Anti‐retrovirals for treatment and prevention – time for new paradigms in our response to the HIV/AIDS epidemic?
(Source: Developing World Bioethics)
Source: Developing World Bioethics - July 18, 2013 Category: Medical Ethics Authors: Quarraisha Abdool Karim, Ronald Bayer Tags: EDITORIAL Source Type: research

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 epidemi...
Source: Developing World Bioethics - June 25, 2013 Category: Medical Ethics Authors: Florian Ostmann, Carla Saenz Tags: Original Article Source Type: research

Disease Control Priorities for Neglected Tropical Diseases: Lessons from Priority Ranking Based on the Quality of Evidence, Cost Effectiveness, Severity of Disease, Catastrophic Health Expenditures, and Loss of Productivity
ConclusionBy exploring how several criteria relevant to the multi‐facetted characteristics of NTDs can be taken into account simultaneously, we are able to suggest how improved priority settings among NTDs can be realised. (Source: Developing World Bioethics)
Source: Developing World Bioethics - May 31, 2013 Category: Medical Ethics Authors: Elisabeth Marie Strømme, Kristine Bærøe, Ole Frithjof Norheim Tags: Original Article Source Type: research

Collaborative International Research: Ethical and Regulatory Issues Pertaining to Human Biological Materials at a South African Institutional Research Ethics Committee
ConclusionsResearchers and the REC did not adequately address the inter‐related ethical and regulatory issues pertaining to HBMs. There was a lack of congruence between the ethical guidelines of developed countries and their actions which are central to the access to HBMs in collaborative research. HBMs may be leaving South Africa without EPs and MTAs during the process of international collaborative research. (Source: Developing World Bioethics)
Source: Developing World Bioethics - May 31, 2013 Category: Medical Ethics Authors: Aslam Sathar, Amaboo Dhai, Stephan Linde Tags: Original Article Source Type: research

Ethical Use of Antiretroviral Resources for HIV Prevention in Resource Poor Settings
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. (Source: Developing World Bioethics)
Source: Developing World Bioethics - May 31, 2013 Category: Medical Ethics Authors: Stuart Rennie Tags: Original Article Source Type: 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 low...
Source: Developing World Bioethics - May 31, 2013 Category: Medical Ethics Authors: J.C. Lindsey, S.K. Shah, G.K. Siberry, P. Jean‐Philippe, M.J. Levin Tags: Original Article Source Type: research

Exploitation and community engagement: Can Community Advisory Boards successfully assume a role minimising exploitation in international research?
Abstract It has been suggested that community advisory boards (CABs) can play a role in minimising exploitation in international research. To get a better idea of what this requires and whether it might be achievable, the paper first describes core elements that we suggest must be in place for a CAB to reduce the potential for exploitation. The paper then examines a CAB established by the Shoklo Malaria Research Unit under conditions common in resource‐poor settings – namely, where individuals join with a very limited understanding of disease and medical research and where an existing organisational structure is not re...
Source: Developing World Bioethics - May 31, 2013 Category: Medical Ethics Authors: Bridget Pratt, Khin Maung Lwin, Deborah Zion, Francois Nosten, Bebe Loff, Phaik Yeong Cheah Tags: Original Article Source Type: research

Ethical Considerations in Determining Standard of Prevention Packages for HIV Prevention Trials: Examining PrEP
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. (Source: Developing World Bioethics)
Source: Developing World Bioethics - May 31, 2013 Category: Medical Ethics Authors: Bridget Haire, Morenike Oluwatoyin Folayan, Catherine Hankins, Jeremy Sugarman, Sheena McCormack, Gita Ramjee, Mitchell Warren Tags: Original Article Source Type: research

Community Members' Engagement with and Involvement in Genomic Research: Lessons to Learn from the Field
Abstract In this paper, we describe the potential role laypersons on ethics committees can play in ensuring community concerns are addressed in the design and implementation of genomic research. We draw inferences from the outcome of an empirical study of the impact of training of laypersons to address community engagement issues in ethics review of research protocol. While this paper does not advocate a particular solution, it describes the importance of community engagement in genomic research, the current limitations there are in engaging communities in the design of these research projects and how communities can be in...
Source: Developing World Bioethics - April 17, 2013 Category: Medical Ethics Authors: Morenike O. Folayan, Kolawole S. Oyedeji, Olawunmi A. Fatusi Tags: Original Article Source Type: research

Promoting Research Integrity in Africa: An African Voice of Concern on Research Misconduct and the Way Forward
Abstract African researchers and their collaborators have been making significant contributions to useful research findings and discoveries in Africa. Despite evidence of scientific misconduct even in heavily regulated research environments, there is little documented information that supports prevalence of research misconduct in Africa. Available literature on research misconduct has focused on the developed world, where credible research integrity systems are already in place. Public attention to research misconduct has lately increased, calling for attention to weaknesses in current research policies and regulatory fram...
Source: Developing World Bioethics - April 17, 2013 Category: Medical Ethics Authors: Francis Kombe, Eucharia Nkechinyere Anunobi, Nyanyukweni Pandeni Tshifugula, Douglas Wassenaar, Dimpho Njadingwe, Salim Mwalukore, Jonathan Chinyama, Bodo Randrianasolo, Perpetua Akindeh, Priscilla S. Dlamini, Felasoa Noroseheno Ramiandrisoa, Naina Ranaiv Tags: Original Article Source Type: research

Survey on Ethical Conduct Thresholds in Cardiologal Medical Practice in Argentina
Abstract The purpose of this study was to analyze the attitude of a group of cardiologists on the ethical conducts they would accept or adopt when encountered with different hypothetical situations of medical practice. Between August and September of 2011, 700 Argentine cardiologists were surveyed in situations which posed ethical dilemmas in the patient‐physician relationship, among colleagues or involving financial agreements with employers or the pharmaceutical industry. Ethical conflicts were evidenced in a series of inappropriate conducts such as differential fees, trips and meals sponsored by laboratories, splittin...
Source: Developing World Bioethics - April 17, 2013 Category: Medical Ethics Authors: Hernán C. Doval, Carlos D. Tajer, Raúl A. Borracci, Carmen Nuñez, Marisa Samarelli, Susana Tamini Tags: Original Article Source Type: research

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 measur...
Source: Developing World Bioethics - April 1, 2013 Category: Medical Ethics Authors: Nora J. Kenworthy, Nicola Bulled Tags: Original Article Source Type: research

Engaging Diverse Social and Cultural Worlds: Perspectives on Benefits in International Clinical Research From South African Communities
Abstract The issue of benefits in international clinical research is highly controversial. Against the background of wide recognition of the need to share benefits of research, the nature of benefits remains strongly contested. Little is known about the perspectives of research populations on this issue and the extent to which research ethics discourses and guidelines are salient to the expectations and aspirations existing on the ground. This exploratory study contributes to filling this void by examining perspectives of people in low‐income South African communities on benefits in international clinical research. Twent...
Source: Developing World Bioethics - April 1, 2013 Category: Medical Ethics Authors: Olga Zvonareva, Nora Engel, Eleanor Ross, Ron Berghmans, Ames Dhai, Anja Krumeich Tags: Original Article Source Type: research

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 ...
Source: Developing World Bioethics - April 1, 2013 Category: Medical Ethics Authors: Bridget Haire, John M. Kaldor Tags: Original Article Source Type: research

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 wi...
Source: Developing World Bioethics - March 22, 2013 Category: Medical Ethics Authors: Vibian Angwenyi, Dorcas Kamuya, Dorothy Mwachiro, Vicki Marsh, Patricia Njuguna, Sassy Molyneux Tags: ARTICLE Source Type: research