facing certain death, but still no cure nor vaccine is yet available. Experience with the process of research and development indicates that it requires more than a decade of development to produce a new drug with costs in the hundreds (...) of millions of dollars. Intellectual property protection is critically important in assuring that drug development continues. Partnerships between industry and the public sector have increased access to new therapies in developing countries and promise to enhance access to both patented and generic medicines in the future. (shrink)

This article examines how growing fears, insecurities and uncertainties during the COVID-19 pandemic have prompted an emotional distance from others. The aim is to explore how global solidarity and nationalism are challenged and constructed as collective emotional processes concerning ‘others’. Drawing on social theories of emotions during crises and emotions towards others, this study looks at policy decisions around vaccines and health services and their associated emotions in the context of Korea, which has a relatively small migrant population and (...) a short history of supporting people in lower-income countries. The study finds that the COVID-19 pandemic has strengthened nationalism, both ethnic nationalism and cosmopolitan nationalism. This points to the need to highlight global norms such as human rights and justice and cultivate foundational emotions such as empathy and compassion. This article suggests paying attention to the role of emotions in generating othering practices and developing global solidarity. (shrink)

There is too much that we do not know about COVID-19. The longer we take to find it out, the more lives will be lost. In this paper, we will defend a principle of risk parity: if it is permissible to expose some members of society (e.g. health workers or the economically vulnerable) to a certain level of ex ante risk in order to minimize overall harm from the virus, then it is permissible to expose fully informed volunteers to a (...) comparable level of risk in the context of promising research into the virus. We apply this principle to three examples of risky research: skipping animal trials for promising treatments, human challenge trials to speed up vaccine development, and low-dose controlled infection or “variolation.” We conclude that if volunteers, fully informed about the risks, are willing to help fight the pandemic by aiding promising research, there are strong moral reasons to gratefully accept their help. To refuse it would implicitly subject others to still graver risks. (shrink)

This seminal collection on the ethical issues associated with infectious disease is the first book to correct bioethics’ glaring neglect of this subject. Timely in view of public concern about SARS, AIDS, avian flu, bioterrorism and antibiotic resistance. Brings together new and classic papers by prominent figures. Tackles the ethical issues associated with issues such as quarantine, vaccination policy, pandemic planning, biodefense, wildlife disease and health care in developing countries.

This seminal collection on the ethical issues associated with infectious disease is the first book to correct bioethics’ glaring neglect of this subject. Timely in view of public concern about SARS, AIDS, avian flu, bioterrorism and antibiotic resistance. Brings together new and classic papers by prominent figures. Tackles the ethical issues associated with issues such as quarantine, vaccination policy, pandemic planning, biodefense, wildlife disease and health care in developing countries.

Modern medicine has done much in the fields of infectious diseases and emergencies to aid cure. In most other fields, it is mostly control that it aims for, which is another name for palliation. Pharmacology, psychopharmacology included, is mostly directed towards such control and palliation too. The thrust, both of clinicians and research, must now turn decisively towards prevention and cure. Also, longevity with well-being is modern medicine's other big challenge. Advances in vaccines for hypertension, diabetes, cancers etc, deserve (...) attention; as also, the role of meditation, yoga, spirituality etc in preventing disease at various levels. Studies on longevity, life style changes and healthy centenarians deserve special scrutiny to find what aids longevity with wellbeing. A close look at complementary and alternative medicine is needed to find any suitable models they may have, cutting aside their big talk and/or hostility towards mainstream medical care. Medicine is a manifestation of the human eros, and should not become a means of its thanatos. It must realise its true potential, so that eros prevails, and thanatos prevails only ultimately, not prematurely. (shrink)

This paper discusses how to apply a collective decision model of the principle of voluntary informed consent in African communitarian culture, in a culturally sensitive way, in order to protect research candidates from potential exploitations and abuses. Dismissing cultural and ethical skepticism surrounding the global application of the principle of voluntary informed consent, the paper ultimately concludes that international collaboration on diagnostic and therapeutic medical research in Africa, especially HIV vaccine trials, is a moral imperative.

The scientific community, we hold, often provides society with knowledge—that the HIV virus causes AIDS, that anthropogenic climate change is underway, that the MMR vaccine is safe. Some deny that we have this knowledge, however, and work to undermine it in others. It has been common to refer to such agents as “denialists”. At first glance, then, denialism appears to be a form of skepticism. But while we know that various denialist strategies for suppressing belief are generally effective, little (...) is known about which strategies are most effective. We see this as an important first step toward their remediation. This paper leverages the approximate comparison to various forms of philosophical skepticism to design an experimental test of the efficacy of four broad strategies of denial at suppressing belief in specific scientific claims. Our results suggest that assertive strategies are more effective at suppressing belief than questioning strategies. (shrink)

In the lead article of the May‐June 2021 issue of the Hastings Center Report, Nancy Jecker and Caesar Atuire argue that the Covid‐19 crisis is best understood as a syndemic, “a convergence of biosocial forces that interact with one another to produce and exacerbate clinical disease and prognosis.” A syndemic framework, the authors advise, will enable bioethicists to recognize the ethical principles that should guide efforts to reduce the unequal effects that Covid‐19 has on populations. Drawing on sub‐Saharan African conceptions (...) of solidarity, the authors lay out an approach to global vaccine distribution that prioritizes low‐ and middle‐income countries. Like Jecker and Atuire's article, an essay by philosopher Keisha Ray pushes bioethicists to recognize broader justice‐oriented responsibilities with the aid of a wide‐angle lens. Ray's essay focuses on contemporary examples of environmental injustices that sicken, disable, or kill Black people. (shrink)