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In a concerted response to the horrors of Nazi medical practices the biomedical community produced the Nuremberg Code of 1947, an authoritative declaration of the role of consent in medical research. This was followed in 1964 by the Declaration of Helsinki, which represented an extension of the effort to codify ethical standards.
These documents gave birth to one of the central projects of modern biomedical ethics, one now centered around upon the notion that individual autonomy must be respected, and that the key to achieving this lies in informed consent: it is informed consent that makes it possible for an individual to permit or refuse, autonomously, a proposed action.
This is an eminently liberal equation, one with a history whose roots lie at the heart of Enlightenment thinking. Sixty years after the Nuremberg Code and forty years since the Helsinki Declaration, the equation has become almost universally accepted as a cornerstone of medical ethics.
The language of informed consent has, in those intervening years, been extended from medical research to clinical practice, to apply to patients as well as research subjects, and more recently, to the use of medical information and human tissues. Informed consent requirements bear weight throughout medical practice and extend beyond: in one direction, to moral, political and legal debates about medicine; in another, to the everyday practices of non-medical healthcare professionals; in a third, to patients and research subjects, who recognize and draw upon it themselves.
Alongside this expansion the standards for seeking and giving consent have been made more exacting and more explicit, and given a more thorough theoretical underpinning in conceptions of individual autonomy. Against this body of accepted thinking and practice Manson and O'Neill offer a thoroughgoing critique identifying serious inadequacies in the project to secure informed consent standards.
They note, for example, that standards for consent for medical research cannot be used as a model for medical treatment: all too often patients are not in a position to give any kind of consent, never mind informed consent - the gap between demanded and possible consent cannot be closed.
Meanwhile, demands for specific rather than general consent run the project into further difficulties. Genuinely specific consent requirements would preclude secondary analyses of data, for example, while even averagely-competent research subjects are unlikely to be able to evaluate in any satisfactory way information about "the aims, methods, sources of funding, and any possible conflicts of interest, institutional affiliations, the anticipated benefits and potential risks" of a study (10). The attempt to bring this sort of rigor to clinical practice is even less feasible, and has produced vast quantities of bewilderingly lengthy and complex consent forms.
Similarly, demands for fully explicit consent are unmeetable: explicit consent always relies, eventually, upon tacit understandings, agreements and assumptions, including ones about what counts as consent and how it can be given.
If the consent standards demanded of current biomedical practice are unfeasible, the thinking underlying them is also unsatisfactory. In the Nuremberg Code "consent matters because it can be used to protect research subjects and patients against grave wrongs" (17). But more recently it has come to be seen as a necessary condition of their autonomy, a basic ethical value - and this is one of the drivers of the quest for ever-more exacting standards and wider application. It is far from easy however to establish individual autonomy - informed choice, in the dominant liberal political model - as such a value. Nor does the model of individual choice illuminate in any useful way the medical sphere, one largely of public goods, public standards, public provision public policies.
In the absence of a very plausible theoretical justification for informed consent procedures, the identifiable drivers look distinctly unappetizing: bureaucratic pusillanimity, the litigation culture, an imaginative pursuit of an idea that served a different purpose.
So current thinking around issues of consent in bioethics is theoretically unsatisfactory, and demands standards that can't possibly be met. One response would be simply to ignore the gap, and muddle along with practices that fail to meet consent requirements. Another would be to abandon or roll back the informed consent project. Yet another would be to attempt to live up to the standards rigorously - and though doomed to failure anyway, this would be at the cost of ruling out as impermissible a great deal of current treatment and research.
But the authors suggest a more constructive alternative, to rethink the nature of informed consent, to find an account of it that is both more practically feasible and theoretically justifiable. At the heart of this approach they identify a rethinking not of consent, but of information.
"Information" has come increasingly to denote informational content rather than information acts; alongside this, a metaphor of communication as a conduit for informational content has dominated. In this metaphor information is "stuff" that is transferred, stored, exchanged, recorded, shared and so on. This metaphor is not wrong or bad, but it does color and obscure. What is obscured, or even squeezed out, by this metaphor is the idea of communication as an act, representing an engagement between the communicating parties, and with it an important sense that information is context-dependent, norm-dependent and agent-dependent.
In contrast, Manson and O'Neill set out "an agency model of communication ... that locates informed consent in communicative transactions between agents. It provides a framework for a transactional model of informed consent, which emphasizes what is said and what is done both by those who request consent, and by those who respond by giving or refusing their consent." (69) In this way, less elusive ethical principles than that of individual autonomy are allowed to permeate the discourse of informed consent. The standards that are uncontroversially valued in communicative transactions (because they communication itself depends upon them) are familiar ones: honesty, clarity, intelligibility, relevance, comprehension, attention to the needs and abilities of the other party, affirmation of mutual understanding and so on.
This move immediately releases the pressure stoked up by the idea of information as "stuff", according to which informed consent is consent against a backdrop of as much informational content as possible, the more the better, and in which any opportunity for more of it means that consent is not yet properly informed. Instead, focus shifts to how communication takes place, the quality of the communicative transactions, and where it places the agents who take part in it.
This shift of focus makes a difference in other areas of bioethics where galloping demands for standards of consent have dragged consent-seeking into difficulty. Where rights over personal information are regarded as a right over content, then researchers and clinicians become tangled up in difficulties about the possession of information -- as if it were once again, "stuff" -- regardless of its implications or relevance, or how it might be used, or what interests might lie in it. And in this way it leads to an exorbitant and distorted view of obligations with respect to such information, expressed in strenuous theorizing, over-reaching data protection legislation and unwieldy practices.
A refocus on communicative action rather than information content makes it possible to outline clearer and simpler obligations: of confidence, fairness, appropriate use - obligations that directly refer to how people act, rather than indirectly by referring to what may or may not happen to information.
Two final chapters deal with related questions about genetic information (it is not, they argue, to be treated as a special case of information) and trust and accountability in biomedicine (mere accountability should not be permitted to undermine or usurp relations of trust); in both, the idea of information as dynamic communication, exchange, transaction rather than inert "stuff" digs the debate out of a hole, by offering an alternative to the information-as-content metaphor.
This is an ambitious and timely book, one that is up to the job of defying a tide of opinion and practice. It will not turn back that tide on its own, but it represents a compelling and very forcefully-argued move against it. It deserves above all to reach the attention of the policy-makers who for too long have drifted with the tide, and who have allowed a simple idea -- that informed consent can protect patients and research subjects -- to grow unchecked, and sprawl, and collapse under its own unsustainable weight.
© 2008 Daniele Procida
Daniele Procida, Cardiff University School of Medicine
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