Promoting Research Integrity in Africa: An African Voice of Concern on Research Misconduct and the Way Forward

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.     

Development of health biotechnology in developing countries: Can private-sector players be the prime movers?

Health biotechnology has rapidly become vital in helping healthcare systems meet the needs of the poor in developing countries. This key industry also generates revenue and creates employment opportunities in these countries. To successfully develop biotechnology industries in developing nations, it is critical to understand and improve the system of health innovation, as well as the role of each innovative sector and the linkages between the sectors. Countries' science and technology capacities can be strengthened only if there are non-linear linkages and strong interrelations among players throughout the innovation process; these relationships generate and transfer knowledge related to commercialization of the innovative health products. The private sector is one of the main actors in healthcare innovation, contributing significantly to the development of health biotechnology via knowledge, expertise, resources and relationships to translate basic research and development into new commercial products and innovative processes. The role of the private sector has been increasingly recognized and emphasized by governments, agencies and international organizations. Many partnerships between the public and private sector have been established to leverage the potential of the private sector to produce more affordable healthcare products. Several developing countries that have been actively involved in health biotechnology are becoming the main players in this industry. The aim of this paper is to discuss the role of the private sector in health biotechnology development and to study its impact on health and economic growth through case studies in South Korea, India and Brazil. The paper also discussed the approaches by which the private sector can improve the health and economic status of the poor.     

Biosafety and risk assessment framework for selectable marker genes in transgenic crop plants: a case of the science not supporting the politics

Selectable marker gene systems are vital for the development of transgenic crops. Since the creation of the first transgenic plants in the early 1980s and their subsequent commercialization worldwide over almost an entire decade, antibiotic and herbicide resistance selectable marker gene systems have been an integral feature of plant genetic modification. Without them, creating transgenic crops is not feasible on purely economic and practical terms. These systems allow the relatively straightforward identification and selection of plants that have stably incorporated not only the marker genes but also genes of interest, for example herbicide tolerance and pest resistance. Bacterial antibiotic resistance genes are also crucial in molecular biology manipulations in the laboratory. An unprecedented debate has accompanied the development and commercialization of transgenic crops. Divergent policies and their implementation in the European Union on one hand and the rest of the world on the other (industrialized and developing countries alike), have resulted in disputes with serious consequences on agricultural policy, world trade and food security. A lot of research effort has been directed towards the development of marker-free transformation or systems to remove selectable markers. Such research has been in a large part motivated by perceived problems with antibiotic resistance selectable markers; however, it is not justified from a safety point of view. The aim of this review is to discuss in some detail the currently available scientific evidence that overwhelmingly argues for the safety of these marker gene systems. Our conclusion, supported by numerous studies, most of which are commissioned by some of the very parties that have taken a position against the use of antibiotic selectable marker gene systems, is that there is no scientific basis to argue against the use and presence of selectable marker genes as a class in transgenic plants.     

A Framework to Link International Clinical Research to the Promotion of Justice in Global Health

How international research might contribute to justice in global health has not been substantively addressed by bioethics. Theories of justice from political philosophy establish obligations for parties from high‐income countries owed to parties from low and middle‐income countries. We have developed a new framework that is based on Jennifer Ruger's health capability paradigm to strengthen the link between international clinical research and justice in global health. The ‘research for health justice’ framework provides direction on three aspects of international clinical research: the research target, research capacity strengthening, and post‐trial benefits. It identifies the obligations of justice owed by national governments, research funders, research sponsors, and investigators to trial participants and host communities. These obligations vary from those currently articulated in international research ethics guidelines. Ethical requirements of a different kind are needed if international clinical research is to advance global health equity.     

Challenges and opportunities for enhancing biotechnology and technology transfer in developing countries

Biotechnological innovation is gaining increased recognition as an important tool for improving global health. The challenge, however, lies in defining the role of technology transfer to develop therapies for diseases prevalent in developing countries. During the past decade, a large disparity emerged between the developed and developing world in accessing affordable medicines because of the pharmaceutical industry's focus on health areas bearing greatest profits. Discussed herein are several mechanisms that provide partial solutions to this challenge. The Office of Technology Transfer of the US National Institutes of Health has increased its technology licensing pertaining to neglected diseases to partners in developing regions. Establishing partnerships through the transfer of technologies and assisting indigenous institutions build R and D capacity may positively impact policies on protection of intellectual property rights and increase multinational company investments in lesser-developed countries. This will most probably result in the development of more accessible therapies for those in need.     

A research agenda for helminth diseases of humans: health research and capacity building in disease-endemic countries for helminthiases control

Capacity building in health research generally, and helminthiasis research particularly, is pivotal to the implementation of the research and development agenda for the control and elimination of human helminthiases that has been proposed thematically in the preceding reviews of this collection. Since helminth infections affect human populations particularly in marginalised and low-income regions of the world, they belong to the group of poverty-related infectious diseases, and their alleviation through research, policy, and practice is a sine qua non condition for the achievement of the United Nations Millennium Development Goals. Current efforts supporting research capacity building specifically for the control of helminthiases have been devised and funded, almost in their entirety, by international donor agencies, major funding bodies, and academic institutions from the developed world, contributing to the creation of (not always equitable) North-South "partnerships". There is an urgent need to shift this paradigm in disease-endemic countries (DECs) by refocusing political will, and harnessing unshakeable commitment by the countries' governments, towards health research and capacity building policies to ensure long-term investment in combating and sustaining the control and eventual elimination of infectious diseases of poverty. The Disease Reference Group on Helminth Infections (DRG4), established in 2009 by the Special Programme for Research and Training in Tropical Diseases (TDR), was given the mandate to review helminthiases research and identify research priorities and gaps. This paper discusses the challenges confronting capacity building for parasitic disease research in DECs, describes current capacity building strategies with particular reference to neglected tropical diseases and human helminthiases, and outlines recommendations to redress the balance of alliances and partnerships for health research between the developed countries of the "North" and the developing countries of the "South". We argue that investing in South-South collaborative research policies and capacity is as important as their North-South counterparts and is essential for scaled-up and improved control of helminthic diseases and ultimately for regional elimination.     

Mountain biodiversity conservation and management: a paradigm shift in policies and practices in the Hindu Kush-Himalayas

Mountains occupy 24% of the global land surface area and are home to 12% of the world’s population. They have ecological, aesthetic, and socioeconomic significance, not only for people living in mountain areas, but for those living beyond. Mountains need specific attention for their contribution to global goods and services, especially by developing and implementing mountain specific policies. Conservation policies have evolved from the protection of charismatic species, to habitat and ecosystem/landscape conservation, and, finally, to people-oriented conservation approaches. This paper, with particular reference to paradigm shifts in the Hindu Kush-Himalayan (HKH) region, discusses the evolution of conservation policies, developments in conservation practices, the status of protected area management, wetland conservation initiatives and the landscape approach, community-based conservation initiatives, and the convergence of policies and practices. In the HKH region, conservation efforts now adopt participatory approaches, implement policies of decentralised governance for biodiversity management, and empower local communities in biodiversity management. The paradigm shift in the policies and practices related to conservation has been gradual and has included the acceptance of communities as an integral part of national level conservation initiatives, together with the integration of many global conventions. There are many successful pilots in the HKH region that deserve upscaling by the countries from the region. Realising the importance of mountains as hotspots of biodiversity, and due to their role as providers of global goods and services, the Convention on Biological Diversity adopted the Programme of Work on Mountain Biodiversity. Such a decision specific to mountains provides enormous opportunities for both conservation and development. Recent challenges posed by climate change need to be integrated into overall biodiversity conservation and management agendas, especially in mountain areas. The HKH region has been identified as a blank spot for data by the Inter-Governmental Panel on Climate Change, indicating the need to develop regional database and sharing mechanisms. This is a tall task, but one that holds enormous opportunity for the HKH countries and institutions with regional mandates to address the emerging challenges of climate change on biodiversity conservation by reducing scientific uncertainty.     

Off‐Shoring Clinical Research: Exploitation and the Reciprocity Constraint

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.     

Prospective sustainability assessment: the case of wood in automotive applications

Purpose

The introduction of renewable materials into automotive applications is perceived as an innovative lightweight solution. Wood-based materials are advantageous in that they have potentially lower environmental impacts as compared with other materials such as steel. However, using wood per se does not automatically ensure more sustainability. Few prospective sustainability assessment methods or studies on the use of wood-based materials in automotive applications have been carried out, although these are needed to reduce unintended, negative sustainability effects and to support sustainable oriented research and innovation. Therefore, this study was conducted to assess the potential sustainability effects and consequences of introducing a wood-based component into an automotive application.

Methods

A combination of methods was used to analyze the potential sustainability effects when introducing wood into automotive applications. This prospective life cycle sustainability analysis solely relied on secondary data. The environmental impacts were analyzed using a simplified environmental life cycle assessment on the product level. A multi-regional input-output-based assessment was conducted to model the country-specific environmental and socioeconomic consequences. The potential shift in social risks and opportunities on a national scale was analyzed by conducting a generic social life cycle assessment. Various aspects of each approach differ, with each providing a specific perspective of the system under study.

Results and discussion

The results indicate that implementing wood into automotive application can have environmental, social, and economic benefits, according to most of the indicators analyzed. Mostly due to the product weight reduction due to the use of a wood-based component, the results show that environmental impacts decrease. Some possible consequences of using wood-based materials are increased value added and increasing the number of jobs in European countries. Similarly, the social risks and opportunities are shifted from countries all over the world to European countries, which perform better than developing countries according to several indicators. However, some indicators, such as migrant acceptance or local supplier quantity, perform better in the current situation.

Conclusions

The presented case study is particularly notable, because the results clearly indicate the advantages of using wood-based materials in automotive applications, although the application of such relatively holistic and complex approaches often may lead to rather indifferent pictures. Policy makers, researchers, and companies can apply this combination of methods that rely solely on generic data to obtain both feasible and informative results. These methods also allow users to link the product level assessment with a regional and social perspective and screen critical topics to support sustainability research and innovation.

     

Governing synthetic biology for global health through responsible research and innovation

Synthetic biology (SynBio) is a global endeavour with research and development programs in many countries, and due (in part) to its multi-use characteristics it has potential to improve global health in the area of vaccine development, diagnostics, drug synthesis, and the detection and remediation of environmental toxins. However, SynBio will also concurrently require global governance. Here we present what we have learnt from the articles in this Special Issue, and the workshop we hosted in The Hague in February of 2012 on SynBio, global health, and global governance that generated many of the papers appearing here. Importantly we take the notion of ‘responsible research and innovation’ as a guiding perspective. In doing so our understanding of governance is one that shifts its focus from preventing risks and other potential negative implications, and instead is concerned with institutions and practices involved in the inclusive steering of science and technology towards socially desirable outcomes. We first provide a brief overview of the notion of global health, and SynBio’s relation to global health issues. The core of the paper explores some of the dynamics involved in fostering SynBio’s global health pursuits; paying particular attention to of intellectual property, incentives, and commercialization regimes. We then examines how DIYbio, Interactive Learning and Action, and road-mapping activities can be seen as positive and productive forms of governance that can lead to more inclusive SynBio global health research programs.     

Harnessing stem cells for health needs in India

While industrialized countries' stem cell research will be transferable to the developing world, research conducted by developing countries offers the potential to target innovation to local context, make treatments more affordable, and aid in economic development. India demonstrates that stem cell research and development (R&D) is not confined to industrialized countries and has begun to harness stem cells to address its own health needs.     

An intellectual property sharing initiative in agricultural biotechnology: development of broadly accessible technologies for plant transformation

The Public Intellectual Property Resource for Agriculture (PIPRA) was founded in 2004 by the Rockefeller Foundation in response to concerns that public investments in agricultural biotechnology benefiting developing countries were facing delays, high transaction costs and lack of access to important technologies due to intellectual property right (IPR) issues. From its inception, PIPRA has worked broadly to support a wide range of research in the public sector, in specialty and minor acreage crops as well as crops important to food security in developing countries. In this paper, we review PIPRA's work, discussing the failures, successes, and lessons learned during its years of operation. To address public sector's limited freedom-to-operate, or legal access to third-party rights, in the area of plant transformation, we describe PIPRA's patent 'pool' approach to develop open-access technologies for plant transformation which consolidate patent and tangible property rights in marker-free vector systems. The plant transformation system has been licensed and deployed for both commercial and humanitarian applications in the United States (US) and Africa, respectively.     

Publics and vaccinomics: beyond public understanding of science

Vaccines have been among the most effective tools for addressing global public health challenges. With the advent of genomics, novel approaches for vaccine discovery are opening up new opportunities for vaccine development and applications, particularly with the expectation of personalized vaccines and the possibility of addressing a broader range of infectious diseases. In this context, it is useful to reflect on the social contexts of vaccine development as these have been influenced by social, ethical, political challenges. This article discusses the historical context of vaccine controversies and factors that help explain public acceptance and resistance, illustrating that these challenges go well beyond simple public misunderstandings. The broader vaccine challenges evident along the innovation trajectory, from development to commercialization and implementation include problems in research and development, organizational issues, and legal and regulatory challenges that may collectively contribute to public resistance or confidence. The recent history of genomics provides further lessons that the developing field of vaccinomics can learn from.     

OBPC Symposium: maize 2004 &; beyond—Can agricultural biotechnology contribute to global food security?

Summary Bioengineering approaches provide unprecedented opportunities for reducing poverty, food insecurity, child malnutrition, and natural resource degradation. Genetic engineering offers outstanding potential to increase the efficiency of crop improvement. Thus agricultural biotechnology could enhance global food production and availability in a sustainable way. Small farmers in developing countries are faced with many problems and constraints which biotechnology may assist. Yet, there are varying levels of opposition to the use of this technology in most countries and it is especially intense in Europe. While there is certain public apprehension with the use of bioengineering in food improvement, the primary hurdles facing this technology are the stringent and burdensome regulatory requirements for commercialization, opposition from the special interest groups, apprehension by the food industry especially with the whole foods, and trade barriers including rigid policies on traceability and labeling. Bioengineered crops such as soybean, maize, cotton, and canola with a few traits have already made a remarkable impaet on food production and environmental quality. But, in the developing world, bioengineering of crops such as bananas, cassava, yams, sweet potatoes, sorghum, rice, maize, wheat, millet, and legumes, along with livestock, can elearly contribute to global food security. However, the integration of biotechnology into agricultural research in developing countries faces many challenges which must be addressed: financial, technical, political, environmental, activism, intellectual-property, biosafety, and trade-related issues. To ensure that developing countries can harness the benefit of this technology with minimal problems, concerted efforts must be pursued to create an awareness of its potential benefits and to address the concerns related to its use through dialog among the various stakeholders: policy makers, scientists, trade groups, food industry, consumer organizations, farmer groups, media, and non-governmental organizations. Biotechnology holds great promise as a new tool in the scientific toolkit for generating applied agricultural technologies; however, per se it is not a panacea for the worlds problems of hunger and poverty.     

Regulatory and associated political issues with respect to Bt transgenic maize in the European union

Legislation at the national level in Europe as well as that developed by the European Union (EU) generally permits release and commercialization of genetically modified organisms (GMOs). However, only 10 plant/event combinations were registered as of 2002: three maize events (Bt176, Mon810, and Bt11), with the other seven divided among carnation (3), oil-seed rape (2), tobacco (1), and raddiccio (1). Of these, only one maize event (Bt176) has been registered as a legal variety, and this was in Spain, where 22,000ha have been planted annually since 1998. In this paper, we first provide an overview on the complexity of EU GMO legislation. Then we discuss the minor role that results of EU-funded biosafety research have had on governmental policy. Finally, we provide information about initiatives for post-commercialization monitoring plans of Bt maize in Europe. As a result of the slow progress to date, we conclude that commercialization of GMOs will be seriously delayed in the EU for the next several years.     

Globalization of biotechnology: The agglomeration of dispersed knowledge and information and its implications for the political economy of technology in developing countries

This study examines a contradictory development in the era of globalization wherein country-specific economic and socio-political institutional environment limits the global flow of technological knowledge and information, particularly in the biotechnology sector. International collaborations for developing new biotechnologies has increased significantly in recent years, but these have virtually bypassed firms in developing countries. The international flow of technologies tends to agglomerate in developed economies particularly in the US, where an appropriate mix of economic choices, social regulation and state action fostered institutional environments that facilitated the development and commercialization of biotechnologies. Moreover, with the heightening competition in the global economy, state and firms of developed economies have evolved into a relationship of close partnership. This shows that, far from being irrelevant, the state remains a political entity that structures the innovation system in order to promote the well-being of its firms. This calls for a re-thinking of the role of the state in technological and economic development, particularly among the developing economies.     

Bio-Fuel Crops Research for Energy Security and Rural Development in Developing Countries

Soaring prices of fossil fuels, geo-political issues and environmental pollution associated with fossil fuel use has led to worldwide interest in the production and use of bio-fuels. Both the developed and developing countries have developed a range of policies to encourage production of combustible fuels from plants that triggered public and private investments in bio-fuel crop research and development, and bio-fuels production. In this article, we discuss the potential benefits of bio-fuels in increasing the farmers’ incomes, reducing environment pollution, the crop options and research and development interventions required to generate feedstocks to produce bio-fuels to meet projected demand without compromising food/fodder security in developing countries.     

我国生物技术基地平台建设政策研究

生物技术基地平台是开展生物技术研究、生产和服务的重要基础保障,生物技术基地平台相关政策在指导和推动我国生物技术基地平台建设发展中发挥着重要作用。以近十年来中共中央、国务院以及科技部等政府部门制定的生物技术基地平台政策为研究对象,梳理归纳我国生物技术基地平台政策的价值内涵,探讨建设规律,以期为基地平台的创新发展提供借鉴指导。     

Who does all the research in conservation biology?

Much of the worlds biodiversity is located within countries with developing economies. We therefore examine how well developing nations and their scientists are represented in three international conservation biology journals (Conservation Biology, Biological Conservation, Biodiversity and Conservation). We found: (1) that 28% of studies were from lower income countries and only 15% of all papers had primary authors from these nations. Of papers from lower income countries, although 80% had at least one local author, only 47% had primary authors from the country where the study was conducted. (2) Lower income countries had more research with a strong applied focus compared to research from high-income countries. (3) In lower income countries research was often funded by international sources but the primary authors of these studies were from affluent nations. (4) The three journals differed in how well they represented lower income nations and their scientists, reflecting their editorial policies for including research from lower income nations. The main reason for the large discrepancy in a countrys output of conservation research is due to the difference in a nations ability to invest in science. However, a brief survey of authors suggests that there is a large amount of information available in lower income and non-English speaking countries that is not easily accessible to the international conservation community. Journals may therefore need to consider altering their policies if we are to improve the representation of research by scientists in lower income nations.