Strengthening Local Review of Research in Africa:Is the IRB Model Relevant?
Research

Carl H. Coleman and Marie-Charlotte Bouësseau 

, 12/22/2006

Strengthening Local Review of Research in Africa:Is the IRB Model Relevant?

(Research) Permanent link

The amount of medical research in Africa is growing rapidly, but many of these countries lack adequate mechanisms exist to protect the interests of prospective research participants and their communities. As the National Bioethics Advisory Commission observed in 2001, there are “legitimate reasons to question the capacity of host countries to support and conduct prior ethics review” of collaborative research, including limited resources, lack of experience and expertise, and potential conflicts of interest. Other commentators have echoed these concerns, including the Nuffield Council on Bioethics in a report released last year. Strengthening the ethics review capacity of low and middle-income countries is therefore an important goal of international bioethics and human rights.

To that end, the European Commission's Science and Society program recently funded an initiative by fifteen African countries called Networking for Ethics on Biomedical Research in Africa. The goal of the NEBRA project was to survey the participating countries' existing systems for ethics review of research involving human participants and develop a strategy for strengthening it. We participated in this project on behalf of the Ethics, Trade, Human Rights and Health Law department of the World Health Organization, which was a member of the NEBRA steering committee. In reviewing the experiences of these countries, it became clear to us that attempting to replicate American-style institutional review boards as the primary mechanism for ethics oversight of research would do little to serve African peoples’ most pressing needs.

First, the structure of the American IRB system is a poor fit for African countries. The IRB system is premised on the importance of “local” review of research (i.e., review in the institution in which the research will take place), as well as a separation between IRBs and the agencies that regulate them. In many African countries, however, institutional-level committees that exist independently of regulatory authorities may lack sufficient legitimacy to be effective. In addition, they may find it difficult to reject research protocols, or to insist on substantial changes that might lead sponsors to reconsider working with the institution, if foreign research is an institution's primary means of financial support. By contrast, a centralized committee housed within a government agency may be in a better position to take strong positions and ensure that those decisions are respected. In addition, creating a single centralized committee is likely to be simpler, and less costly, than attempting to create separate committees at every research institution in the country.

Second, the most critical ethical issues related to medical research in Africa are not the protocol-specific issues that IRBs are designed to address. When an IRB in the United States receives a protocol, its job is to determine whether the proposed study complies with general ethical principles and regulatory requirements, not to consider whether a different study, perhaps addressing an entirely different problem, might be a better use of limited human resources or offer a better justification for exposing participants to risk. Questions about the prioritization of different types of medical research are generally left to other entities, such as funders or medical journal editors. In many developing countries, however, no one is considering big-picture questions about the relative importance of different types of medical research. Research “agendas” are often dictated solely by the market-driven priorities of foreign research sponsors, rather than by any proactive decisions by the countries themselves. In this context, thinking about the prioritization of limited research resources, and ensuring that research addresses the most pressing health needs of the country’s population, is one of the most important ethical issues to be considered.

A similar point applies to the way research is funded. In the United States, IRBs are generally not responsible for reviewing the terms of research funding. They may become interested in funding arrangements when there are concerns about conflicts of interest, or when funders seek to restrict researchers’ freedom to publish the results of a study, but their role is not to ask whether the overall arrangement is a “good deal” for the institution or the larger community in which the research will be conducted. For African countries, however, evaluating the obligations that funders assume in exchange for their access to research participants is at least as important as considering a study’s potential to contribute to generalizable knowledge. Indeed, in countries that have historically lacked access to most of the benefits of scientific progress, the potential for producing generalizable knowledge will rarely, if ever, be a sufficient justification for exposing human participants to the risks of research. An effective ethics review process should therefore ensure that sponsors commit to providing tangible benefits to study participants and the community in which the research is conducted. It should also include mechanisms to ensure that those commitments are actually met.

Finally, while any comprehensive ethics review process must address certain internationally accepted ethical principles (such as that participation be voluntary), the way those principles are applied in the American regulatory system will not always work in African countries. For example, American regulations emphasize the importance of obtaining the individual informed consent of prospective research participants, usually in writing. In African countries, however, it may be inappropriate to design a consent process that focuses on individuals in isolation from their families and communities, and the emphasis on written consent forms may need to be reconsidered. Similarly, as the European Group on Ethics in Science and the New Technologies observed, “different cultures may have different views regarding privacy and personal data.”

As the amount of human research grows in African countries, building these countries’ capacity for ensuring the ethical acceptability of research is undeniably important. However, what constitutes an effective ethics review system will necessarily vary from country to country. As Alejo Carpentier described in his novel El Siglo de las Luces, the French Declaration of Human Rights and the guillotine arrived in Antilles on the same boat. As the globalization of research ethics continues, countries will have to decide which aspects of foreign systems are really worth copying.

- Carl H. Coleman and Marie-Charlotte Bouësseau 

 

Readers respond

I agree with several points made in the article, especially the point that uncritical replication of the U.S. IRB system may not be the best way of improving capacity of ethical review in Africa. However, the article seems to be based on the assumption that there are major initiatives afoot in Africa to do just that. If so, these initiatives should be identified and engaged with. On the other hand, I am aware of several ongoing U.S.-funded initiatives (mainly from the Fogarty International Center, representing an annual investment in Africa of at least $1 million annually) that aim to build research ethics capacity in Africa. I suspect this investment exceeds any similar EU research ethics funding to date. To the best of my knowledge, not one of these programs (I am principle investigator of one of these, SARETI), aims to replicate the U.S. IRB system. Instead, they aim to enhance the ability of African researchers, scientists, research ethics committee members, and other stakeholders to debate precisely the ethical issues raised by Coleman and Bouesseau, and to generate ethically considered solutions to local ethical dilemmas, using the best international resources applied to deep knowledge of local conditions.

The Fogarty program has invested in African institutions that in turn attract African scholars to study research ethics in African settings (although some U.S. universities host similar programs). Simply replicating IRBs is not on the agenda of any of these programs, to the best of my knowledge. Instead, these programs aim to develop research ethics scholarship that is pertinent to Africa and the South generally, and which contributes to the development of indigenous solutions to the many problems associated with conducting health research in Africa, whether it is locally or internationally funded. These problems include the macro issues of the relevance of specific projects to specific regions, the question of sustainable local benefits in relation to risks, and questions about appropriate community consultation process preceding individual informed consent procedures, post-trial access, and standards of care in settings where very little is available in the public domain. European initiatives to contribute to such developments are of course welcome, but should not simply assume that all other initiatives blindly aim to replicate a U.S. IRB model. NEBRA represents a non-U.S.-funded collaborative attempt to build research ethics capacity based on a needs assessment, and such preparatory research is to be welcomed but it not unique to NEBRA.1

A further concern relates to the risk of generating a host of “me-too” European initiatives that, at best, replicate the Fogarty initiatives, and at worst replicate nonindigenous systems of ethics review that do not address, inter alia, the macroeconomic and political questions that permeate ethical review in developing countries. European donors that wish to contribute to Africa research ethics capacity should be careful not to stretch the already thin institutional capacity in Africa by initiating new programs, but should consider supplementing existing African programs that are performing well but could use additional funding to sponsor more African scholars and fellows in their current intensive research ethics programs. A special lack at present is capacity-building opportunities for Francophone and Lusophone African countries.

Doug Wassenaar directs the South African Research Ethics Training Initiative (SARETI). 

1. See the new European TRREE initiative and C. Milford et al., “Perceived Capacity of Selected African Research Ethics Committees to Review HIV Vaccine Trial Protocols, IRB 28, 2 (2005), 1-9.

 

The authors reply:
We do not understand why Mr. Wassenaar interpreted our posting as a criticism of initiatives like the Fogarty program, but that was certainly not our intention. Rather, we were responding to existing African laws and systems that rely extensively on the IRB model of institutional ethics committees. In fact, we work closely with many Fogarty-sponsored programs.

Posted by Greg Kaebnick at 12/22/2006 12:00:00 AM | 


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