This article addresses the pattern of public-private sector partnerships in agricultural research in India, and outlines the implications for policy reforms. The researchers use the innovation system framework to analyse the factors that shape the relationship between the public and private sectors. They use detailed cases studies to illustrate the difficulties and capabilities of public-private interactions.

The paper concludes that although an agricultural innovation system is emerging in India, public-private interactions are neither widespread nor effective. Historically, the administration practices of public agencies have hindered interaction between the public and private sectors. The authors argue that institutional learning and experimentation could change the agricultural research system in India.

This paper examines the role that Indian civil society plays in science and innovation through a case study of agro-processing research in a civil society-led initiative. It investigates how a non-governmental organisation and other key players participate at different stages of the innovation process, highlighting the importance of this type of initiative for research that aims to help the poor.

The article questions existing assumptions and conventional ways of organising agricultural research that place research at the beginning of the innovation chain, followed by extension and application. It uses the innovation systems framework to assess the many players, partnerships and feedback loops involved in the development of spirulina algal technology, including foodstuffs and vitamin supplements, in India. The author says "the idea of innovation as a systems concept does not diminish the importance of science, but instead, locates it in different relationships and positions it along the innovation trajectory". According to the author, this has important implications for how research and development should be organised if they are to benefit the poor. The diverse sources in the innovation process need to be acknowledged to make research and technological development most useful for wider society, and strategies must be devised that are responsive to the needs of users.

This is a briefing paper prepared in advance of the World Summit on Sustainable Development, which was held in Johannesburg in August 2002. Published by one of the architects of the concept of appropriate technologies in development, the non-governmental organisation (NGO) Intermediate Technology Development Group (now known as Practical Action), the paper sums up the position on technology transfer of many other development and campaigning NGOs.

The brief focuses on the potential and actual impacts of technology transfer, particularly through trade and foreign direct investment on poverty reduction and human development in developing countries. The paper argues that most private-sector-mediated technology transfer (for example, through foreign direct investment) makes a limited contribution to poverty reduction in less developed countries. Only through the development of local capabilities to select, use, absorb, adapt and autonomously develop technologies can technology transfer be effective for human and economic development. This demands the development of broad innovation systems and pro-poor research and development efforts in developing countries.

This is the introductory piece in a volume of articles edited by leading scholars in innovation studies analysing the technological and economical development of newly industrialising countries, especially those in East Asia. This introduction focuses on the processes of technological learning through which the capabilities underpinning the economic development of those countries were built up. It emphasises particularly the complementary roles of the acquisition of foreign technologies and domestic technological efforts in these learning processes. Central to this was the major importance of reverse engineering of foreign technologies and other imitative engineering efforts at the early stages of development, and how they evolved to creative imitations and innovative research and development activities as these countries approached the technological frontier.

This book presents the findings of a United Nations University's research programme on the technological development process of selected countries in Asia, namely China, India, Japan, Korea, the Philippines, and Thailand carried out by Asian scholars and scientists. The book focuses on the experiences of these countries in acquiring and mastering foreign technologies, and in some cases, moving to autonomous technological development.

The study concludes that several countries of the countries analysed, particularly the larger ones, have pursued broad-based strategies of technology acquisition, but the results are uneven. There are many successful cases, but in several countries, the potential of investment in technological acquisition and mastery has not been fully accomplished.

This book by Jorge Katz published by ECLAC analyses structural reforms in Latin America and the Caribbean since the 1990s which have transformed regional economies from closed and state-led to more market-oriented and open. The impact of these changes on the growth patterns, technological change and process of innovation in these countries is examined. The book concludes that the development process in the region is uneven across industries, regions and firms.

In this book published by IDRC science and technology policies in African countries are examined through a number of cases studies from different sectors and countries. The authors' key conclusion is that to facilitate the development of their own technological capabilities, countries need to pay more attention to creating enabling macroeconomic environments and technology policies. If successful, the combination of favourable macroeconomic and technology policies should facilitate technological learning, the right technical choices, the building up of appropriate institutions, and effective technological management for both industry and agriculture, including small and medium-sized enterprises.

This book published jointly by IDRC and UNCTAD analyses poverty reduction and the role of science and technology in sustainable human development, technical and vocational education, health and small-scale economic activities, along with other relevant issues. It concludes that science and technology does create potential opportunities for eradicating poverty, but that realizing this potential depends on social and political will and other key issues.

In this article Costello and Zumla suggest that much foreign-led research in developing countries remains semi-colonial in nature and may have negative effects on the countries in which it is conducted. In light of these concerns they ask what principles should lie behind investment in research in developing countries.

To enable research to be translated into practice, the authors suggest that national academic leaders and institutions need to be involved. As a result, academic infrastructure in developing countries needs to be developed through research partnerships. Research led by expatriates should be phased out and replaced by a partnership model in which nationals lead research projects, receiving only external technical support

In this thoughtful article, Emanuel and Miller outline the stances taken by those on both sides of the debate about using placebos in research. The first is that placebos should be used as a control unless this would increase the risk of death or irreversible morbidity as a result. The other view is that if an effective therapy exists then the use of a placebo group should be prohibited (the stance taken in the Declaration of Helsinki).

The authors conclude that both positions are indefensible and that a middle ground on the use of placebo-controlled trials is needed. They argue that placebo-controlled trials are permissible when proven therapies exist, but only if certain ethical and methodological criteria are met.

In this editorial Huston and Peterson suggest that the concern about withholding treatment in research has been inappropriately focused on placebos. They note the difference between the Declaration of Helinksi’s criterion of ‘no proven treatment’ and the regulatory criterion of ‘no irreversible harm’ as standards for the appropriate use of placebo groups in clinical trials, and the debates that have arisen as a result.

The authors propose that instead a broader understanding of the ethics of withholding treatment is required. They question whether concerns about withholding treatment can be addressed solely by identifying an acceptable level of risk and providing careful monitoring of participants. Examples are given of instances in which placebo groups receive adjunctive treatment as part of research, and where placebo groups have outperformed patients who decline to participate in the research and received standard care. They conclude that to protect the best interest of research participants the ethics of withholding treatment needs to be considered in the broader context of clinical trials.

In this article Fitzgerald and M-T Behets outline four incidents that arose while conducting HIV clinical research with women in African and Caribbean countries to illustrate the "massive ethical challenges for researchers in HIV prevention trials". The cases include an HIV-positive husband refusing to use condoms with his HIV-negative spouse, cervical cancer being identified within a country which did not have the facilities to treat it, and the fatal consequences of one participant seeking an illegal abortion and another delaying surgical removal of a dead foetus on the advice of a traditional attendant and a lack of funds for treatment.

The authors note that much HIV research will involve women of reproductive age, particularly that focussed on preventing mother-to-child transmission of HIV. The four cases discussed outline the issues that can arise when research is being conducted among vulnerable women without access to basic medical services, where physical and sexual violence against women is relatively common and social injustice is widespread. In such circumstances the authors ask what responsibilities researchers have to participants who have built up a trusting relationship with them over time. They conclude that meaningful discussion between researchers and relevant communities is required, leading to a participatory research model in which potential participants and community members are involved in study design and implementation.


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Roy Widdus discusses reasons for inadequate access to treatment for infectious diseases in developing countries, and reviews methods to address these. Noting that drugs and vaccines may not be available for a number of reasons — including the lack of incentives for their development or inadequate infrastructure for their delivery — the role of public-private partnerships in addressing these issues is outlined. The author suggests that if appropriately motivated, pharmaceutical companies can contribute expertise in product development, manufacturing, marketing and distribution which are lacking in the public sector. A number of recommendations for action are made to the public sector, private sector and public-private partnerships, including:

• establishing public health priorities for drugs, vaccines, diagnostics and other health products;
• increasing the use of devices such as licensing, tiered royalties, market segmentation, and tiered pricing to make products more accessible to all in need;
• estimating the need, demand and uptake for existing and new products in developing countries collaboratively, since the public sector has the data and the private sector has the expertise.

This collection of short papers from the 'health and human rights' section of The Lancet focuses on the provision of long-term care for participants who become infected with HIV-1 during HIV-1 vaccine trials in resource-poor countries.

• S Berkley argues for provision of antiretroviral treatment to entire communities rather than to individual trial participants.
• D Fitzgerald and colleagues discuss how the HIV Vaccine Trials Network plans to fund treatment at its trial sites.
• J Mukherjee describes how the first step to providing HIV-1 treatment in Haiti was to revitalise the public-health infrastructure.
• T Tucker and C Slack outline plans for a public-private partnership to care for infected trial volunteers in South Africa.

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One frequently-raised issue relating to standards of care in research is the responsibilities researchers have if they identify medical conditions unrelated to the study during the course of research in developing countries. In this article, Leah Belsky and Henry Richardson propose an ethical framework to assist in determining research responsibilities in such circumstances.

The article begins by considering the two extremes of view, the first is that researchers must provide care for unrelated conditions, because they have a duty to help those in need, particularly when they can do so at minimal cost to themselves. The opposing view is that researchers owe nothing to research participants beyond what’s needed to complete the study safely and successfully.

The authors show more sympathy for the first of these two views and propose a model for research-participant relationship that lies between the extremes, but can leave researchers with some responsibility to care for conditions unrelated to the study. A case study of providing HIV treatment in a tuberculosis treatment trial is discussed. 

The authors conclude that attempts should be made by scientists and research ethics committees to anticipate researchers’ responsibilities for conditions unrelated to the study in advance and appropriate funding included in research budgets.

In this review article, Zulfiqar Bhutta focuses on recent developments in informed consent and highlights issues relevant to developing countries. This paper provides a very brief history of consent to medical research, before summarising the provisions on consent provisions in recent reports and guidance. Current areas of concern are identified and briefly discussed, including: procedures for obtaining and documenting consent; community versus individual consent; consent on complex issues; ethical review and feedback, consent from vulnerable populations and the lack of research on consent processes in developing countries. The review concludes by making a number of recommendations for improving consent processes. These involve focusing on improving participant understanding, using innovative materials and processes to explain research, finding alternative and more user-friendly means of documenting consent and involving senior staff and communication experts in the consent process.

This editorial is one of three articles that started the current debate about appropriate standards of care in clinical trials (the other two were an article by Peter Lurie and Sydney Wolfe in the same edition of the New England Journal of Medicine (see below), and an editorial in The Lancet). Marcia Angell criticises the placebo-controlled trials that were conducted to test an intervention to reduce mother-to-child transmission of HIV.

The article refers to the importance of researchers being in equipoise (i.e. not knowingly giving some groups of participants inferior treatment) and of not subsuming the interests of individual participants for the greater good. The author lists justifications that were given by research sponsors for this work: that participants were not being denied treatment that they would otherwise receive and that a placebo-controlled trial was the fastest and most efficient way to obtain information of relevance to the areas where the research was being conducted.

Angell concludes that these justifications were reminiscent of those of the infamous Tuskegee study where participants in the United States were not informed that they were enrolled in research, and were denied effective treatment for syphilis when this became available. Concern is expressed that the HIV study appears to mark a retreat from ethical principles about research conducted in developing countries as set out in international guidance - for example, participants received a local standard of care rather than the ‘best’ current treatment as required in the Declaration of Helsinki - and the reasons for this are critically examined.

This "education and debate section" focuses on the 2000 revision of the Declaration of Helsinki, and comprises four articles commissioned from researchers working in the developing world, the developed world, the pharmaceutical industry, and a patient representative.

South African researcher Stephen Tollman argues that "despite the increasingly inclusive aspirations of the revised declaration, some of the absolute and exclusionary language could unintentionally endanger research in developing countries". Consumer advocate Hilda Bastian lists nine gains for consumer rights arising from the revision, but goes on to discuss a number of perceived problems in more detail. UK researcher Richard Doll distinguishes five different types of medical research and claims that "strict application of the declaration’s principles would make a wide range of clinical, biological and epidemiological research impracticable or invalid".

To some extent this conclusion is mirrored in the article from two members of the pharmaceutical industry. Laurence Hirsch and Harry Guess of Merck Laboratories say that several provisions in the revision do not provide better protection of research participants in clinical trials, and inadvertently hamper the development of safe and effective vaccines and drugs.

Evelyne Shuster opens this article with the Nuremberg Code - the precursor to the Declaration of Helsinki and other international and national guidance on the ethics of medical research. 

Shuster discusses the role of physicians in the formulation of the Code during the famous Nuremberg trials of Nazi physicians. The lawyers' arguments about unethical research conducted in Germany, France, the Netherlands, Britain and the United States demonstrate how views about what constitutes acceptable and unacceptable research have changed over the last century. 

The article goes on to summarise how medical researchers have used the Code, and its effect on guidance and regulation over the five decades following its publication. 

In this article Asad Jamil Raja discusses some of the revised provisions in the 2000 revision of the Declaration of Helsinki and considers their implications for developing countries. Two points singled out for particular consideration are paragraph 19 (which requires a "reasonable likelihood" that research populations will benefit from the results of research) and the controversial paragraph 30 (which concerns what should happen after research).

The article goes on to consider the role of the pharmaceutical industry in medical research and proposes three measures to improve the ethics of healthcare: an examination of the ethics of the pharmaceutical and biotechnology industry, for the World Health Organisation to play a more proactive role in resource allocation for global healthcare and health research, and measures to strengthen the capacity for ethical review in developing countries.