2004年6月1日 | EN
During the past five years there has been a dramatic increase in the number and type of initiatives to build capacity in research ethics in developing countries. In this policy brief Sue Eckstein gives an overview of such initiatives, and indicates that there is unlikely to be a “best way” to build capacity. Instead, many different routes may lead to enhanced levels of understanding about research ethics.
During the past five years there has been a dramatic increase in the number and type of initiatives to build capacity in research ethics in developing countries. In addition to new websites, listservs, workshops and diplomas, several Masters courses and research ethics fellowships have emerged. Training can be largely theoretical, as with bioethics Masters degrees or predominantly practical, as with some of the training provided to members of research ethics committees.
As well as these formal initiatives, there appears to be a growth in collaborations, initiated through personal contact, between research institutions and academics and other research ethics specialists. For example, one participant at a short course at King’s College London requested the collaboration of King’s College academics on an International Union Against Tuberculosis and Lung Disease workshop on research ethics. Such partnerships are likely to increase as a result of the widening global network, and are in themselves a measure of the growing success of the various capacity building initiatives that have been taking place.
That capacity in research ethics in developing countries needs to be increased does not seem to be in dispute. There are, however, differing opinions about which type of capacity building is the most effective and sustainable, which professionals are most usefully trained (for example, research scientists, anthropologists or local health workers), and where training is best provided.
Funders appear to have quite rigid guidelines concerning the kind of initiatives they will fund and the levels of funding that can be allocated. This could result in an abundance of capacity-building initiatives that are all broadly similar, with few smaller, more innovative or experimental initiatives that do not follow the more common models. However, it is possible that as more professionals in developing countries are trained in research ethics, they will be in a good position to listen to what is needed at the local level and access funds for such initiatives.
This policy brief aims to give an overview of the various initiatives to build capacity in research ethics in developing countries, and to provide details of where to access more detailed information about particular types of programmes.
Strategic capacity-building intiatives
There are a number of strategic initiatives to enhance research ethics capacity in developing countries, which are developing at different rates and with varying degrees of effectiveness. These include the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER), the Pan-African Bioethics Initiative (PABIN), the Forum for Ethics Committees in the Confederation of Independent States (FECCIS), the Forum for Ethical Review Committees in the Asian and Western Pacific Region (FERCAP) and the Foro Latinoamericano de Comités de Ética en Investigación en Salud (FLACEIS).
The conferences and symposia held by these organisations offer members the opportunity to network and share strategies for good practice. For example, in February 2002, PABIN held a symposium entitled “Good Ethical Practices in Health Research in Africa” in Cape Town. And in December 2003, FERCAP staged a conference examining the role of ethics committees in contributing to the development of health research in Asia and the Western Pacific.
Increasingly, the World Health Organisation (WHO) is supporting improved ethical standards and review processes for research involving human beings. Several departments have undertaken training programmes for researchers and research ethics committees, and have supported other capacity-building initiatives at local, regional and international levels. For example, the Pan American Health Organisation (PAHO) recently hosted the Fourth Global Forum on Bioethics in Research in Brazil.
The Wellcome Trust’s Ethics of Biomedical Research in Developing Countries grant scheme shares this commitment to building research capacity, and aims to increase the number of experts with the experience and training needed to address ethical questions raised by such research. Its new research funding initiative supports project grants, research studentships and seminars among other capacity-building initiatives.
The Special Programme for Research and Training in Tropical Diseases (TDR) is also addressing the need to build capacity in research ethics. February 2004 saw the appointment of the first Fellow recruited in connection with TDR capacity-building activities in research ethics. It is a joint initiative in collaboration between the TDR’s research capacity training unit, the Ethics and Health Initiative at WHO, and SIDCER.
The ‘critical mass’ concept
It is the perceived need for focused and sustained capacity development in the field of research ethics in developing countries that has led to the creation of year-long courses in bioethics funded by institutions such as the Fogarty International Centre (FIC), the US National Institutes of Health (NIH) and the TDR.
The FIC has awarded grants to a number of institutions, enabling students from developing countries to undertake Masters degrees and fellowships in bioethics (see box). In nearly all cases, research ethics is a significant component of the courses, and common to most of them is a practical assignment in the student’s home country. Case Western Reserve University, for example, is currently training students from Nigeria, Romania, Russia and Uganda.
|Examples of FIC-funded training initiatives
The University of Cape Town’s Centre for Bioethics has received an FIC grant to support international bioethics education for four years through its International Research Ethics Network for South Africa (IRENSA). The programme aims to train a cohort of twelve students each year with the intention of producing a critical mass of mid-career faculty trained in research ethics for the Southern African regions.
The South African Research Ethics Training Initiative (SARETI) is a training programme for scientists, academics and members of research ethics committees, based at the Universities of KwaZulu-Natal and Pretoria. The initiative awards scholarships for Masters degree study and fellowships for shorter periods of formal study or sabbaticals not for degree purposes. The multidisciplinary programme has representation from medical sciences, social sciences, philosophy, ethics and law.The University of Toronto’s Joint Centre for Bioethics (JCB) was also awarded an FIC bioethics research and education grant. It undertook to train 16 mid-career professional from developing countries, with an emphasis on South Asia and Africa. According to the course convenors, its graduates have gone on to teach bioethics in their home institutions, change public policy in healthcare or introduce practical training into their workplaces. They have also been active in publishing, and in applying for further FIC grants to train more graduates in their home countries. The programme has also supported emerging programmes in developing countries by providing advice, site visits and faculty membership. 
It could be argued that this top-down method of providing research ethics training in developed countries to professionals from developing nations is inappropriate and could constitute a kind of ethical imperialism. This issue has been debated by many of the providers of training including Peter Singer of the University of Toronto JCB. While Singer recognises that “the actual capacity needs of a developing country or region are best met (both on grounds of cost effectiveness and cultural appropriateness) by supporting centres and training programmes in developing countries,” he argues that “these centres and programmes themselves need support to build a critical mass of highly trained faculty so they can be highly successful and sustainable.”  He is confident that Northern centres like Toronto have a defined and important role to play in a global programme of bioethics capacity strengthening.
Cross-fertilisation: faculty exchanges and collaboration
Faculty exchange is something that has become an integral part of many bioethics courses. For example, JCB works with the bioethics programme at the University of Cape Town, with staff from Cape Town teaching in Toronto and vice versa. JCB has also been able to strengthen the FIC-funded Centre for the AIDS Programme of Research in South Africa (CAPRISA), based at the University of Natal, by training a lawyer and social scientist who are working to develop research ethics in the context of HIV.
Similarly, SARETI collaborates with its South African partner IRENSA at various levels in improving research ethics capacity in the region. SARETI is also forging alliances with initiatives to advance research ethics capacity in Francophone African countries.
Although much capacity-building activity is concentrated in Africa and Asia, or is intended for students from those regions, there are also some effective initiatives in Latin America. The Training Programme in Research Ethics in the Americas is a flourishing collaboration between Albert Einstein College of Medicine in the United States and the University of Buenos Aires, which aims to establish a network in research ethics in Latin America.
Trainees from any country in Central or South America spend seven months in Buenos Aires and, during this time, develop a plan for introducing research ethics into the institution to which they will return. According to the co-directors, Ruth Macklin and Florencia Luna, informal tracking indicates that the first set of four trainees have begun new activities in research ethics in Peru, Costa Rica, Argentina and Guatemala.
Ongoing support and training
Since these kinds of initiatives can train only a limited number of people, the success of each programme is highly dependent on how well trainees can sustain their ethics work on their return to their home countries.
For example, the nine alumni of the Johns Hopkins University (JHU) initiative have a biennial reunion to allow for feedback once they have returned to the field. An electronic newsletter is produced quarterly, which trainees are encouraged to distribute to local colleagues and research ethics committee members. JHU also emails former trainees every month to inquire about their ethics related activities and sends regular email bulletins listing relevant articles and grant announcements. This kind of activity is a time-consuming but invaluable way of ensuring sustainability.
Other initiatives are also committed to sustainability. For example, in four years’ time SARETI aims to arrange an Africa-wide health research ethics symposium in collaboration with other African ethics organisations. This event is intended to increase the impact and networking potential of SARETI training programmes, facilitate African exchange in health research ethics, strengthen Africa’s voice in the field and offer trainees the opportunity to present work to their peers. Meanwhile, the Training Programme in Research Ethics in the Americas undertakes to provide continual support for trainees once they return to their home countries, for example by providing them with laptop computers.
Intensive training initiatives
While many capacity-building initiatives take place over the course of an academic year and train relatively few individuals, workshops and short courses in research ethics give a large number of participants the chance to immerse themselves in the subject and network with both faculty and peers. These short courses can be an effective way of building capacity in research ethics in developing countries, particularly for participants who may not be able to commit more than a few days or weeks to training, or may not have the academic credentials to qualify for a Masters or Diploma course of study.
Harvard School of Public Health has, to date, held fifteen four-day workshops on “Ethical Issues in International Health Research” in eight countries, in which 700 participants have received a grounding in research ethics. A major factor in the workshops’ success appears to be the resources that are provided both during the workshop and afterwards.
These workshops make extensive use of cases, many of which are on the Harvard website, along with interactive discussions. Effective follow-up of past participants also enables workshop organisers to analyse how their alumni have put the theory into practice, and to respond to participants’ needs when planning future workshops (see box). 
Sample comments from participant evaluation forms
“I have used materials obtained from the course in presentations at the research centre where I work. I have improved my supervision of research assistants and field workers…I plan to compile the materials into a handy manual for use by lay IRB members.”
“I have designed and conducted two workshops on research ethics in Hanoi, Viet Nam using the format of case study discussion. This is I believe the best way of getting people to think about ethics and ethical issues. Though I use the case study design, I have adapted the actual studies to match local interest. I have used the format also in a workshop in Zimbabwe. There is a definite increasing awareness of the need for ethical review in the research programme.”
There are many other short training initiatives, such as the five-day course in Metro Manila, run by the University of the Philippines and funded by the FIC. Additionally, some of the institutions that specialise in year-long training also provide short courses. These are targeted at professionals already working in research ethics, who may be in positions of influence. For example, a one-month training programme was started at JHU in June 2003 for trainees from SARETI.
SARETI itself runs a three-week course for members of South African research ethics committees, and the Training Programme in Research Ethics in the Americas also offers two one-week intensive seminars in Buenos Aires each year, open to members of ethics committees in the city and beyond.
One-off workshops that are devised by Western academics and held in developing countries can be useful in raising awareness about ethics and stimulating dialogue about the importance of ethical review, provided participants arrive with a commitment to research ethics and the support and infrastructure in their home institutions to allow them to put their learning into practice.
However, it has been argued by Nancy Kass of JHU that “short workshops cannot effect a sustained impact on their own… Without sustained local presence, it is unrealistic to imagine that ethics training ultimately will have much impact. And to state the obvious, it is both impractical and inappropriate for that role to be served by a transient professional from the outside.”
There are several exciting and effective initiatives to build capacity in research ethics in developing countries. Crucial to their success appears to be easily accessible information about courses, forums and networks; adequate funding to institutions and students; the provision of comprehensive and comprehensible course material which can be freely accessed and replicated both during and after training; and ongoing and transparent evaluation of courses and other initiatives.
Graduates of Masters and diploma courses and participants on short research ethics courses need to have a personal and institutional commitment to research ethics, a supportive environment in which to function once the training is over, and continuing support and assistance from their training institutions.
However, as none of the capacity-building programmes has been in existence for long – and there is no detailed or systematic evaluation of them in the public domain – it is difficult to give evidence to support claims about impact or effectiveness at present. It is therefore important that effective evaluation of the programmes is undertaken and that the results and conclusions be in the public domain.
What is clear, is that there is unlikely to be a “best way” to build capacity. Instead, many different routes may lead to enhanced levels of understanding about research ethics.
The author would like to thank the many course convenors, centre directors and others who have been extremely helpful in giving access to information, some of which is not yet widely available.
Sue Eckstein is a research fellow at the Centre of Medical Law and Ethics, King’s College London. She is responsible for the management and development of short courses and advanced study days on the ethics of research on humans, the editing of the Manual for Research Ethics Committees, and Centre initiatives relating to developing countries.
1] Singer, P. (2004) University of Toronto MHSc in Bioethics International Stream, NIH grant application
 Kass, N. (2003) Grant Resubmission, PHS 398/2590
 Singer, P. (2004) University of Toronto MHSc in Bioethics International Stream, NIH grant application
 Program on Ethical Issues in International Health Research. Evaluation June 1999-Sept 2001 (Department of Population and International Health Research, Harvard School of Public Health)
Centre for the AIDS Programme of Research in South Africa (CAPRISA)
Fogarty International Centre (FIC)
Foro Latinoamericano de Comités de Ética en Investigación en Salud (FLACEIS)
Forum for Ethical Review Committees in the Asian and Western Pacific Region (FERCAP)
Forum for Ethics Committees in the Confederation of Independent States (FECCIS)International Research Ethics Network for South Africa (IRENSA)
Johns Hopkins - Fogarty African Bioethics Training Program
Harvard School of Public Health: Program on Ethical Issues in International Health Research
Pan-African Bioethics Initiative (PABIN)
South African Research Ethics Training Initiative (SARETI)
Special Programme for Research and Training in Tropical Diseases (TDR)
Strategic Initiative for Developing Capacity in Ethical Review (SIDCER)
Training Program in Research Ethics in the Americas
University of the Philippines: Bioethics Training Project
University of Toronto Joint Centre for Bioethics (JCB)
Wellcome Trust: Ethics of Biomedical Research in Developing Countries grant scheme
World Health Organisation: Ethics and Health Initiative
World Health Organisation: Ethical Standards and Procedures for Research with Human Beings