No one expects the ethics police

This seems to be the season for ethics committee bashing. Something is in the air. First, you had the Science article by Gunsalus et. al. complaining of 'IRB mission creep'. I never heard of that term before, so naturally I turned to Wikipedia:

Mission creep is the expansion of a project or mission beyond its original goals, often after initial successes. The term often implies a certain disapproval of newly adopted goals by the user of the term. Mission creep is usually considered undesirable due to the dangerous path of each success breeding more ambitious attempts, only stopping when a final, often catastrophic, failure occurs. The term was originally applied exclusively to military operations, but has recently been applied to many different fields, mainly the growth of bureaucracies.

Unfortunately, the article by Gunsalus does not really say how IRBs have expanded beyond their original goal of protecting human subjects -- it just goes on (and on) about how the interaction between IRBs and researchers is becoming increasingly bogged down in a quicksand of paperwork. Talk of 'mission creep' sounds more sexy, though.

This month, members of Britain's scientific community are griping about ethical regulations concerning recruitment of research participants. Current regulations state that researchers can only approach patients to ask if they are prepared to take part in research if they have responded positively to a letter from their doctor about the possibility of being in a study. This 'opt in' approach lowers the number of potential research subjects and could create 'participation bias'. Some researchers would be more happy with an 'opt out' approach where they could take liberties in contacting potential research subjects more directly; ethics committees and all their regulations are just getting in the way of good science, again.

But not everyone is buying this. Before contacting potential research participants, you have to know whether they pass your study's inclusion criteria; to do that, you have to know quite a lot about them. And knowing quite a lot about people, say, through their medical records, raises questions about confidentiality that may best be handled by an ... ethics committee.

Impressions of the XVI International AIDS Conference in Toronto

What was hot at the recent International AIDS Conference in Toronto? Answer: new developments in HIV prevention research and policy. Kevin de Cock, the new HIV/AIDS director at WHO, seemed to have summarized the zeitgeist by stating that 'We cannot treat our way out of this epidemic', and hence that halting new HIV infections should be considered the main priority. At the 2004 conference in Bangkok, the conference theme was 'Access for all', a reference to initiatives to get anti-retroviral treatment to needy HIV positive patients worldwide. Now the pendulum of attention seems to have swung somewhat from ensuring treatment of HIV infected persons to preventing people getting infected in the first place. This shift is not surprising, if you think about it: 25 years into the epidemic, there is still no vaccine, still no cure, and the effectiveness of the conventional ('ABC') means to prevent HIV infection seem pretty limited considering that more new HIV infections occurred in 2004 than any previous year of the epidemic. Something has to be done to stem the tide, because, frankly, the virus is winning and we are losing.

What's big in HIV prevention research? Answer: microbicides and male circumcision. The advantage of microbicides is that they are 'female-controlled' prevention methods, which could circumvent the problems associated with negotiating condom use with men. Some of the bigger names (like Melinda Gates, wife of Bill) used microbicide research as a springboard for the idea of 'putting the power in the hands of women' to change the course of the epidemic, but this girl power ideology was soon derided by some public health experts ('Aren't men involved in there somewhere?') and swiftly criticized as inappropriate by gay men's groups.

As far as male circumcision goes, there was not much new data to report, but some cost-effectiveness and epidemiological modeling talks based on a recent South African study strongly suggested that the implementation of male circumcision among non-circumcising groups in sub-Saharan Africa would be economically feasible and have a significant impact on HIV prevalence in Africa over the next twenty years. Interestingly, there was no one on the panel in the session on circumcision from the social sciences or African civil society, and therefore little discussion about the possible political and cultural challenges faced by the initiation of male circumcision into non-circumcising communities in Africa. Many in the audience, however, seemed deeply uncomfortable about the idea of (mostly white people and Western institutions) going in and circumcising African males, no matter what the data currently indicated, unless there was a better understanding of what reforming old and introducing new circumcision practices could entail for local communities.

One surprise was the open criticism of recent policy initatives to accelerate HIV testing. While it makes good sense to explore ways of increasing knowledge of HIV status (around 90% of those HIV infected in sub-Saharan Africa do not know their status), there was much debate about the human costs of policies of 'routine HIV testing' in clinical settings: problems with informed consent, the lack of emphasis on counseling, potential exposure to stigma and the fragile links between testing positive for HIV and having access to AIDS treatment. Amnesty International just weighed in on the issue. The epidemic, and its ethical debates, rage on.

Taking rumor seriously

Much of academic life is spent trawling through largely uninspiring articles in search of some minor insight. But every once in a while you read an article that, unlike the usual stuff, grabs you and does not let go.

This was the case for me with an article that was recently published in, of all things, Tropical Medicine and International Health. Entitled 'Popular concerns about medical research projects in sub-Saharan Africa -- a critical voice in debates about medical research ethics', the authors P.W. Geissler and R.Pools article recast the meaning of popular African rumors surrounding what Western biomedical researchers and institutions are doing in their countries. It is not uncommon to hear talk about organ, body part, blood and placenta theft, and about AIDS and other diseases being deliberately spread by Western scientists to decimate the African population. Instead of regarding these rumors as mere distortions of fact or throwbacks to traditional 'magical' thinking, Geissler and Pool see such rumors as expressions of concern about how foreign research institutions tend to take more than they give to local communities, and how biomedical research in resource-poor countries is suspected to be part of a larger network of exploitive global relationships, a network with long historical roots.

In fact, according to Geissler and Pool, these rumors are a way of doing bioethics; what might condescendingly be called the 'rumor mill' is really a collective meditation on the ethics of international research:

Given local unfamiliarly with the conceptual models and terminology of the international medical ethics debate and the lack of direct engagement of study populations in discussions about ethical concerns, local communities make use of their own models and terminologies to express and debate their concerns. They use a collective set of narrative elements, plots, themes and images that have been used to faciliate discussion of colonial and post-colonial inequality and exploitation ... These rumors are modern debates about ethical practice in a context in which experiences of alienation and exploitation form the backdrop of medical research.

As if to drive home the point about global inequalities, this article is only available if you or your academic institution has a costly subscription to Tropical Medicine and International Health. But if you want a copy, just send me an email.

Hey, where'd you get that body?

Remember the museum exhibit Body Worlds, which first opened in Japan back in 1995, with its 'prenatal wing' that featured the preserved corpse of a woman who died 8 months into pregnancy, including the body of her dead fetus? As you might predict, Body Worlds and its sequels (Body Worlds 3 is currently at the Houston Museum of Natural Science) have been monster hits, drawing some 17 million spectators to see the enhanced sinews and veins. Gunther Von Hagens, the creator of Body Worlds, states that his installations are all about health education and are in the best possible taste, and not at all about sensationalism or voyeurism. Take, for example, his exhibit of a corpse on horseback, who is holding the brain of the horse in one hand, and his own brain in the other. Or 'The Swimmer', cut in half down the middle, with each half doing the crawl in opposite directions. But besides the aesthetics, there has always been the nagging ethical question: where do these corpses come from? Who were these people, and how were their bodies procured?

The New York Times may have part of the answer: China. In factories in China, workers are busy skinning, cleaning, cutting, dissecting, perserving and then exporting human corpses to be used, basically, for entertainment purposes in museums around the globe. And the audit trail of the bodies seems obscure. Van Hagen has always contended that all persons exhibited in Body Worlds freely donated their bodies specifically for this purpose, and Premier Exhibitions (who runs Bodies: The Exhibition) claims that there is no way that 'their' prize corpses could be, for example, executed Chinese prisoners. But, according to the NYT article, no one connected to the multi-million dollar 'body plastination' industry seems to be in any big hurry to demand (or supply) proof that the bodies were donated, or have tried to contact family members to ask if they are aware that their loved one is currently on display somewhere.

Happy Birthday to this

I almost forgot: this blog has been going on for one year now. Over the past 12 months, there have been interesting comments from time to time, and the Global Bioethics Blog has been blogrolled here and cited there. I have discovered to my delight that the site has received hits from the Democratic Republic of Congo, Zimbabwe, Uganda, Mozambique and Zambia. (We are still waiting for Gabon, Angola and Central African Republic.) I hope that the site offers some relief from mainstream bioethics in the North, with its heavy emphasis on embryos, and its unpalatable ideological conflicts.

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.