Most recent papers:

• Ethical Challenges of Obtaining Informed Consent: Qualitative Research on the Perspectives of Tuberculosis Patients Participating in Human Genomic Research in Ethiopia.
  Herani S. Dembu, Polly J. Price, Jessica Sales, Liya Wassie.
  Developing World Bioethics. 3 days ago
  ["Developing World Bioethics, EarlyView. ", "\nABSTRACT\nThe use of human genetic variation to comprehend complex diseases has also introduced several ethical, legal, and societal issues (ELSI). Despite the important contribution of Human Genome Research (HGR), full comprehension of these issues by all its stakeholders remains challenging. This research focused on exploring the understanding of research participants on the informed consent process of HGR. Nineteen Ethiopian TB patients, who participated in genomics research, were purposely selected for in‐depth interviews. Their recorded responses were transcribed into text‐based versions and analyzed thematically using MAXQDA Analysis Software.\nThe patterns in the informed consent process showed the following themes: Therapeutic misconception, Limited clarity on perceived benefit, Partial understanding of third‐party use, Addressed suspicion or concerns, Mixed feelings about sample and data extraction, Concerns about sample governance, Variations in information and understanding, Barriers and facilitators to comprehension, and Volunteerism and influencing factors. The findings incorporated both the strengths and challenges of the consenting process of a genomic study, while informing the need for ethical improvements.\n"]

  May 15, 2026   doi: 10.1111/dewb.70030   open full text
• The Commercialisation of Private Healthcare in Malaysia: Examining the Impact of Revenue Pressures and Defensive Medicine on Doctor's Professional Autonomy.
  Astrid Sinarti Hassan, Rafiz Abdul Rani.
  Developing World Bioethics. 3 days ago
  ["Developing World Bioethics, EarlyView. ", "\nABSTRACT\nThe commercialisation of Malaysia's private healthcare sector has intensified conflicts between doctor's professional autonomy and financial pressures, raising ethical and legal concerns. Private practitioners increasingly face incentives to prioritise revenue‐generating treatments, leading to defensive medicine, excessive testing and escalating healthcare costs. These financial and legal pressures undermine clinical independence, shifting the doctor‐patient relationship toward a transactional model. This study employs a qualitative analytical approach to examine how financial imperatives shape medical decision‐making and defensive practices in Malaysia's private healthcare sector. By assessing revenue‐driven policies, litigation risks and their impact on professional autonomy, the analysis highlights the need for standardised guidelines, interdisciplinary collaboration and transparency in decision‐making. Strengthening regulatory safeguards is crucial to preserving medical ethics while ensuring financial sustainability in private healthcare.\n"]

  May 15, 2026   doi: 10.1111/dewb.70034   open full text
• Of Muftis and Morals: Reviving Philosophical Discourse in Islamic Bioethics.
  Ruaim Muaygil.
  Developing World Bioethics. 5 days ago
  ["Developing World Bioethics, EarlyView. ", "\nABSTRACT\nIslamic bioethics is a recent, albeit growing, academic discipline. Despite commendable contributions, the field remains critically limited. Most notably, its methodology of strict application of Islamic law to ethical analyses and recommendations often lacks sufficient moral analysis, intellectual engagement, or social context. The practice's emphasis on religio‐legal rulings‐ without an investigation of their underpinning moral values‐ has resulted in a field of inquiry devoid of robust normative foundations and dependent upon ineffective and unsubstantiated claims. This paper calls for a revival of Islamic philosophical discourse to enrich Islamic bioethical practice. Although once popularized by Medieval Muslim philosophers like Ibn Sina (Avicenna) and Ibn Rushd (Averroes), philosophical discourse has fallen out of favor in the Muslim world, largely due to a perceived tension with religion. This work highlights the rich tradition of philosophical discourse in the Medieval Muslim world, disproving claims of an inherent conflict between philosophy and Islam. Following an Islamic philosophical framework, three goals for Islamic bioethics are established. First, theoretical rigor aimed at continually re‐assessing and re‐understanding concepts integral to the practice of bioethics such as personhood, dignity, futility, autonomy, and justice. Second, a shift from essentialist understandings of the Quran‐ and other sources of Islamic law‐ to more contextual examinations in the formulation of ethical opinions. Third, an active and interdisciplinary collaboration between Muslim scholars in the determination of Islamic rulings on medical matters. Only when these goals are met is the practice of Islamic bioethics capable of meeting the needs of Muslim patients and clinicians.\n"]

  May 13, 2026   doi: 10.1111/dewb.70035   open full text
• Contextualising Mental Privacy in South Africa: Legal, Ethical, and Socio‐Cultural Considerations With Policy Recommendations.
  Marietjie Botes, Melodie Labuschaigne, Camille Casteleyn, Becky Inkster, Mark Sheppard.
  Developing World Bioethics. 11 days ago
  ["Developing World Bioethics, EarlyView. ", "\nABSTRACT\nMental privacy is a growing concern as neurotechnologies and digital mental health tools collect and process sensitive brain‐related data. In South Africa, cultural and religious diversity adds complexity to protecting mental privacy, with traditional healing practices, communal decision‐making, and spiritual beliefs influencing mental health perceptions and care. This article examines the ethical, legal, and socio‐cultural challenges of mental privacy in South Africa, focusing on cognitive autonomy, informed consent, and exploitation risks. It critiques global regulatory frameworks, highlighting the limitations of the EU's GDPR and the fragmented US approach in addressing culturally diverse and economically unequal contexts. The article proposes enhancements to South Africa's Protection of Personal Information Act, emphasising the need for explicit classification of neural and mental health data as sensitive categories. Additionally, it recommends culturally informed consent processes, collaboration with traditional and religious leaders, and public awareness initiatives to ensure inclusive mental privacy protections that respect cultural diversity while safeguarding individual rights.\n"]

  May 07, 2026   doi: 10.1111/dewb.70033   open full text
• The Protective Precautionary Principle: Safeguarding the Vulnerable in Genome Editing.
  Nucharee Wongsamut.
  Developing World Bioethics. May 04, 2026
  ["Developing World Bioethics, EarlyView. ", "\nABSTRACT\nThis article provides the philosophical grounds for the Protective Precautionary Principle (PPP). This principle prioritizes protecting disadvantaged populations from the risks posed by new technologies, such as human heritable genome editing. I argue that the Protective Precautionary Principle is better suited for morally assessing applications of heritable genome editing than other formulations of the Precautionary Principle, including the Reasonable Precautionary Principle, the Rawlsian Core Precautionary Principle, and the Sufficientarian Precautionary Principle. The Protective Precautionary Principle permits heritable genome editing research only if it reflects a commitment to epistemic humility. Moreover, such research must avoid imposing significant risks on vulnerable populations unless substantial measures are in place to mitigate potential harms.\n"]

  May 04, 2026   doi: 10.1111/dewb.70031   open full text
• No Surgery Without a License? Biopolitical Governance and Blood Donation Certificates in China.
  Yuxin Dai.
  Developing World Bioethics. May 04, 2026
  ["Developing World Bioethics, EarlyView. ", "\nABSTRACT\nThis article analyzes China's blood donation certificate system—whereby patients must present proof of donation for surgical priority—as a biopolitical technology of governance. Drawing on Foucault's framework, we examine how this informal practice operates through three mechanisms: temporal discipline that leverages medical urgency for compliance, territorial fragmentation that binds biological citizenship to local jurisdictions, and the paradox of anti‐commodification that generates quasi‐markets despite legal prohibitions on blood selling. The 2018 ban on mutual‐aid donation eliminated legal mobilization pathways while institutional pressures persisted, transforming certificate requirements from biological exchange into administrative conditioning. We argue that the system's power lies precisely in the gap between formal voluntariness and practical compulsion—a space where biopower operates below legal accountability while extracting biological resources and cultivating civic complicity. This analysis illuminates how contemporary governance increasingly functions through administrative mechanisms that transform healthcare access from universal right into contribution‐contingent privilege.\n"]

  May 04, 2026   doi: 10.1111/dewb.70032   open full text
• The Role of Research Funders in Promoting Ethical International Health Research Collaborations.
  George Kwasi Barimah, Charles F. Hayfron‐Benjamin, Bennett Allen, Kyle Ferguson, Amos Laar.
  Developing World Bioethics. April 16, 2026
  ["Developing World Bioethics, EarlyView. ", "\nABSTRACT\n\nBackground\nInternational health research collaborations (IHRCs) between High Income countries (HICs) and Low‐and Middle‐Income Countries (LMICs) are essential in global health research, yet ethical challenges including the inequitable sharing of rewards and burdens among the research actors remain insufficiently addressed. We explored the notices of funding opportunities and official guidance documents of three major research funders to assess how funding agencies structure and promote the ethical conduct of IHRCs.\n\n\nMethods\nWe conducted a content analysis of publicly available notices of funding opportunities and official guidance documents from the National Institutes of Health, European Commission, and Wellcome Trust. Using a structured data collection instrument, we cataloged content within the notices related to equitable data sharing, scientific capacity development, authorship, and intellectual property ownership.\n\n\nResults\nWe reviewed 21 International Health Research Collaboration (IHRC)‐related documents issued between 2017 and 2021. Documents reviewed included funding opportunity announcements, grant compliance documents, and funders’ code of ethics. While all three funders had general provisions for data sharing, none had guidelines specific to data management within IHRC context including the potential use of data for secondary purposes without the prior consent of researchers in LMICs. Although all funders had general guidelines on the ownership of results, guidelines specifying the distribution of ownership rights among HIC and LMIC collaborators were absent. Specific guidelines on how researchers in LMICs and HICs would benefit from each other's expertise as well as authorship guidelines within the IHRC context were absent from all funder's notices of funding opportunities.\n\n\nConclusions\nGuidelines that promote ethical conduct of IHRCs were absent from documents reviewed from the three top funders of global health research. Development and inclusion of such guidelines in funding announcements could promote ethical IHRCs.\n"]

  April 16, 2026   doi: 10.1111/dewb.70026   open full text
• The Confucian Case for a Married Couple's Social Embryo Freezing.
  Rui Deng, Ruiping Fan.
  Developing World Bioethics. March 12, 2026
  ["Developing World Bioethics, Volume 26, Issue 1, Page 50-57, March 2026. ", "\nABSTRACT\nCurrent policies in mainland China strictly distinguish between social egg or embryo freezing and medical egg or embryo freezing. Single women are not allowed to undergo social egg freezing, and even married couples are prohibited from social embryo freezing. This paper argues, from the perspective of Confucian virtue ethics, which is still the most influential traditional ethical framework in contemporary Chinese society, that prohibiting married couples from social embryo freezing cannot be justified. It also refutes the arguments supporting this ban point by point, showing that they are morally unfounded. The paper concludes that the ban should be lifted. This is not intended to encourage married couples to freeze embryos or to consider social embryo freezing an ideal reproductive choice according to Confucian ethics. Rather, it aims to highlight an important Confucian ethical point: just because social embryo freezing is not an ideal reproductive choice, it does not necessarily justify prohibition by state power."]

  March 12, 2026   doi: 10.1111/dewb.70002   open full text
• Making Advanced Therapies Affordable and Accessible: Two Strategic Approaches.
  Ubaka Ogbogu, Lauren Albrecht.
  Developing World Bioethics. March 12, 2026
  ["Developing World Bioethics, Volume 26, Issue 1, Page 66-78, March 2026. ", "\nABSTRACT\nThis article explores two complementary strategies for addressing the affordability and access challenges facing advanced therapies. As high development costs and limited market access have led to the withdrawal of several therapies, the article examines how these barriers create ‘valleys of death’ that prevent innovation from reaching patients. Through the case of Glybera and other examples, it outlines a rehabilitative approach focused on reforming current systems through improved reimbursement schemes, regulatory streamlining, and more efficient manufacturing. It also presents a transformative approach that embeds affordability and access from the beginning of the research and development process, encouraging local innovation, equitable intellectual property practices, and adaptive regulatory frameworks. Lessons from the COVID‐19 vaccine experience demonstrate the real‐world potential of these strategies to ensure that promising therapies are not only developed, but also equitably delivered worldwide.\n"]

  March 12, 2026   doi: 10.1111/dewb.70004   open full text
• Mpox and the Ethics of Outbreak Management: Lessons for Future Public Health Crises.
  Adetayo E. Obasa, Marietjie Botes, Anita Kleinsmidt, Ciara Staunton.
  Developing World Bioethics. March 12, 2026
  ["Developing World Bioethics, Volume 26, Issue 1, Page 43-49, March 2026. ", "\nABSTRACT\nMpox, first identified in captive monkeys in 1958 and recognized in humans by 1970 in the Democratic Republic of Congo, was historically confined to sporadic zoonotic outbreaks in Central and West Africa. These outbreaks, often driven by rodent‐to‐human transmission in resource‐limited settings, reflect persistent systemic health disparities. In recent years, mpox has also been reported in high‐income countries (including the United States, United Kingdom and Europe), underscoring its global health implications beyond traditionally endemic regions. This article examines the mpox outbreak through the lens of public health ethics, evaluating how core ethical frameworks—justice (encompassing equitable vaccine distribution and addressing health inequities), solidarity and respect for rights (including intellectual property considerations)—shape outbreak management strategies. These strategies are ensuring equitable access to vaccines and therapeutics amid intellectual property barriers, combating stigma and misinformation through transparent risk communication and fostering international solidarity in coordinating responses. The analysis highlights how neglect of these principles exacerbates existing disparities and undermines the effectiveness of interventions. Integrating ethical principles into outbreak responses is critical for building public trust, accountability and community resilience. By distilling lessons from the mpox response, this article contributes to ongoing debates in public health ethics and outbreak preparedness, arguing that ethically grounded approaches are essential for fair and effective management of future public health crises.\n"]

  March 12, 2026   doi: 10.1111/dewb.70001   open full text
• Between Exclusion and Legitimacy: Identity Negotiation and Ethical Dilemmas of Chinese Lesbians in the Assisted Reproduction System.
  Yuan Liu.
  Developing World Bioethics. March 12, 2026
  ["Developing World Bioethics, Volume 26, Issue 1, Page 23-31, March 2026. ", "\nABSTRACT\nIn China's current assisted reproduction system, marriage and sexual orientation serve as key entry barriers, leaving lesbians facing institutional exclusion under the dual identities of “unmarried” and “non‐heterosexual.” The marriage system, heterosexual norms, and technical regulations jointly construct the institutional structure that excludes them from the legal reproductive system. Drawing on the theoretical frameworks of reproductive justice and biopolitics, this article analyzes how Chinese lesbians navigate state institutional restrictions on their reproductive rights, drawing on literature research and five in‐depth interviews. Despite current closed policies, some interviewees, in response to hypothetical questions, expressed openness to the strategic identity path of “single motherhood.” This article proposes that, in the context of future policy relaxation, this path may become an important tool for negotiating entry into the legal reproductive system. The study finds that this strategy not only demonstrates individuals' negotiation of legitimacy within institutional interstices, but also reveals the complex tensions between moral norms, legal gaps, and kinship structures. This article argues that the ethical governance of reproductive technology should not screen reproductive eligibility based on the criteria of “qualified citizenship,” but should instead be based on the principles of human rights and equality, responding to the legitimate needs of marginalized groups.\n"]

  March 12, 2026   doi: 10.1111/dewb.70019   open full text
• Informed Consent as a Human Right in the Inter‐American Human Rights System (IAHRS).
  Diana Rocío Bernal‐Camargo, Ana Isabel Gómez–Córdoba.
  Developing World Bioethics. March 12, 2026
  ["Developing World Bioethics, Volume 26, Issue 1, Page 11-16, March 2026. ", "\nABSTRACT\nInformed consent is presented as a fundamental right and principle in modern medical practice. It involves obtaining permission from a patient before any medical procedure, treatment, or research protocol. Although not explicitly recognized as a standalone right in international human rights instruments, informed consent in healthcare is considered a right derived from other rights, such as the rights to health and freedom. The jurisprudence of international human rights courts has permitted the reinterpretation of informed consent beyond just a bioethical principle. This article argues for the normative recognition of informed consent as a self‐standing human right, rather than simply a derivative right or an ethical guideline. It does this by analyzing related cases from the Inter‐American Court of Human Rights to demonstrate how its jurisprudence, though often linking informed consent to related rights like health, personal integrity, and self‐determination, supports an understanding of informed consent as a distinct and fundamental right. The source also mentions that its recognition as a right in fundamental laws, such as the Colombian Constitution, should be achieve through the application of these international standards or via the concept of emerging rights.\n"]

  March 12, 2026   doi: 10.1111/dewb.70005   open full text
• Clinical, Bioethical, and Regulatory Challenges in Pregnancy With Death by Neurological Criteria: An Analysis in the Colombian Context.
  Boris Julián Pinto‐Bustamante, María Carolina Abaunza‐Barrero, Andrés José Vargas‐Ardila, Ana Isabel Gómez‐Córdoba, Liliana Paola Correa‐Pérez, Julián Rodríguez‐Cely, Habib Georges Moutran‐Barroso, Diana Alejandra Alfonso‐Ayala, Edna Margarita De la Hoz‐Suárez, Laura Natalia Cabra‐Rojas.
  Developing World Bioethics. March 12, 2026
  ["Developing World Bioethics, Volume 26, Issue 1, Page 58-65, March 2026. ", "\nABSTRACT\nThis article explores the ethical and legal challenges of death by neurological criteria (DNC) in a 20‐week pregnant patient, focusing on the tension between patient autonomy and fetal well‐being. Through an educational clinical case, it analyzes the clinical, bioethical, and legal aspects, considering advance directives, family expectations, and biomedical possibilities. The case raises ethical concerns about the instrumentalization of the woman's body when prolonging life support during pregnancy. The analysis emphasizes the importance of respecting the patient's autonomy and ensuring posthumous dignity. It also highlights the role of interdisciplinary teams in balancing clinical, ethical, and emotional factors in decision‐making. The discussion underscores principles such as autonomy, best interests, and proportionality, promoting ethical management aligned with individual values. Finally, it offers practical tools for healthcare professionals facing similar situations, fostering comprehensive family support and informed bioethical deliberation.\n"]

  March 12, 2026   doi: 10.1111/dewb.70003   open full text
• Chinese Bioethics of Trust and Autonomy: How Doctors Make Patient Referrals After the Introduction of a Two‐Way Referral System.
  Zihan Wu, Ping Yu.
  Developing World Bioethics. March 12, 2026
  ["Developing World Bioethics, Volume 26, Issue 1, Page 32-42, March 2026. ", "\nABSTRACT\nBased on 24 semi‐structured interviews with secondary hospital doctors, we empirically investigate how a new two‐way referral system in China influences the alignment between referring doctors, patients, and doctors who receive referrals. In particular, we focus on how this system addresses the challenges of trust, autonomy, and bioethics during the shared decision‐making process. Our research shows that the two‐way referral system has spawned new acquaintance networks, therefore improving communication and collaboration between doctors. Especially during upward referrals, benefits associated with care continuity have been made possible. However, doctors still tend to adopt defensive patient‐centered strategies in referral communication. They consult patients' desires and play an information provider role. This is influenced by both procedural requirements imposed by managerial rules and uncertainty caused by medical consumerism. Thus, we argue that the Chinese bioethical issue of doctor–patient relationships has gradually turned to a mismatch of concerns between doctors and patients.\n"]

  March 12, 2026   doi: 10.1111/dewb.12491   open full text
• Global Interdependence, Just Vaccine Allocation, and Compensatory Justice: A New Model.
  Kalen J. Fredette.
  Developing World Bioethics. March 12, 2026
  ["Developing World Bioethics, Volume 26, Issue 1, Page 17-22, March 2026. ", "\nABSTRACT\nDuring the COVID‐19 pandemic, numerous models were offered for how scarce vaccine resources should be distributed. Proposed vaccine distribution models generally were divided between nationalist models, which give preference to nationals, and cosmopolitan models, which ignore national boundaries. More defensible international vaccine distribution program proposals incorporate ethical considerations from both cosmopolitanism and nationalist models. To date, however, proposed models have insufficiently considered how global interdependence has resulted in economic and ecological harms by high‐income countries (HICs) against low‐to‐middle income countries (LMICs). Because these harms create health burdens for the populations of LMICs, compensatory justice should impact distribution determinations. This paper argues that adequately factoring in global interdependence, compensatory justice, as well as the disproportionate impact of pandemics on LMICs, just vaccine distribution may require prioritizing LMIC populations over those of HICs."]

  March 12, 2026   doi: 10.1111/dewb.12486   open full text
• Improving the Ethical Permissibility of Medical Electives in Lower‐Resource Settings.
  Simon Paul Jenkins.
  Developing World Bioethics. January 19, 2026
  ["Developing World Bioethics, EarlyView. ", "\nABSTRACT\nThis paper presents a moral‐theoretical evaluation of medical electives, applying different frameworks of distributive justice to the phenomenon of healthcare students visiting countries with less access to resources in order to bolster their own learning. Currently, discussions of ethical issues around these medical electives largely focuses on issues arising during the placement experience itself, in the form of dilemmas to which an individual must react in an ethical way. Applying different frameworks of distributive justice to the wider issue of how an elective project is designed and organised suggests that electives need to focus a great deal more on conferring benefits to host communities – that is, the communities being visited by students from wealthier settings – than is currently the case. To avoid the charge that medical electives are impermissibly extractive insofar as they impose burdens on host communities that are not justified by appeal to the benefits that the visiting students (or their communities) enjoy, I propose that both students and educators in the healthcare professions consider advocating an offsetting system to compensate host communities for the harms caused by the elective's taking place. The offsetting could comprise a monetary payment, a resolution to work in a lower‐resource setting in the future, or some combination of those two things. While this system may not even be permissible under all the distributive justice frameworks considered, it represents an improvement on the current state of affairs whilst still allowing trainees to gain useful experiences from electives.\n"]

  January 19, 2026   doi: 10.1111/dewb.70024   open full text
• Perceptions of Research Integrity Among Medical Researchers in Shanghai Teaching Hospitals: A Cross‐Sectional Survey.
  Zikai Zhang, Lei Huang, Yufei Huang, Zhenbo Zhang, Wei Chen.
  Developing World Bioethics. December 31, 2025
  ["Developing World Bioethics, EarlyView. ", "\nABSTRACT\nResearch integrity has become a pressing concern in China, which accounts for a large share of global retractions. Yet little is known about how research integrity is understood and enacted within teaching hospitals. In this cross‐sectional study, we surveyed 106 medical researchers across four Shanghai hospitals to assess their awareness, attitudes, and practices regarding scientific misconduct, as well as the role of integrity education. Most respondents reported familiarity with definitions of fabrication, falsification, and plagiarism and expressed strong disapproval of these behaviors. Nonetheless, 11%–22% indicated some degree of tolerance toward selective reporting or unjustified authorship, and firsthand reports of witnessed misconduct were uncommon. Participation in formal courses or lectures on research integrity was associated with higher knowledge scores and stronger agreement with ethical principles. These findings reveal a tension between high awareness and partial tolerance, highlighting the importance of exploring how institutional cultures and incentive systems may influence ethical behavior in future research and policy efforts."]

  December 31, 2025   doi: 10.1111/dewb.70022   open full text
• Bioethics and Transitional Justice: LGBTQI+ Victims In the Colombian Post‐Conflict.
  María Lucía Rivera‐Sanín, Diana Acevedo‐Zapata.
  Developing World Bioethics. December 08, 2025
  ["Developing World Bioethics, EarlyView. ", "\nABSTRACT\nThis paper explores the role of bioethics in addressing the specific challenges faced by LGBTQI+ victims in Colombia's transitional justice process. It argues that queer and feminist bioethics offer both theoretical and practical contributions to the core aims of truth, reparation, and non‐repetition by critically engaging with the biomedical discourses at the base of prejudice‐based violence. The pathologization of sexual and gender diversity is examined as a structural condition of victimization and re‐victimization during and after the armed conflict. Drawing on reports, testimonies, and conceptual frameworks, the paper reflects on how bioethical perspectives can support recognition, dignity, and structural transformation. Rather than advancing prescriptive solutions, the analysis emphasizes the need for ongoing critical engagement with the medical, legal, and social imaginaries that sustain inequality. The article positions bioethics as a field capable of contributing to transitional justice by fostering reflection on difference, responsibility, and the epistemic dimensions of reparation.\n"]

  December 08, 2025   doi: 10.1111/dewb.70016   open full text
• Contributions of Community Advisory Board and Experience of Study Participants in TB/MDR‐TB Clinical Trial Management in Addis Ababa, Ethiopia: A Qualitative Study.
  Yemisrach Seralegne, Abaraham G/Medihin, Ermiyas Hundito, Hawult Adane, Bizunesh Sintayehu.
  Developing World Bioethics. December 07, 2025
  ["Developing World Bioethics, EarlyView. ", "\nABSTRACT\nCommunity Advisory Boards (CABs), as a form of community engagement, provide an important mechanism to ensure that research aligns with community needs and priorities by representing broader community interests and guiding research accordingly. Tuberculosis (TB) and multidrug‐resistant tuberculosis (MDR‐TB) remain significant public health concerns, particularly due to resistance to key first‐line anti‐TB medications, and individuals affected by these conditions often face stigma and discrimination that hinder timely diagnosis and treatment adherence. Addressing these challenges requires community‐driven strategies and improved access to health services, with CABs serving a central role in bridging gaps between researchers, healthcare providers, and affected communities. This study explored the contributions of CAB members in supporting TB/MDR‐TB clinical trials, the challenges experienced by trial participants, and the strategies employed to address these challenges. Using an exploratory qualitative design, in‐depth interviews were conducted with 17 stakeholders involved in TB/MDR‐TB clinical trials, and data were analyzed using deductive thematic analysis. The findings highlight persistent stigma and discrimination, limited understanding of the role and functions of CABs, inconsistent budget allocation, reduced participation, and diminished CAB influence throughout the research process. The study underscores the essential role of CABs in enhancing community engagement in TB/MDR‐TB clinical trials and emphasizes the need for greater awareness, advocacy, and institutional support to strengthen their contributions. Adequate and sustained funding, along with systematic planning and implementation, is critical for reinforcing CAB roles and promoting more ethical, inclusive, and responsive public health research practices in Ethiopia and other low‐ and middle‐income countries.\n"]

  December 07, 2025   doi: 10.1111/dewb.70014   open full text
• Causes and Consequences of Lack of Transparency In Iran's Healthcare System: A Qualitative Interview Study.
  Hossein Bouzarjomehri, Mohammadreza Maleki, Iravan Masoudi‐Asl, Mohammad Ranjbar, Yasaman Herandi, Mohsen Khosravi.
  Developing World Bioethics. December 07, 2025
  ["Developing World Bioethics, EarlyView. ", "\nABSTRACT\nLack of transparency in healthcare systems is a critical challenge that undermines accountability, fuels corruption, and erodes public trust. While transparency has been shown to generate multiple positive outcomes, the Iranian healthcare system continues to suffer from significant deficits in this area. To investigate this issue, a qualitative approach was employed, which involved conducting 35 in‐depth interviews with experts and social activists engaged in healthcare system transparency at all levels, recruited through purposive stratified sampling method. This was followed by a thematic analysis aimed at exploring the causes and consequences of the phenomenon. The results indicated that the causes of the lack of transparency in the Iranian healthcare system can be categorized into four main domains: sociopolitical, psychological and behavioral, organizational, and ethical and legal factors. Additionally, the consequences of the lack of transparency can be classified into three primary categories: ethical, organizational, and social factors. The findings of this study provide needed data to enhance transparency and cultivate a culture of openness and accountability in the Iranian healthcare system and other similar contexts.\n"]

  December 07, 2025   doi: 10.1111/dewb.70015   open full text
• Ubuntu Vis‐à‐Vis the Saying “We Are All in This Together” in the Context of the COVID‐19 Pandemic.
  John Mark Ogu.
  Developing World Bioethics. October 30, 2025
  ["Developing World Bioethics, EarlyView. ", "\nABSTRACT\nThis article analyzes the interplay between Ubuntu's philosophy: “I am, because we are; and because we are, therefore I am” with the expression “We are all in this together,” which resounded mostly in North America and Europe during the COVID‐19 pandemic. This article argues that the expression “We are all in this together” directly or indirectly adopted Ubuntu's philosophy of relational solidarity in handling and navigating the COVID‐19 pandemic. The expression implicitly acknowledges that pandemics can be mitigated through collaboration, shared responsibility, and relational solidarity.\n"]

  October 30, 2025   doi: 10.1111/dewb.70010   open full text
• Reframing Justice in Healthcare AI: An Ubuntu‐Based Approach for Africa.
  Aloysius Ochasi, Abdoul Jalil Djiberou Mahamadou, Russ B. Altman, Levi U. C. Nkwocha.
  Developing World Bioethics. October 15, 2025
  ["Developing World Bioethics, EarlyView. ", "\nABSTRACT\nThere is an ongoing debate on how to balance the benefits and risks of artificial intelligence (AI), especially in healthcare. In resource‐constrained settings, such as Africa, where access to quality care remains a challenge, AI has the potential to improve efficiency, accessibility, and patient outcomes. Yet, its development and deployment raise complex ethical, legal, ecological, and socioeconomic concerns. To ensure context‐sensitive solutions, this paper introduces Ubuntu, a traditional African ethical philosophy, as a guiding framework for AI in African healthcare. Ubuntu offers a people‐centered alternative to dominant Western‐centric models, providing a culturally grounded lens for interpreting justice‐related principles in line with Africa's unique needs and realities. Drawing on Ubuntu's five core values of communalism, interdependence, humanism, sharing, and compassion, we analyze how these principles can ethically guide AI across three normative pillars: justice and fairness, solidarity, and sustainability. For each, we identify risks and offer concrete, culturally resonant strategies to address them. In doing so, we undertake a distinctive scholarly contribution that meaningfully enriches the emerging discourse on decolonizing AI by reframing Ubuntu not only as a moral compass but also as a strategic tool for structural reform and innovation.\n"]

  October 15, 2025   doi: 10.1111/dewb.70007   open full text
• Anaesthesia Waste Gases and Bioethics: Balancing Patient Care, Environmental Responsibility, and Occupational Safety.
  Shibu Sasidharan, Harpreet Dhillon.
  Developing World Bioethics. June 15, 2025
  ["Developing World Bioethics, EarlyView. ", "\nABSTRACT\nAnaesthesia waste gases (AWGs) represent a significant yet often overlooked contributor to healthcare's environmental footprint, with implications extending beyond ecological concerns to encompass occupational hazards and complex ethical considerations. This article examines the intersection of AWGs and bioethics through the framework of environmental stewardship, occupational health principles, patient‐centered care, and distributive justice. Contemporary volatile anaesthetics possess global warming potentials thousands of times greater than carbon dioxide, while implicated occupational exposures raise concerns about reproductive health and neurological function among healthcare workers. The bioethical paradigms of principalism—encompassing nonmaleficence, beneficence, autonomy, and justice—and environmental ethics provide structured approaches to addressing these multifaceted challenges. This review synthesizes current evidence regarding AWGs' environmental and occupational impacts, evaluates emerging mitigation strategies, and proposes an integrated ethical framework to guide clinical practice, institutional policy, and professional standards in anaesthesiology.\n"]

  June 15, 2025   doi: 10.1111/dewb.12489   open full text
• Models for truth‐telling in physician‐patient encounters: what can we learn from Yoruba concept of Ooto?
  Cornelius Ewuoso.
  Developing World Bioethics. September 29, 2017
  Empirical studies have now established that many patients make clinical decisions based on models other than Anglo American model of truth‐telling and patient autonomy. Some scholars also add that current medical ethics frameworks and recent proposals for enhancing communication in health professional‐patient relationship have not adequately accommodated these models. In certain clinical contexts where health professional and patients are motivated by significant cultural and religious values, these current frameworks cannot prevent communication breakdown, which can, in turn, jeopardize patient care, cause undue distress to a patient in certain clinical contexts or negatively impact his/her relationship with the community. These empirical studies have now recommended that additional frameworks developed around other models of truth‐telling; and which take very seriously significant value‐differences which sometimes exist between health professional and patients, as well as patient's cultural/religious values or relational capacities, must be developed. This paper contributes towards the development of one. Specifically, this study proposes a framework for truth‐telling developed around African model of truth‐telling by drawing insights from the communitarian concept of ootọ́ amongst the Yoruba people of south west Nigeria. I am optimistic that if this model is incorporated into current medical ethics codes and curricula, it will significantly enhance health professional‐patient communication.

  September 29, 2017   doi: 10.1111/dewb.12177   open full text
• Reconciling female genital circumcision with universal human rights.
  John‐Stewart Gordon.
  Developing World Bioethics. September 18, 2017
  One of the most challenging issues in cross‐cultural bioethics concerns the long‐standing socio‐cultural practice of female genital circumcision (FGC), which is prevalent in many African countries and the Middle East as well as in some Asian and Western countries. It is commonly assumed that FGC, in all its versions, constitutes a gross violation of the universal human rights of health, physical integrity, and individual autonomy and hence should be abolished. This article, however, suggests a mediating approach according to which one form of FGC, the removal of the clitoris foreskin, can be made compatible with the high demands of universal human rights. The argument presupposes the idea that human rights are not absolutist by nature but can be framed in a meaningful, culturally sensitive way. It proposes important limiting conditions that must be met for the practice of FGC to be considered in accordance with the human rights agenda.

  September 18, 2017   doi: 10.1111/dewb.12173   open full text
• Quarantine, isolation and the duty of easy rescue in public health.
  Alberto Giubilini, Thomas Douglas, Hannah Maslen, Julian Savulescu.
  Developing World Bioethics. September 18, 2017
  We address the issue of whether, why and under what conditions, quarantine and isolation are morally justified, with a particular focus on measures implemented in the developing world. We argue that the benefits of quarantine and isolation justify some level of coercion or compulsion by the state, but that the state should be able to provide the strongest justification possible for implementing such measures. While a constrained form of consequentialism might provide a justification for such public health interventions, we argue that a stronger justification is provided by a principle of State Enforced Easy Rescue: a state may permissibly compel individuals to engage in activities that entail a small cost to them but a large benefit to others, because individuals have a moral duty of easy rescue to engage in those activities. The principle of State Enforced Easy Rescue gives rise to an Obligation Enforcement Requirement: the state should create the conditions such that submitting to coercive or compulsive measures becomes a fundamental moral duty of individuals, i.e. a duty of easy rescue. When the state can create such conditions, it has the strongest justification possible for implementing coercive or compulsive measures, because individuals have a moral duty to temporarily relinquish the rights that such measures would infringe. Our argument has significant implications for how public health emergencies in the developing world should be tackled. Where isolation and quarantine measures are necessary, states or the international community have a moral obligation to provide certain benefits to those quarantined or isolated.

  September 18, 2017   doi: 10.1111/dewb.12165   open full text
• African communal basis for autonomy and life choices.
  Polycarp Ikuenobe.
  Developing World Bioethics. September 05, 2017
  I argue that the metaphysical capacity of autonomy is not intrinsically valuable; it is valuable only when used in relation to a community's values and instrumentally for making the proper choices that will promote one's own and the community's well‐being. I use the example of the choice to take one's life by suicide to illuminate this view. I articulate a plausible African conception of personhood as a basis for the idea of relational autonomy. I argue that this conception is better understood as a social‐moral thesis, and not a metaphysical thesis. A metaphysical thesis gives an account of the abstract nature of an atomic individual, his agency, and rational choice. The social‐moral thesis indicates that personhood and autonomy are positive and relational to the life plans, well‐being, material conditions, and the best means for achieving them that are made available and possible by harmonious living in a community. This idea of autonomy is not just having the capacity of freewill; it also involves how such freewill is used, in terms of how an individual's choices are guided by internalized communal values.

  September 05, 2017   doi: 10.1111/dewb.12161   open full text
• ‘We are the eyes and ears of researchers and community’: understanding the role of community advisory groups in representing researchers and communities in Malawi.
  Deborah Nyirenda, Salla Sariola, Kate Gooding, Mackwellings Phiri, Rodrick Sambakunsi, Elvis Moyo, Chiwoza Bandawe, Bertie Squire, Nicola Desmond.
  Developing World Bioethics. September 05, 2017
  Community engagement to protect and empower participating individuals and communities is an ethical requirement in research. There is however limited evidence on effectiveness or relevance of some of the approaches used to improve ethical practice. We conducted a study to understand the rationale, relevance and benefits of community engagement in health research. This paper draws from this wider study and focuses on factors that shaped Community Advisory Group (CAG) members’ selection processes and functions in Malawi. A qualitative research design was used; two participatory workshops were conducted with CAG members to understand their roles in research. Workshop findings were triangulated with insights from ethnographic field notes, key informant interviews with stakeholders, focus group discussions with community members and document reviews. Data were coded manually and thematic content analysis was used to identify main issues. Results have shown that democratic selection of CAG members presented challenges in both urban and rural settings. We also noted that CAG members perceived their role as a form of employment which potentially led to ineffective representation of community interests. We conclude that democratic voting is not enough to ensure effective representation of community's interests of ethical relevance. CAG members’ abilities to understand research ethics, identify potential harms to community and communicate feedback to researchers is critical to optimise engagement of lay community and avoid tokenistic engagement.

  September 05, 2017   doi: 10.1111/dewb.12163   open full text
• Community sensitization and decision‐making for trial participation: a mixed‐methods study from The Gambia.
  Susan Dierickx, Sarah O'Neill, Charlotte Gryseels, Edna Immaculate Anyango, Melanie Bannister‐Tyrrell, Joseph Okebe, Julia Mwesigwa, Fatou Jaiteh, René Gerrets, Raffaella Ravinetto, Umberto D'Alessandro, Koen Peeters Grietens.
  Developing World Bioethics. August 16, 2017
  Background Ensuring individual free and informed decision‐making for research participation is challenging. It is thought that preliminarily informing communities through ‘community sensitization’ procedures may improve individual decision‐making. This study set out to assess the relevance of community sensitization for individual decision‐making in research participation in rural Gambia. Methods This anthropological mixed‐methods study triangulated qualitative methods and quantitative survey methods in the context of an observational study and a clinical trial on malaria carried out by the Medical Research Council Unit Gambia. Results/discussion Although 38.7% of the respondents were present during sensitization sessions, 91.1% of the respondents were inclined to participate in the trial when surveyed after the sensitization and prior to the informed consent process. This difference can be explained by the informal transmission of information within the community after the community sensitization, expectations such as the benefits of participation based on previous research experiences, and the positive reputation of the research institute. Commonly mentioned barriers to participation were blood sampling and the potential disapproval of the household head. Conclusion Community sensitization is effective in providing first‐hand, reliable information to communities as the information is cascaded to those who could not attend the sessions. However, further research is needed to assess how the informal spread of information further shapes people's expectations, how the process engages with existing social relations and hierarchies (e.g. local political power structures; permissions of heads of households) and how this influences or changes individual consent.

  August 16, 2017   doi: 10.1111/dewb.12160   open full text
• Research in epidemic and emergency situations: A model for collaboration and expediting ethics review in two Caribbean countries.
  Derrick Aarons.
  Developing World Bioethics. July 28, 2017
  Various forms of research are essential in emergency, disaster and disease outbreak situations, but challenges exist including the long length of time it takes to get research proposals approved. Consequently, it would be very advantageous to have an acceptable model for efficient coordination and communication between and among research ethics committees/IRBs and ministries of health, and templates for expediting (done with speed and efficiency) ethical review of research proposals in emergency and epidemic situations to be used across the Caribbean and in other low and middle income countries. This project involved a literature search and the interviewing of ministry of health officials, public health practitioners, and research ethics committee/IRB members in Jamaica and St. Lucia, to obtain suggestions for the best model for efficient coordination and communication between research ethics committees (RECs), and developed a template for expediting review of research protocols in epidemic and emergency conditions.

  July 28, 2017   doi: 10.1111/dewb.12157   open full text
• Haitian people's expectations regarding post‐disaster humanitarian aid teams’ actions.
  Lonzozou Kpanake, Ronald Jean‐Jacques, Paul Clay Sorum, Etienne Mullet.
  Developing World Bioethics. July 28, 2017
  The way people at the receiving end of humanitarian assistance perceive this intervention may provide invaluable bottom‐up feedback to improve the quality of the intervention. We analyzed and mapped Haitians’ views regarding international humanitarian aid in cases of natural disaster. Two hundred fifty participants–137 women and 113 men aged 18‐67–who had suffered from the consequences of the earthquake in 2010 were presented with a series of vignettes depicting a humanitarian team's action and were asked to what extent these actions corresponded to what ought to be expected from an international aid mission. Four factors were considered in the vignettes (a) whether the team worked in close association with local institutions, (b) whether it was composed of competent people who were prepared for their mission, (c) whether they treated people as a function of immediate needs, and (d) whether they behaved in a respectful way. Through cluster analysis, five qualitatively different positions were found: (a) Complete hostility to any kind of humanitarian aid (6%); (b) Strong hostility to humanitarian aid in the case of disrespectful attitudes or behaviors (4%); (c) Technical competence is the only factor that matters (25%); (d) Both manifestation of respect for the population and technical competence matter (38%) and (e) Undetermined (27%). Most Haitians expect humanitarian teams to be technically competent, but even very competent aid is not considered adequate if provided in an arrogant and disrespectful manner.

  July 28, 2017   doi: 10.1111/dewb.12158   open full text
• “You Cannot Collect Data Using Your Own Resources And Put It On Open Access”: Perspectives From Africa About Public Health Data‐Sharing.
  Evelyn Anane‐Sarpong, Tenzin Wangmo, Claire Leonie Ward, Osman Sankoh, Marcel Tanner, Bernice Simone Elger.
  Developing World Bioethics. July 25, 2017
  Data‐sharing is a desired default in the field of public health and a source of much ethical deliberation. Sharing data potentially contributes the largest, most efficient source of scientific data, but is fraught with contextual challenges which make stakeholders, particularly those in under‐resourced contexts hesitant or slow to share. Relatively little empirical research has engaged stakeholders in discussing the issue. This study sought to explore relevant experiences, contextual, and subjective explanations around the topic to provide a rich and detailed presentation of what it means to different stakeholders and contexts to share data and how that can guide practice and ethical guidance. A qualitative design involving interviews was undertaken with professionals working in public health institutions endowed with data (HDSS), ethics committees, and advisory agencies which help shape health research in Africa. A descriptive form of thematic analysis was used to summarize results into six key themes: (1) The role of HDSSs in research using public health data and data‐sharing; (2) Ownership and funding are critical factors influencing data‐sharing; (3) Other factors discourage data‐sharing; (4) Promoting and sustaining data‐sharing; (5) Ethical guidance structures; and (6) Establishing effective guidance. The themes reveal factors regarding the willingness or not to share and an intricate ethical system that current discourse could reflect. Many of the concerns resonate with the literature, but a whole other gamut of people and process issues; commitments, investments, careers, and the right ethical guidance are needed to realize a sustainable goal of reaching ‘share’ as a default.

  July 25, 2017   doi: 10.1111/dewb.12159   open full text
• The ethics and politics of patient‐physician mistrust in contemporary China.
  Yunxiang Yan.
  Developing World Bioethics. July 17, 2017
  Focusing on the shared sense of victimization and disadvantage‐ness by both patients and doctors/medical workers in cases of medical conflicts, this paper aims to examine the current patient‐doctor tensions in the larger context of moral transformation in Chinese society since the 1980s. Although the decline of public trust in certain aspects is closely associated with the impact of commodification and commercialization of medical sector during the past two decades, other factors play important role as well. In the case of patient‐doctor tension, mutual disrespect and mistrust also result from the ongoing process of individualization and the remaking of moral self, in which the individual demand for respect, dignity, and trust seem to have unexpectedly and ironically contributed to the rise of tensions and conflicts between patients and doctors as well as other medical workers.

  July 17, 2017   doi: 10.1111/dewb.12155   open full text
• Regulating clinical trials in India: the economics of ethics.
  Gerard Porter.
  Developing World Bioethics. July 09, 2017
  The relationship between the ethical standards for the governance of clinical trials and market forces can be complex and problematic. This article uses India as a case study to explore this nexus. From the mid‐2000s, India became a popular destination for foreign‐sponsored clinical trials. The Indian government had sought to both attract clinical trials and ensure these would be run in line with internationally accepted ethical norms. Reports of controversial medical research, however, triggered debate about the robustness and suitability of India's regulatory system. In response to civil society pressure and interventions by the Supreme Court, the Indian government proposed additional measures aimed at strengthening protections for clinical trial participants. Whilst the reforms can be seen as a victory for human rights activists, they have also been criticised as being overly burdensome for sponsors. Indeed, their announcement prompted an exodus of clinical trials from India. Fearful of losing business to ‘rival’ countries, the Indian government is revisiting some of its proposals. The Indian example suggests that research ethics frameworks and national policies for economic development are increasingly intertwined. Host countries are in theory free to improve the lot of research participants, but doing so may make them appear less attractive to foreign sponsors, who can simply shift their activities to more industry‐friendly jurisdictions. Although these economic pressures are unlikely to lead to a regulatory ‘race to the bottom’, they may limit host countries' ability to enact socially desirable reforms.

  July 09, 2017   doi: 10.1111/dewb.12156   open full text
• Conceptualizations of fairness and legitimacy in the context of Ethiopian health priority setting: Reflections on the applicability of accountability for reasonableness.
  Kadia Petricca, Asfaw Bekele.
  Developing World Bioethics. May 22, 2017
  A critical element in building stronger health systems involves strengthening good governance to build capacity for transparent and fair health planning and priority setting. Over the past 20 years, the ethical framework Accountability for Reasonableness (A4R) has been a prominent conceptual guide in strengthening fair and legitimate processes of health decision‐making. While many of the principles embedded within the framework are congruent with Western conceptualizations of what constitutes procedural fairness, there is a paucity in the literature that captures the degree of resonance between these principles and the views of decision makers from non‐Western settings; particularly in Africa, where many countries have only recently, within the last 20‐30 years, become more democratic. This paper contributes to the ethics literature by examining how Ethiopian decision makers conceptualize fair and legitimate health decision‐making, and reflects on the degree of conceptual resonance between these views and the principles embedded in A4R. A qualitative case study approach from three districts in Ethiopia was undertaken. Fifty‐eight decision makers from district, regional, zonal, and national levels were interviewed to describe their conceptualization of fairness and legitimacy in the district health planning process. Findings revealed that Ethiopians have a broad conception of fairness and legitimacy that while congruent with procedural justice, also aligned with principles of distributive and organizational justice. Researchers and practitioners seeking to strengthen procedural fairness in health priority setting must therefore recognize the significance of other philosophical dimensions influencing how fairness and legitimacy of health decision‐making are constructed within the Ethiopian setting.

  May 22, 2017   doi: 10.1111/dewb.12153   open full text
• Corruption or professional dignity: An ethical examination of the phenomenon of “red envelopes” (monetary gifts) in medical practice in China.
  Wei Zhu, Lijie Wang, Chengshang Yang.
  Developing World Bioethics. May 21, 2017
  In the medical practice in China, giving and taking “red envelopes” (monetary gifts) is a common phenomenon although few openly admit it. This paper, based on our empirical study including data collected from interviews and questionnaires with medical professionals and patients, attempts to explore why “red envelopes” have become a serious problem in the physician‐patient relationship and how the situation can be improved. Previous studies show that scholars tend to correlate the spread of “red envelopes” in health care sector to the commercialization trend, the general erosion of traditional values, and the lowering of the moral level in the medical field. However, in this paper, the authors argue that medical professionals’ choice of taking “red envelopes” is actually more a way to compensate for their problematic self‐image and marred dignity in real practice. Medical professionals in China as a whole are in an embarrassing situation where the work pressure and income, and the sense of pride that used to be part of their profession are not comparable to each other. Under this circumstance, we believe that the effective way to deal with the “red envelopes” issue does not lie solely in introducing more stringent regulations or granting medical professionals higher payments, but rather in protecting and enhancing the professional dignity of all those working in healthcare. And on top of that, there must also be effort to cultivate a more favorable moral environment.

  May 21, 2017   doi: 10.1111/dewb.12152   open full text
• The views of ethics committee members and medical researchers on the return of individual research results and incidental findings, ownership issues and benefit sharing in biobanking research in a South Indian city.
  Manjulika Vaz, Mario Vaz, Srinivasan K.
  Developing World Bioethics. May 17, 2017
  The return of individual research results and incidental findings from biobanking research is a much debated ethical issue globally but has extensive relevance in India where the burden of out of pocket health care expenses is high for the majority. The views of 21 ethics committee (EC) members and 22 researchers from Bengaluru, India, concerning the ethics of biobanking research were sought through in‐depth interviews using an unfolding case vignette with probes. A shared view among most was that individual research results which are ‘actionable’ or have ‘clinical significance’ should be returned to the sample contributors through their treating physicians. This was seen as an ethical obligation and a moral duty on the side of the researcher to “give back” to the person who contributed to the research. The challenges foreseen were that of resources, both financial and personnel, for the time and counseling needed to accompany the disclosure of results. Perceptions of ‘ownership’ appear to influence the concept of benefit sharing. While benefit sharing in financial terms was considered ethically challenging, certain researchers and ethics committee members made a case for “two way altruism” where the researcher in return for the altruistic ‘valuable contribution’, shares with the contributor/ community, benefits of the research which could include research findings, improved patient care, and more affordable access to the new diagnostic tests or products arising from the research. This defines the emerging ethic of “giving back” which goes beyond individual rights and ensures reciprocity and distributive justice.

  May 17, 2017   doi: 10.1111/dewb.12143   open full text
• Age‐related inequalities in health and healthcare: the life stages approach.
  Nancy S. Jecker.
  Developing World Bioethics. May 16, 2017
  How should healthcare systems prepare to care for growing numbers and proportions of older people? Older people generally suffer worse health than younger people do. Should societies take steps to reduce age‐related health inequalities? Some express concern that doing so would increase age‐related inequalities in healthcare. This paper addresses this debate by (1) presenting an argument in support of three principles for distributing scarce resources between age groups; (2) framing these principles of age group justice in terms of life stages; and (3) indicating policy implications that merit further attention in light of rapidly aging societies.

  May 16, 2017   doi: 10.1111/dewb.12148   open full text
• Opt‐in or opt‐out to increase organ donation in South Africa? Appraising proposed strategies using an empirical ethics analysis.
  Harriet Etheredge, Claire Penn, Jennifer Watermeyer.
  Developing World Bioethics. May 16, 2017
  Utilising empirical ethics analysis, we evaluate the merits of systems proposed to increase deceased organ donation in South Africa (SA). We conclude that SA should maintain its soft opt‐in policy, and enhance it with ‘required transplant referral’ in order to maximise donor numbers within an ethically and legally acceptable framework. In SA, as is the case worldwide, the demand for donor organs far exceeds the supply thereof. Currently utilising a soft opt‐in system, SA faces the challenge of how to increase donor numbers in a context which is imbued with inequalities in access to healthcare, multiplicitous personal beliefs and practices, distrust of organ transplant and varying levels of education and health literacy. We argue that a hard opt‐in, opt‐out or mandated consent system would be problematic, and we present empirical data from Gauteng Province illustrating barriers to ethically sound practice in soft consent systems. Ultimately, we argue that in spite of some limitations, a soft opt‐in system is most realistic for SA because its implementation does not require extensive public education campaigns at national level, and it does not threaten to further erode trust at a clinical level. However, to circumvent some of the clinical‐level barriers identified in our empirical study, we propose a contextually sensitive option for “enabling” soft opt‐in through “required transplant referral”. We argue that this system is legally defensible, enhances ethical practice and could also increase donor numbers as it has in many other countries.

  May 16, 2017   doi: 10.1111/dewb.12154   open full text
• Informed consent, community engagement, and study participation at a research site in Kigali, Rwanda.
  Jennifer Ilo Nuil, Evelyne Kestelyn, Grace Umutoni, Lambert Mwambarangwe, Marie M. Umulisa, Janneke Wijgert, Raffaella Ravinetto.
  Developing World Bioethics. May 11, 2017
  People enroll in medical research for many reasons ranging from decisions regarding their own or family members' health situation to broader considerations including access to health and financial resources. In socially vulnerable communities the choice to participate is often based on a risk‐benefit assessment that goes beyond the medical aspects of the research, and considers the benefits received. In this qualitative study, we examined the motivations of Rwandan women to participate in a non‐commercial collaborative research study examining the safety, acceptability, and adherence of a contraceptive vaginal ring in Rwanda juxtaposed with the perceptions of the research within the community. 351 women attended the screening visit, four were excluded because they were not able to complete the assessment of understanding. The remaining participants' ages ranged from 17 to 38 and 80% had primary level of education or below. 120 were enrolled. Findings highlighted motivations for joining the study that were relayed both formally by the clinic (e.g. testing and treatment) and informally by the community including the positive aspects of the ring. There were also some negative rumors circulating regarding the research site, likely from excluded participants who faced potential stigma based on that exclusion. It was understood by most participants that they were enrolled in a research study and participants actively sought out enrollment in the research for a variety of reasons. The experiences demonstrate that although inequalities in access to health care may create conflicting situations around the study, it is possible to form partnerships between a research center and participants/their partners, for research about reproductive health.

  May 11, 2017   doi: 10.1111/dewb.12149   open full text
• Defining Health Research for Development: The perspective of stakeholders from an international health research partnership in Ghana and Tanzania.
  Claire Leonie Ward, David Shaw, Evelyn Anane‐Sarpong, Osman Sankoh, Marcel Tanner, Bernice Elger.
  Developing World Bioethics. May 03, 2017
  Objectives The study uses a qualitative empirical method to define Health Research for Development. This project explores the perspectives of stakeholders in an international health research partnership operating in Ghana and Tanzania. Methods We conducted 52 key informant interviews with major stakeholders in an international multicenter partnership between GlaxoSmithKline (GSK, Vaccine Developer) and the global health nonprofit organisation PATH and its Malaria Vaccine Initiative program (PATH/MVI, Funder‐Development Partner), (RTS, S) (NCT00866619). The respondents included teams from four clinical research centres (two centres in Ghana and two in Tanzania) and various collaborating partners. This paper analyses responses to the question: What is Health Research for Development? Results Based on the stakeholders’ experience the respondents offered many ways of defining Health Research for Development. The responses fell into four broad themes: i) Equitable Partnerships; ii) System Sustainability; iii) Addressing Local Health Targets, and iv) Regional Commitment to Benefit Sharing. Conclusion Through defining Health Research for Development six key learning points were generated from the four result themes: 1) Ensure there is local research leadership working with the collaborative partnership, and local healthcare system, to align the project agenda and activities with local research and health priorities; 2) Know the country‐specific context ‐ map the social, health, legislative and political setting; 3) Define an explicit development component and plan of action in a research project; 4) Address the barriers and opportunities to sustain system capacity. 5) Support decentralised health system decision‐making to facilitate the translation pathway; 6) Govern, monitor and evaluate the development components of health research partnerships. Overall, equity and unity between partners are required to deliver health research for development.

  May 03, 2017   doi: 10.1111/dewb.12144   open full text
• Ethics of community engagement in field trials of genetically modified mosquitoes.
  David B. Resnik.
  Developing World Bioethics. May 03, 2017
  Effective community engagement is an important legal, ethical, and practical prerequisite for conducting field trials of genetically modified mosquitoes, because these studies can substantially impact communities and it is usually not possible to obtain informed consent from each community member. Researchers who are planning to conduct field trials should develop a robust community engagement strategy that meets widely recognized standards for seeking approval from the affected population, such as timeliness, consent, information sharing, transparency, understanding, responsiveness, mutual understanding, inclusiveness, and respectfulness. Additional research is needed on the effectiveness of different methods of engaging communities in field trials of genetically modified mosquitoes and how to respond to public opposition to genetically modified organisms. For research programs involving the genetic modification of disease vectors to move forward, they must have public acceptance and support, which cannot be achieved without effective community engagement.

  May 03, 2017   doi: 10.1111/dewb.12147   open full text
• H3Africa: An Africa exemplar? Exploring its framework on protecting human research participants.
  Obiajulu Nnamuchi.
  Developing World Bioethics. May 03, 2017
  The Human Heredity and Health in Africa (H3Africa) Consortium is a conglomeration of research and infrastructure projects spread throughout Africa whose aim is to apply genomic methodology to diseases affecting the people in the region. Its operation is innovative in the sense that it is doing something new; that is, filling a hitherto existing void in genomic research capability of African scientists and infusing resources and manpower to institutions and investigators across Africa. But aside from developing and sustaining capacity in genomic research and biorepositories, H3Africa is also invested in developing appropriate ethical regulatory regime to govern research in these areas. This latter concern –research ethics governance – is the major subject of this paper. Specifically, the paper discusses protection of research participants as envisaged by H3Africa in the area of consent, safeguarding privacy, maintaining confidentiality of health information and sharing of data/biospecimens. The ultimate goal is to determine whether H3Africa initiatives and processes are consistent or at odds with international guidelines and best practices.

  May 03, 2017   doi: 10.1111/dewb.12150   open full text
• A critique of the principle of ‘respect for autonomy’, grounded in African thought.
  Kevin G. Behrens.
  Developing World Bioethics. May 03, 2017
  I give an account how the principle of ‘respect for autonomy’ dominates the field of bioethics, and how it came to triumph over its competitors, ‘respect for persons’ and ‘respect for free power of choice’. I argue that ‘respect for autonomy’ is unsatisfactory as a basic principle of bioethics because it is grounded in too individualistic a worldview, citing concerns of African theorists and other communitarians who claim that the principle fails to acknowledge the fundamental importance of understanding persons within the nexus of their communal relationships. I defend the claim that ‘respect for persons’ is a more appropriate principle, as it is able to acknowledge both individual decision making and the essential relationality of persons. I acknowledge that my preference for ‘respect for persons’ is problematic because of the important debate around the definition of ‘personhood’ in bioethics discourse. Relying on Thaddeus Metz's conception of moral status, I propose a relational definition of personhood that distinguishes between persons with agency and persons without agency, arguing that we have different moral obligations to these distinct categories of persons. I claim that this conception of personhood is better able to accommodate our moral intuitions than conventional approaches, and that it is able to do so without being speciesist or question‐begging.

  May 03, 2017   doi: 10.1111/dewb.12145   open full text
• Mapping research ethics committees in Africa: evidence of the growth of ethics review of health research in Africa.
  Boitumelo Mokgatla, Carel IJsselmuiden, Doug Wassenaar, Mary Kasule.
  Developing World Bioethics. May 03, 2017
  Health research initiatives worldwide are growing in scope and complexity, particularly as they move into the developing world. Expanding health research activity in low‐ and middle‐income countries has resulted in a commensurate rise in the need for sound ethical review structures and functions in the form of Research Ethics Committees (RECs). The urgent need for continued capacity development in Africa has necessitated research initiatives to identify existing capacity. This discussion paper describes the mapping of RECs in Africa through MARC (Mapping African Research Ethics Capacity) project, second phase (2012 to date) and discusses the findings. MARC provides a platform and tool on COHRED's Health Research HRWeb, which can be used by RECs and key stakeholders in health research in Africa to identify capacity, constraints and development needs.

  May 03, 2017   doi: 10.1111/dewb.12146   open full text
• The Patient‐Worker: A Model for Human Research Subjects and Gestational Surrogates.
  Emma Ryman, Katy Fulfer.
  Developing World Bioethics. January 13, 2017
  We propose the ‘patient‐worker’ as a theoretical construct that responds to moral problems that arise with the globalization of healthcare and medical research. The patient‐worker model recognizes that some participants in global medical industries are workers and are owed worker's rights. Further, these participants are patient‐like insofar as they are beneficiaries of fiduciary relationships with healthcare professionals. We apply the patient‐worker model to human subjects research and commercial gestational surrogacy. In human subjects research, subjects are usually characterized as either patients or as workers. Through questioning this dichotomy, we argue that some subject populations fit into both categories. With respect to commercial surrogacy, we enrich feminist discussions of embodied labor by describing how surrogates are beneficiaries of fiduciary obligations. They are not just workers, but patient‐workers. Through these applications, the patient‐worker model offers a helpful normative framework for exploring what globalized medical industries owe to the individuals who bear the bodily burdens of medical innovation.

  January 13, 2017   doi: 10.1111/dewb.12141   open full text
• Social Responsibility and the State's Duty to provide Healthcare: An Islamic Ethico‐Legal Perspective.
  Aasim I. Padela.
  Developing World Bioethics. December 30, 2016
  The United Nations Educational, Scientific and Cultural Organization's (UNESCO) Declaration on Bioethics and Human Rights asserts that governments are morally obliged to promote health and to provide access to quality healthcare, essential medicines and adequate nutrition and water to all members of society. According to UNESCO, this obligation is grounded in a moral commitment to promoting fundamental human rights and emerges from the principle of social responsibility. Yet in an era of ethical pluralism and contentions over the universality of human rights conventions, the extent to which the UNESCO Declaration can motivate behaviors and policies rests, at least in part, upon accepting the moral arguments it makes. In this essay I reflect on a state's moral obligation to provide healthcare from the perspective of Islamic moral theology and law. I examine how Islamic ethico‐legal conceptual analogues for human rights and communal responsibility, ḥuqūq al‐’ibād and farḍ al‐kifāyah and other related constructs might be used to advance a moral argument for healthcare provision by the state. Moving from theory to application, I next illustrate how notions of human rights and social responsibility were used by Muslim stakeholders to buttress moral arguments to support American healthcare reform. In this way, the paper advance discourses on a universal bioethics and common morality by bringing into view the concordances and discordances between Islamic ethico‐legal constructs and moral arguments advanced by transnational health policy advocates. It also provides insight into applied Islamic bioethics by demonstrating how Islamic ethico‐legal values might inform the discursive outputs of Muslim organizations.

  December 30, 2016   doi: 10.1111/dewb.12140   open full text
• A Look at Uganda's Early HIV Prevention Strategies Through a Moderate ‘African’ Communitarian Lens.
  Jane Wathuta.
  Developing World Bioethics. December 28, 2016
  This paper seeks to highlight the benefits of prioritizing moderate African communitarian principles as partly demonstrated in the HIV prevention strategies implemented in Uganda in the late 1980s. Pertinent lessons could be drawn so as to achieve the HIV prevention targets envisioned in the post‐2015 development era. Communitarianism emphasizes the importance of communities as part of healthy human existence. Its core ethical values include the virtues of generosity, compassion, and solidarity. Persuasion through communication, consensus through dialogue, and the awareness and commitment to responsibilities towards other members of the community, are chief practices relied upon to achieve appropriate social behaviour. All these elements signify individual rootedness in communities and contribute to the healthy existence of its members. Communitarianism is usually classified as either authoritarian/radical or responsive/moderate, depending on the primacy given to either community interests or the individual will and rights. Moderate communitarianism recognizes the individual's capacity for moral reasoning, virtue and free choice. The ensuing form of society is deemed more ethical as it relies on education in the virtues, moral persuasion and informal social controls, without stifling individual identity, agency, and capacity for self‐determination. If moderate African communitarianism, in particular, can to a certain extent be associated with the significant aspects of Uganda's HIV prevention strategies in the stated period, then its present‐day relevance for HIV prevention and other public health interventions may be emphasized accordingly. This applies especially in view of the ongoing efforts to achieve a balance between individual and collective interests in bioethics.

  December 28, 2016   doi: 10.1111/dewb.12139   open full text
• Application of Ethical Principles to Research using Public Health Data in The Global South: Perspectives from Africa.
  Evelyn Anane‐Sarpong, Tenzin Wangmo, Osman Sankoh, Marcel Tanner, Bernice Simone Elger.
  Developing World Bioethics. December 22, 2016
  Existing ethics guidelines, influential literature and policies on ethical research generally focus on real‐time data collection from humans. They enforce individual rights and liberties, thereby lowering need for aggregate protections. Although dependable, emerging public health research paradigms like research using public health data (RUPD) raise new challenges to their application. Unlike traditional research, RUPD is population‐based, aligned to public health activities, and often reliant on pre‐collected longitudinal data. These characteristics, when considered in relation to the generally lower protective ethico‐legal frameworks of the Global South, including Africa, highlight ethical gaps. Health and demographic surveillance systems are examples of public health programs that accommodate RUPD in these contexts. We set out to explore the perspectives of professionals with a working knowledge of these systems to determine practical ways of appropriating the foundational principles of health research to advance the ever growing opportunities in RUPD. We present their perspectives and in relation to the literature and our ethical analysis, make context relevant recommendations. We further argue for the development of a framework founded on the discussions and recommendations as a minimum base for achieving optimal ethics for optimal RUPD in the Global South.

  December 22, 2016   doi: 10.1111/dewb.12138   open full text
• Punishment of Minor Female Genital Ritual Procedures: Is the Perfect the Enemy of the Good?
  Allan J. Jacobs, Kavita Shah Arora.
  Developing World Bioethics. December 19, 2016
  Female genital alteration (FGA) is any cutting, removal or destruction of any part of the external female genitalia. Various FGA practices are common throughout the world. While most frequent in Africa and Asia, transglobal migration has brought ritual FGA to Western nations. All forms of FGA are generally considered undesirable for medical and ethical reasons when performed on minors. One ritual FGA procedure is the vulvar nick (VN). This is a small laceration to the vulva that does not cause morphological changes. Besides being performed as a primary ritual procedure it has been proposed as a substitute for more extensive forms of FGA. Measures advocated or taken to reduce the burden of FGA can be punitive or non‐punitive. Even if it is unethical to perform VN, we argue that it also is unethical to attempt to suppress it through punishment. First, punishment of VN is likely to cause more harm than good overall, even to those ostensibly being protected. Second, punishment is likely to exceed legitimate retributive ends. We do not argue in favor of performing VN. Rather, we argue that non‐punitive strategies such as education and harm reduction should be employed.

  December 19, 2016   doi: 10.1111/dewb.12135   open full text
• Beneficial Coercion in Psychiatric Care: Insights from African Ethico‐Cultural System.
  Cornelius Olukunle Ewuoso.
  Developing World Bioethics. December 19, 2016
  There is a ‘catch 22’ situation about applying coercion in psychiatric care. Autonomous choices undeniably are rights of patients. However, emphasizing rights for a mentally‐ill patient could jeopardize the chances of the patient receiving care or endanger the public. Conversely, the beneficial effects of coercion are difficult to predict. Thus, applying coercion in psychiatric care requires delicate balancing of individual‐rights, individual well‐being and public safety, which has not been achieved by current frameworks. Two current frameworks may be distinguished: the civil liberty approach and the Stone model. Both frameworks are restrictive, and not respectful of human dignity. In a civil liberty approach, individuals who are severely mentally‐ill but not dangerous would be denied care because they do not meet the dangerousness threshold or because the use of coercion will not lead to rebirthing of autonomy. This is unsatisfactory. Albeit involuntary interventions such as talk therapies, peer‐support etc., may not always lead to rebirthing of autonomy or free patients from mental illness; they can however help to maintain the dignity of each mentally ill patient. In place of these frameworks, this study proposes a new ethical framework for applying coercion in psychiatric care that is respectful of human dignity. Specifically, it draws on insights from the African ethico‐cultural system by using the Yoruba concept Omo‐olu‐iwabi to develop this new framework. This way, the study shows that only a more respectful approach for applying coercion in psychiatric care can lead to the careful balancing of the competing interests of individual's rights, individual's well‐being and public safety.

  December 19, 2016   doi: 10.1111/dewb.12137   open full text
• Designing research funding schemes to promote global health equity: An exploration of current practice in health systems research.
  Bridget Pratt, Adnan A. Hyder.
  Developing World Bioethics. November 23, 2016
  International research is an essential means of reducing health disparities between and within countries and should do so as a matter of global justice. Research funders from high‐income countries have an obligation of justice to support health research in low and middle‐income countries (LMICs) that furthers such objectives. This paper investigates how their current funding schemes are designed to incentivise health systems research in LMICs that promotes health equity. Semi‐structured in‐depth interviews were performed with 16 grants officers working for 11 funders and organisations that support health systems research: the Alliance for Health Policy and Systems Research, Comic Relief, Doris Duke Foundation, European Commission, International Development Research Centre, Norwegian Agency for Development Cooperation, Research Council of Norway, Rockefeller Foundation, UK Department of International Development, UK Medical Research Council, and Wellcome Trust. Thematic analysis of the data demonstrates their funding schemes promote health systems research with (up to) five key features that advance health equity: being conducted with worst‐off populations, focusing on research topics that advance equitable health systems, having LMIC ownership of the research agenda, strengthening LMIC research capacity, and having an impact on health disparities. The different types of incentives that encouraged proposed projects to have these features are identified and classified by their strength (strong, moderate, weak). It is suggested that research funders ought to create and maintain funding schemes with strong incentives for the features identified above in order to more effectively help reduce global health disparities.

  November 23, 2016   doi: 10.1111/dewb.12136   open full text
• Reexamining the Prohibition of Gestational Surrogacy in Sunni Islam.
  Ruaim A. Muaygil.
  Developing World Bioethics. October 20, 2016
  Advances in reproductive medicine have provided new, and much needed, hope for millions of people struggling with infertility. Gestational surrogacy is one such development that has been gaining popularity with infertile couples, especially those unable to benefit from other reproductive procedures such as In Vitro Fertilization. For many Muslim couples, however, surrogacy remains a nonviable option. Islamic scholars have deemed the procedure incompatible with Islam and have prohibited its use. This paper examines the arguments presented for proscribing surrogacy arrangements in Sunni Islam in particular. These include preservation of lineage, exclusion of third parties in reproduction, upholding the rights of the child, and protection from the negative effects of surrogacy arrangements. The rationales for banning surrogacy are subsequently refuted utilizing Islamic law “Sharia”, bioethics, and medical evidence. The paper also presents reasons for why surrogacy is not only consistent with Sunni Islamic teachings, but is also both ethically justified and medically necessary. Lastly, Islamic scholars are urged to take into account the arguments presented in this paper and reconsider their rulings on the permissibility of surrogacy.

  October 20, 2016   doi: 10.1111/dewb.12133   open full text
• Power Difference and Risk Perception: Mapping Vulnerability within the Decision Process of Pregnant Women towards Clinical Trial Participation in an Urban Middle‐Income Setting.
  Geerte C. Den hollander, Joyce l. Browne, Daniel Arhinful, Rieke Graaf, Kerstin Klipstein‐Grobusch.
  Developing World Bioethics. October 20, 2016
  To address the burden of maternal morbidity and mortality in low‐ and middle‐income countries (LMICs), research with pregnant women in these settings is increasingly common. Pregnant women in LMIC‐context may experience vulnerability related to giving consent to participate in a clinical trial. To recognize possible layers of vulnerability this study aims to identify factors that influence the decision process towards clinical trial participation of pregnant women in an urban middle‐income setting. This qualitative research used participant observation, in‐depth interviews, and focus group discussion with medical staff and pregnant women eligible for trial participation, at a regional hospital in Accra, Ghana. Besides lack of familiarity with modern scientific concepts, specific factors influencing the decision‐making process were identified. These include a wide power difference between health provider and patient, and a different perception of risk through externalization of responsibility of risk management within a religious context as well as a context shaped by authority. Also, therapeutic misconception was observed. The combination of these factors ensued women to rely on the opinion of the medical professional, rather than being guided by their own motivation to participation. Although being a (pregnant) woman per se should not render the label of being vulnerable, this study shows there are factors that influence the decision process of pregnant woman towards trial participation in a LMIC context that can result in vulnerability. The identification of context‐specific factors that can create vulnerability facilitates adaptation of the design and conduct of research in a culturally competent manner.

  October 20, 2016   doi: 10.1111/dewb.12132   open full text
• Research Involving Health Providers and Managers: Ethical Issues Faced by Researchers Conducting Diverse Health Policy and Systems Research in Kenya.
  Sassy Molyneux, Benjamin Tsofa, Edwine Barasa, Mary Muyoka Nyikuri, Evelyn Wanjiku Waweru, Catherine Goodman, Lucy Gilson.
  Developing World Bioethics. October 04, 2016
  There is a growing interest in the ethics of Health Policy and Systems Research (HPSR), and especially in areas that have particular ethical salience across HPSR. Hyder et al (2014) provide an initial framework to consider this, and call for more conceptual and empirical work. In this paper, we respond by examining the ethical issues that arose for researchers over the course of conducting three HPSR studies in Kenya in which health managers and providers were key participants. All three studies involved qualitative work including observations and individual and group interviews. Many of the ethical dilemmas researchers faced only emerged over the course of the fieldwork, or on completion, and were related to interactions and relationships between individuals operating at different levels or positions in health/research systems. The dilemmas reveal significant ethical challenges for these forms of HPSR, and show that potential ‘solutions’ to dilemmas often lead to new issues and complications. Our experiences support the value of research ethics frameworks, and suggest that these can be enriched by incorporating careful consideration of context embedded social relations into research planning and conduct. Many of these essential relational elements of ethical practice, and of producing quality data, are given stronger emphasis in social science research ethics than in epidemiological, clinical or biomedical research ethics, and are particularly relevant where health systems are understood as social and political constructs. We conclude with practical and research implications.

  October 04, 2016   doi: 10.1111/dewb.12130   open full text
• The Vulnerability of Study Participants in the Context of Transnational Biomedical Research: From Conceptual Considerations to Practical Implications.
  Helen Grete Orth, Silke Schicktanz.
  Developing World Bioethics. October 04, 2016
  Outsourcing clinical trials sponsored by pharmaceutical companies from industrialized countries to low‐ (middle)‐income countries – summarized as transnational biomedical research (TBR) – has lead to many concerns about ethical standards. Whether study participants are particularly vulnerable is one of those concerns. However, the concept of vulnerability is still vague and varies in its definition. Despite the fact that important international ethical guidelines such as the Declaration of Helsinki by the World Medical Association or the Ethical Guidelines for Biomedical Research Involving Human Subjects by the Council of International Organizations of Medical Sciences refer to vulnerability as ethical principle, each of their approaches are different. To overcome these shortcomings, we analyze and unite different approaches of vulnerability and develop practical criteria in order to operationalize the concept especially for the context of TBR. These criteria refer to the context of a study as well as the characteristics and the current living situation of study participants. Based on a case study of an HIV‐vaccine‐trial conducted in India we demonstrate how those criteria can be applied in a retrospective way to identify potential ethical conflicts. The criteria can also indicate a prospective function for ethical pre‐assessment. For this, we provide an outlook for three major topics: 1. Vulnerability as a normative concept: Different ways of protection; 2. The relevance of transparency and 3. Vulnerability as an instrument to increase decision participation of human subjects.

  October 04, 2016   doi: 10.1111/dewb.12131   open full text
• Evaluating the Usefulness of Compulsory Licensing in Developing Countries: A Comparative Study of Thai and Brazilian Experiences Regarding Access to Aids Treatments.
  Samira Guennif.
  Developing World Bioethics. October 04, 2016
  While compulsory licensing (CL) is described in the TRIPS agreement as flexibility to protect public health by improving access to medicines in developing countries, a recent literature contends adversely that CL may harm public health. Therefore, this article intends to evaluate the usefulness of CL in the South through the prism of obligations and goals entrusted to patent holders (the effective and non‐abusive exploitation of patents in order to achieve industrial and health developments) and in light of experiences in Thailand and Brazil regarding access to antiretroviral drugs. In this way, it shows that the obligations assigned to patent holders were better served by the recipients of CL and brought significant health and industrial benefits in the two high middle‐income countries. In particular, CL allowed the scaling‐up of free and universal access to antiretroviral drugs by assuring the financial sustainability of these public health programs endangered by monopolistic practices from patent holders.

  October 04, 2016   doi: 10.1111/dewb.12124   open full text
• Research Ethics Education in Post‐Graduate Medical Curricula in I.R. Iran.
  Nazila Nikravanfard, Faezeh Khorasanizadeh, Kazem Zendehdel.
  Developing World Bioethics. August 16, 2016
  Research ethics training during post‐graduate education is necessary to improve ethical standards in the design and conduct of biomedical research. We studied quality and quantity of research ethics training in the curricula of post‐graduate programs in the medical science in I.R. Iran. We evaluated curricula of 125 post‐graduate programs in medical sciences in I.R. Iran. We qualitatively studied the curricula by education level, including the Master and PhD degrees and analyzed the contents and the amount of teaching allocated for ethics training in each curriculum. We found no research ethics training in 72 (58%) of the programs. Among the 53 (42%) programs that considered research ethics training, only 17 programs had specific courses for research ethics and eight of them had detailed topics on their courses. The research ethics training was optional in 25% and mandatory in 76% of the programs. Post‐graduate studies that were approved in the more recent years had more attention to the research ethics training. Research ethics training was neglected in most of the medical post‐graduate programs. We suggest including sufficient amount of mandatory research ethics training in Master and PhD programs in I.R. Iran. Further research about quality of research ethics training and implementation of curricula in the biomedical institutions is warranted.

  August 16, 2016   doi: 10.1111/dewb.12122   open full text
• The Enemy as a Patient: What can be Learned from the Emotional Experience of Physicians and Why does it Matter Ethically?
  Gil Rubinstein, Miriam Ethel Bentwich.
  Developing World Bioethics. August 16, 2016
  This qualitative research examines the influence of animosity on physicians during clinical encounters and its ethical implications. Semi‐structured interviews were conducted with ten Israeli‐Jewish physicians: four treated Syrians and six treated Palestinian terrorists/Hezbollah militants or Palestinian civilians. An interpretive phenomenological analysis was used to uncover main themes in these interviews. Whereas the majority of physicians stated they are obligated to treat any patient, physicians who treated Syrians exhibited stronger emotional expression and implicit empathy, while less referring to the presence of the Israeli‐Arab conflict. In contrast, physicians who treated enemy combatants or Palestinian civilians showed the exact opposite. Linking these results to the “Implicit Bias” theory, the role of empathy and the beneficence principle in medical ethics, we argue that: (a) the unconscious decreased emotional involvement among the latter group of physicians is a deficiency that needs to be recognized; and (b) this deficiency undermines the principle of beneficence, thereby possibly influencing the fulfillment of the commitment to treat patients. Acknowledging and addressing the potential emotional and ethical deficiencies entailed in encounters with the so‐called enemy‐patients are of importance to the global medical community, since such encounters are increasingly an integral part of the current political realities faced by both the developed and developing worlds.

  August 16, 2016   doi: 10.1111/dewb.12125   open full text
• Informed Consent in Health Research: Challenges and Barriers in Low‐and Middle‐Income Countries with Specific Reference to Nepal.
  Pramod R. Regmi, Nirmal Aryal, Om Kurmi, Puspa Raj Pant, Edwin Teijlingen, Sharada P. Wasti.
  Developing World Bioethics. August 12, 2016
  Obtaining ‘informed consent’ from every individual participant involved in health research is a mandatory ethical practice. Informed consent is a process whereby potential participants are genuinely informed about their role, risk and rights before they are enrolled in the study. Thus, ethics committees in most countries require ‘informed consent form’ as part of an ethics application which is reviewed before granting research ethics approval. Despite a significant increase in health research activity in low‐and middle‐income countries (LMICs) in recent years, only limited work has been done to address ethical concerns. Most ethics committees in LMICs lack the authority and/or the capacity to monitor research in the field. This is important since not all research, particularly in LMICs region, complies with ethical principles, sometimes this is inadvertently or due to a lack of awareness of their importance in assuring proper research governance. With several examples from Nepal, this paper reflects on the steps required to obtain informed consents and highlights some of the major challenges and barriers to seeking informed consent from research participants. At the end of this paper, we also offer some recommendations around how can we can promote and implement optimal informed consent taking process. We believe that paper is useful for researchers and members of ethical review boards in highlighting key issues around informed consent.

  August 12, 2016   doi: 10.1111/dewb.12123   open full text
• Dilemmas in international research and the value of practical wisdom.
  Kimberly Jarvis.
  Developing World Bioethics. July 18, 2016
  When conducting research in an international setting, in a country different than that of the researcher, unpredictable circumstances can arise. A study conducted by a novice North American researcher with a vulnerable population in northern Ghana highlights these happenings with an emphasis placed on the ethical challenges encountered. An illustration from the research is used to highlight an ethical dilemma while in the field, and how utilizing a moral decision‐making framework can assist in making choices about a participant's right to autonomy, privacy, and confidentiality during the research process. Moral frameworks, however, can never be enough to solve a dilemma since guidelines only describe what to aim for and not how to interpret or use them. Researchers must therefore strive to move beyond these frameworks to employ practical wisdom or phronesis so to combine the right thing to do with the skill required to figure out what the right choice is. The skill of practical wisdom must be acquired because without it international researchers indecisively fumble around with good intentions, often leaving a situation in worse shape than they found it.

  July 18, 2016   doi: 10.1111/dewb.12121   open full text
• Benefit Sharing in a Global Context: Working Towards Solutions for Implementation.
  Daniel J. Hurst.
  Developing World Bioethics. April 01, 2016
  Due to the state of globalized clinical research, questions have been raised as to what, if any, benefits those who contribute to research should receive. One model for compensating research participants is “benefit sharing,” and the basic premise is that, as a matter of justice, those who contribute to scientific research should share in its benefits. While incorporated into several international documents for over two decades, benefit sharing has only been sparsely implemented. This analysis begins by addressing the concept of benefit sharing, its historical development, and how it has been applied in the context of virus sharing for influenza research. The second portion of this analysis presents recommendations for ensuring benefit sharing. These recommendations are threefold: 1) an emphasis on social pressure, 2) the revision of international documents as means to ensure benefit sharing, and 3) greater collaboration between sponsor IRB and host country IRB. Because clinical research is a globalized industry, a global model will be proposed in the second that focuses on collaboration between the sponsor and host country. This collaboration is vital in order to ensure that proper forms of benefit sharing are accomplished as a matter of justice.

  April 01, 2016   doi: 10.1111/dewb.12118   open full text
• The Saudi Law of Ethics of Research on Living Creatures and its Implementing Regulations.
  Ghiath Alahmad.
  Developing World Bioethics. March 03, 2016
  The Kingdom of Saudi Arabia passed a Law and Implementing Regulations of Ethics of Research on Living Creatures in 14/09/1431 Hijri (24/08/2010). We have performed an ethical analysis of this law and, accordingly, this paper discusses the major components, key strengths, and weaknesses of this law. The Saudi system considers Islamic Shariah in addition to international research ethics guidelines. The Law and its Implementing Regulations contain all ethical requirements for research. We conclude that this law can serve as an example, not only for other Arab countries in the region that have similar values and social structure to the Kingdom of Saudi Arabia, but also for other Islamic countries.

  March 03, 2016   doi: 10.1111/dewb.12114   open full text
• From Ethical Exceptionalism to Ethical Exceptions: The Rule and exception Model and the Changing Meaning of Ethics In German Bioregulation.
  Kathrin Braun.
  Developing World Bioethics. February 12, 2016
  Germany is an interesting case with respect to the governance of reprogenetics. It has a strong profile in the technosciences and high aims regarding the global bioeconomy, yet her regulation of human genetics, reproductive medicine and embryo research has for a long time been rather restrictive. German biopolitical exceptionalism has often been explained by reference to Catholicism and the legacy of the Nazi past. The Germans, so goes the common story, have learnt the lessons of history and translated them into unconditional respect for human dignity, which in turn translates into unconditional protection of human life, including the human embryo, and the firm repudiation of any eugenic distinction between ‘life worth to live’ and ‘life not worth to live’. This, however, is not the whole story. Alongside deontological strictness we find another strand of governing body politics and reprogenetics in Germany, the rule‐and‐exception model, running from the mid‐1970s abortion law via the 2002 Stem Cell Act to the 2011 regulation of pre‐implantation genetic diagnosis. In contrast to the former, that strongly draws on Kant and his concept of human dignity, the latter bears resemblances to Carl Schmitt's concept of state of exception. The article will show that the rule‐and‐exception model builds the exception into the rule and transforms the meaning and mandate of ethics, namely from safeguarding ethical standards to deciding about the exception. Given that the exception has now tended to become the rule, the question is whether the lessons of history will govern German reprogenetics for much longer.

  February 12, 2016   doi: 10.1111/dewb.12103   open full text
• Factors Affecting Women's Autonomous Decision Making In Research Participation Amongst Yoruba Women Of Western Nigeria.
  Chitu Womehoma Princewill, Ayodele S. Jegede, Karin Nordström, Bolatito Lanre‐Abass, Bernice Simone Elger.
  Developing World Bioethics. February 12, 2016
  Research is a global enterprise requiring participation of both genders for generalizable knowledge; advancement of science and evidence based medical treatment. Participation of women in research is necessary to reduce the current bias that most empirical evidence is obtained from studies with men to inform health care and related policy interventions. Various factors are assumed to limit autonomy amongst the Yoruba women of western Nigeria. This paper seeks to explore the experience and understanding of autonomy by the Yoruba women in relation to research participation. Focus is on factors that affect women's autonomous decision making in research participation. An exploratory qualitative approach comprising four focus group discussions, 42 in‐depth interviews and 14 key informant interviews was used. The study permits a significant amount of triangulation, as opinions of husbands and religious leaders are also explored. Interviews and discussions were audiotaped and transcribed verbatim. Content analysis was employed for data analysis. Findings show that concepts of autonomy varied amongst the Yoruba women. Patriarchy, religion and culture are conceived to have negative impact on the autonomy of women in respect to research participation. Among the important findings are: 1) male dominance is strongly emphasized by religious leaders who should teach equality, 2) while men feel that by making decisions for women, they are protecting them, the women on the other hand see this protection as a way of limiting their autonomy. We recommend further studies to develop culturally appropriate and workable recruitment methods to increase women's participation in research.

  February 12, 2016   doi: 10.1111/dewb.12112   open full text
• What Makes Health Systems Research in Developing Countries Ethical? Application of the Emanuel Framework for Clinical Research to Health Systems Research.
  Doug Wassenaar, Abbas Rattani.
  Developing World Bioethics. February 12, 2016
  The growing importance of health systems research has opened debate about appropriate ethical frameworks and guidelines for the ethical review and conduct of health systems research. In this article we consider a detailed proposal from Hyder et al. (2014) and consider it in relation to the conventional criteria for ethics review of clinical research outlined by Emanuel et al. (2004; 2008) and argue that the Emanuel criteria can be usefully applied to the review of health systems research to supplement the Hyder et al. proposals. We argue further that health systems researchers and reviewers would benefit from many of the debates that have characterized the ethics of clinical research over the past three decades.

  February 12, 2016   doi: 10.1111/dewb.12101   open full text
• Understanding Health Research Ethics in Nepal.
  Jeevan Raj Sharma, Rekha Khatri, Ian Harper.
  Developing World Bioethics. February 03, 2016
  Unlike other countries in South Asia, in Nepal research in the health sector has a relatively recent history. Most health research activities in the country are sponsored by international collaborative assemblages of aid agencies and universities. Data from Nepal Health Research Council shows that, officially, 1,212 health research activities have been carried out between 1991 and 2014. These range from addressing immediate health problems at the country level through operational research, to evaluations and programmatic interventions that are aimed at generating evidence, to more systematic research activities that inform global scientific and policy debates. Established in 1991, the Ethical Review Board of the Nepal Health Research Council (NHRC) is the central body that has the formal regulating authority of all the health research activities in country, granted through an act of parliament. Based on research conducted between 2010 and 2013, and a workshop on research ethics that the authors conducted in July 2012 in Nepal as a part of the on‐going research, this article highlights the emerging regulatory and ethical fields in this low‐income country that has witnessed these increased health research activities. Issues arising reflect this particular political economy of research (what constitutes health research, where resources come from, who defines the research agenda, culture of contract research, costs of review, developing Nepal's research capacity, through to the politics of publication of data/findings) and includes questions to emerging regulatory and ethical frameworks.

  February 03, 2016   doi: 10.1111/dewb.12109   open full text
• Measurement, “scriptural economies,” and social justice: governing HIV/AIDS treatments by numbers in a fragile state, the Central African Republic (CAR).
  Pierre‐Marie David.
  Developing World Bioethics. February 03, 2016
  Fragile states have been raising increasing concern among donors since the mid‐2000s. The policies of the Global Fund to fight HIV/AIDS, Malaria, and Tuberculosis (GF) have not excluded fragile states, and this source has provided financing for these countries according to standardized procedures. They represent interesting cases for exploring the meaning and role of measurement in a globalized context. Measurement in the field of HIV/AIDS and its treatment has given rise to a private outsourcing of expertise and auditing, thereby creating a new form of value based on the social process of registration and the creation of realities produced by the intervention itself. These “scriptural economies” must be questioned in terms of the production of knowledge, but also in terms of social justice. Governing HIV/AIDS treatments by numbers in a fragile state is explored in this article through the experience of the Central African Republic (CAR) in terms of epidemiology and access to antiretroviral drugs. The unexpected effects of performance‐based programs in this context underline the need for global health governance to be re‐embedded into a social justice framework.

  February 03, 2016   doi: 10.1111/dewb.12107   open full text
• Raising the Barriers to Access to Medicines in the Developing World – The Relentless Push for Data Exclusivity.
  Lisa Diependaele, Julian Cockbain, Sigrid Sterckx.
  Developing World Bioethics. January 27, 2016
  Since the adoption of the WTO‐TRIPS Agreement in 1994, there has been significant controversy over the impact of pharmaceutical patent protection on the access to medicines in the developing world. In addition to the market exclusivity provided by patents, the pharmaceutical industry has also sought to further extend their monopolies by advocating the need for additional ‘regulatory’ protection for new medicines, known as data exclusivity. Data exclusivity limits the use of clinical trial data that need to be submitted to the regulatory authorities before a new drug can enter the market. For a specified period, generic competitors cannot apply for regulatory approval for equivalent drugs relying on the originator's data. As a consequence, data exclusivity lengthens the monopoly for the original drug, impairing the availability of generic drugs. This article illustrates how the pharmaceutical industry has convinced the US and the EU to impose data exclusivity on their trade partners, many of them developing countries. The key arguments formulated by the pharmaceutical industry in favor of adopting data exclusivity and their underlying ethical assumptions are described in this article, analyzed, and found to be unconvincing. Contrary to industry's arguments, it is unlikely that data exclusivity will promote innovation, especially in developing countries. Moreover, the industry's appeal to a property rights claim over clinical test data and the idea that data exclusivity can prevent the generic competitors from ‘free‐riding’ encounters some important problems: Neither legitimize excluding all others.

  January 27, 2016   doi: 10.1111/dewb.12105   open full text
• Beyond the Sterility of a Distinct African Bioethics: Addressing the Conceptual Bioethics Lag in Africa.
  Gerald M. Ssebunnya.
  Developing World Bioethics. January 25, 2016
  In the current debate on the future of bioethics in Africa, several authors have argued for a distinct communitarian African bioethics that can counter the dominancy of Western atomistic principlism in contemporary bioethics. In this article I examine this rather contentious argument and evaluate its validity and viability. Firstly, I trace the contextual origins of contemporary bioethics and highlight the rise and dominance of principlism. I particularly note that principlism was premised on a content‐thin notion of the common morality that is in need of enrichment. I also contend that bioethics is essentially two‐dimensional, being both conceptual and empirical, and indicate the lag in Africa with regard to conceptual bioethics. I then appeal for authentic engagement by 1) African health care professionals, 2) African health care training institutions, 3) Africa's bioethics development partners, and 4) African bioethicists and philosophers, towards addressing this critical lag. I underline the need to maintain the essential universality of bioethics as a discipline. I particularly argue against the pursuit of a distinct African bioethics, as it appears to be rooted in sterile African ethno‐philosophy. Rather, African bioethicists and philosophers would do well to elucidate the universalisability of insights from traditional African thought, for the benefit of bioethics as a whole. Thus we must engage beyond the sterility of a distinct African bioethics ‐ authentically reflecting on the essentially universal contemporary bioethical concerns ‐ to effectively articulate a viable trajectory for bioethics in Africa.

  January 25, 2016   doi: 10.1111/dewb.12106   open full text
• No ethical divide between China and the West in human embryo research.
  Xiaomei Zhai, Vincent Ng, Reidar Lie.
  Developing World Bioethics. January 21, 2016
  This is a discussion of the reaction to the recent research article publication in the journal Protein & Cell by a group of scientists at Sun Yat‐sen University using the CRISPR/Cas9 technique on editing non‐viable human zygotes. Many commentators condemned the Chinese scientists for overstepping ethical boundaries long accepted in Western countries and accused China of having lax regulations on genomic research in general. We argue that not only did this research follow strict ethical standards and fully comply with current regulations, but China also has a well‐developed regulatory framework governing such research comparable to many developed countries. We see the reactions among Western commentators as a misunderstanding of the current situation and an expression of a lack of willingness to acknowledge China as an equal partner in the international debate about proper limits to the development of new biotechnologies.

  January 21, 2016   doi: 10.1111/dewb.12108   open full text
• The Italian Way to Stem Cell Research: Rethinking the Role of Catholic Religion in Shaping Italian Stem Cell Research Regulations.
  Lorenzo Beltrame.
  Developing World Bioethics. January 21, 2016
  Stem cell research regulations are highly variable across nations, notwithstanding shared and common ethical concerns. Dominant in political debates has been the so‐called embryo question. However, the permissibility of human embryonic stem cell (hESC) research varies among national regulatory frameworks. Scholars have explained differences by resorting to notions of political culture, traditions of ethical reasoning, discursive strategies and political manoeuvring of involved actors. Explanations based on the role of religion or other cultural structural variables are also employed. This paper analyses the emerging of the Italian regulatory framework on stem cell research using an analytical framework that considers the interplay between cultural structural features, political culture, traditions of ethical reasoning, institutional settings and the discursive and political agency of the actors involved. It aims also to explain the role of Roman Catholic Church in shaping the Italian stem cell research regulation not by treating religion as an autonomous causal factor, but through the analysis of the agency of Catholic and allied actors in the Italian political culture and institutional setting.

  January 21, 2016   doi: 10.1111/dewb.12104   open full text
• Reconsidering counselling and consent.
  David R. Hall, Anton A. Niekerk.
  Developing World Bioethics. December 01, 2015
  In the current era patient autonomy is enormously important. However, recently there has also been some movement back to ensure that trust in the doctor's skill, knowledge and virtue is not excluded in the process. These new nuances of informed consent have been referred to by terms such as beneficent paternalism, experience‐based paternalism and we would add virtuous paternalism. The purpose of this paper is to consider the history and current problematic nature of counselling and consent. Starting with the tradition founded by Hippocrates we trace and seek to understand how relevant aspects of the patient‐doctor relationship have evolved under the influences of subsequent moral theories. Finally we tentatively endorse certain modes of counselling in the current era in order to promote morally sound, good clinical practice.

  December 01, 2015   doi: 10.1111/dewb.12100   open full text
• Post‐trial obligations in the Declaration of Helsinki 2013: classification, reconstruction and interpretation.
  Ignacio Mastroleo.
  Developing World Bioethics. October 19, 2015
  The general aim of this article is to give a critical interpretation of post‐trial obligations towards individual research participants in the Declaration of Helsinki 2013. Transitioning research participants to the appropriate health care when a research study ends is a global problem. The publication of a new version of the Declaration of Helsinki is a great opportunity to discuss it. In my view, the Declaration of Helsinki 2013 identifies at least two clearly different types of post‐trial obligations, specifically, access to care after research and access to information after research. The agents entitled to receive post‐trial access are the individual participants in research studies. The Declaration identifies the sponsors, researchers and host country governments as the main agents responsible for complying with the post‐trial obligations mentioned above. To justify this interpretation of post‐trial obligations, I first introduce a classification of post‐trial obligations and illustrate its application with examples from post‐trial ethics literature. I then make a brief reconstruction of the formulations of post‐trial obligations of the Declaration of Helsinki from 2000 to 2008 to correlate the changes with some of the most salient ethical arguments. Finally I advance a critical interpretation of the latest formulation of post‐trial obligations. I defend the view that paragraph 34 of ‘Post‐trial provisions’ is an improved formulation by comparison with earlier versions, especially for identifying responsible agents and abandoning ambiguous ‘fair benefit’ language. However, I criticize the disappearance of ‘access to other appropriate care’ present in the Declaration since 2004 and the narrow scope given to obligations of access to information after research.

  October 19, 2015   doi: 10.1111/dewb.12099   open full text
• Maintaining Research Integrity While Balancing Cultural Sensitivity: A Case Study and Lessons From the Field.
  Rebekah Sibbald, Bethina Loiseau, Benedict Darren, Salem A. Raman, Helen Dimaras, Lawrence C. Loh.
  Developing World Bioethics. September 11, 2015
  Contemporary emphasis on creating culturally relevant and context specific knowledge increasingly drives researchers to conduct their work in settings outside their home country. This often requires researchers to build relationships with various stakeholders who may have a vested interest in the research. This case study examines the tension between relationship development with stakeholders and maintaining study integrity, in the context of potential harms, data credibility and cultural sensitivity. We describe an ethical breach in the conduct of global health research by a arising from the ad‐hoc participation of a community stakeholder external to the visiting research group. A framework for reflection is developed from a careful examination of underlying factors and presented with a discussion of consequences and mitigation measures. This framework aims to present lessons learned for researchers working abroad who might face similar situations in their work.

  September 11, 2015   doi: 10.1111/dewb.12089   open full text
• The Challenges of Research Informed Consent in Socio‐Economically Vulnerable Populations: A Viewpoint From the Democratic Republic of Congo.
  Marion Kalabuanga, Raffaella Ravinetto, Vivi Maketa, Hypolite Muhindo Mavoko, Blaise Fungula, Raquel Inocêncio da Luz, Jean‐Pierre Van Geertruyden, Pascal Lutumba.
  Developing World Bioethics. September 07, 2015
  In medical research, the ethical principle of respect for persons is operationalized into the process of informed consent. The consent tools should be contextualized and adapted to the different socio‐cultural environment, especially when research crosses the traditional boundaries and reaches poor communities. We look at the challenges experienced in the malaria Quinact trial, conducted in the Democratic Republic of Congo, and describe some lessons learned, related to the definition of acceptable representative, the role of independent witness and the impact of socio‐economic vulnerability. To ensure children's protection, consent is required by the parents or, in their absence, by a legally mandated representative. In our setting, children's responsibility is often entrusted permanently or temporarily to relatives or friends without a tribunal mandate. Hence, a notion of ‘culturally acceptable representative’ under supervision of the local Ethics Committee may be more suitable. To ensure protection of illiterate subjects, an independent witness is required to confirm that the consent was freely given. However, in low‐literacy contexts, potential witnesses often don't have any previous relationship with patient and there may be power‐unbalance in their relationship, rather than genuine dialogue. In poor communities, trial participation may be seen as an opportunity to secure access to healthcare. Poverty may also lead to ‘competition’ to access the research‐related benefits, with a risk of disturbance at societal or household level. Adjusting consent procedures to sociocultural and socioeconomic realities is essential for fulfilling the underlying ethical principles. This requires a collaborative dialogue between researchers, regulators and ethics committees.

  September 07, 2015   doi: 10.1111/dewb.12090   open full text
• Eugenics and Mandatory Informed Prenatal Genetic Testing: A Unique Perspective from China.
  Di Zhang, Vincent H. Ng, Zhaochen Wang, Xiaomei Zhai, Reidar K. Lie.
  Developing World Bioethics. July 29, 2015
  The application of genetic technologies in China, especially in the area of prenatal genetic testing, is rapidly increasing in China. In the wealthy regions of China, prenatal genetic testing is already very widely adopted. We argue that the government should actively promote prenatal genetic testing to the poor areas of the country. In fact, the government should prioritize resources first to make prenatal genetic testing a standard routine care with an opt‐out model in these area. Healthcare professions would be required to inform pregnant women about the availability of genetic testing and provide free testing on a routine basis unless the parents choose not to do so. We argue that this proposal will allow parents to make a more informed decision about their reproductive choices. Secondarily, this proposal will attract more healthcare professionals and other healthcare resources to improve the healthcare infrastructures in the less‐developed regions of the country. This will help to reduce the inequity of accessing healthcare services between in different regions of China. We further argue that this policy proposal is not practicing eugenics.

  July 29, 2015   doi: 10.1111/dewb.12088   open full text
• Attitudes toward Post‐Trial Access to Medical Interventions: A Review of Academic Literature, Legislation, and International Guidelines.
  Kori Cook, Jeremy Snyder, John Calvert.
  Developing World Bioethics. June 05, 2015
  There is currently no international consensus around post‐trial obligations toward research participants, community members, and host countries. This literature review investigates arguments and attitudes toward post‐trial access. The literature review found that academic discussions focused on the rights of research participants, but offered few practical recommendations for addressing or improving current practices. Similarly, there are few regulations or legislation pertaining to post‐trial access. If regulatory changes are necessary, we need to understand the current arguments, legislation, and attitudes towards post‐trial access and participants and community members. Given that clinical trials conducted in low‐income countries will likely continue, there is an urgent need for consideration of post‐trial benefits for participants, communities, and citizens of host countries. While this issue may not be as pressing in countries where participants have access to healthcare and medicines through public schemes, it is particularly important in regions where this may not be available.

  June 05, 2015   doi: 10.1111/dewb.12087   open full text
• Uterine Transplantation: Ethical Considerations within Middle Eastern Perspectives.
  Zaid Altawil, Thalia Arawi.
  Developing World Bioethics. May 15, 2015
  The field of reproductive medicine witnessed a breakthrough in September 2014 with the first successful live birth post uterine transplantation. This success represents the culmination of decades' worth of research on infertility and reproductive medicine. This subject of infertility gathers special attention in the Middle East, as childbearing is given paramount importance in the family unit. And as with any new medical advancement, Middle Eastern people look to their religious authorities for guidance. This paper describes the various ethical quandaries related to uterine transplantation, from a perspective of the religious and societal factors that are unique to the Middle East, and embeds them within the conversation of its alternative solutions.

  May 15, 2015   doi: 10.1111/dewb.12085   open full text
• Anything to Stay Alive: The Challenges of a Campaign for an Experimental Drug.
  Nathan Geffen.
  Developing World Bioethics. May 15, 2015
  Drug‐resistant tuberculosis (TB) has a high mortality rate. Most medicines used to treat it are poorly tested and have terrible side effects. Activists have campaigned for patients with drug‐resistant TB to have access to experimental drugs, particularly one called bedaquiline, before these have been approved by regulatory authorities such as the Food and Drug Administration (FDA) in the United States (US) and the Medicines Control Council (MCC) in South Africa. Some activists have also campaigned for bedaquiline to be approved by regulatory authorities before testing of the drug is completed. These campaigns raise ethical concerns about whether patients should be offered experimental, unapproved, medicines for the treatment of life‐threatening illnesses, and if authorities should approve drugs for life‐threatening illnesses when vital questions about safety and efficacy remain outstanding.

  May 15, 2015   doi: 10.1111/dewb.12084   open full text
• African Bioethics vs. Healthcare Ethics in Africa: A Critique of Godfrey Tangwa.
  Ademola K. Fayemi.
  Developing World Bioethics. April 24, 2015
  It is nearly two decades now since the publication of Godfrey Tangwa's article, ‘Bioethics: African Perspective’, without a critical review. His article is important because sequel to its publication in Bioethics, the idea of ‘African bioethics’ started gaining some attention in the international bioethics literature. This paper breaks this relative silence by critically examining Tangwa's claim on the existence of African bioethics. Employing conceptual and critical methods, this paper argues that Tangwa's account of African bioethics has some conceptual, methodic and substantive difficulties, which altogether do not justify the idea of African bioethics, at least for now. Contra Tangwa, this article establishes that while African bioethics remains a future possibility, it is more cogent that current efforts in the name of ‘African bioethics’ be primarily re‐intensified towards ‘Healthcare ethics in Africa’.

  April 24, 2015   doi: 10.1111/dewb.12082   open full text
• Managing Human Tissue Transfer Across National Boundaries – An Approach from an Institution in South Africa.
  Safia Mahomed, Kevin Behrens, Melodie Slabbert, Ian Sanne.
  Developing World Bioethics. February 17, 2015
  With biobank research on the increase and the history of exploitation in Africa, it has become necessary to manage the transfer of human tissues across national boundaries. There are many accepted templates of Material Transfer Agreements (MTAs) that currently exist internationally. However, these templates do not address the specific concerns of South Africa and even of Africa as a continent. This article will examine three significantly important ethico‐legal concepts that were deliberated and carefully adapted by a South African Institution to suit the transfer of Human Biological Materials (HBMs) and associated data for biobank research, namely: informed consent; benefit sharing arrangements; and ownership together with intellectual property rights in human tissues. The discussion includes an analysis of current practice; the ethico‐legal challenges in the South African/African context; the decisions made with regard to how the related ethico‐legal challenges were addressed in the MTA; and justifications for implementing these decisions. The processes considered could be of benefit to other developing world countries who consider it necessary to manage the transfer of HBMs across national boundaries.

  February 17, 2015   doi: 10.1111/dewb.12080   open full text
• Against Permitted Exploitation in Developing World Research Agreements.
  Danielle M. Wenner.
  Developing World Bioethics. February 17, 2015
  This paper examines the moral force of exploitation in developing world research agreements. Taking for granted that some clinical research which is conducted in the developing world but funded by developed world sponsors is exploitative, it asks whether a third party would be morally justified in enforcing limits on research agreements in order to ensure more fair and less exploitative outcomes. This question is particularly relevant when such exploitative transactions are entered into voluntarily by all relevant parties, and both research sponsors and host communities benefit from the resulting agreements. I show that defenders of the claim that exploitation ought to be permitted rely on a mischaracterization of certain forms of interference as unjustly paternalistic and two dubious empirical assumptions about the results of regulation. The view I put forward is that by evaluating a system of constraints on international research agreements, rather than individual transaction‐level interference, we can better assess the alternatives to permitting exploitative research agreements.

  February 17, 2015   doi: 10.1111/dewb.12081   open full text
• Managing Ethical Challenges to Mental Health Research in Post‐Conflict Settings.
  Anna Chiumento, Muhammad Naseem Khan, Atif Rahman, Lucy Frith.
  Developing World Bioethics. January 08, 2015
  Recently the World Health Organization (WHO) has highlighted the need to strengthen mental health systems following emergencies, including natural and manmade disasters. Mental health services need to be informed by culturally attuned evidence that is developed through research. Therefore, there is an urgent need to establish rigorous ethical research practice to underpin the evidence‐base for mental health services delivered during and following emergencies.

  January 08, 2015   doi: 10.1111/dewb.12076   open full text
• Reviewing HIV‐Related Research in Emerging Economies: The Role of Government Reviewing Agencies.
  Patrina Sexton, Katrina Hui, Donna Hanrahan, Mark Barnes, Jeremy Sugarman, Alex John London, Robert Klitzman.
  Developing World Bioethics. November 10, 2014
  Little research has explored the possible effects of government institutions in emerging economies on ethical reviews of multinational research. We conducted semi‐structured, in‐depth telephone interviews with 15 researchers, Research Ethics Committees (RECs) personnel, and a government agency member involved in multinational HIV Prevention Trials Network (HPTN) research in emerging economies. Ministries of Health (MOH) or other government agencies often play pivotal roles as facilitators or barriers in the research ethics approval process. Government agency RECs reviewing protocols may face particular challenges, as they can lack resources, be poorly organized, have inconsistent review processes and limited expertise, and use differing definitions of national interests, including upholding national reputation and avoiding potential exploitation and stigma of the country's population. The MOH/governmental review body may be affected by power dynamics and politics in study reviews; may consider issues both related and unrelated to research ethics as understood elsewhere; and may prioritize particular diseases, treatments, or interventions over other topics/types of research. Poor communication and deeply‐rooted tensions may exist between sponsor and host countries, impeding optimal interactions and reviews. Investigators must understand and plan for the potential effects of governmental agencies on multinational collaborative research, including preserving adequate time for agency review, and contacting these agencies beforehand to address issues that may arise. Better understanding of these issues can aid and advance appropriate global scientific collaboration.

  November 10, 2014   doi: 10.1111/dewb.12072   open full text
• Making Tenofovir Accessible In The Brazilian Public Health System: Patent Conflicts And Generic Production.
  Juliana Veras.
  Developing World Bioethics. May 29, 2014
  In May 2011, the Brazilian Ministry of Health announced the distribution of the first batch of locally produced generic tenofovir disoproxil fumarate (TDF) to support its program of universal and free access for the treatment of HIV/AIDS. The inclusion of TDF in the public health program illustrates what has been considered the ‘Brazilian model’ of HIV/AIDS response, as it illustrates the current phase of the Brazilian pharmaceutical economy. Brazil is known for having managed to control the expansion of HIV/AIDS through a unique initiative combining the public health and the industrial production of generics. But, if at first local manufacturers could freely copy ARVs and produce cheaper generic versions that were delivered to the Ministry of Health, since the country started to grant patents on drugs in 1996, the sustainability of this policy has been challenged by the high cost of patented second‐line HIV/AIDS treatments. In order to assure continuity of the local production of ARVs, and keep the program of public health alive, Brazilians are now forced to deal with conflicts of drugs' intellectual property rights in order to open the path to generic production. This article aims to describe the experiences surrounding TDF in Brazil and the unprecedented conflicts and challenges it has brought for our different interviewees. Blurring the frontier between the public and the private, the TDF case was driven at the same time by an ethic of drug access and regulation of drug quality, which has inspired Brazilians to intervene and transform the world they live in.

  May 29, 2014   doi: 10.1111/dewb.12052   open full text
• The Right to Health and Medicines: The Case of Recent Multilateral Negotiations on Public Health, Innovation and Intellectual Property.
  German Velasquez.
  Developing World Bioethics. May 12, 2014
  The negotiations of the intergovernmental group known as the ‘IGWG’, undertaken by the Member States of the WHO, were the result of a deadlock in the World Health Assembly held in 2006 where the Member States of the WHO were unable to reach an agreement on what to do with the 60 recommendations in the report on ‘Public Health, Innovation and Intellectual Property Rights submitted to the Assembly in the same year by a group of experts designated by the Director General of the WHO. The result of these negotiations was the ‘Global strategy and plan of action on public health, innovation and intellectual property’ which was approved by the World Health Assembly in 2008. The intention of the Global Strategy and Plan of Action (GSPOA) which was produced by the IGWG was to substantially reform the pharmaceuticals' research and development system in view of the findings that this system, whose purpose is to produce medicines for diseases which affect the greater part of the world population which lives in developing countries, had failed. The intellectual property rights imposed by the Agreement on Trade‐Related Aspects of Intellectual Property Rights (TRIPS) and the recent trade agreements could become one of the main obstacles to access to medicines. The GSPOA makes a critical analysis of this reality, and opens the door to searching for new solutions to this problem.

  May 12, 2014   doi: 10.1111/dewb.12049   open full text
• Systemic Negligence: Why It Is Morally Important for Developing World Bioethics.
  Chhanda Chakraborti.
  Developing World Bioethics. April 25, 2014
  In the context of clinical and non‐clinical biomedical practices, negligence is usually understood as a lapse of a specific professional duty by a healthcare worker or by a medical facility. This paper tries to delineate systemic negligence as another kind of negligence in the context of health systems, particularly in developing countries, that needs to be recognized and addressed. Systemic negligence is not just a mere collection of stray incidences of medical errors and system failures in a health system, but is proposed in this paper as a more pervasive kind of neglect. Several non‐medical factors, such as lack of social and political will, also contribute to it and hence is more difficult to address in a health system. This paper argues that recognizing systemic negligence and including it research agenda have special moral importance for researchers in developing world bioethics, public health ethics and for health activists in the developing world. For, it can be a potent health system barrier, and can seriously impair efforts to ensure patient safety, particularly in the weaker health systems. As it erodes accountability in a health system, addressing it is also important for the twin goals of ensuring patient safety and improving health system performance. Above all, it needs to be addressed because the tolerance of its persistence in a health system seems to undervalue health as a social good.

  April 25, 2014   doi: 10.1111/dewb.12063   open full text
• Needs‐Driven Versus Market‐Driven Pharmaceutical Innovation: The Consortium for the Development of a New Medicine against Malaria in Brazil.
  Koichi Kameda.
  Developing World Bioethics. April 25, 2014
  The prevailing model for encouraging innovation based on patents and market‐oriented raises at least two economic and ethical issues: it imposes barriers on individuals and developing countries governments' access to medicines by defining prices that do not match their income, and the unavailability of new or appropriate products to address the health problems of these populations. In the last decade, this scenario has undergone some changes due to the emergence of new actors, the contribution of aid resources, the introduction to the market of new products against neglected diseases, the development of new governmental healthcare policies and research programs, etc. One example of such initiatives is the Fixed‐Dose Artesunate Combination Therapy (FACT) project consortium, which brought together institutions with different natures from both the North and the South, for the development of two antimalarial fixed‐dose combinations recommended by the WHO – artesunate‐amodiaquine (ASAQ) and artesunate‐mefloquine (ASMQ). This paper proposes to describe and analyze the ASMQ consortium, which is the result of a new pharmaceutical development approach, based on a different paradigm – needs‐driven instead of market‐driven –, collaborative, with strategic participation of institutions from the South, funded by alternative resources (public and philanthropic). Thus, it represents an interesting object of study for bioethical debates on intellectual property and innovation, and its analysis is justified in light of the current debate on ways of stimulating needs‐driven pharmaceutical innovation.

  April 25, 2014   doi: 10.1111/dewb.12056   open full text
• Global Health Care Justice, Delivery Doctors and Assisted Reproduction: Taking a Note From Catholic Social Teachings.
  Cristina Richie.
  Developing World Bioethics. April 21, 2014
  This article will examine the Catholic concept of global justice within a health care framework as it relates to women's needs for delivery doctors in the developing world and women's demands for assisted reproduction in the developed world. I will first discuss justice as a theory, situating it within Catholic social teachings. The Catholic perspective on global justice in health care demands that everyone have access to basic needs before elective treatments are offered to the wealthy. After exploring specific discrepancies in global health care justice, I will point to the need for delivery doctors in the developing world to provide basic assistance to women who hazard many pregnancies as a priority before offering assisted reproduction to women in the developed world. The wide disparities between maternal health in the developing world and elective fertility treatments in the developed world are clearly unjust within Catholic social teachings. I conclude this article by offering policy suggestions for moving closer to health care justice via doctor distribution.

  April 21, 2014   doi: 10.1111/dewb.12060   open full text
• Between Relativism and Imperialism: Navigating Moral Diversity in Cross‐Cultural Bioethics.
  Daniel Beck.
  Developing World Bioethics. April 21, 2014
  The need for explicit theoretical reflection on cross‐cultural bioethics continues to grow as the spread of communication technologies and increased human migration has made interactions between medical professionals and patients from different cultural backgrounds much more common. I claim that this need presents us with the following dilemma. On the one hand, we do not want to operate according to an imperialist ethical framework that denies and silences the legitimacy of cultural values other than our own. On the other hand, we do not want to backslide into a form of cultural relativism that is unable to critically appraise cultural practices that are harmful, unjust, or oppressive. I examine two prominent attempts – the principlism of Tom Beauchamp and James Childress and the Contractarianism of Robert Baker – to frame cross‐cultural bioethics between these two extremes and argue that both approaches have significant flaws. The principlist approach fails to provide a non‐question begging way to identify cross‐cultural norms that does not already assume the universal legitimacy of moral principles dominant in North American society. Baker's contractarianism cannot grapple with the realities of political power imbalances that often characterize cross‐cultural moral disputes. I suggest that a naturalized feminist framework, though not free of its own theoretical difficulties, provides the best alternative for approaching moral diversity respectfully and critically.

  April 21, 2014   doi: 10.1111/dewb.12059   open full text
• Patent Funded Access to Medicines.
  Tom Andreassen.
  Developing World Bioethics. April 21, 2014
  Instead of impeding access to essential medicines in developing countries, the essay explores why and how patents can serve as a source of funding for the much needed access to medicine. Instead of a weakening of patents, prolonged protection periods are suggested in circumstances where there is widespread lack of access. The revenues from extended patents are seen as a source of funding for drug donations to the least developed countries.

  April 21, 2014   doi: 10.1111/dewb.12058   open full text
• Bioethics in the Malay‐Muslim Community in Malaysia: A Study on the Formulation of Fatwa on Genetically Modified Food by the National Fatwa Council.
  Noor Munirah Isa, Azizan Baharuddin, Saadan Man, Chang Lee Wei.
  Developing World Bioethics. April 21, 2014
  The field of bioethics aims to ensure that modern scientific and technological advancements have been primarily developed for the benefits of humankind. This field is deeply rooted in the traditions of Western moral philosophy and socio‐political theory. With respect to the view that the practice of bioethics in certain community should incorporate religious and cultural elements, this paper attempts to expound bioethical tradition of the Malay‐Muslim community in Malaysia, with shedding light on the mechanism used by the National Fatwa Council to evaluate whether an application of biological sciences is ethical or not. By using the application of the genetically modified food as a case study, this study has found that the council had reviewed the basic guidelines in the main references of shari'ah in order to make decision on the permissibility of the application. The fatwa is made after having consultation with the experts in science field. The council has taken all factors into consideration and given priority to the general aim of shari'ah which to serve the interests of mankind and to save them from harm.

  April 21, 2014   doi: 10.1111/dewb.12057   open full text
• Asserting The Primacy of Health Over Patent Rights: A Comparative Study of the Processes that Led to the Use of Compulsory Licensing in Thailand and Brazil.
  Stephanie T. Rosenberg.
  Developing World Bioethics. April 21, 2014
  Since the 1970s, the United States has adopted a trade policy agenda that has forced countries to trade away flexible patent provisions for access to US markets. While pharmaceutical companies have argued that the recognition of patent rights is essential for recovering investments in research and development of pharmaceuticals and incentivizing future innovation, the lack of competition has had damaging consequences for public health, as companies tend to set the prices of treatments beyond the reach of consumers and government programs. Thailand and Brazil are bound by law to provide universal access to anti‐retroviral treatment (ART) to People Living with HIV/AIDS (PLWHA). This has been made possible in part due to the universal health care systems in each country and the countries' local technical and industrial capacities that provide the government with affordable generic medicines. The introduction of stronger intellectual property protection laws however, has limited possibilities for procuring generic medicines and inflated the cost of treatment. Between 2006–2008, Thailand and Brazil used compulsory licensing to authorize generic competition against the consent of the pharmaceutical companies in order to guarantee the right to health and ensure the viability of government health budgets. This paper will demonstrate how the interaction between individual / collective action and structural and institutional elements in Thailand and Brazil produced propitious conditions for each country to assert the primacy of health over patent rights.

  April 21, 2014   doi: 10.1111/dewb.12050   open full text
• Access to Medicines and Distributive Justice: Breaching Doha's Ethical Threshold.
  Rachel Kiddell‐Monroe.
  Developing World Bioethics. April 21, 2014
  The global health crisis in non‐communicable diseases (NCDs) reveals a deep global health inequity that lies at the heart of global justice concerns. Mirroring the HIV/AIDS epidemic, NCDs bring into stark relief once more the human consequences of trade policies that reinforce global inequities in treatment access. Recognising distributive justice issues in access to medicines for their populations, World Trade Organisation (WTO) members confirmed the primacy of access to medicines for all in trade and public health in the landmark Doha Declaration on the TRIPS Agreement and Public Health of 2001.

  April 21, 2014   doi: 10.1111/dewb.12046   open full text
• Ethical Implications of Case‐Based Payment in China: A Systematic Analysis.
  Pingyue Jin, Nikola Biller‐Andorno, Verina Wild.
  Developing World Bioethics. April 20, 2014
  How health care providers are paid affects how medicine is practiced. It is thus important to assess provider payment models not only from the economic perspective but also from the ethical perspective. China recently started to reform the provider payment model in the health care system from fee‐for‐service to case‐based payment. This paper aims to examine this transition from an ethical perspective. We collected empirical studies on the impact of case‐based payment in the Chinese health care system and applied a systematic ethical matrix that integrates clinical ethics and public health ethics to analyze the empirical findings. We identified eleven prominent ethical issues related to case‐based payment. Some ethical problems of case‐based payment in China are comparable to ethical problems of managed care and diagnosis related groups in high‐income countries. However, in this paper we discuss in greater detail four specific ethical issues in the Chinese context: professionalism, the patient‐physician relationship, access to care and patient autonomy. Based on the analysis, we cautiously infer that case‐based payment is currently more ethically acceptable than fee‐for‐service in the context of China, mainly because it seems to lower financial barriers to access care. Nonetheless, it will be difficult to justify the implementation of case‐based payment if no additional measures are taken to monitor and minimize its existing negative ethical implications.

  April 20, 2014   doi: 10.1111/dewb.12055   open full text
• Biomedicine, Public Health, and Citizenship in the Advent of Antiretrovirals in Botswana.
  Fanny Chabrol.
  Developing World Bioethics. April 11, 2014
  Often celebrated as a model of development in Africa, Botswana nonetheless endured a severe HIV epidemic. This article describes the singularity of the Botswana experience in facing AIDS and creating the widest possible access to antiretroviral medications for its citizens. Through exploration of different sets of actors and the construction of their ethics of treatment, it is possible to examine how free and universal access was created within the national antiretroviral program. This article underscores the importance of the site and the local dynamics in the advent of an ethics of access to treatment for Botswana citizens. At the intersection of national citizenship, pharmaceutical philanthropy, and biomedical collaborations, Botswana is an exemplary case (one of the first and unique in its kind) of global health programs for access to drugs in which patients' rights are tied to science and pharmaceutical development. As such it also bears some limitations and concerns over its sustainability.

  April 11, 2014   doi: 10.1111/dewb.12051   open full text
• [Re]considering Respect for Persons in a Globalizing World.
  Aasim I. Padela, Aisha Y. Malik, Farr Curlin, Raymond De Vries.
  Developing World Bioethics. April 11, 2014
  Contemporary clinical ethics was founded on principlism, and the four principles: respect for autonomy, nonmaleficence, beneficence and justice, remain dominant in medical ethics discourse and practice. These principles are held to be expansive enough to provide the basis for the ethical practice of medicine across cultures. Although principlism remains subject to critique and revision, the four‐principle model continues to be taught and applied across the world. As the practice of medicine globalizes, it remains critical to examine the extent to which both the four‐principle framework, and individual principles among the four, suffice patients and practitioners in different social and cultural contexts. Using the four‐principle model we analyze two accounts of surrogate decision making – one from the developed and one from the developing world – in which the clinician undertakes medical decision‐making with apparently little input from the patient and/or family. The purpose of this analysis is to highlight challenges in assessing ethical behaviour according to the principlist model. We next describe cultural expectations and mores that inform both patient and clinician behaviors in these scenarios in order to argue that the principle of respect for persons informed by culture‐specific ideas of personhood may offer an improved ethical construct for analyzing and guiding medical practice in a globalized and plural world.

  April 11, 2014   doi: 10.1111/dewb.12045   open full text
• Reuse Of Pacemakers In Ghana And Nigeria: Medical, Legal, Cultural And Ethical Perspectives.
  Aloysius Ochasi, Peter Clark.
  Developing World Bioethics. April 11, 2014
  According to the World Health Organization (WHO) cardiovascular disease (CVD) is the leading cause of death globally. Over 80% of CVD deaths take place in low‐ and middle‐income countries (LMICs). It is estimated that 1 million to 2 million people worldwide die each year due to lack of access to an implantable cardiac defibrillator (ICD) or a pacemaker. Despite the medical, legal, cultural and ethical controversies surrounding the pacemaker reutilization, studies done so far on the reuse of postmortem pacemakers show it to be safe and effective with an infection rate of 1.97% and device malfunction rate of 0.68%. Pacemaker reutilization can be effectively and safely done and does not pose significant additional risk to the recipient. Heart patients with reused pacemakers have an improved quality of life compared to those without pacemakers. The thesis of this paper is that pacemaker reutilization is a life‐saving initiative in LMICs of Nigeria and Ghana. It is cost effective; consistent with the principles of beneficence, nonmaleficence, and justice with a commitment to stewardship of resources and the Common Good. Used pacemakers with adequate battery life can be properly sterilized for use by patients in LMICs who cannot afford the cost of a new pacemaker.

  April 11, 2014   doi: 10.1111/dewb.12047   open full text
• A Brief History of Biomedical Research Ethics in Iran: Conflict of Paradigms.
  Kiarash Aramesh.
  Developing World Bioethics. April 11, 2014
  During the past two decades, Iran has experienced a noteworthy growth in its biomedical research sector. At the same time, ethical concerns and debates resulting from this burgeoning enterprise has led to increasing attention paid to biomedical ethics. In Iran, Biomedical research ethics and research oversight passed through major periods during the past decades, separated by a paradigm shift. Period 1, starting from the early 1970s, is characterized by research paternalism and complete reliance on researchers as virtuous and caring physicians. This approach was in concordance with the paternalistic clinical practice of physicians outside of research settings during the same period. Period 2, starting from the late 1990s, was partly due to revealing of ethical flaws that occurred in biomedical research in Iran. The regulatory and funding bodies concluded that it was not sufficient to rely solely on the personal and professional virtues of researchers to safeguard human subjects' rights and welfare. The necessity for independent oversight, emphasized by international declarations, became obvious and undeniable. This paradigm shift led to the establishment of research ethics committees throughout the country, the establishment of academic research centers focusing on medical ethics (MEHR) and the compilation of the first set of national ethical guidelines on biomedical research–one of the first and most important projects conducted by and in the MEHR. Although not yet arrived, ‘period 3’ is on its way. It is predictable from the obvious trends toward performance of high‐quality clinical research and the appearance of a highly educated new generation, especially among women.

  April 11, 2014   doi: 10.1111/dewb.12053   open full text
• Perceived Quality of Informed Refusal Process: A Cross‐Sectional Study from Iranian Patients' Perspectives.
  Mehrdad Farzandipour, Abbas Sheikhtaheri, Monireh Sadeqi Jabali.
  Developing World Bioethics. April 11, 2014
  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.

  April 11, 2014   doi: 10.1111/dewb.12054   open full text
• Overcoming Entrenched Disagreements: the Case of Misoprostol for Post‐Partum Haemorrhage.
  Narcyz Ghinea, Wendy Lipworth, Miles Little, Ian Kerridge, Richard Day.
  Developing World Bioethics. November 08, 2013
  The debate about whether misoprostol should be distributed to low resource communities to prevent post‐partum haemorrhage (PPH), recognised as a major cause of maternal mortality, is deeply polarised. This is in spite of stakeholders having access to the same evidence about the risks and benefits of misoprostol. To understand the disagreement, we conducted a qualitative analysis of the values underpinning debates surrounding community distribution of misoprostol. We found that different moral priorities, epistemic values, and attitudes towards uncertainty were the main factors sustaining the debate. With this understanding, we present a model for ethical discourse that might overcome the current impasse.

  November 08, 2013   doi: 10.1111/dewb.12040   open full text
• Mind the gap: An empirical study of post‐trial access in HIV biomedical prevention trials.
  Bridget Haire, Christopher Jordens.
  Developing World Bioethics. November 08, 2013
  The principle of providing post‐trial access for research participants to successful products of that research is widely accepted and has been enshrined in various declarations and guidelines. While recent ethical guidelines recognise that the responsibility to provide post‐trial access extends to sponsors, regulators and government bodies as well as to researchers, it is the researchers who have the direct duty of care to participants. Researchers may thus need to act as advocates for trial participants, especially where government bodies, sponsors, and regulatory bodies have complex interests vested in decisions about whether or not new interventions are made available, how, and to whom. This paper provides an empirical account of post‐trial access in the context of HIV prevention research. It describes both access to the successful products of research and the provision antiretroviral drugs for trial participants who acquire HIV. First, we provide evidence that, in the current system, there is considerable variation in the duration and timeliness of access. We then argue that by analysing the difficulties faced by researchers to this point, and their efforts to meet this obligation, much can be learned about how to secure post‐trial access in HIV biomedical preventions trials. While researchers alone have a limited obligation, their advocacy on behalf of trial participants may be necessary to call the other parties to account.

  November 08, 2013   doi: 10.1111/dewb.12039   open full text
• Considerations for a Human Rights Impact Assessment of a Population Wide Treatment for HIV Prevention Intervention.
  Johanna Hanefeld, Virginia Bond, Janet Seeley, Shelley Lees, Nicola Desmond.
  Developing World Bioethics. November 08, 2013
  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.

  November 08, 2013   doi: 10.1111/dewb.12038   open full text
• The Social Value of Knowledge and International Clinical Research.
  Danielle M. Wenner.
  Developing World Bioethics. November 08, 2013
  In light of the growth in the conduct of international clinical research in developing populations, this paper seeks to explore what is owed to developing world communities who host international clinical research. Although existing paradigms for assigning and assessing benefits to host communities offer valuable insight, I criticize their failure to distinguish between those benefits which can justify the conduct of research in a developing world setting and those which cannot. I argue that the justification for human subjects research is fundamentally grounded in the social value of knowledge, and that this value is context‐dependent in a manner which should inform our ethical evaluation of the conduct of research in specific settings. I propose a new framework for the assessment of research benefits assigned to developing world host communities, a natural implication of which is to limit the types of research projects which may permissibly be conducted in developing world settings.

  November 08, 2013   doi: 10.1111/dewb.12037   open full text
• Separate Goals, Converging Priorities: On the Ethics of Treatment as Prevention.
  Florian Ostmann, Carla Saenz.
  Developing World Bioethics. June 25, 2013
  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.

  June 25, 2013   doi: 10.1111/dewb.12021   open full text
• From modeling to morals: Imagining the future of HIV PREP in Lesotho.
  Nora J. Kenworthy, Nicola Bulled.
  Developing World Bioethics. June 25, 2013
  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 PrEP's potential successes and pitfalls in a developing country, given the country's 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.

  June 25, 2013   doi: 10.1111/dewb.12029   open full text
• Ethical Considerations in Determining Standard of Prevention Packages for HIV Prevention Trials: Examining PrEP.
  Bridget Haire, Morenike Oluwatoyin Folayan, Catherine Hankins, Jeremy Sugarman, Sheena McCormack, Gita Ramjee, Mitchell Warren.
  Developing World Bioethics. May 31, 2013
  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.

  May 31, 2013   doi: 10.1111/dewb.12032   open full text
• Engaging Diverse Social and Cultural Worlds: Perspectives on Benefits in International Clinical Research From South African Communities.
  Olga Zvonareva, Nora Engel, Eleanor Ross, Ron Berghmans, Ames Dhai, Anja Krumeich.
  Developing World Bioethics. May 31, 2013
  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. Twenty‐four individuals with and without experience of being involved in clinical research participated in in‐depth interviews. Respondents felt that ancillary care should be provided to clinical research participants, while a clinical study conducted in particular community should bring better health to its members through post‐trial benefits. Respondents' perspectives were grounded in the perception that the ultimate goal of international clinical research is to improve local health. We argue that perspectives and understandings of the respondents are shaped by local moral traditions rather than clinical research specificities and require attention as valid moral claims. It is necessary to acknowledge such claims and cultural worlds from which they emerge, thus building the foundation for equal and embracing dialogue to bridge different perspectives and handle contradicting expectations.

  May 31, 2013   doi: 10.1111/dewb.12030   open full text
• Exploitation and community engagement: Can Community Advisory Boards successfully assume a role minimising exploitation in international research?
  Bridget Pratt, Khin Maung Lwin, Deborah Zion, Francois Nosten, Bebe Loff, Phaik Yeong Cheah.
  Developing World Bioethics. May 31, 2013
  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 relied upon to serve as the CAB. Using the Tak Province Border Community Ethics Advisory Board (T‐CAB) as a case study, we assess the extent to which it might be able to take on a role minimising exploitation were it to decide to do so. We investigate whether, after two years in operation, T‐CAB is capable of assessing clinical trials for exploitative features and addressing those found to have them. The findings show that, although T‐CAB members have gained knowledge and developed capacities that are foundational for one‐day taking on a role to reduce exploitation, their ability to critically evaluate studies for the presence of exploitative elements has not yet been strongly demonstrated. In light of this example, we argue that CABs may not be able to perform such a role for a number of years after initial formation, making it an unsuitable responsibility for many short‐term CABs.

  May 31, 2013   doi: 10.1111/dewb.12031   open full text
• Collaborative International Research: Ethical and Regulatory Issues Pertaining to Human Biological Materials at a South African Institutional Research Ethics Committee.
  Aslam Sathar, Amaboo Dhai, Stephan Linde.
  Developing World Bioethics. May 31, 2013
  Human Biological Materials (HBMs) are an invaluable resource in biomedical research. Objective To determine if researchers and a Research Ethics Committee (REC) at a South African institution addressed ethical issues pertaining to HBMs in collaborative research with developed countries. Study Design Ethically approved retrospective cross‐sectional descriptive audit. Results Of the 1305 protocols audited, 151 (11.57%) fulfilled the study's inclusion criteria. Compared to other developed countries, a majority of sponsors (90) were from the USA (p = 0.0001). The principle investigators (PIs) in all 151 protocols informed the REC of their intent to store HBMs. Only 132 protocols informed research participants (P < 0.0001). In 148 protocols informed consent (IC) was obtained from research participants, 116 protocols (76.8%) solicited broad consent compared to specific consent (32; 21.2%) [p < 0.0001]. In 105 cases a code was used to maintain confidentiality. HBMs were anonymised in 14 protocols [p < 0.0001]. More protocols informed the REC (90) than the research participants (67) that HBMs would be exported (p = 0.011). Export permits (EPs) and Material Transfer Agreements (MTAs) were not available in 109 and 143 protocols, respectively. Conclusions Researchers 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.

  May 31, 2013   doi: 10.1111/dewb.12018   open full text
• 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.
  Elisabeth Marie Strømme, Kristine Bærøe, Ole Frithjof Norheim.
  Developing World Bioethics. May 31, 2013
  Background In the context of limited health care budgets in countries where Neglected Tropical Diseases (NTDs) are endemic, scaling up disease control interventions entails the setting of priorities. However, solutions based solely on cost‐effectiveness analyses may lead to biased and insufficiently justified priorities. Objectives The objectives of this paper are to 1) demonstrate how a range of equity concerns can be used to identify feasible priority setting criteria, 2) show how these criteria can be fed into a multi‐criteria decision‐making matrix, and 3) discuss the conditions under which this decision‐making procedure should be carried out in a real‐world decision‐making context. Methods This paper draws on elements from theories of decision analysis and ethical theories of fair resource allocation. We explore six typical NTD interventions by employing a modified multi‐criteria decision analysis model with predefined criteria, drawn from a priority setting guide under development by the WHO. To identify relevant evidence for the six chosen interventions, we searched the PubMed and Cochrane databases. Discussion Our in vitro multi‐criteria decision analysis suggested that case management for visceral leishmaniasis should be given a higher priority than mass campaigns to prevent soil‐transmitted helminthic infections. This seems to contradict current health care priorities and recommendations in the literature. We also consider procedural conditions that should be met in a contextualised decision‐making process and we stress the limitations of this study exercise. Conclusion By 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.

  May 31, 2013   doi: 10.1111/dewb.12016   open full text
• Ethical Tradeoffs in Trial Design: Case Study of an HPV Vaccine Trial in HIV‐Infected Adolescent Girls in Lower Income Settings.
  J.C. Lindsey, S.K. Shah, G.K. Siberry, P. Jean‐Philippe, M.J. Levin.
  Developing World Bioethics. May 31, 2013
  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.

  May 31, 2013   doi: 10.1111/dewb.12028   open full text
• Ethical Use of Antiretroviral Resources for HIV Prevention in Resource Poor Settings.
  Stuart Rennie.
  Developing World Bioethics. May 31, 2013
  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.

  May 31, 2013   doi: 10.1111/dewb.12022   open full text
• Community Members' Engagement with and Involvement in Genomic Research: Lessons to Learn from the Field.
  Morenike O. Folayan, Kolawole S. Oyedeji, Olawunmi A. Fatusi.
  Developing World Bioethics. April 17, 2013
  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 indirectly engaged in the design and implementation of genomic research through the engagement of laypersons on ethics committees. However, to ensure that these laypersons can play this role, their capacity needs to be built to play this role appropriately. There is evidence to show that where resources are invested in building the capacity of laypersons to play their role as community ‘watchdogs’ in research, they play this role aptly. Community engagement is important in genomic research as genomic researchers will increasingly require community perspectives in critical ethics decision making.

  April 17, 2013   doi: 10.1111/dewb.12020   open full text
• Promoting Research Integrity in Africa: An African Voice of Concern on Research Misconduct and the Way Forward.
  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 Ranaivo.
  Developing World Bioethics. April 17, 2013
  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 frameworks. Africa needs policies, structural and governance systems that promote responsible conduct of research. To begin to offset this relative lack of documented evidence of research misconduct, contributors working in various research institutions from nine African countries agreed to share their experiences to highlight problems and explore the need to identify strategies to promote research integrity in the African continent. The experiences shared include anecdotal but reliable accounts of previously undocumented research misconduct, including some ‘normal misbehavior’ of frontline staff in those countries. Two broad approaches to foster greater research integrity are proposed including promotion of institutional and individual capacity building to instil a culture of responsible research conduct in existing and upcoming research scientist and developing deterrent and corrective policies to minimize research misconduct and other questionable research practices. By sharing these experiences and through the strategies proposed, the authors hope to limit the level of research misconduct and promote research integrity in Africa.

  April 17, 2013   doi: 10.1111/dewb.12024   open full text
• Survey on Ethical Conduct Thresholds in Cardiologal Medical Practice in Argentina.
  Hernán C. Doval, Carlos D. Tajer, Raúl A. Borracci, Carmen Nuñez, Marisa Samarelli, Susana Tamini.
  Developing World Bioethics. April 17, 2013
  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, splitting fees, overbilling, self‐referral, charging for patient referral, financial compensation for ordering medical procedures, and various situations derived from the relationship with employers. In general, financial compensation from the pharmaceutical industry was more accepted than the conflictive situations which directly involved patients, colleagues or employers. The rejection of these conducts, the physicians' deontological education and the improvement of financial and organizational conditions in medical practice will help to encourage better medical professionalism and avoid unseemly behaviors.

  April 17, 2013   doi: 10.1111/dewb.12025   open full text
• Ethics of ARV Based Prevention: Treatment‐as‐Prevention and PrEP.
  Bridget Haire, John M. Kaldor.
  Developing World Bioethics. April 17, 2013
  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.

  April 17, 2013   doi: 10.1111/dewb.12026   open full text
• Great Expectations: Teaching Ethics to Medical Students in South Africa.
  Kevin Gary Behrens, Robyn Fellingham.
  Developing World Bioethics. February 15, 2013
  Many academic philosophers and ethicists are appointed to teach ethics to medical students. We explore exactly what this task entails. In South Africa the Health Professions Council's curriculum for training medical practitioners requires not only that students be taught to apply ethical theory to issues and be made aware of the legal and regulatory requirements of their profession, it also expects moral formation and the inculcation of professional virtue in students. We explore whether such expectations are reasonable. We defend the claim that physicians ought to be persons of virtuous character, on the grounds of the social contract between society and the profession. We further argue that since the expectations of virtue of health care professionals are reasonable, it is also sound reasoning to expect ethics teachers to try to inculcate such virtues in their students, so far as this is possible. Furthermore, this requires of such teachers that they be suitable role models of ethical practice and virtue, themselves. We claim that this applies to ethics teachers who are themselves not members of the medical profession, too, even though they are not bound by the same social contract as doctors. We conclude that those who accept employment as teachers of ethics to medical students, where as part of their contractual obligation they are expected to inculcate moral values in their students, ought to be prepared to accept their responsibility to be professionally ethical, themselves.

  February 15, 2013   doi: 10.1111/dewb.12017   open full text
• The Ethics of Engaged Presence: A Framework for Health Professionals in Humanitarian Assistance and Development Work.
  Matthew R. Hunt, Lisa Schwartz, Christina Sinding, Laurie Elit.
  Developing World Bioethics. December 21, 2012
  In this article, we present an ethics framework for health practice in humanitarian and development work: the ethics of engaged presence. The ethics of engaged presence framework aims to articulate in a systematic fashion approaches and orientations that support the engagement of expatriate health care professionals in ways that align with diverse obligations and responsibilities, and promote respectful and effective action and relationships. Drawn from a range of sources, the framework provides a vocabulary and narrative structure for examining the moral dimensions of providing development or humanitarian health assistance to individuals and communities, and working with and alongside local and international actors. The elements also help minimize or avoid certain miscalculations and harms. Emphasis is placed on the shared humanity of those who provide and those who receive assistance, acknowledgement of limits and risks related to the contributions of expatriate health care professionals, and the importance of providing skillful and relevant assistance. These elements articulate a moral posture for expatriate health care professionals that contributes to orienting the practice of clinicians in ways that reflect respect, humility, and solidarity. Health care professionals whose understanding and actions are consistent with the ethics of engaged presence will be oriented toward introspection and reflective practice and toward developing, sustaining and promoting collaborative partnerships.

  December 21, 2012   doi: 10.1111/dewb.12013   open full text
• Ethical Issues in Field Trials of Genetically Modified Disease‐Resistant Mosquitoes.
  David B. Resnik.
  Developing World Bioethics. December 21, 2012
  Mosquito‐borne diseases take a tremendous toll on human populations, especially in developing nations. In the last decade, scientists have developed mosquitoes that have been genetically modified to prevent transmission of mosquito‐borne diseases, and field trials have been conducted. Some mosquitoes have been rendered infertile, some have been equipped with a vaccine they transmit to humans, and some have been designed to resist diseases. This article focuses on ethical issues raised by field trials of disease‐resistant, genetically modified mosquitoes. Some of these issues include: protecting the public and the environment from harm, balancing benefits and risks, collaborating with the local community, avoiding exploitation, and safeguarding the rights and welfare of research subjects. One of the most difficult problems involves protecting the welfare of community members who will be impacted by the release of mosquitoes but who are not enrolled in the study as research subjects. To address this concern, field trials should take place only when the targeted disease is a significant public health problem in an isolated area, the benefits of the trial for the community are likely to outweigh the risks, community leaders approve of the trial, and there are measures in place to protect the welfare of un‐enrolled community members, such as informing the community about the study and offering free treatment to people who contract mosquito‐borne diseases. Since the justification of any field trial depends on a careful examination of the scientific and ethical issues, proposed studies should be evaluated on a case‐by‐case basis.

  December 21, 2012   doi: 10.1111/dewb.12011   open full text
• Alternatives of Informed Consent for Storage and Use of Human Biological Material for Research Purposes: Brazilian Regulation.
  Gabriela Marodin, Paulo Henrique Condeixa de França, Jennifer Braathen Salgueiro, Marcia Luz da Motta, Gysélle Saddi Tannous, Anibal Gil Lopes.
  Developing World Bioethics. December 21, 2012
  Informed consent is recognized as a primary ethical requirement to conduct research involving humans. In the investigations with the use of human biological material, informed consent (IC) assumes a differentiated condition on account of the many future possibilities. This work presents suitable alternatives for IC regarding the storage and use of human biological material in research, according to new Brazilian regulations. Both norms – Resolution 441/11 of the National Health Council, approved on 12 May 2011, and Ordinance 2.201 (NATIONAL GUIDELINES FOR BIOREPOSITORIES AND BIOBANKS OF HUMAN BIOLOGICAL MATERIAL FOR RESEARCH PURPOSE) of the Brazil Ministry of Health, approved on 14 September 2011 – state that the consent of subjects for the collection, storage and use of samples stored in Biobanks is necessarily established by means of a Free and Informed Consent Form (ICF). In order to obtain individual and formal statements, this form should contain the following two mutually exclusive options: an explanation about the use of the stored material in each research study, and the need for new consent or the waiver thereof when the material is used for a new study. On the other hand, ICF suitable for Biorepositories must be exclusive and related to specific research. Although Brazilian and international regulations identify the main aspects to be included in the IC, efforts are still necessary to improve the consent process, so that the document will become a bond of trust between subject and researcher.

  December 21, 2012   doi: 10.1111/dewb.12012   open full text
• On Abortion: Exploring Psychological Meaning and Attitudes in a Sample of Mexican Gynecologists.
  Ma. Luisa Marván, Asunción Álvarez del Río, Zaira Campos.
  Developing World Bioethics. November 22, 2012
  Elective abortion has become an issue of ethical and political debate in many countries including Mexico. As gynecologists are directly involved in the practice of abortion, it is important to know the psychological meaning that the term ‘elective abortion’ has for them. This study explores the psychological meaning and attitudes toward elective abortion of one hundred and twenty‐three Mexican gynecologists. We used the semantic networks technique, which analyzed the words the participants associated with the term ‘elective abortion’. The defining words most frequently used by participants implied a negative sanction. There were important differences by gender and religiosity: male gynecologists, as well as those with strong religious beliefs (mainly Catholics), revealed a more negative psychological meaning and more negative attitudes than females or physicians with weak religious beliefs. A contribution of the present study is that it highlights the importance of psychology to enhancing understanding of the issue of elective abortion.

  November 22, 2012   doi: 10.1111/dewb.12005   open full text
• Ethical Considerations in Clinical Trials: A Critique of the ICH‐GCP Guideline.
  Sharon Kaur, Choong Yeow Choy.
  Developing World Bioethics. November 22, 2012
  This article examines issues relating to ethics decision‐making in clinical trials. The overriding concern is to ensure that the well being and the interests of human subjects are adequately safeguarded. In this respect, this article will embark on a critical analysis of the ICH‐GCP Guideline. The purpose of such an undertaking is to highlight areas of concern and the shortcomings of the existing ICH‐GCP Guideline. Particular emphasis is made on how ethics committees perform their duties and responsibilities in line with the principles outlined in the ICH‐GCP Guideline. This article will draw attention to the need for a new approach to addressing the weaknesses of the ICH‐GCP Guideline in its present form.

  November 22, 2012   doi: 10.1111/dewb.12004   open full text
• Why Restrictions on the Immigration of Health Workers Are Unjust.
  Javier Hidalgo.
  Developing World Bioethics. November 22, 2012
  Some bioethicists and political philosophers argue that rich states should restrict the immigration of health workers from poor countries in order to prevent harm to people in these countries. In this essay, I argue that restrictions on the immigration of health workers are unjust, even if this immigration results in bad health outcomes for people in poor countries. I contend that negative duties to refrain from interfering with the occupational liberties of health workers outweighs rich states' positive duties to prevent harm to people in sending countries. Furthermore, I defend this claim against the objection that health workers in poor countries acquire special duties to their compatriots that render them liable to coercive interference.

  November 22, 2012   doi: 10.1111/dewb.12006   open full text
• Developing Ethical Awareness in Global Health: Four Cases for Medical Educators.
  Mary White, Jessica Evert.
  Developing World Bioethics. October 01, 2012
  In recent years, the growth of interest in global health among medical students and residents has led to an abundance of short‐term training opportunities in low‐resource environments. Given the disparities in resources, needs and expectations between visitors and their hosts, these experiences can raise complex ethical concerns. Recent calls for best practices and ethical guidelines indicate a need for the development of ethical awareness among medical trainees, their sponsoring and host institutions, and supervising faculty. As a teaching tool to promote this awareness, we developed a scenario that captures many common ethical issues from four different perspectives. Each perspective is presented in case format followed by questions. Taken together, the four cases may be used to identify many of the elements of a well‐designed global health training experience.

  October 01, 2012   doi: 10.1111/dewb.12000   open full text
• Guest Authors in An Iranian Journal.
  Mahsa Ghajarzadeh.
  Developing World Bioethics. October 01, 2012
  Background Although most biomedical journals have adopted the authorship criteria established by the International Committee of Medical Journal Editors (ICMJE) in 1985, little is known about the extent Iranian researchers are familiar with these criteria. Objectives The study seeks to evaluate the number of authors fulfilling ICMJE authorship criteria (considering the names mentioned in the byline of 12 issues of the Archives of Iranian Medicine (AIM) journal), and to determine the type of contribution made by each author. Materials and Methods The fulfilment of authorship criteria and contribution percentage of each researcher were evaluated according to their position in the bylines of 12 issues of the Archives of Iranian Medicine (AIM) journal published from January 2005 to October 2007. We asked corresponding authors to answer our questionnaire which was designed to assess authorship criteria and contribution. Results A total of 576 researchers' names were in the studied article bylines. The ratio of authors to articles was 3.48 in 2005, 4.06 in 2006, and 5.59 in 2007. Sixty three out of 128 corresponding authors (49.21%) responded to our questionnaire, so we evaluated 296 researchers' names, from which 186 authors (62.83%) met the authorship criteria; 110 authors (37.17%) were identified as guest authors, 97 of which deserved to be mentioned in the acknowledgement section. The major criteria used for authors order was their participation in research projects in addition to article writing, mostly determined by the corresponding author. Two authors (0.67%) whose names were not mentioned in the articles were considered to be ghost writers as the articles were based on the results of their thesis. Conclusion It is essential to make Iranian researchers familiar with ICMJE authorship criteria and to encourage applying the criteria in scientific writing.

  October 01, 2012   doi: 10.1111/dewb.12002   open full text
• Animal Research Ethics in Africa: Is Tanzania Making Progress?
  Misago Seth, Fredy Saguti.
  Developing World Bioethics. September 24, 2012
  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.

  September 24, 2012   doi: 10.1111/dewb.12001   open full text
• Impact of Three Years Training on Operations Capacities of Research Ethics Committees in Nigeria.
  Morenike Oluwatoyin Folayan, Aisha Adaranijo, Florita Durueke, Ademola Ajuwon, Adebayo Adejumo, Oliver Ezechi, Kola Oyedeji, Olayide Akanni.
  Developing World Bioethics. September 24, 2012
  This paper describes a three‐year project designed to build the capacity of members of research ethics committes to perform their roles and responsibilities efficiently and effectively. The project participants were made up of a cross‐section of the membership of 13 Research Ethics Committees (RECs) functioning in Nigeria. They received training to develop their capacity to evaluate research protocols, monitor trial implementation, provide constructive input to trial staff, and assess the trial's success in promoting community engagement in the research. Following the training, technical assistance was provided to participants on an ongoing basis and the project's impacts were assessed quantitatively and qualitatively. Results indicate that sustained investment in capacity building efforts (including training, ongoing technical assistance, and the provision of multiple tools) improved the participants’ knowledge of both the ethical principles relevant to biomedical research and how effective REC should function. Such investment was also shown to have a positive impact on the knowledge levels of other RECs members (those who did not receive training) and the overall operations of the RECs to which the participants belonged. Building the capacity of REC members to fulfill their roles effectively requires sustained effort and investment and pays off by enabling RECs to fulfill their essential mission of ensuring that trials are conducted safely and ethically.

  September 24, 2012   doi: 10.1111/j.1471-8847.2012.00340.x   open full text
• ‘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.
  Jennifer Koen, Zaynab Essack, Catherine Slack, Graham Lindegger, Peter A. Newman.
  Developing World Bioethics. September 24, 2012
  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.

  September 24, 2012   doi: 10.1111/j.1471-8847.2012.00338.x   open full text
• Prevalence of Scientific Misconduct Among a Group of Researchers in Nigeria.
  Patrick Okonta, Theresa Rossouw.
  Developing World Bioethics. September 19, 2012
  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 (X2 = 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.

  September 19, 2012   doi: 10.1111/j.1471-8847.2012.00339.x   open full text
• Ethics Education in Research Involving Human Beings in Undergraduate Medicine Curriculum in Brazil.
  Maria Rita Garbi Novaes, Dirce Guilhem, Elena Barragan, Stewart Mennin.
  Developing World Bioethics. September 19, 2012
  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.

  September 19, 2012   doi: 10.1111/j.1471-8847.2012.00336.x   open full text
• Research Integrity in Greater China: Surveying Regulations, Perceptions and Knowledge of Research Integrity from a Hong Kong Perspective.
  Sara R. Jordan, Phillip W. Gray.
  Developing World Bioethics. September 19, 2012
  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.

  September 19, 2012   doi: 10.1111/j.1471-8847.2012.00337.x   open full text
• Embryo Donation In Iran: An Ethical Review.
  Leila Afshar, Alireza Bagheri.
  Developing World Bioethics. June 18, 2012
  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.

  June 18, 2012   doi: 10.1111/j.1471-8847.2012.00334.x   open full text
• Off‐Shoring Clinical Research: Exploitation And The Reciprocity Constraint.
  Agomoni Ganguli Mitra.
  Developing World Bioethics. June 18, 2012
  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.

  June 18, 2012   doi: 10.1111/j.1471-8847.2012.00332.x   open full text
• Acceptance And Perception Of Nigerian Patients To Medical Photography.
  W.L. Adeyemo, B.O. Mofikoya, O.A. Akadiri, O. James, A.A. Fashina.
  Developing World Bioethics. June 18, 2012
  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.

  June 18, 2012   doi: 10.1111/j.1471-8847.2012.00328.x   open full text