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South African Journal of Science

Print version ISSN 0038-2353

S. Afr. j. sci. vol.104 n.11-12 Pretoria Nov./Dec. 2008

 

SCIENCE POLICY

 

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

 

 

Solomon R. BenatarI, *; Christopher L. VaughanII

IBioethics Centre, Faculty of Health Sciences, University of Cape Town, Observatory 7925, South Africa; and Joint Centre for Bioethics, Dalla Lana School of Public Health, University of Toronto, Canada
IIMRC/UCT Medical Imaging Research Unit, Faculty of Health Sciences, University of Cape Town, Observatory 7925, South Africa

 

 


ABSTRACT

Powerful global forces shape and skew the science research agenda, generally. We describe these and the local forces that fashion research priorities in science, technology and health in South Africa. We conclude with some comments on the governance of research ethics globally and locally.


 

 

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.16 Local 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. Subjects with every conceivable disease are readily available in large numbers, local scientists lack resources, research is generally less expensive than in northern countries, and it is popularly thought that ethics review of research protocols is less thorough than in the developed world.

It has been estimated that approximately US$150 million is spent on clinical research in South Africa annually, and the amount of funded research in other African countries, particularly magnet countries such as Kenya and Nigeria, is growing rapidly.

The increasing volume of research in developing regions of the world, coupled to inadequate resources for training in research ethics, makes them vulnerable to exploitative research. Research ethics committees (RECs) in Africa face two serious problems: (1) insufficient resources; and (2) a lack of expertise in research ethics. Public health-care structures in the region are notoriously under-funded. As a result, research and research ethics have a relatively low priority, compared with the provision of care and training of health-care personnel.

 

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.22

Within 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.28 The 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.29 Deliberate 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

A 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.31 Kitcher'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.

 

Governance of research ethics

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.32

National 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.33 Unethical research continues, despite all this interest.34

The 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.35 The 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.36

Sensitivity 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 2002.38

All 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.39

Following 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.40 It 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 high-quality 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 international collaborative research is expanding rapidly and cross-cultural understanding is required,41 both programmes are making highly valued contributions to capacity-building 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.44 To 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.45 It 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.46

Strong, 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.47

In addition to health science faculties, all academic facilities and all disciplines within such institutions that undertake research on human subjects should set up research ethics committees. While procedural requirements need to be met to ensure appropriate accountability, excessive focus on bureaucratic aspects of research ethics governance should be avoided.48

 

Conclusions

Research agendas globally and locally are significantly shaped by economic and political forces focused on acquiring and maintaining economic and other power, and by the interests of scientists in pursuing interesting intellectual questions.

More focus is now being placed by government on steering the research agenda towards relevant local problems in South Africa (and in other countries). This is appropriate, but there is danger of inhibiting useful scientific curiosity and progress, if steering becomes too dominant. In addition, if market forces are allowed to have a greater influence, as in the U.K.,4 this may enhance economic growth but not necessarily be good for either research or health.

Research ethics, previously inadequately governed, is now increasingly becoming dominated by justifiable procedural processes, but these should not overshadow vitally important substantive knowledge of the ethics of research and the process of moral reasoning. More emphasis is required on professionalism,49 including education on substantive issues in research ethics, on the social responsibility of being a scientist,33 and on capacity building in professional ethics.

Benatar's research is funded in part by the U.S. National Institutes of Health's Fogarty International Center (Grant number 1R25 TW06057), and the University of Toronto's Joint Centre for Bioethics. Vaughan's research is funded in part by the U.S. National Institutes of Health (Grant numbers R21 CA101705 and R21 AI 067659), the South African Medical Research Council, and the National Research Foundation.

 

1. Weigmann K. (2004). Fashion of the times. EMBO Rep. 5(11), 1028–1031.        [ Links ]

2. Benatar S.R. (1998). Global disparities in health and human rights: a critical commentary. Am. J. Publ. Hlth 88, 295–300.        [ Links ]

3. Alexander T. (1996). Unravelling Global Apartheid: an overview of world politics. Polity Press, Cambridge.        [ Links ]

4. Pollock A.M., McNally N. and Kerrison S. (2006). Best research: the new UK medical research strategy helps industry but will it improve health? Br. Med. J. 332, 247–248.        [ Links ]

5. Daar A.S., Thorsteinsdóttir H., Martin D.K., Smith A.C., Nast S. and Singer P.A. (2002). Top 10 biotechnologies for improving health in developing countries. Nature Genetics 32, 229–332.        [ Links ]

6. Wadman M. (2007). Stem-cell issue moves up the US agenda. Nature 446, 842.        [ Links ]

7. Bill and Melinda Gates Foundation (www.gatesfoundation.org).        [ Links ]

8. The Global Fund (www.theglobalfund.org/en).        [ Links ]

9. Hauchler I. (1994). Global Trends: The World Almanac of Development and Peace. Continuum Press, New York.        [ Links ]

10. U.S. Department of Health and Human Services (2002). Bioterror funding provides blueprint to build a strong new public health infrastructure. Online at: www.hhs.gov/news/press/2002pres/20020125.html        [ Links ]

11. Mervis J. (2004). Caught in a squeeze between tax cuts and military spending. Science 50, 583.        [ Links ]

12. Burrows G. (2002). The No-nonsense Guide to the Arms Trade. New Internationalist Publications, Oxford.        [ Links ]

13. Global Forum for Health Research (2002). The 10/90 Report on Health Research 2001–2002. Global Forum for Health Research, Geneva.        [ Links ]

14. Trouiller P., Olliaro O., Torreele E., Orbinski J., Laing R. and Ford N. (2002). Drug development for neglected diseases: a deficient market and a public health failure. Lancet 359, 2188–2194.        [ Links ]

15. Iglehart J.K. (1999). American health services expenditure. N. Engl. J. Med. 340, 70–76.        [ Links ]

16. Pouris A. (2003). South Africa's research publication record: the last 10 years. S. Afr. J. Sci. 99, 425–428.        [ Links ]

17. Vaughan C.L., Reddy B.D., Noakes T.D. and Moran V.C. (2007). A commentary on the intellectual health of the nation. S. Afr. J. Sci. 103, 22–26.        [ Links ]

18. Adam R. (2004). Science and technology in South Africa: a reflection of our democracy. In Science and Technology in South Africa: Progress and Achievements in the First Decade of Democracy, 1994–2004, ed. G. Addison, pp. xiv–xvii. Department of Science and Technology, Pretoria.        [ Links ]

19. Mangena M. (2004). An African flowering. In Science and Technology in South Africa: Progress and Achievements in the First Decade of Democracy, 1994–2004, ed. G. Addison, pp. viii–xi. Department of Science and Technology, Pretoria.        [ Links ]

20. World Fact Book South Africa (www.cia.gov/library/publications/the-world-factbook/print/sf.html).        [ Links ]

21. Department of Science and Technology: National Survey of Research and Experimental Development 2005/06. Online at www.hsrc.ac.za/R& DSurvey        [ Links ]

22. Promoting South African S & T Capacities for the 21st century: from policy to reality (2004). Academy of Science of South Africa, Pretoria.        [ Links ]

23. Council on Health Research for Development. COHRED Statement, 2007: Are international health research programmes doing enough to develop research systems and skills in low and middle income countries? Online at: www.cohred.org/main/publications/COHRED_statement.php        [ Links ]

24. Benatar S.R. (2004). Health care reform and the crisis of HIV and AIDS in South Africa. N. Engl. J. Med. 351, 81–92.        [ Links ]

25. Jelsma J. and Singh S. (2005). Research protocols: lessons from ethical review. S. Afr. Med. J. 5, 107–108.        [ Links ]

26. Relman A.S. and Angell M. (2002). How the drug industry distorts medicine and politics: America's other drug problem. The New Republic Dec. 16, 227(25), 27–41.        [ Links ]

27. Bakan J. (2004). The Corporation: The pathological pursuit of profit and power. Constable, London.        [ Links ]

28. Medical Research Council Strategic Plan 2005– 2010: Building a healthy nation through research. Online at: www.mrc.ac.za/about/background.htm        [ Links ]

29. Comroe J.H. Jr and Dripps R.D. (1976). Scientific basis for the support of biomedical science. Science 192, 105–111.        [ Links ]

30. Bundred P., Martineau T. and Kitchiner D. (2004). Factors affecting the global migration of health professionals. Harvard Hlth Pol. Rev. 5(2), 77–87.        [ Links ]

31. Kitcher P. (2007). Scientific research – who should govern? NanoEthics 1(3), 177–184.        [ Links ]

32. Loue S. (2000). Textbook of Research Ethics: Theory and Practice. Kluwer, New York.        [ Links ]

33. U.S. National Academies of Science (1994). On being a Scientist: Responsible Conduct in Research. National Academy Press, Washington, DC.        [ Links ]

34. See for example: Unethical research. Committee on Publication Ethics (online at: www.publicationethics.org.uk/ cases/onefourfive).        [ Links ]

35. Social Science and Humanities Research Council of Canada: Qualitative Research in the Context of the TCPS. Online at: www.pre.ethics.gc.ca/english/ workgroups/sshwc/consultation_instructions07.cfm        [ Links ]

36. Benatar S.R. (2000). Avoiding exploitation in clinical research. Camb. Q. Healthcare Ethics 9, 562–565.        [ Links ]

37. NIH, John E. Fogarty International Center for Advanced Study in Health Sciences: Fogarty International Center International Bioethics Education and Career Development Award. Online at: www.fic.nih.gov/programs/ training_grants/bioethics/index.htm        [ Links ]

38. Medical Research Council of South Africa. Guidelines on ethics for medical research (www.mrc.ac.za).        [ Links ]

39. Ethics in health research: principles, structure and processes. Department of Health (2004): www.info.gov.za/speeches/ 2005/05042612151004.htm. Pretoria.        [ Links ]

40. National Health Act 2004. Government Gazette July 23, 2004, No. 26595. Online at www.info.gov.za/ gazette/acts/2003/a61-03.pdf        [ Links ]

41. Benatar S.R. (2004). Towards progress in resolving dilemmas in international research ethics. J. Law Med. Ethics 32(4), 574–582.        [ Links ]

42. International Research Ethics Network for Southern Africa [IRENSA](www.irensa.org).        [ Links ]

43. South Africa Research Ethics Training Initiative [SARETI] (http://shsph.up.ac.za/sareti.htm).        [ Links ]

44. Milford C., Wassenaar D. and Slack C. (2006). Resources and need of research ethics committees in Africa: preparations for HIV vaccine trials. IRB Ethics and Human Research 28(2), 1–9.        [ Links ]

45. South Africa Research Ethics Committee (SAREC) Newsletter. Online at: http://academic.sun.ac.za/ health/support_services/research/ethics/ethics_news.pdf        [ Links ]

46. Volmink J. and Dare L. (2005). Addressing inequalities in research capacity in Africa. Br. Med. J. 331, 705–706.        [ Links ]

47. Cleaton-Jones P. (2006). Research injury in clinical trials in South Africa. Lancet 367, 458–459.        [ Links ]

48. U.K. Department of Health (2005). Report of the Ad Hoc Advisory Group on the operation of NHS Research Ethics Committees. London.        [ Links ]

49. Royal College of Physicians of London (2005). Doctors in Society: medical professionalism in a changing world 6 (Suppl. 1).        [ Links ]

 

 

* Author for correspondence. E-mail: solomon.benatar@uct.ac.za; solly.benatar@utoronto.ca