African thoughts and perspectives on research ethics: Identifying some central problem areas.
Poul Ndebele Ethics and Health Research in Low Income Societies (2003), p.14. The ENRECA Health Network Department of International Health, Institute of Public Health, Panum Panum, Copenhagen N, Denmark.
Introduction As international collaborative research in Africa and other developing nations has been on the increase during the past two decades, the scientific community has found itself coming face to face with a growing number of ethical questions about its obligations when conducting research in the developing world and especially in Africa with its serious burden of disease and poverty. Whilst Africa appears to be quite an attractive place to scientists because of the numbers game, it presents so many challenges when it comes to the application of the ethical principles of respect for persons, beneficence, non maleficence and justice. What is now emerging is the fact that there are many different issues that must be understood by people conducting research in Africa, both about the societies and about ethical questions and dilemmas. In this paper, I intend to highlight some problem areas we face in Africa in trying to operationalise the ethical principles and ethical guidelines and the “Universal ethical Principles” of respect for persons, beneficence/nonmaleficence and justice. I will also suggest alternative views and the way forward as a way of presenting an African voice to international discussions on the ethical conduct of research in developing countries. Recent years have seen growing international debate about the ethics of conducting medical research in Africa and other developing countries. Concerns are being expressed about the validity of applying ethical principles and international guidelines that may be unquestionably accepted in a particular cultural setting to another cultural setting. The concerns could partly have been fuelled by fears of medical-ethical imperialism and fears about the use of double standards especially in international collaborative research.1 The current discussion surrounding the conduct of research in Africa and other developing countries is understandable bearing in mind the involvement of unsuspecting and uninformed human beings in very risky studies in the past as well as the recent experiences relating to the HIV AIDS trials conducted in Africa and other developing countries and sponsored by developed countries. In African societies in general, there are serious imbalances in power between the researchers and research participants and these increase the risk of exploitation of the vulnerable parties. Populations in most African countries share several characteristics which render them potentially vulnerable to exploitation in the conduct of research and these include: • the low levels of economic capacity • limited experience with or understanding of scientific research • limited local infrastructure, personnel, and technical capacity for providing health care and treatment options • limited experience and capacity for conducting ethical and scientific review • factors that make the obtaining of individual informed consent challenging2 It is important to note, moreover, that these same concerns are not limited to Africa and other developing countries but also obtain in the context of research conducted in developed countries – although to a limited extent. As a word of caution - most of the research ethics literature on Africa leaves one with the impression that there is something called an “African culture” and that societies in Africa have been stagnant over time. I wish to acknowledge that there is so much diversity in Africa in terms of culture, urbanisation, education and industrialisation, and that even with all that diversity the above characteristics still hold and my views are therefore still generalisable. My thoughts on the challenges and problem areas in the area of research ethics are based on my experiences in the area of health research, numerous discussions at various fora with several other concerned members from various parts of Africa through the initiatives of PABIN, SARETI, AMANET, Fogarty and other s and also through my current work in the area of research ethics as well as my experiences with several RECs in several African Countries. Various sets of international research ethics guidelines exist, all of which are statements of principles for investigators, but none of which have legal authority. The most widely consulted sets of guidelines include the Declaration of Helsinki, the Council for International Organisations of Medical Sciences Guidelines, and the Guidelines on Good Clinical Practice. Debates about ethics in medical research take place against a backdrop of international guidelines that have primarily been drafted in response to the way that medical research is conducted in developed countries and, in places, may therefore be of limited relevance to developing countries.3 From the debates that are currently going on, it seems that most people agree on principles at the most abstract level, but usually have some differences on how these principles ought to be operationalised in any specific context.
Aspects of research that have proved particularly controversial in Africa include the relevance of the research to the research participants as well as their communities as well as nations. At present, many developing countries have a limited capacity to determine national health and research priorities, or to conduct relevant research. As a result, they become dependent on the interests of external sponsors. In such circumstances developing countries may find it difficult to refuse offers to sponsor research, even if it is unlikely to benefit their populations, because of the accompanying incentives, such as improved healthcare facilities and other benefits to individual researchers, their institutions and even policy makers and politicians.4 Typically, developed countries sponsor or conduct research in developing countries for some combination of the following four reasons; the host country might desire information about effective and affordable interventions for an indigenous health problem, in order to be marketed in some developing countries, drugs and biologicals, even if already tested and approved in other countries, must be approved by national regulatory authorities, it is more efficient to conduct research in a country in which the condition being studied is more prevalent or it might be less expensive and faster to conduct research in developing countries. Conducting research in Africa often poses special challenges and these mainly arise from the combined effects of distinctive histories, cultures, politics, judicial systems, and economic situations. There is extreme poverty that afflicts so many, and primary health care services are generally inadequate, due to many factors and the high prices of drugs often places them out of reach of both individuals and developing country governments. Some justification is therefore necessary for conducting research in developing countries other than its less stringent or less complex regulatory or ethical requirements. Whatever the reason or combination of reasons, sponsors and researchers must ensure that these activities are conducted ethically and that they are responsive to the health needs of the country or community and that they do not exploit either the participants or the populations of the host country. Informed consent To date, debates are still raging amongst researchers, ethics review committees and others regarding the procedural aspects of informed consent. The requirement to obtain voluntary informed consent from human participants before they are enrolled in research is a fundamental tenet of research ethics and was one of the main requirements proclaimed in the Nuremberg Code. It has appeared in all subsequent published national and international codes, regulations, and guidelines pertaining to research ethics, including those in developing countries, such as India, Thailand, and Uganda. Nevertheless, there is an ongoing discussion about the value and importance of particular approaches to informed consent in other countries. The concept of the person Problems involving the interpretation and application of the requirement to obtain voluntary informed consent and its underlying ethical principles, arise for researchers, ethics review committees, and others. For example, the CIOMS Guidelines specifically address the practical difficulties in dealing with informed consent as follows: Some [individuals] may be relatively incapable of informed consent because they are illiterate, unfamiliar with the concepts of medicine held by the investigators, or living in communities in which the procedures typical of informed-consent discussions are unfamiliar or alien to the ethos of the community.5 What has generally emerged from these debates is the fact that some of the interpretations and methods used in some western countries in obtaining informed consent might not be appropriate in Africa because of different cultural or social norms. The problem that starts to emerge though even at this very general and higher level is the overemphasis of the U.S and international guidelines on the individual as a person who is rational and exists in isolation from others. This brings problems when brought to the African situation where a person is viewed as a part of society and as inseparable from others. In our Bantu languages we have the concept of ubuntuism and ubuntuism is about people and about connectedness. We say umuntu ngu muntu ngabantu meaning a person is a person with and amongst other people. A person in our cultures is closely related to others, such as the extended family and is also related to those who have passed (the ancestors) and those yet to be born (the future). This certainly brings in some problems of involving others in the informed consent which in the western sense is a dialogue between the researcher and the research participant. 6 A number of procedural issues usually arise during the process of obtaining informed consent and these require careful consideration before determining whether voluntary informed consent can be obtained. These include, for example, determining when it is necessary to obtain written consent and when oral consent should be permitted; when, if ever, the need in some cultures to obtain a community leader's or a family member's permission before seeking an individual's consent; and standards of disclosure for research participants in our cultures in which people lack basic information about modern science or have different explanations of disease causation which emanates from traditional and non-scientific beliefs. It is important to distinguish procedural challenges from those that reflect substantive differences in ethical standards. Developed country regulations and international guidelines are often criticised for focusing primarily on the informed consent document and requiring written consent. This is difficult to implement among illiterate individuals in African villages and such documents may be viewed as dangerous to sign in countries with oppressive regimes. In our Zimbabwean rural areas, a signed document is rather too formal and scientists would rather do with verbal consent which is also a sign that our communities trust the scientists very much and would rather even trust them with their own lives. Informed consent needs to be focused on the
process, rather than on documentation. The local ethics review committees as well as the local researchers need to be given flexibility and local discretion over the documentation of informed consent in accordance with local cultural norms and ethics review committees should grant such waivers only if the research protocols specify how the researchers and others could verify that research participants have given their voluntary informed consent Belief systems and disclosure of information Belief systems in some cultures do not explain health care interventions with the same concepts that are used in modern medical science. In a study we conducted in Gokwe in Zim-babwe we were talking about malaria and the participants were talking about “nyongo” which they said was caused by eating immature sugar cane. The “nyongo has the same signs and symptoms as malaria and to them mosquitoes were not a serious problem besides the occasional bites. We had to go back and re-do our questionnaires in such a way that we could now capture the episodes of “Nyongo” or malaria. Some would be against such an idea as it is seen as reinforcing wrong information, but for our team it was the only way we could capture the information we needed (but at the same time we made sure we provided information on malaria). Researchers, in consultation with community representatives need to develop pro-cedures to ensure that potential participants understand the information provided in the consent process and this entails the use of community advisory boards or such similar structures. Involvement of community leaders in informed consent One issue that continues to attract debate in the area of international research is that of community leaders and their role in facilitating access to the community. In rural Africa, investigators often need to obtain permission from a community leader or village council before approaching potential research participants. Where custom requires that permission of a community representative be granted before researchers may approach potential research participants, researchers need to be sensitive to such local requirements and in no case may permission from a community representative or council replace the requirement of a competent individual's voluntary informed consent. The role of community leaders or elders needs to be viewed as an integral part of the process of recruiting research participants. There are however some unfortunate situations where the decision of the elders cannot be opposed and hence people cannot decline to participate in research once they know that the elders have given their permission. The community leaders otherwise need to be taken as gatekeepers and as such as another layer of protection besides the ethics review committee as they assist in ensuring that their people are protected. One of the most important precautionary measures that need to be considered when dealing with gatekeepers is that permission obtained from the gatekeeper must not be substituted for the need to take separate and full informed consent of the participants. For obtaining permission of the gatekeeper, no pre-condition demanding sharing of information or data obtained should be accepted. In the process of research or data collection, adequate care should be taken to ensure that the relationship between the gatekeeper and the participants is not jeopardised in any way. Greater care should also be exercised in protecting participants from possible victimisation by gatekeepers while publishing and disseminating results of research. Acknowledging the existence of gatekeepers is to acknowledge the existence of other political systems and structures besides the western democratic model of governance which hinges on individual freedoms. Involvement of family members in informed consent Another common feature in African society is that of potential participants consulting other persons such as family members during the informed consent process. In the western societies, the individual is the one who makes a decision affecting him or her (perhaps with some bit of consultation of close family members), but there are some societies in which the rights of the group are also considered very important. These are societies where the individuals do not act very autonomously and their decisions and actions are aimed towards the good of society as well as for maintaining social equilibrium. They are part of a collective, and that collective participates in these decisions. Some women from our cultures might have problems getting permission from their spouses to participate in clinical trials, for example. Problems have been evident especially in microbicide trials conducted in several African countries. The microbicide is supposed to be a weapon that women who cannot negotiate condom use for whatever reason can use without the knowledge of their husbands (chemical condom). Researchers have had to decide how they can involve the women without the permission from their spouses. Unfortunately there have been some nasty incidences of violence against some of the female participants by their partners. These issues have been the focus of growing ethics committee members and researchers attention, in recent years. The requirement of consulting spouses is often viewed as problematic as it has implications for individual informed consent. In some cases household heads usually men are expected to speak for their unmarried adult daughters and even sons. The involvement of family members need not be discouraged in all cases since involving family or community members in the informed consent process might even enhance the individual's ability to make his or her own choices and to give informed consent or informed refusal. When a potential participant wishes to involve family members, researchers should take steps to accommodate this request. Researchers need to acknowledge the close-knitness in especially African societies and the interdependence that exists among
family members. My view is that this reliance on other members of the family also needs to be seen again as an added layer of protection. The paternalistic view which is adopted by many guidelines also applies to rural African societies which have put up some measures to protect ‘those who cannot make decisions for themselves’. Right to withdraw In the informed consent process, the right to withdraw is very important and serves to empower the research participant. In Africa unfortunately, the right to withdraw may mean very little or nothing to the research participants. The right to withdraw may mean nothing when people can only access treatment through participating in research. It also means very little if withdrawal can affect the relationship of the research participant with the only physician serving that area. The right to withdraw especially in studies that provide anti retroviral treatment for HIV/AIDS means nothing if withdrawal results in the withdrawal of life long treatment. The right to withdraw may mean little if withdrawal results in drug resistance and researchers take all steps necessary to ensure that drug resistance does not develop. The fact that community members trust of researchers means that they may forfeit their right to withdraw from research as they believe that withdrawal does not always serve their interest. Therapeutic misconception Several studies conducted in Africa on informed consent especially in the context of microbicide and vaccine trials have shown that the issue of therapeutic misconception requires some serious attention. In microbicide and vaccine trials participants have this sense of false confidence and feel that they can engage in risky behaviours since they are protected by the microbicide or vaccine.7 Researchers in Africa have to deal with this serious challenge and come up with ways of disclosing information that ensures that participants are well informed and hence take their own informed decisions with regards to what happens to their bodies. Such innovative processes should be flexible enough to acknowledge the differences in understanding among individuals. Researchers need to strive for a balance that maximises potential benefits and opportunities, recognises and extends individual autonomy, and minimises risks associated with participation in scientific inquiry. Undue inducements and coercion The issues of undue inducements and coercion also take centre stage in Africa especially in the context of international research. The scientist in the African context is someone who knows all and someone who should not be questioned. The problem of coercion becomes even more serious when a physician is involved in the recruitment of his/her patients or members from the community he/she serves. The problem of undue inducements is created by the poor economies of developing countries and people are forced to consider the benefits and ignore the risks associated with a particular study. In some cases, the amounts offered to participants as compensation appear reasonable to the sponsors and other participants in developed countries, and yet they are irresistible in developing countries. My view is that in the interest of protecting locally funded research, some of the benefits may have to be converted into community benefits such as supporting clinics or engaging in other community projects which promote good health. At least that way we can ensure that we are dealing with the 10/90 gap in an ethical manner. The above discussion has illustrated that informed consent involves complex interactions between moral values, and cultural and political values. Informed consent processes and procedures therefore need to be formed on the basis of cultural appropriateness and acceptability.8 Upholding the principle of respect for autonomy does not only entail respect-ing the individual person, but should even go as far as respecting their convictions culture and traditions. The above has also illustrated that informed consent is a complex process involving negotiation between the researcher and the research participants (and their significant others) and that this process varies from individual to individual and from society to society. The discussion suggests the need for researchers to be trained in skills to make sensitive judgements according to the demands of the situation. Standard of care issues Perhaps the most contentious issue at present is the standard of care that should be provided to participants in the control group of clinical trials. A few countries in Africa such as Uganda and South Africa, have formulated their own national ethical statements, which provide an intermediate step between the principles set out in international guidance and decisions about how these should be applied within these countries. However, national and international guidelines cannot be effective unless countries have appropriate mechanisms for their implementation. Another question that is receiving an increasing amount of attention — particularly within the context HIV/AIDS research — is what should happen once a research project in a developing country is completed. Concerns include: • Ensuring that the intervention if found successful can be availed to the whole community (and or country) • Ensuring that researchers receive appropriate recognition of, and where appropriate a share of the financial rewards for, their endeavours • How to sustain improvements to healthcare systems made during research • In the vaccine and microbicide arena what happens to those who are infected during the trial
The questions have been extending beyond the research participants to include the community at large. For some, the answer is that everyone should be given the most effective treatment, regardless of cost. Many developing countries are wrestling with issues of poverty, basic health care, and sanitation, and are unable to provide every sick person with cutting-edge or even effective treatments. The Helsinki Declaration's requirement that every patient be given the best possible treatment "that would otherwise be available" worries proponents of egalitarian access to care because of its implication that if no treatment is available, as is the case in many developing countries, then doing nothing for a control group would satisfy the declaration's principle9 and hence the question ; Is no standard a standard at all? Over-researched communities In several African countries, there are some research centres that are internationally known. These centres of excellence are mostly situated in poor rural areas and all the major studies are conducted in these centres as well as their surrounding areas. Some of these areas are now over-researched and most of the literature is from these areas. In some situations this phenomenon has resulted in the stigmatisation of the communities. An example is the Hlabisa community in South Africa who are now referred to as the “AIDS People” since most of the studies on HIV in South Africa have been conducted in that community. The communities in these areas serve as “Human Laboratories” and end up bearing all the burdens of research. Researchers need to ask themselves the reason why they have chosen a particular area for their study. Is it because the people are too receptive or is it to take advantage of the existing infrastructure. Certainly burdens and benefits from research need to be shared out equally among all communities. Challenges related to ethical review in Africa Besides all the above challenges related to the application of ethical guidelines and principles, there are also some challenges that relate to ethical review in Africa and these also need attention. A significant proportion of the institutions in Africa do not have ethics committees. In some institutions, ethics committees were established to meet the requirements of the sponsoring agents and these as such merely serve as rubber stamping authorities. Some Ethics Committees have inadequate ethical review processes and mechanisms and their reviewers and members are poorly equipped for ethical review. The problem of Ethics Committee shopping is still rampant since the EC system is still in its infancy in most African Countries (when a proposal is rejected by one ethics committee, the researchers resubmit it to another ethics committee). Several Ethics Committees lack written procedures and some do not document their activities. Some committees are poorly grounded and hence are not recognised by the researchers and also by the institutions and some are underresourced even to the extent that they do not have office space and stationery. Other problems bedevilling ethics committees relate to the abuse of expedited review process, interference from outsiders, researchers, politicians etc (lack of independence), gender imbalance as well as the non involvement of lay persons. Conclusion In view of all the above challenges, in this paper I take the view that Research Ethics Committees need to be set up in all countries and institutions where they are not in existence and where these already exist, they need to be strengthened so that they can make informed decisions on important issues. An essential safeguard for research participants is an effective ethical review process for proposed research. Particular care is however needed when determining how research ethics committees can be adequately trained and resourced, while remaining independent of governments, institutions and research sponsors. Besides putting in place an ethical review and monitoring system, researchers need to be conscientised in the ethical conduct of research. Researchers must not only be aware of international guidelines governing research but must also be willing and able to look beyond their own cultural values I put forward that RECs in African countries should play the extra role of ensuring that the researchers and their institutions negotiate on behalf of participants and communities before research is performed. I also submit that research protection programmes should also include some out reach programmes for the public who are the potential research participants. Institutions and agencies from Developed countries should support research that addresses specifically the application of ethical principles in various cultural settings as well as sponsoring workshops and conferences during which international researchers can share their knowledge and experiences. Whilst this paper has touched on so many challenges we are facing in Africa in trying to operationalise the principles and international guidelines, I hope that it has succeeded in illustrating the definite need for the enhancement of research protection systems in Africa. This may take time, but it is the only way to bring about true change in the ethics of health research in Africa. I commend organisations which are already involved in supporting several programmes in Africa and elsewhere, that are geared towards the improvement of developing countries research protection mechanisms. I also wish to specifically commend DANIDA and the ENRECA Health Research Network for organising this event and do hope that the event will serve as a milestone in the promotion of the ethical conduct of research in Africa and the world at large. References 1. Ijsselmuiden, C., & Faden, R. (1992). Research and informed consent in Africa – another look. New England Journal of Medicine, 326, 830-834 2. UNAIDS. 2000. Guidance document on ethical considerations in HIV preventive vaccine research.
3. Benatar S. et al. 2002. Reflections and recommendations on research ethics in developing Countries. Social Science and Medicine. 54 (2002) 1131-1141. 4. National Bioethics Advisory Commission (US). 2001Ethical and policy issues in international research: Clinical trials in developing Countries. 5. Council for international Organisations of the Medical Sciences. 1993. International Ethical Guidelines for Biomedical Research involving human subjects. CIOMS. Geneva 6. Tangwa G. (2000) The traditional African perception of a person: Some implications for Bioethics. Hastings Center Report 3095):39-43. 7. Nuffield Council on Bioethics (2002). The ethics of research related to healthcare in developing countries. 8. Ramjee G. et al. 2000. Challenges in the conduct of vaginal microbicide effectiveness trials in the developing world. AIDS 2000, 14:2553-2557. 9. World Medical Assembly (2000). Declaration of Helsinki: Ethical principles for research involving human subjects. WMA; Geneva.