School of Historical and Philosophical Studies - Research Publications

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    An ethical pathway for gene editing
    Savulescu, J ; Singer, P (WILEY, 2019-02-01)
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    Evaluating priority setting success in healthcare: a pilot study
    Sibbald, SL ; Gibson, JL ; Singer, PA ; Upshur, R ; Martin, DK (BMC, 2010-05-19)
    BACKGROUND: In healthcare today, decisions are made in the face of serious resource constraints. Healthcare managers are struggling to provide high quality care, manage resources effectively, and meet changing patient needs. Healthcare managers who are constantly making difficult resource decisions desire a way to improve their priority setting processes. Despite the wealth of existing priority setting literature (for example, program budgeting and marginal analysis, accountability for reasonableness, the 'describe-evaluate-improve' strategy) there are still no tools to evaluate how healthcare resources are prioritised. This paper describes the development and piloting of a process to evaluate priority setting in health institutions. The evaluation process was designed to examine the procedural and substantive dimensions of priority setting using a multi-methods approach, including a staff survey, decision-maker interviews, and document analysis. METHODS: The evaluation process was piloted in a mid-size community hospital in Ontario, Canada while its leaders worked through their annual budgeting process. Both qualitative and quantitative methods were used to analyze the data. RESULTS: The evaluation process was both applicable to the context and it captured the budgeting process. In general, the pilot test provided support for our evaluation process and our definition of success, (i.e., our conceptual framework). CONCLUSIONS: The purpose of the evaluation process is to provide a simple, practical way for an organization to better understand what it means to achieve success in its priority setting activities and identify areas for improvement. In order for the process to be used by healthcare managers today, modification and contextualization of the process are anticipated. As the evaluation process is applied in more health care organizations or applied repeatedly in an organization, it may become more streamlined.
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    'Relief of oppression': An organizing principle for researchers' obligations to participants in observational studies in the developing world
    Lavery, JV ; Bandewar, SVS ; Kimani, J ; Upshur, REG ; Plummer, FA ; Singer, PA (BIOMED CENTRAL LTD, 2010-06-30)
    BACKGROUND: A central question in the debate about exploitation in international research is whether investigators and sponsors from high-income countries (HIC) have obligations to address background conditions of injustice in the communities in which they conduct their research, beyond the healthcare and other research-related needs of participants, to aspects of their basic life circumstances. DISCUSSION: In this paper, we describe the Majengo sexually transmitted disease (STD) Cohort study, a long-term prospective, observational cohort of sex workers in Nairobi, Kenya. Despite important scientific contributions and a wide range of benefits to the women of the cohort, most of the women have remained in the sex trade during their long-standing participation in the cohort, prompting allegations of exploitation. The Majengo STD cohort case extends the debate about justice in international research ethics beyond clinical trials into long-term observational research. We sketch the basic features of a new approach to understanding and operationalizing obligations of observational researchers, which we call 'relief of oppression'. 'Relief of oppression' is an organizing principle, analogous to the principle of harm reduction that is now widely applied in public health practice. Relief of oppression aims to help observational researchers working in conditions of injustice and deprivation to clarify their ethical obligations to participants. It aims to bridge the gap between a narrow, transaction-oriented account of avoiding exploitation and a broad account emphasizing obligations of reparation for historic injustices. We propose that relief of oppression might focus researchers' consideration of benefits on those that have some relevance to background conditions of injustice, and so elevate the priority of these benefits, in relation to others that might be considered and negotiated with participants, according to the degree to which the participating communities are constrained in their realization of fundamental freedoms. SUMMARY: The over-arching aim of relief of oppression is that, within the range of benefits negotiated over time with the local communities and organizations, an increasing proportion reflects a shared interest in improving participants' fundamental freedoms. We describe how harm reduction serves as a useful analogy for how we envision relief of oppression functioning in international research.
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    The road to commercialization in Africa: lessons from developing the sickle-cell drug Niprisan
    Perampaladas, K ; Masum, H ; Kapoor, A ; Shah, R ; Daar, AS ; Singer, PA (BIOMED CENTRAL LTD, 2010-12-01)
    BACKGROUND: Developing novel drugs from traditional medicinal knowledge can serve as a means to improve public health. Yet countries in sub-Saharan Africa face barriers in translating traditional medicinal knowledge into commercially viable health products. Barriers in moving along the road towards making a new drug available include insufficient manufacturing capacity; knowledge sharing between scientists and medical healers; regulatory hurdles; quality control issues; pricing and distribution; and lack of financing. The case study method was used to illustrate efforts to overcome these barriers during the development in Nigeria of Niprisan - a novel drug for the treatment of sickle cell anemia, a chronic blood disorder with few effective therapies. DISCUSSION: Building on the knowledge of a traditional medicine practitioner, Nigeria's National Institute for Pharmaceutical Research and Development (NIPRD) developed the traditional herbal medicine Niprisan. The commercialization of Niprisan reached a number of commercial milestones, including regulatory approval in Nigeria; securing US-based commercial partner XeChem; demonstrating clinical efficacy and safety; being awarded orphan drug status by the US Food and Drug Administration; and striking important relationships with domestic and international groups. Despite these successes, however, XeChem did not achieve mainstream success for Niprisan in Nigeria or in the United States. A number of reasons, including inconsistent funding and manufacturing and management challenges, have been put forth to explain Niprisan's commercial demise. As of this writing, NIPRD is considering options for another commercial partner to take the drug forward. SUMMARY: Evidence from the Niprisan experience suggests that establishing benefit-sharing agreements, fostering partnerships with established research institutions, improving standardization and quality control, ensuring financial and managerial due diligence, and recruiting entrepreneurial leaders capable of holding dual scientific and business responsibilities should be incorporated into future drug development initiatives based on traditional medicines. Country-level supporting policies and conditions are also important. With more experience and support, and an improved environment for innovation, developing new drugs from traditional medicines may be an attractive approach to addressing diseases in sub-Saharan Africa and other regions.
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    Shared Principles of Ethics for Infant and Young Child Nutrition in the Developing World
    Singh, JA ; Daar, AS ; Singer, PA (BMC, 2010-06-08)
    BACKGROUND: The defining event in the area of infant feeding is the aggressive marketing of infant formula in the developing world by transnational companies in the 1970s. This practice shattered the trust of the global health community in the private sector, culminated in a global boycott of Nestle products and has extended to distrust of all commercial efforts to improve infant and young child nutrition. The lack of trust is a key barrier along the critical path to optimal infant and young child nutrition in the developing world. DISCUSSION: To begin to bridge this gap in trust, we developed a set of shared principles based on the following ideals: Integrity; Solidarity; Justice; Equality; Partnership, cooperation, coordination, and communication; Responsible Activity; Sustainability; Transparency; Private enterprise and scale-up; and Fair trading and consumer choice. We hope these principles can serve as a platform on which various parties in the in the infant and young child nutrition arena, can begin a process of authentic trust-building that will ultimately result in coordinated efforts amongst parties. SUMMARY: A set of shared principles of ethics for infant and young child nutrition in the developing world could catalyze the scale-up of low cost, high quality, complementary foods for infants and young children, and eventually contribute to the eradication of infant and child malnutrition in the developing world.
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    Innovative health service delivery models in low and middle income countries - what can we learn from the private sector?
    Bhattacharyya, O ; Khor, S ; McGahan, A ; Dunne, D ; Daar, AS ; Singer, PA (BMC, 2010-01-01)
    BACKGROUND: The poor in low and middle income countries have limited access to health services due to limited purchasing power, residence in underserved areas, and inadequate health literacy. This produces significant gaps in health care delivery among a population that has a disproportionately large burden of disease. They frequently use the private health sector, due to perceived or actual gaps in public services. A subset of private health organizations, some called social enterprises, have developed novel approaches to increase the availability, affordability and quality of health care services to the poor through innovative health service delivery models. This study aims to characterize these models and identify areas of innovation that have led to effective provision of care for the poor. METHODS: An environmental scan of peer-reviewed and grey literature was conducted to select exemplars of innovation. A case series of organizations was then purposively sampled to maximize variation. These cases were examined using content analysis and constant comparison to characterize their strategies, focusing on business processes. RESULTS: After an initial sample of 46 studies, 10 case studies of exemplars were developed spanning different geography, disease areas and health service delivery models. These ten organizations had innovations in their marketing, financing, and operating strategies. These included approaches such a social marketing, cross-subsidy, high-volume, low cost models, and process reengineering. They tended to have a narrow clinical focus, which facilitates standardizing processes of care, and experimentation with novel delivery models. Despite being well-known, information on the social impact of these organizations was variable, with more data on availability and affordability and less on quality of care. CONCLUSIONS: These private sector organizations demonstrate a range of innovations in health service delivery that have the potential to better serve the poor's health needs and be replicated. There is a growing interest in investing in social enterprises, like the ones profiled here. However, more rigorous evaluations are needed to investigate the impact and quality of the health services provided and determine the effectiveness of particular strategies.
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    The case for conducting first-in-human (phase 0 and phase 1) clinical trials in low and middle income countries
    Kapiriri, L ; Lavery, JV ; Singer, PA ; Mshinda, H ; Babiuk, L ; Daar, AS (BMC, 2011-10-18)
    BACKGROUND: Despite the increase in the number of clinical trials in low and middle income countries (LMICs), there has been little serious discussion of whether First in Human (FIH; phase 0 and phase 1) clinical trials should be conducted in LMICs, and if so, under what conditions. Based on our own experience, studies and consultations, this paper aims to stimulate debate on our contention that for products meant primarily for conditions most prevalent in LMICs, FIH trials should preferably be done first in those countries. DISCUSSION: There are scientific and pragmatic arguments that support conducting FIH trials in LMIC. Furthermore, the changing product-development and regulatory landscape, and the likelihood of secondary benefits such as capacity building for innovation and for research ethics support our argument. These arguments take into account the critical importance of protecting human subjects of research while developing capacity to undertake FIH trials. SUMMARY: While FIH trials have historically not been conducted in LMICs, the situation in some of these countries has changed. Hence, we have argued that FIH should be conducted in LMICs for products meant primarily for conditions that are most prevalent in those contexts; provided the necessary protections for human subjects are sufficient.
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    Science-based health innovation in sub-Saharan Africa
    Al-Bader, S ; Masum, H ; Simiyu, K ; Daar, AS ; Singer, PA (BIOMED CENTRAL LTD, 2010-12-01)
    In recent years emerging markets such as India, China, and Brazil have developed appropriate business models and lower-cost technological innovations to address health challenges locally and internationally. But it is not well understood what capabilities African countries, with their high disease burden, have in science-based health innovation.This gap in knowledge is addressed by this series in BMC International Health and Human Rights. The series presents the results of extensive on-the-ground research in the form of four country case studies of health and biotechnology innovation, six studies of institutions within Africa involved in health product development, and one study of health venture funds in Africa. To the best of our knowledge it is the first extensive collection of empirical work on African science-based health innovation.The four country cases are Ghana, Rwanda, Tanzania and Uganda. The six case studies of institutions are A to Z Textiles (Tanzania), Acorn Technologies (South Africa), Bioventures venture capital fund (South Africa), the Malagasy Institute of Applied Research (IMRA; Madagascar), the Kenyan Medical Research Institute (KEMRI; Kenya), and Niprisan's development by Nigeria's National Institute for Pharmaceutical Research and Development and Xechem (Nigeria).All of the examples highlight pioneering attempts to build technological capacity, create economic opportunities, and retain talent on a continent significantly affected by brain drain. They point to the practical challenges for innovators on the ground, and suggest potentially helpful policies, funding streams, and other support systems.For African nations, health innovation represents an opportunity to increase domestic capacity to solve health challenges; for international funders, it is an opportunity to move beyond foreign aid and dependency. The shared goal is creating self-sustaining innovation that has both health and development impacts. While this is a long-term strategy, this series shows the potential of African-led innovation, and indicates how it might balance realism against opportunity. There is ample scope to learn lessons more systematically from cases like those we discuss; to link entrepreneurs, scientists, funders, and policy-makers into a network to share opportunities and challenges; and ultimately to better support and stimulate African-led health innovation.
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    Science-based health innovation in Uganda: creative strategies for applying research to development
    Kamunyori, S ; Al-Bader, S ; Sewankambo, N ; Singer, PA ; Daar, AS (BIOMED CENTRAL LTD, 2010-12-01)
    BACKGROUND: Uganda has a long history of health research, but still faces critical health problems. It has made a number of recent moves towards building science and technology capacity which could have an impact on local health, if innovation can be fostered and harnessed. METHODS: Qualitative case study research methodology was used. Data were collected through reviews of academic literature and policy documents and through open-ended, face-to-face interviews with 30 people from across the science-based health innovation system, including government officials, researchers in research institutes and universities, entrepreneurs, international donors, and non-governmental organization representatives. RESULTS: Uganda has a range of institutions influencing science-based health innovation, with varying degrees of success. However, the country still lacks a coherent mechanism for effectively coordinating STI policy among all the stakeholders. Classified as a least developed country, Uganda has opted for exemptions from the TRIPS intellectual property protection regime that include permitting parallel importation and providing for compulsory licenses for pharmaceuticals. Uganda is unique in Africa in taking part in the Millennium Science Initiative (MSI), an ambitious though early-stage $30m project, funded jointly by the World Bank and Government of Uganda, to build science capacity and encourage entrepreneurship through funding industry-research collaboration. Two universities - Makerere and Mbarara - stand out in terms of health research, though as yet technology development and commercialization is weak. Uganda has several incubators which are producing low-tech products, and is beginning to move into higher-tech ones like diagnostics. Its pharmaceutical industry has started to create partnerships which encourage innovation. CONCLUSIONS: Science-based health product innovation is in its early stages in Uganda, as are policies for guiding its development. Nevertheless, there is political will for the development of STI in Uganda, demonstrated through personal initiatives of the President and the government's willingness to invest heavily for the long term in support of STI through the Millennium Science Initiative. Activities to support technology transfer and private-public collaboration have been put in motion; these need to be monitored, coordinated, and learned from. In the private sector, there are examples of incremental innovation to address neglected diseases driven by entrepreneurial individuals and South-South collaboration. Lessons can be learned from their experience that will help support Ugandan health innovation.
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    Venture capital on a shoestring: Bioventures' pioneering life sciences fund in South Africa
    Masum, H ; Singer, PA (BIOMED CENTRAL LTD, 2010-12-01)
    BACKGROUND: Since 2000, R&D financing for global health has increased significantly, with innovative proposals for further increases. However, although venture capital (VC) funding has fostered life sciences businesses across the developed world, its application in the developing world and particularly in Africa is relatively new. Is VC feasible in the African context, to foster the development and application of local health innovation?As the most industrially advanced African nation, South Africa serves as a test case for life sciences venture funding. This paper analyzes Bioventures, the first VC company focused on life sciences investment in sub-Saharan Africa. The case study method was used to analyze the formation, operation, and investment support of Bioventures, and to suggest lessons for future health venture funds in Africa that aim to develop health-oriented innovations. DISCUSSION: The modest financial success of Bioventures in challenging circumstances has demonstrated a proof of concept that life sciences VC can work in the region. Beyond providing funds, support given to investees included board participation, contacts, and strategic services. Bioventures had to be proactive in finding and supporting good health R&D.Due to the fund's small size, overhead and management expenses were tightly constrained. Bioventures was at times unable to make follow-on investments, being forced instead to give up equity to raise additional capital, and to sell health investments earlier than might have been optimal. With the benefit of hindsight, the CFO of Bioventures felt that partnering with a larger fund might benefit similar future funds. Being better linked to market intelligence and other entrepreneurial investors was also seen as an unmet need. SUMMARY: BioVentures has learned lessons about how the traditional VC model might evolve to tackle health challenges facing Africa, including how to raise funds and educate investors; how to select, value, and support investments; and how to understand the balance between financial and social returns. The experience of the fund suggests that future health funds targeting ailments of the poor might require investors that accept health benefits as part of their overall "return." Learning from Bioventures may help develop health innovation funding for sub-Saharan African that has combined health, financial, and economic development impacts.