Unformatted text preview: American Ethnologist n Volume 32 Number 2 May 2005 indicators of whole groups, however formed or damaged by social and economic context, are enfolded into regimes of international and local forms of protection, in which ethics becomes a ‘‘workable document.’’ The issue of human-subjects protection, thus, moves beyond scripted procedural issues of informed consent and into questions of legal capacities and the aggregate human conditions of which they are generative (Marks 2000). What alternatives are there to counteract perceived widespread abuse and inadequate protection of research subjects? What work is to be done locally, scientifically, and administratively to link biologies back to regimes of protection? In the Chernobyl context, I documented how, in the newly independent Ukrainian state, radiation research clinics and nongovernmental organizations mediated an informal economy of illness and claims to what I refer to as a ‘‘biological citizenship’’—a massive demand for but selective access to a form of social welfare based on scientific and legal criteria that both acknowledge injury and compensate for it. Such struggles over a biological citizenship took place in a context of fundamental losses (related to employment and state protections against inflation, widespread corruption, and a corrosion of legal and political categories).34 Assaults on health became the coinage through which sufferers staked claims for biomedical resources, social equity, and human rights. This type of biosocial fabric, in which the very idea of citizenship becomes charged with the superadded burden of survival, is one of many being converted into a model of cost-effective ethical variability in globalized human research. Commercial sponsors argue that clinical trials ¨ provide social and material goods to treatment-naıve populations where those goods otherwise might not be available; if these populations do not want the goods, then sponsors can always go somewhere else. ‘‘There are so many places that we can work that we just bypass it all together,’’ one CRO executive told me. In other words, sponsors are free to bargain down the price and ‘‘work the ethics’’ (in terms of equivalent medications) of any trial.35 The circulation of such experimental goods and the relative absence of public scandal over how they circulate do not make the task of gathering more information on the sites and sources of clinical research data any less urgent— particularly in a moment when the FDA actively promotes the ‘‘search for sites and sources of data’’ around the world to fulfill its ‘‘mandate to determine the safety and efficacy’’ of new drugs (Office of Inspector General, Department of Health and Human Services 2001:42). In the early 1970s, when the scandal over the use of prison subjects broke, the FDA claimed it had little documentation, citing its duty to protect intellectual property. Today the FDA resists gathering data on the out-migration of human research, on the basis that location of testing is proprietary information. One might want to rethink whether anonymity of the sources of clinical research data is a defensible idea anymore. Conclusion
In this article, I have sketched an ethnographic approach to human-subjects research—examining its practices and strategies across a variety of international, state, and economic spheres—in the context of an emerging industry of human-subjects research. The overriding empirical problem centers on the apparent ease of access to new treatment-poor populations. In the pharmaceutical pursuit of these new global subjects, one can observe how deliberations over the ethics of research in crisis-ridden areas are set against—even eclipsed by—the market ethics of industry scientists and regulators. Rather than evening the starting conditions in which global human-subjects research is conducted, ethics as ethical variability itself becomes the industry norm, even consciously deployed in pharmaceutical development. Ethics should protect people from harm. Case-based observation and analysis suggest that the procedural issues that are relied on in realizing human-subjects protection are insulating researchers from the contexts of inequality in which they work. In contrast, current bioethical commentary on the movement of human trials to developing countries centers on the need to produce better ways of deriving informed consent from human subjects and exporting the IRB model at a quicker pace. The purpose here is to ensure that the autonomy of individuals takes precedence over the demands of science or the interests of society, with the idea that such autonomy can counteract coerciveness in research wherever it takes place. An exclusive focus on informed consent narrows one’s vision of what is, in reality, a broad array of factors that are overwhelming ethics. What one is not seeing as a result of the incursion of procedural norms (at least, not yet) is the exercise of free will by autonomous agents in human research. Rather, population-wide processes that support reification (and, in some cases, capitalization) of social and biological difference continue to operate. This ethnographic assessment of the human-subjects research industry brings into focus emergent ethical arrangements around disease and populations where public health resources have dropped off and where the creation of new poverty is a chronic process. Rather than focusing on normative theory of ethics and ideal conditions, I maintain the importance of apprehending the norms that are being propagated and how they are being refashioned in actual and diverse conditions. Understanding the existing variability in the regulation of ethics and the coinages through which consent, autonomy, and drug markets evolve helps build an ethnographic context that 192 ...
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This note was uploaded on 10/10/2010 for the course ENG 000121 taught by Professor Mcgrand during the Spring '10 term at Cornell.
- Spring '10