Friday, August 04, 2006

Ethics committees for sale

PLoS Medicine has just published an interesting discussion under the title 'Should Society Allow Research Ethics Boards to be run as For-Profit Enterprises?'. Ezekiel Emanuel, from the Department of Clinical Ethics at the National Institute of Health, sees nothing wrong in ethics committees financially supported by (say) pharmaceutical companies whose protocols for new drugs are being reviewed by those very committees. The bottom line for Emanuel is the quality of the ethical review, not how the ethics committee is financially supported. Besides, he goes on, non-profit ethics committees also have their own problems with conflict of interest, i.e. committee members may be evaluating the research of their co-workers, and IRB members may look kindly on certain protocols when whole university laboratories are being built by Big Pharma. Going on yet further, Emanuel writes that having a non-profit ethics committee does not guarantee good review and protection of human subjects: John Hopkins, Duke University, Rush University, University of Colorado and University of Rochester, have all had their research suspended for ethics violations.

For Emanuel, in short, the money does not matter: an ethics committee could be financed to the hilt by those whose research it reviews, or it could charge substantial fees for each protocol reviewed, but as long as the review is sufficiently thorough, where's the problem?. (Interestingly, Emanuel has also argued that offering financial inducements to research participants is not an ethical problem either, as long as the risk/benefit relationship is acceptable.)

Trudo Lemmens and Carl Elliot will have none of it. They cite examples of abusive research being permitted by professionalized ethical review committees whose members have substantial ties to the industry they are supposed to be regulating, and point out that the increasingly incestuous relationship between universities (and their IRBs) and multi-national corporations (and their money) is something that should be resisted, not emulated. Unlike Emanuel, who seemingly thinks that money has neither symbolic meaning nor real effects, Lemmens and Elliot worry that unless all ethics committees are regulated by the state, they will just serve to grease the wheels of private industry instead of protecting human participants in research.

It is interesting to try to view this debate from out of a developing world perspective. For better or for worse, developing countries see North American ethics committees and regulatory structure as models -- not the least because of all the 'ethics capacity building' initiatives in low-income countries conducted by countries of the North. In this light, Emanuel's point of view may be welcomed in some quarters as a justification for local practices: seeking payment from researchers for ethical review already common practice in (for example) Malawi. Ethical review committees in sub-Saharan Africa often complain that they are underfunded, and seek payment from researchers as a way of remaining solvent. How good can the ethical review be if there is no money for a committee coordinator, a database, a photocopy machine, stamps or even paper? Obviously some financial support is a necessary condition of quality review. On the other hand, Emanuel's position could easily be used to justify private companies bankrolling ethics committees in the developing world to faciliate its outsourced research activities.

The missing element is the state: in many developing countries, little state money is devoted to research, and only the slightest fraction to ethical review of research. Where the state is absent, money from private companies (usually from overseas) may enter. Carl Elliot once wrote a piece called 'Is that a bioethicist I see in your pocket?'. Perhaps soon whole bioethics committees will be in somebody's pocket.