Wednesday, January 03, 2007

Research ethics committees, Africa style

The Hastings Center's Bioethics Forum has an interesting post on the appropriateness of the 'American model' of research ethics committees for Africa. In the US, institutional review boards (IRBs) are housed mainly in research institutions (universities, usually), which are independent of the research funding agencies (such as the National Institutes of Health, CDC or the Gates Foundation). This allows members of the IRB to focus on the details of protocols, and to see if they meet regulatory requirements, without worrying about why (in the world) the funders saw fit to bankroll the project under review. In the US, the 'local IRB review' model has led to a frightening proliferation of IRBs, including professional IRBs for hire, as well as a whole industry surrounding human research protections.

In Africa, as authors Coleman and Bouesseau point out, things are both institutionally and contextually different. The creation of an extensive network of local IRBs in every research institution in low-resource countries would be impractical: who would pay for them all? And while local IRBs in the USA have political clout because they have the weight (including financial support) of their home research institution behind them, and a quasi-legal regulatory framework that their home institution must abide by, ethics committees in Africa start from a position of vulnerability and dependence. Decisions by African ethics committees may not be taken seriously by national regulative bodies, and since their home institution often relys heavily on money from externally sponsored research, these committees often find it difficult to reject protocols that bring in funds, infrastructual improvements and employment opportunities. The alternative model proposed by Coleman and Bouesseau is centralization: one ethics committee, working on a national level and housed in a government agency, would be cheaper and possibly have more credibility and clout than local ethics committees.

Perhaps. The viability of a centralization model depends on the condition of the government agency in question. Just last week, reports of corruption severely disrupting supplies of AIDS drugs to patients in Cameroon were all over the African and international press. How credible would an ethics committee housed in the current Ministry of Public Health in Cameroon be? In any case, the centralization model can only be a stopgap solution. To the extent that African-led research is encouraged (and it should be) and more and more biomedical research is conducted in Africa, no centralized committee could reasonably review all the protocols properly. Right now, every research protocol in Zimbabwe is double-reviewed: once by a local committee, once by the National Ethics Board. This is not a system that is built to last.

Coleman and Bouesseau make the important point that ethics committees in Africa -- unlike their counterparts in America -- should not be 'neutral' in regard to the issue of why a certain research proposal has been funded and whether it should take place at all. A key ethical concern for ethical committees in Africa should be whether the research in question will actually bring a significant benefit to the local community that weighs favorably with the risks the participants are taking. Of course, African ethical committees would have to be empowered to take such a principled stand, and power is precisely what is in unequal supply.