Showing papers in "Developing World Bioethics in 2013"

Engaging Communities to Strengthen Research Ethics in Low-Income Settings: Selection and Perceptions of Members of a Network of Representatives in Coastal Kenya

Abstract: There is wide agreement that community engagement is important for many research types and settings, often including interaction with ‘representatives’ of communities. There is relatively little published experience of community engagement in international research settings, with available information focusing on Community Advisory Boards or Groups (CAB/CAGs), or variants of these, where CAB/G members often advise researchers on behalf of the communities they represent. In this paper we describe a network of community members (‘KEMRI Community Representatives’, or ‘KCRs’) linked to a large multi-disciplinary research programme on the Kenyan Coast. Unlike many CAB/Gs, the intention with the KCR network has evolved to be for members to represent the geographical areas in which a diverse range of health studies are conducted through being typical of those communities. We draw on routine reports, self-administered questionnaires and interviews to: 1) document how typical KCR members are of the local communities in terms of basic characteristics, and 2) explore KCR's perceptions of their roles, and of the benefits and challenges of undertaking these roles. We conclude that this evolving network is a potentially valuable way of strengthening interactions between a research institution and a local geographic community, through contributing to meeting intrinsic ethical values such as showing respect, and instrumental values such as improving consent processes. However, there are numerous challenges involved. Other ways of interacting with members of local communities, including community leaders, and the most vulnerable groups least likely to be vocal in representative groups, have always been, and remain, essential.

Prevalence of Scientific Misconduct Among a Group of Researchers in Nigeria

Abstract: Background: There is a dearth of information on the prevalence of scientific misconduct from Nigeria. Objectives: This study aimed at determining the prevalence of scientific misconduct in a group of researchers in Nigeria. Factors associated with the prevalence were ascertained. Method: A descriptive study of researchers who attended a scientific conference in 2010 was conducted using the adapted Scientific Misconduct Questionnaire-Revised (SMQ-R). Results: Ninety-one researchers (68.9%) admitted having committed at least one of the eight listed forms of scientific misconduct. Disagreement about authorship was the most common form of misconduct committed (36.4%) while plagiarism was the least (9.2%). About 42% of researchers had committed falsification of data or plagiarism. Analysis of specific acts of misconduct showed that committing plagiarism was inversely associated with years in research (Fisher exact p-value = 0.02); falsifying data was related to perceived low effectiveness of the institution’s rules and procedures for reducing scientific misconduct (X 2 = 6.44, p-value = 0.01); and succumbing to pressure from study sponsor to engage in unethical practice was related to sex of researcher (Fisher exact p-value = 0.02). Conclusions: The emergent data from this study is a cause for serious concern and calls for prompt intervention. The best response to reducing scientific misconduct will proceed from measures that contain both elements of prevention and enforcement. Training on research ethics has to be integrated into the curriculum of undergraduate and postgraduate students while provision should be made for in-service training of researchers. Penalties against acts of scientific misconduct should be enforced at institutional and national levels.

Evolving friendships and shifting ethical dilemmas: fieldworkers' experiences in a short term community based study in Kenya.

Abstract: Fieldworkers (FWs) are community members employed by research teams to support access to participants, address language barriers, and advise on culturally appropriate research conduct. The critical role that FWs play in studies, and the range of practical and ethical dilemmas associated with their involvement, is increasingly recognised. In this paper, we draw on qualitative observation and interview data collected alongside a six month basic science study which involved a team of FWs regularly visiting 47 participating households in their homes. The qualitative study documented how relationships between field workers and research participants were initiated, developed and evolved over the course of the study, the shifting dilemmas FWs faced and how they handled them. Even in this one case study, we see how the complex and evolving relationships between fieldworkers and study participants had important implications for consent processes, access to benefits and mutual understanding and trust. While the precise issues that FWs face are likely to depend on the type of research and the context in which that research is being conducted, we argue that appropriate support for field workers is a key requirement to strengthen ethical research practice and for the long term sustainability of research programmes.

Field workers at the interface.

Abstract: This issue of Developing World Bioethics includes a collection of papers on intermediary staff and volunteers working at the interface between research institutions and researchers, and the communities from which research participants are recruited. ‘Field worker’ – a short hand commonly used in many research settings – refers here to those whose main role is face-to-face engagement with participants, who usually speak the participants’ first language, who are from or live in the study areas, and whose work entails moving around the study areas or health facilities. Field workers can be differentiated from medical or scientific staff for whom only part of their duties entail direct interaction with participants, and who are primarily based in the research institution or the clinic. In international research settings field workers are variously called research assistants, community interviewers, data collectors, fieldworkers, field assistants, assessors, follow up staff or defaulter tracers. Although some may hold first degrees or certificates, many are secondary school leavers without higher education opportunity; overall they are formally less qualified than clinical and research staff. Instead, field workers often have extensive informal training and experience from earlier volunteering and jobs in research centres or the NGO sector, which often require similar tasks and expertise.1 Their roles may include communicating about studies and mobilisation and follow-up of participants, conducting interviews, and carrying out relatively simple biomedical data-collection procedures such as taking temperatures and collecting finger prick blood samples.

Ethical Considerations in Determining Standard of Prevention Packages for HIV Prevention Trials: Examining PrEP

Abstract: The successful demonstration that antiretroviral (ARV) drugs can be used in diverse ways to reduce HIV acquisition or transmission risks – either taken as pre-exposure prophylaxis (PrEP) by those who are uninfected or as early treatment for prevention (T4P) by those living with HIV – expands the armamentarium of existing HIV prevention tools. These findings have implications for the design of future HIV prevention research trials. With the advent of multiple effective HIV prevention tools, discussions about the ethics and the feasibility of future HIV prevention trial designs have intensified. This article outlines arguments concerning the inclusion of newly established ARV-based HIV prevention interventions as standard of prevention in HIV prevention trials from multiple perspectives. Ultimately, there is a clear need to incorporate stakeholders in a robust discussion to determine the appropriate trial design for each study population.

Ethical challenges that arise at the community interface of health research: village reporters' experiences in Western Kenya.

Abstract: Community Engagement (CE) has been presented by bio-ethicists and scientists as a straightforward and unequivocal good which can minimize the risks of exploitation and ensure a fair distribution of research benefits in developing countries. By means of ethnographic fieldwork undertaken in Kenya between 2007 and 2009 we explored how CE is understood and enacted in paediatric vaccine trials conducted by the Kenyan Medical Research Institute and the US Centers for Disease Control (KEMRI/CDC). In this paper we focus on the role of paid volunteers who act as an interface between villagers KEMRI/CDC. Village Reporters’ (VRs) position of being both with the community and with KEMRI/CDC is advantageous for the conduct of trials. However it is also problematic in terms of exercising trust, balancing allegiances and representing community views. VRs role is shaped by ambiguities related to their employment status and their dual accountability to researchers and their villages. VRs are understandably careful to stress their commitment to self-less community service since it augments their respectability at community level and opens up opportunities for financial gain and self-development. Simultaneously VRs association with KEMRI/CDC and proximity to trial participants requires them to negotiate implicit and explicit expectations for material and medical assistance in a cultural setting in which much importance is placed on sharing and mutuality. To ensure continuity of productive interactions between VRs, and similar community intermediaries, and researchers, open discussion is needed about the problematic aspects of relational ethics, issues concerning undue influence, power relations and negotiating expectations.

Working with Community Health Workers as ‘Volunteers’ in a Vaccine Trial: Practical and Ethical Experiences and Implications

Abstract: Community engagement is increasingly emphasized in biomedical research, as a right in itself, and to strengthen ethical practice We draw on interviews and observations to consider the practical and ethical implications of involving Community Health Workers (CHWs) as part of a community engagement strategy for a vaccine trial on the Kenyan Coast CHWs were initially engaged as an important network to be informed about the trial However over time, and in response to community advice, they became involved in trial information sharing and identifying potential participants; thereby taking on roles that overlapped with those of employed fieldworkers (FWs) While CHWs involvement was generally perceived as positive and appreciated, there were challenges in their relations with FWs and other community members, partly related to levels and forms of remuneration Specifically, payment of CHWs was not as high as for FWs and was based on ‘performance’ This extrinsic motivation had the potential to crowd out CHWs intrinsic motivation to perform their pre-existing community roles CHWs remuneration potentially also contributed to CHWs distorting trial information to encourage community members to participate; and to researchers encouraging CHWs to utilize their social connections and status to increase the numbers of people who attended information giving sessions Individual consent processes were protected in this trial through final information sharing and consent being conducted by trained clinical staff who were not embedded in study communities However, our experiences suggest that roles and remuneration of all front line staff and volunteers involved in trials need careful consideration from the outset, and monitoring and discussion over time

'She's my sister-in-law, my visitor, my friend' -- challenges of staff identity in home follow-up in an HIV trial in Western Kenya.

Abstract: Identities ascribed to research staff in face-to-face encounters with participants have been raised as key ethical challenge in transnational health research. 'Misattributed' identities that do not just deviate from researchers' self-image, but obscure unequivocal aspects of researcher identity - e.g. that they are researchers - are a case of such ethical problem. Yet, the reasonable expectation of unconcealed identity can conflict with another ethical premise: confidentiality; this poses challenges to staff visiting participants at home. We explore these around a case study of 'follow-up' staff, observed during an ethnographic study of a Kenyan HIV 'trial community', which included participant observation, conversations, and interviews with staff (n = 79) and participants (n = 89). We found that because of the need to maintain confidentiality and because of some suspicions towards researchers, research staff drew upon alternative identities - presenting themselves to non-participants as relatives or friends, rather than as researchers. Several staff experienced this as necessary but uncomfortable. Simultaneously, staff and participants forged close relations in line with their fictional identities, which however also posed challenges because they entailed personal responsibilities that were difficult to live up to, due to limited resources, and the trial's limited duration. Similar challenges may arise in transnational HIV treatment programmes and should be explored further in that context.

'It looks like you just want them when things get rough': civil society perspectives on negative trial results and stakeholder engagement in HIV prevention trials.

Abstract: Civil society organizations (CSOs) have significantly impacted on the politics of health research and the field of bioethics. In the global HIV epidemic, CSOs have served a pivotal stakeholder role. The dire need for development of new prevention technologies has raised critical challenges for the ethical engagement of community stakeholders in HIV research. This study explored the perspectives of CSO representatives involved in HIV prevention trials (HPTs) on the impact of premature trial closures on stakeholder engagement. Fourteen respondents from South African and international CSOs representing activist and advocacy groups, community mobilisation initiatives, and human and legal rights groups were purposively sampled based on involvement in HPTs. Interviews were conducted from February-May 2010. Descriptive analysis was undertaken across interviews and key themes were developed inductively. CSO representatives largely described positive outcomes of recent microbicide and HIV vaccine trial terminations, particularly in South Africa, which they attributed to improvements in stakeholder engagement. Ongoing challenges to community engagement included the need for principled justifications for selective stakeholder engagement at strategic time-points, as well as the need for legitimate alternatives to CABs as mechanisms for engagement. Key issues for CSOs in relation to research were also raised.

Ethics of ARV based prevention: treatment-as-prevention and PrEP.

Abstract: Published data show that new HIV prevention strategies including treatment-as-prevention and pre-exposure prophylaxis (PrEP) using oral antiretroviral drugs (ARVs) are highly, but not completely, effective if regimens are taken as directed. Consequently, their implementation may challenge norms around HIV prevention. Specific concerns include the potential for ARV-based prevention to reframe responsibility, erode beneficial sexual norms and waste resources. This paper explores what rights claims uninfected people can make for access to ARVs for prevention, and whether moral claims justify the provision of ARV therapy to those who do not yet clinically require treatment as a way of reducing HIV transmission risk. An ethical analysis was conducted of the two strategies, PrEP and treatment-as-prevention, using a public health stewardship model developed by the Nuffield Bioethics Council to consider and compare the application of PrEP and treatment-as-prevention strategies. We found that treating the person with HIV rather than the uninfected person offers advantages in settings where there are limited opportunities to access care. A treatment-as-prevention strategy that places all the emphasis upon the positive person's adherence however carries a disproportionate burden of responsibility. PrEP remains an important option for receptive partners who face increased biological vulnerability. We conclude that the use of ARV for prevention is ethically justified, despite imperfect global to drugs for those in clinical need. The determination of which ARV-based HIV prevention strategy is ethically preferable is complex and must take into account both public health and interpersonal considerations.

Embryo donation in iran: an ethical review

Abstract: Iran is the only Muslim country that has legislation on embryo donation, adopted in 2003. With an estimated 10-15% of couples in the country that are infertile, there are not any legal or religious barriers that prohibit an infertile couple from taking advantage of Assisted Reproductive Technologies (ARTs). Although all forms of ARTs available in Iran have been legitimized by religious authorities, there is a lack of legislation in all ARTs except embryo donation. By highlighting ethical issues in embryo donation, the paper presents a critical review of the Act of Embryo Donation in Iran. The paper argues that the Act does not provide enough safeguards for the future child and assurance for the safety of the donated embryos. It also does not restrict embryo donation to surplus embryos from infertile couples and is silent about the number of embryos that could be donated by each couple as well as the number of recipients for donated embryos by a couple. The Act is also silent about the issues of genetic linkage (nasab) and heritage which are challenging issues, especially in a conservative Islamic society. As a result, the future child may not inherit from their birth parents, as it is not required by the Act, or from the genetically related parents under the anonymity policy. Finally there is no standard national protocol or guidelines to evaluate the safety of the donated embryos. The paper concludes that despite its benefits, the Act lacks clarity, and it is subject to misunderstanding and confusion.

Acceptance and perception of Nigerian patients to medical photography.

Abstract: The aim of the study was to determine the acceptance and perception of Nigerian patients to medical photography. A self-administered questionnaire was distributed among Nigerian patients attending oral and maxillofacial surgery and plastic surgery clinics of 3 tertiary health institutions. Information requested included patients' opinion about consent process, capturing equipment, distribution and accessibility of medical photographs. The use of non-identifiable medical photographs was more acceptable than identifiable to respondents for all purposes (P = 0.003). Most respondents were favourably disposed to photographs being taken for inclusion in the case note, but opposed to identifiable photographs being used for other purposes most especially in medical websites and medical journals. Female respondents preferred non-identifiable medical photographs to identifiable ones (P = 0.001). Most respondents (78%) indicated that their consent be sought for each of the outline needs for medical photography. Half of the respondents indicated that identifiable photographs may have a negative effect on their persons; and the most commonly mentioned effects were social stigmatization, bad publicity and emotional/psychological effects. Most of the respondents preferred the use of hospital-owned camera to personal camera/personal camera-phone for their medical photographs. Most respondents (67.8%) indicated that they would like to be informed about the use of their photographs on every occasion, and 74% indicated that they would like to be informed of the specific journal in which their medical photographs are to be published. In conclusion, non-identifiable rather than identifiable medical photography is acceptable to most patients in the studied Nigerian environment. The use of personal camera/personal camera-phone should be discouraged as its acceptance by respondents is very low. Judicious use of medical photography is therefore advocated to avoid breach of principle of privacy and confidentiality in medical practice.

Feedback of Research Findings for Vaccine Trials: Experiences from Two Malaria Vaccine Trials Involving Healthy Children on the Kenyan Coast

Abstract: Internationally, calls for feedback of findings to be made an ‘ethical imperative’ or mandatory have been met with both strong support and opposition. Challenges include differences in issues by type of study and context, disentangling between aggregate and individual study results, and inadequate empirical evidence on which to draw. In this paper we present data from observations and interviews with key stakeholders involved in feeding back aggregate study findings for two Phase II malaria vaccine trials among children under the age of 5 years old on the Kenyan Coast. In our setting, feeding back of aggregate findings was an appreciated set of activities. The inclusion of individual results was important from the point of view of both participants and researchers, to reassure participants of trial safety, and to ensure that positive results were not over-interpreted and that individual level issues around blinding and control were clarified. Feedback sessions also offered an opportunity to re-evaluate and re-negotiate trial relationships and benefits, with potentially important implications for perceptions of and involvement in follow-up work for the trials and in future research. We found that feedback of findings is a complex but key step in a continuing set of social interactions between community members and research staff (particularly field staff who work at the interface with communities), and among community members themselves; a step which needs careful planning from the outset. We agree with others that individual and aggregate results need to be considered separately, and that for individual results, both the nature and value of the information, and the context, including social relationships, need to be taken into account.

Research integrity in greater China: surveying regulations, perceptions and knowledge of research integrity from a Hong Kong perspective.

Abstract: In their 2010 article ‘Research Integrity in China: Problems and Prospects’, Zeng and Resnik challenge others to engage in empirical research on research integrity in China. Here we respond to that call in three ways: first, we provide updates to their analysis of regulations and allegations of scientific misconduct; second, we report on two surveys conducted in Hong Kong that provide empirical backing to describe ways in which problems and prospects that Zeng and Resnik identify are being explored; and third, we continue the discussion started by Zeng and Resnik, pointing to ways in which China's high-profile participation in international academic research presents concerns about research integrity. According to our research, based upon searches of both English and Chinese language literature and policies, and two surveys conducted in Hong Kong, academic faculty and research post-graduate students in Hong Kong are aware of and have a positive attitude towards responsible conduct of research. Although Hong Kong is but one small part of China, we present this research as a response to concerns Zeng and Resnik introduce and as a call for a continued conversation.

Ethical Use of Antiretroviral Resources for HIV Prevention in Resource Poor Settings

Abstract: The effectiveness of antiretroviral regimes (ARVs) to reduce risk of HIV transmission from mother to child and as post-exposure prophylaxis has been known for almost two decades. Recent research indicates ARVs can also reduce the risk of HIV transmission via sexual intercourse in two other ways. With pre-exposure prophylaxis (PrEP), ARVs are used to reduce risk of HIV acquisition among persons who are HIV negative and significantly exposed to the virus. With treatment as prevention (TasP), ARVs are used to reduce risk of HIV transmission from persons who are already HIV positive. The development of these new prevention strategies raises a rationing problem: given the chronic shortage of ARVs for HIV-infected persons in need of treatment, is it ethically justified to allocate ARVs for PrEP and/or TasP? This article examines the intuitively appealing view that allocation of ARVs for treatment should be the highest priority, the use of ARVs for TasP should be a secondary priority, and that utilizing ARVs for PrEP would be unethical. I will argue that selective, evidence-based allocation of ARVs for prevention in certain cases could be ethically justified even when there is insufficient anti-retroviral access for all those needing it for treatment.

From modeling to morals: imagining the future of HIV PREP in Lesotho.

Abstract: Amidst growing global endorsements of new biomedical HIV prevention strategies ARV-based pre-exposure prophylaxis (ARV PrEP) has garnered considerable attention as a potentially promising prevention strategy. Though it may offer more effective protection for certain at-risk groups than conventional prevention strategies (such as sexual partner reduction condom use and prevention of mother-to-child transmission) PrEP is more costly. PrEP requires more ongoing contact between individuals and providers and a level of surveillance from the health system that is not necessary with other preventive measures. In this sense it represents a new bio-technology for HIV prevention that poses particular challenges for worldwide implementation given developing countries struggling health systems and incomplete HIV treatment programs. Since the emergence of PrEP has stimulated ethical discussions premised on incomplete knowledge of efficacy and implementation this paper explores the ethical parameters of a likely scenario for PrEP usage in a single resource-poor country. We first develop a plausible model for PrEP deployment and utilization based on current PrEP research while carefully considering the reigning institutional values of feasibility and effectiveness in global health approaches. Drawing on ethnographic research of HIV treatment and prevention approaches in Lesotho we address ethical questions arising from this scenario of PrEP delivery. Lesotho presents a compelling and emblematic case study of PrEPs potential successes and pitfalls in a developing country given the countrys high HIV prevalence struggles to achieve universal access to HIV treatment regimes continued existence of stigma around the epidemic and difficulties in addressing persistent social inequalities that fuel infections.

Ethics education in research involving human beings in undergraduate medicine curriculum in Brazil.

Abstract: Introduction The Brazilian national curriculum guidelines for undergraduate medicine courses inspired and influenced the groundwork for knowledge acquisition, skills development and the perception of ethical values in the context of professional conduct. Objective The evaluation of ethics education in research involving human beings in undergraduate medicine curriculum in Brazil, both in courses with active learning processes and in those with traditional lecture learning methodologies. Methods Curricula and teaching projects of 175 Brazilian medical schools were analyzed using a retrospective historical and descriptive exploratory cohort study. Thirty one medical schools were excluded from the study because of incomplete information or a refusal to participate. Active research for information from institutional sites and documents was guided by terms based on 69 DeCS/MeSH descriptors. Curriculum information was correlated with educational models of learning such as active learning methodologies, tutorial discussions with integrated curriculum into core modules, and traditional lecture learning methodologies for large classes organized by disciplines and reviewed by occurrence frequency of ethical themes and average hourly load per semester. Results Ninety-five medical schools used traditional learning methodologies. The ten most frequent ethical themes were: 1 – ethics in research (26); 2 – ethical procedures and advanced technology (46); 3 – ethic-professional conduct (413). Over 80% of schools using active learning methodologies had between 50 and 100 hours of scheduled curriculum time devoted to ethical themes whereas more than 60% of traditional learning methodology schools devoted less than 50 hours in curriculum time to ethical themes. Conclusion The data indicates that medical schools that employ more active learning methodologies provide more attention and time to ethical themes than schools with traditional discipline-based methodologies. Given the importance of ethical issues in contemporary medical education, these findings are significant for curriculum change and modification plans in the future of Brazilian medical education.

Animal Research Ethics in Africa: Is Tanzania Making Progress?

Abstract: The significance of animals in research cannot be over-emphasized. The use of animals for research and training in research centres, hospitals and schools is progressively increasing. Advances in biotechnology to improve animal productivity require animal research. Drugs being developed and new interventions or therapies being invented for cure and palliation of all sorts of animal diseases and conditions need to be tested in animals for their safety and efficacy at some stages of their development. Drugs and interventions for human use pass through a similar development process and must be tested pre-clinically in laboratory animals before clinical trials in humans can be conducted. Therefore, animals are important players in research processes which directly and indirectly benefit animals and humans. However, questions remain as to whether these uses of animals consider the best interests of animals themselves. Various research and training institutions in Tanzania have established some guidelines on animal use, including establishing animal ethics committees. However, most institutions have not established oversight committees. In institutions where there may be guidelines and policies, there are no responsible committees or units to directly oversee if and how these guidelines and policies are enforced; thus, implementation becomes difficult or impossible. This paper endeavours to raise some issues associated with the responsible use of animals in research and training in Tanzania and highlights suggestions for improvement of deficiencies that exist in order to bridge the gap between what ought to be practised and what is practised.

Off-shoring clinical research: exploitation and the reciprocity constraint.

Abstract: The last 20 years have seen a staggering growth in the practice of off-shoring clinical research to low-and middle-income countries (LICs and MICs), a growth that has been matched by the neoliberal policies adopted by host countries towards attracting trials to their shores. A recurring concern in this context is the charge of exploitation, linked to various aspects of off-shoring. In this paper, I examine Alan Wertheimer's approach and offer an alternative view of understanding exploitation in this context. I will suggest that the justification for the enterprise of research is largely dependent on its integration within a health system from which participants regularly benefit and I argue that an attention to a principle of reciprocity will enable us to better recognize and address exploitation in international research.

Ethical tradeoffs in trial design: case study of an HPV vaccine trial in HIV-infected adolescent girls in lower income settings.

Abstract: The Declaration of Helsinki and the Council of the International Organization of Medical Sciences provide guidance on standards of care and prevention in clinical trials. In the current and increasingly challenging research environment, the ethical status of a trial design depends not only on protection of participants, but also on social value, feasibility, and scientific validity. Using the example of a study assessing efficacy of a vaccine to prevent human papilloma virus in HIV-1 infected adolescent girls in low resource countries without access to the vaccine, we compare several trial designs which rank lower on some criteria and higher on others, giving rise to difficult trade-offs. This case demonstrates the need for developing more nuanced guidance documents to help researchers balance these often conflicting criteria.

Anti-retrovirals for treatment and prevention--time for new paradigms in our response to the HIV/AIDS epidemic?

Abstract: Since 2010, there have been several studies demonstrating the prevention benefits of the prophylactic use of antiretrovirals in diverse populations – discordant couples, men who have sex in men, heterosexual men and women, and most recently in injecting drug users in Africa, Asia, Europe and the Americas. Notably the United States Food and Drug Administration (USFDA) has approved package insert relabeling of the combination of tenofovir and emtricitabine/ Truvada for prophylactic use. Further, the HPTN 052 trial in discordant, heterosexual couples has demonstrated that antiretroviral treatment of the infected partner in discordant couples can prevent transmission of HIV to the uninfected partner, thereby expanding the individual level survival benefit of anti-retroviral treatment to a dyadic level prevention benefit. These new findings add to a confluence of studies centrally around the use of antiretrovirals for treating patients with AIDS, preventing vertical transmission of HIV and reducing transmission of HIV sexually and parenterally. Anti-retrovirals work by reducing viral load in infected individuals and hence transmission to the uninfected individuals. They also do so by providing substantial protection for the uninfected, thus reducing the risk of the acquisition of HIV infection. While these scientific advances have injected much needed hope and enthusiasm in an otherwise desolate prevention landscape raising the possibility of an AIDSfree generation and/or control of the epidemic it has also generated much debate and discussion in terms of future prevention science research as well as issues relating to implementation of these new findings and optimising use of ARVs to prevent HIV transmission and acquisition. In contrast to medical male circumcision, a once-off procedure, use of anti-retrovirals for treatment and prevention requires product to be used and high rates of adherence to be effective making research and implementation more challenging. From the outset these advances have posed a host of complex questions involving everything from global funding, priority setting, national prevention strategies and clinical decision-making. The series of papers that comprise this special issue while by no means complete or comprehensive, aims to advance these deliberations both in terms of future research as well as implementation. These papers complement and build on other published literature in the field dealing with critically important ethical issues targeting of PrEP to key populations, criteria for rationing and prioritising use of ARVs based on severity of disease and whether they should be standard of care in research. Collectively the papers in this issue provide further insights into the complexity of the issues. Our response to HIV/AIDS to date has set new precedents in responding to a public health crisis. About a decade ago it was inconceivable that ARV treatment would be available in resource constrained settings. Today, through PEPFAR and the GFATM the impossible has become possible and there is growing evidence at a country level of increases in life expectancy and prevention benefits from treatment provision with modest coverage rates. Significantly many concerns about poor adherence in resource constrained settings have been shown to be unfounded despite the weak health care 1 J.M. Baeten, D. Donnell, P. Ndase, et al. Antiretroviral prophylaxis for HIV prevention in heterosexual men and women. N Engl J Med 2012; 367(5): 399–410. 2 R.M. Grant, J.R. Lama, P.L. Anderson, et al. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. N Engl J Med 2010; 363(27): 2587–2599. 3 M. Thigpen, P. Kebaabetswe, D. Smith, et al. Daily oral antiretroviral use for the prevention of HIV infection in heterosexually active young adults in Botswana: results from the TDF2 study. International AIDS Conference; 2011; Rome; 2011. 4 Q. Abdool Karim, S.S. Abdool Karim, J.A. Frohlich, et al. Effectiveness and Safety of Tenofovir Gel, an Antiretroviral Microbicide, for the Prevention of HIV Infection in Women. Science 2010; 329: 1168–1174. 5 K. Choopanya, M. Martin, P. Suntharasamai, et al. Antiretroviral prophylaxis for HIV infection in injecting drug users in Bangkok, Thailand (the Bangkok Tenofovir Study): a randomised, double-blind, placebo-controlled phase 3 trial. The Lancet 2013; 381(9883): 2083– 2090. 6 U.S. Food and Drug Administration. Truvada for PrEP Fact Sheet: Ensuring Safe and Proper Use. Washington, DC: U.S. Department of Health & Human Services/U.S. Food & Drug Administration. Available at: http://www.fda.gov/downloads/NewsEvents/Newsroom/ FactSheets/UCM312279.pdf. [Accessed 14 June 2013]. 2012. 7 M.S. Cohen, Y.Q. Chen, M. McCauley, et al. Prevention of HIV-1 infection with early antiretroviral therapy. The New England journal of medicine 2011; 365(6): 493–505. 8 J.A. Singh, S.S. Abdool Karim, Q.A. Karim, et al. Enrolling Adolescents in Research on HIV and Other Sensitive Issues: Lessons from South Africa. PLoS Med 2006; 3(7): e180. 9 R. Macklin & E. Cowan. Given financial constraints, it would be unethical to divert antiretroviral drugs from treatment to prevention. Health Affairs 2012; 31(7): 1537–1544. 10 B. Haire, J. Kaldor & C.F. Jordens. How Good Is ‘Good Enough’? The Case for Varying Standards of Evidence According to Need for New Interventions in HIV Prevention. Am J Bioeth 2012; 12(6): 21–30. 11 F. Tanser, T. Barnighausen, E. Grapsa, J. Zaidi & M.L. Newell. High coverage of ART associated with decline in risk of HIV acquisition in rural KwaZulu-Natal, South Africa. Science 2013; 339(6122): 966–971. bs_bs_banner bioethics developing world

Separate Goals, Converging Priorities: On the Ethics of Treatment as Prevention

Abstract: Recent evidence confirming that the administration of antiretroviral drugs (ARVs) to HIV-infected persons may effectively reduce their risk of transmission has revived the discussion about priority setting in the fight against HIV/AIDS. The fact that the very same drugs can be used both for treatment purposes and for preventive purposes (Treatment as Prevention) has been seen as paradigm-shifting and taken to spark a new controversy: In a context of scarce resources should the allocation of ARVs be prioritized based on the goal of providing treatment or on the goal of preventing the spread of the HIV epidemic? Contributions to this discussion tend to assume that treatment and prevention constitute two divergent goals that entail conflicting priorities. We challenge that assumption on the basis of both conceptual and empirical examination. We argue that as far as the provision of ARVs to HIV-infected persons is concerned the goals of treatment and prevention do not entail conflicting priorities; to the contrary they dictate converging strategies for the optimal allocation of ARVs. In light of the current evidence the concept of Treatment as Prevention can indeed be seen as paradigm-shifting yet in a novel way: Rather than extending the tension between the goals of treatment and prevention to the level of drug-allocation it dissolves this tension by providing a rationale for a unified strategy for allocating ARVs. (c) 2013 John Wiley & Sons Ltd. The Pan American Health Organization retains copyright and all other rights in the manuscript of this Separate Goals Converging Priorities: On the Ethics of Treatment as Prevention as submitted for publication.