Developing World Bioethics
December 2015 Volume 15, Issue 3 Pages iii–iii, 115–275
http://onlinelibrary.wiley.com/doi/10.1111/dewb.2015.15.issue-2/issuetoc

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Considerations for a Human Rights Impact Assessment of a Population Wide Treatment for HIV Prevention Intervention (pages 115–124)
Johanna Hanefeld, Virginia Bond, Janet Seeley, Shelley Lees and Nicola Desmond
Article first published online: 8 NOV 2013 | DOI: 10.1111/dewb.12038
Abstract
Increasing attention is being paid to the potential of anti-retroviral treatment (ART) for HIV prevention. The possibility of eliminating HIV from a population through a universal test and treat intervention, where all people within a population are tested for HIV and all positive people immediately initiated on ART, as part of a wider prevention intervention, was first proposed in 2009. Several clinical trials testing this idea are now in inception phase. An intervention which relies on universally testing the entire population for HIV will pose challenges to human rights, including obtaining genuine consent to testing and treatment. It also requires a context in which people can live free from fear of stigma, discrimination and violence, and can access services they require. These challenges are distinct from the field of medical ethics which has traditionally governed clinical trials and focuses primarily on patient researcher relationship. This paper sets out the potential impact of a population wide treatment as prevention intervention on human rights. It identifies five human right principles of particular relevance: participation, accountability, the right to health, non-discrimination and equality, and consent and confidentiality. The paper proposes that explicit attention to human rights can strengthen a treatment as prevention intervention, contribute to mediating likely health systems challenges and offer insights on how to reach all sections of the population.

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Perceived Quality of Informed Refusal Process: A Cross-Sectional Study from Iranian Patients’ Perspectives (pages 172–178)
Mehrdad Farzandipour, Abbas Sheikhtaheri and Monireh Sadeqi Jabali
Article first published online: 11 APR 2014 | DOI: 10.1111/dewb.12054
Abstract
Patients have the right to refuse their treatment; however, this refusal should be informed. We evaluated the quality of the informed refusal process in Iranian hospitals from patients’ viewpoints. To this end, we developed a questionnaire that covered four key aspects of the informed refusal process including; information disclosure, voluntariness, comprehension, and provider-patient relationship. A total of 284 patients who refused their treatment from 12 teaching hospitals in the Isfahan Province, Iran, were recruited and surveyed to produce a convenience sample. Patients’ perceptions about the informed refusal process were scored and the mean scores of the four components were calculated. The findings showed that the practice of information disclosure (9.6 ± 6.4 out of 22 points) was perceived to be moderate, however, comprehension (2.3 ± 1.4 out of 4 points), voluntariness (8.7 ± 1.5 out of 12 points) and provider–patient relationship (10.2 ±  5.2 out of 16 points) were perceived to be relatively good. We found that patients, who refused their care before any treatment had commenced, reported a lower quality of information disclosure and voluntariness. Patients informed by nurses and those who had not had a previous related admission, reported lower scores for comprehension and relationship. In conclusion, the process of obtaining informed refusal was relatively satisfactory except for levels of information disclosure. To improve current practices, Iranian patients need to be better informed about; different treatment options, consequences of treatment refusal, costs of not continuing treatment and follow-ups after refusal. Developing more informative refusal forms is needed.

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Enhancing Research Ethics Review Systems in Egypt: The Focus of an International Training Program Informed by an Ecological Developmental Approach to Enhancing Research Ethics Capacity (pages 199–207)
Hillary Anne Edwards, Tamer Hifnawy and Henry Silverman
Article first published online: 3 JUN 2014 | DOI: 10.1111/dewb.12062
Abstract
Recently, training programs in research ethics have been established to enhance individual and institutional capacity in research ethics in the developing world. However, commentators have expressed concern that the efforts of these training programs have placed ‘too great an emphasis on guidelines and research ethics review’, which will have limited effect on ensuring ethical conduct in research. What is needed instead is a culture of ethical conduct supported by national and institutional commitment to ethical practices that are reinforced by upstream enabling conditions (strong civil society, public accountability, and trust in basic transactional processes), which are in turn influenced by developmental conditions (basic freedoms of political freedoms, economic facilities, social opportunities, transparency guarantees, and protective security). Examining this more inclusive understanding of the determinants of ethical conduct enhances at once both an appreciation of the limitations of current efforts of training programs in research ethics and an understanding of what additional training elements are needed to enable trainees to facilitate national and institutional policy changes that enhance research practices. We apply this developmental model to a training program focused in Egypt to describe examples of such additional training activities.

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Improving the Quality of Host Country Ethical Oversight of International Research: The Use of a Collaborative ‘Pre-Review’ Mechanism for a Study of Fexinidazole for Human African Trypanosomiasis (pages 241–247)
Carl H. Coleman, Chantal Ardiot, Séverine Blesson, Yves Bonnin, Francois Bompart, Pierre Colonna, Ames Dhai, Julius Ecuru, Andrew Edielu, Christian Hervé, François Hirsch, Bocar Kouyaté, Marie-France Mamzer-Bruneel, Dionko Maoundé, Eric Martinent, Honoré Ntsiba, Gérard Pelé, Gilles Quéva, Marie-Christine Reinmund, Samba Cor Sarr, Abdoulaye Sepou, Antoine Tarral, Djetodjide Tetimian, Olaf Valverde, Simon Van Nieuwenhove and Nathalie Strub-Wourgaft
Article first published online: 14 JUL 2014 | DOI: 10.1111/dewb.12068
Abstract
Developing countries face numerous barriers to conducting effective and efficient ethics reviews of international collaborative research. In addition to potentially overlooking important scientific and ethical considerations, inadequate or insufficiently trained ethics committees may insist on unwarranted changes to protocols that can impair a study’s scientific or ethical validity. Moreover, poorly functioning review systems can impose substantial delays on the commencement of research, which needlessly undermine the development of new interventions for urgent medical needs. In response to these concerns, the Drugs for Neglected Diseases Initiative (DNDi), an independent nonprofit organization founded by a coalition of public sector and international organizations, developed a mechanism to facilitate more effective and efficient host country ethics review for a study of the use of fexinidazole for the treatment of late stage African Trypanosomiasis (HAT). The project involved the implementation of a novel ‘pre-review’ process of ethical oversight, conducted by an ad hoc committee of ethics committee representatives from African and European countries, in collaboration with internationally recognized scientific experts. This article examines the process and outcomes of this collaborative process.

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To What did They Consent? Understanding Consent Among Low Literacy Participants in a Microbicide Feasibility Study in Mazabuka, Zambia (pages 248–256)
Esther Munalula-Nkandu, Paul Ndebele, Seter Siziya and JC Munthali
Article first published online: 1 AUG 2014 | DOI: 10.1111/dewb.12069

We conducted a study to review the consenting process in a vaginal Microbicide feasibility study conducted in Mazabuka, Zambia. Participants were drawn from those participating in the microbicide study. A questionnaire and focus group discussion were used to collect information on participants understanding of study aims, risks and benefits. Altogether, 200 participants took part in this study. The results of the study showed that while all participants signed or endorsed their thumbprints to the consent forms, full informed consent was not attained from most of the participants since 77% (n = 154) of the participants had numerous questions about the study and 34% (n = 68) did not know who to get in touch with concerning the study. Study objectives were not fully understood by over 61% of the participants. Sixty four percent of the participants were not sure of the risks of taking part in the microbicide study. A significant number thought the study was all about determining their HIV status. Some participants were concerned that their partners were not on the trial as they were convinced that being on the study meant that that they had a lifetime protection from HIV infection. The process of obtaining consent was inadequate as various phases of the study were not fully understood. We recommend the need for researchers to reinforce the consenting process in all studies and more so when studies are conducted in low literacy populations.