Global and local forces shaping the research agenda and the governance of research ethics

Global forces shaping the research agenda The ‘knowledge society’ emerged at the end of the 20th century and is becoming the new catchphrase in political, scientific and economic circles. Scientific research, the most important source of new knowledge, has been influenced by almost every aspect of social life. Some of these forces, briefly reviewed in Box 1, illustrate that the pursuit of knowledge is not value-free. In general terms it is true to say that the questions that are asked and researched by scientists are those that attract resources, or that are driven by those with resources who seek answers that are of interest or value to themselves.


Global forces shaping the research agenda
The 'knowledge society' emerged at the end of the 20th century and is becoming the new catchphrase in political, scientific and economic circles. 1 Scientific research, the most important source of new knowledge, has been influenced by almost every aspect of social life.Some of these forces, briefly reviewed in Box 1, illustrate that the pursuit of knowledge is not value-free.In general terms it is true to say that the questions that are asked and researched by scientists are those that attract resources, or that are driven by those with resources who seek answers that are of interest or value to themselves.

Local forces shaping the research agenda
Not too surprisingly, the influence of the market on South African science is evident in the fact that science is strongest in those disciplines that have been influenced by the country's national wealth.These include fields such as ecology, geology and geosciences, plant and animal sciences, and astronomy. 16Local forces shaping the research agenda include the amount of expenditure on research and development, bottom-up (or aggregation) forces, top-down (or steering) forces and the skewed expenditure on health care (Box 2).
African countries are under pressure from overseas sponsors and their researchers to accommodate increasing numbers of clinical trials using research subjects from local populations.

Science and technology priorities
There has been growth in steering of research in order to shift priorities back towards local needs in South Africa.The priorities that have been determined centrally for science and technology are research on energy, natural resources, building human capacity, biodiversity and such aspects of life in Africa as governance, efficiency, economic productivity and political instability. 22ithin health care, steering to control research is exemplified by the Essential National Health Research programme and the recent South African Medical Research Council strategy to maximize health research investment by addressing the burden of diseases and the degree of inequity in health in our country. 28The aim is to promote health and development on the basis of equity and social justice by prioritizing research on water and sanitation, AIDS, violence, women's health, health systems, development research, intersectoral research, and capacity-building in research.

Balancing aggregation and steering
The debate about whether research should be spearheaded by scientific curiosity, or be mission orientated to solve specific problems, has been long and heated.Comroe and Dripps showed many years ago that 41% of advances in the treatment of cardiopulmonary disease between 1940 and 1970 had resulted from research that was not directed at solving a clinical problem. 29Deliberate steering of research has not been prominent in South Africa, but the tide has turned.An appropriate balance must be achieved.If powerful global forces dominate the research agenda in South Africa, then many local and relevant needs will not be researched.On the other hand, if local steering dominates, over-emphasis on relevant research may eclipse the 'blue sky' (curiosity-driven) research of creative scientists, and displace them to more attractive research environments, thus contributing further to the brain drain. 30 recent evaluation by a philosopher regarding who should govern scientific research provides an interesting historical perspective on the balance between scientific autonomy and external governance. 31itcher 's conceptual analysis identifies three functional subsystems as a collective or social endeavour that involves both scientists and those with the ability to contribute through democratic processes: (1) an inquiry subsystem to identify which scientific questions should be pursued; (2) a certification subsystem to identify what new knowledge is genuine; and (3) a transmission subsystem to make such new knowledge widely available.He thus suggests a scientific forum approach that would be more democratic, without relying merely on majority decisions.

International
High profile international interest in the ethics of human research was initiated by the revelation of atrocious experiments carried out by the Nazis, and the resulting Nuremberg Code in 1949.Prominence given in the 1960s to ongoing unethical research on humans in prestigious medical schools in the U.S. and the U.K., and the public outcry in 1972 on exposure of the 40-year-long U.S. Public Health Service study of the natural history of untreated syphilis in a cohort of black men in America, boosted interest in regulating human research. 32ational and international guidelines have since facilitated universal approaches to regulation of human research.These include the World Medical Association's Declaration of Helsinki, the Council for the Organisations of Medical Sciences (CIOMS), and the Nuffield Council on Bioethics.The U.S. National Academies of Science have promoted the education of scientists in ethics and social responsibility. 33Unethical research continues, despite all this interest. 34he ethics of research on humans is also applicable to research in the social sciences.There have been recent strong objections by social scientists about the application of the biomedical model of protection of research subjects to social science research. 35The HIV/AIDS pandemic has greatly increased sensitivity to the range of psychological and physical harms that may follow unethical medical and social science research.These concerns have been buttressed by the growth of research as an international collaborative endeavour with the potential to exploit vulnerable subjects and researchers in poor countries. 36ensitivity to the need to reduce such exploitation led the U.S. National Institutes of Health to fund 18 centres around the world (with an annual budget of $4 million) through its Fogarty International Center, to promote capacity-building education in research ethics in developing countries. 37

National
Many countries have formulated their own local guidelines for research on humans.Guidelines on the ethics of medical research were first formulated by the South African Medical Research Council in 1979.These were subsequently updated in 1987, 1993 and 2002. 38ll medical schools in South Africa have had research ethics committees for many years.Most REC members have been senior clinicians and scientists, but few have had any significant training in research ethics.Recently there has been a trend towards a wider spread of committee members-inclusive of junior members of faculty, women, nurses, other health professionals and lay members-many of whom have had training in research ethics.
In the early 2000s, the South African minister of health appointed an Interim National Health Research Ethics Committee (INHREC).During the four years of its existence, this committee produced a set of national guidelines for medical research, and developed plans for the registration, and ultimately accreditation, of all RECs in the country. 39ollowing passage of the 2004 Health Act, the National Research Ethics Council, legislated for in the act, has now been formed.The council's tasks will include issuing regulations for every REC in the country to become accredited, establishment of a clinical trial register, and a requirement that all REC members must have some training in research ethics. 40It is anticipated that increasing pressure will force other African countries, where substantial research is done, with sponsorship from developed countries to enact similar regulations.This is likely to lead to a growing demand for highquality research ethics training.
South Africa is currently the site of two Fogarty-funded programmes: the International Research Ethics Network for Southern Africa (IRENSA) based in Cape Town, and the South African Research Ethics Initiative (SARETI) that allies the universities of Pretoria and KwaZulu-Natal.Each of these programmes has a different focus.In an era in which interna-• Link between power and money has a long history, and the progress and 'development' of nations are generally measured in economic terms.
• A sevenfold increase of the global economy in the past 50 years is associated with widening disparities in wealth and health between the top quintile of the world's population and the bottom quintile. 2,3The U.K. Department of Health recently launched a strategy to promote national economic growth by harnessing biomedical research to meet the needs of industry and enhance research productivity through market competition. 4

Scientific curiosity
• Scientific curiosity became a powerful force after World War II, when the U.S. government was convinced that providing resources for scientists to pursue their ideas would foster economic prosperity.
• Advances in science and technology have allowed exploration of very large structures (the universe) and very small structures (viruses, genetic structures, and nano-particles).Growth has been stimulated by military and space research, and by human and plant genetic biotechnology.
• Because advances in these areas contribute to national power and prestige, they attract vast sums of money.Indeed, biotechnological advances are seen by some as the solution to health problems in the developing world. 5,6A burst of major philanthropy for health from the Bill and Melinda Gates Foundation, 7 the Global Fund 8 and others in recent years has steered research towards diseases requiring intensive research on a large scale.

Military research and the political economy of war
• In the 1980s, 64% of $487 billion research and development expenditure in the U.S. was devoted to military research, 7% to space research, and only 22% to various forms of civilian research.
• In same decade the then European Council spent 26% of $320 billion on the military and 5% on space, with 59% on civilian research. 9In 2002, following the events of 9/11, the United States increased expenditure on bio-terrorism research tenfold. 10Research expenditure increased by 8%, while funding for the National Institutes of Health barely kept pace with inflation, increasing by just 2.6%, whereas support for the National Science Foundation declined by 2.5%. 11,12lective valuation of lives • The global research agenda is influenced by consideration of the lives of the wealthy and powerful.
• Of approximately $70 billion spent each year on medical research in the late 1990s, 90% was spent on research on those diseases that cause 10% of the global burden of disease. 13Of 1393 new drugs marketed between 1975 and 1999, only 16 were for tropical diseases or tuberculosis. 14This research agenda is largely shaped by the pharmaceutical market (amounting to about $406 billion globally in 2002), with 60% of profits being made in the U.S.A. (with 5% of the world's population).
• In the early 2000s, 87% of $2.2 trillion annual health expenditure in the world was spent on 16% of the world's population, who bear 7% of the global burden of disease, expressed in disability-adjusted life years (DALYs). 15al collaborative research is expanding rapidly and cross-cultural understanding is required, 41 both programmes are making highly valued contributions to capacitybuilding in international research ethics in southern Africa.42,43 The overall goal of the IRENSA diploma programme is to develop and nourish sustainable, multidisciplinary expertise in international research ethics in southern Africa.More specifically, it prepares mid-career health and allied professionals to assume positions of leadership in research ethics in their home institutions.This programme is unique on the African continent in focusing exclusively on training mid-career professionals in three intensive two-week modules, spread throughout one year, with assignments carried out at their home institutions.Between 2003 and 2008, IRENSA had trained 71 mid-career professionals (41 men, 30 women, 28 white, 43 black) drawn from 20 institutions in South Africa and from 11 institutions in 8 other African countries.
The overall goal of SARETI is to build capacity for ethical review of health research and strengthen Africa's institutional training capacity.To achieve these goals, it offers a multidisciplinary, modular master's degree programme, an advanced, non-degree programme resulting in a certificate, and a training programme for 40 ERC members. 44To date, SARETI has sponsored 16 master 's students from nine African countries, and 17 non-degree fellows from seven African countries, in addition to several self-funded students.
One of the spin-offs of these educational programmes has been to stimulate the formation of a network of chairs of South African Human Health Research Ethics Committees.This has significantly improved liaison across the country.A newsletter from the Bioethics Unit at the University of Stellenbosch on research ethics activities in the country further facilitates such networking. 45It is important to recognize, as Volmink and Dare have pointed out, that: Research with, rather than in or about Africa, is the goal.This will demand joint working to set agendas for research and mutual respect for countries' priorities, values and choices.Partnerships should be transparent, clearly showing what each side brings and what each stands to gain.Furthermore, there must be clear mechanisms to ensure that some funds for research are directed to strengthening the capacity to conduct research, manage research, and develop skills in scientific writing. 46rong, well-motivated and well-governed research ethics committees can make a significant contribution to achieving these goals.
The recent stand taken by the chairpersons of RECs in South Africa not to permit studies that fail to provide insurance cover for research-related projects is one example of how improved knowledge and coordination in South African RECs is making such a contribution. 47n addition to health science faculties,