There are many ethical, legal and regulatory issues surrounding the acquisition, possession and use of genetic information. But what is genetic information, and why and when do such issues arise? Here the aim is to provide something by way of an answer to these questions, and I will do so by focusing on whether certain regulatory instruments that apply to the use of personal information ought to apply to archives or collections of human tissues, in so far as such samples – including blocks, slides and other artefacts – contain genetic information.

Human tissue samples are acquired and stored for a variety of good reasons: for example, as part of a process of individual diagnosis, or as part of a forensic investigation or autopsy. Samples may also be taken and stored for teaching and training purposes, or as part of clinical audit and performance assessment, and so on. In the UK – which is to be our focus – actions involving human tissue fall under the regulatory scope of the Human Tissue Act 2004 (HTA04). But most human tissue samples contain genetic material and genetic material is standardly assumed to contain genetic information, including personal information about the source of the tissue: information about their current or future state of health, for example. In the UK the legal instrument that pertains to the storage and use of personal information is the Data Protection Act 1998 (DPA98). DPA98 specifies a range of obligations upon those responsible – typically in institutions – for the acquisition, storage or use of certain types of information.

We have argued that current thinking about informed consent is problematic, and that we need to rethink the part that it can play in biomedical practice. But how exactly should we go about this? One approach would be to focus first on the underlying ethical justifications for such demanding consent requirements. We might, for example, raise questions about the coherence of putting so much weight on respect for individual autonomy in biomedical ethics. Or we might, if we were of a consequentialist bent, focus on the costs and implications of current informed consent procedures and argue that in certain cases their costs outweigh their benefits.

Our preferred, rather more radical, approach is to expose ways in which current thinking about informed consent rests upon a distorted conception of the nature and significance of information and communication. In fact, we shall argue, there are two different kinds of distortion implicit in current thinking about informed consent. One distortion derives from reliance on autonomy-based justifications for informed consent; we postpone discussion of these issues until Chapter 4. The second, more general distortion derives from the metaphorical framework that we use to think and talk about information and communication. Contemporary thinking about information hides and downplays many important aspects of communication and information, including the fact that communicating and informing are types of action and interaction, so depend on a normative framework against which such action succeeds or fails.

INTRODUCTION

Informed consent has a long and distinguished history in liberal political theory and economic thought that goes back to the great debates of the European Enlightenment. The core of the social contract tradition is the claim that freely given consent legitimates action that would otherwise be unacceptable, and in particular the use of coercive power by governments. The basic arguments for market economics appeal to the moral legitimacy of consensual transactions, and contrast them with illegitimate economic transactions based on force, coercion or fraud, such as theft, confiscation and forced labour. These traditional claims have been reworked and reinvigorated in the last thirty years in influential revivals of liberal contractualism in political philosophy and of market thinking in economics.

These debates in politics and economics have been paralleled in biomedical ethics, where informed consent has come to play a larger and larger part, and is now the most discussed theme in Western medical ethics and research ethics. Informed consent procedures have been embedded in clinical and research practice, and in a range of legislative and regulatory regimes that govern the use of personal and medical information and human tissues. Appeals to informed consent and its role in justifying clinical and research practice are now so well entrenched that their presence, indeed their necessity, and their justification are rarely questioned.

In this book we raise a number of questions about standard views of the role of informed consent in biomedical ethics.

Informed consent is the most discussed, indeed the most hackneyed, theme in bioethics. Yet many widely accepted accounts of informed consent are riddled with problems. They offer justifications that are less than convincing, and set standards that are less than feasible. In this book we have proposed a new way of thinking about informed consent. We believe that our approach offers a more convincing account of informed consent, of reasons why it matters and of standards it should meet.

We looked first at widely accepted accounts of informed consent requirements, and found that they typically propose exaggerated and impractical standards. Unsurprisingly these standards are routinely flouted and ignored in biomedical practice. While some ‘failures’ arise because clinicians and researchers do not live up to standards that they could have met, many arise because the standards advocated propose – or presuppose – inaccurate, excessive or even impossible views of informing and consenting. We identified three possible responses to these mismatches between aspirations and realities.

The first response would be to look for lower, more practicable, standards that could be satisfied either by current practices, or by making feasible changes in those practices. The second would be to reaffirm current standards and continue with current clinical and research practices, in the full knowledge that practice and standards diverge, and that there is no prospect of patching matters up by introducing a few favoured ‘improvements’.

We began rethinking informed consent by arguing that it is best viewed as a distinctive kind of communicative transaction, which agents may use to waive ethical and legal requirements in specific ways. For example, consent procedures can be used to waive norms that prohibit invasive action, thereby permitting medical treatment and research participation. Without ways of setting aside general prohibitions on invasive action, both medical treatment and research would be severely restricted. Patients would go without care; medical research would generally be impossible.

In this chapter we turn to the ways in which informed consent can be used to waive prohibitions on action that would otherwise be intrusive rather than invasive. Where invasive action violates either others' bodily integrity (it may force or restrain, injure or harm, even mutilate, poison or kill), or their liberty or property (it may threaten, enter, steal, damage or destroy property), intrusive action, by contrast, infringes a specific range of liberty rights, often referred to as privacy rights. There are many conceptions of privacy, and of privacy rights. For example, in the US discussions of privacy rights are often viewed very broadly as encompassing the liberty rights that protect individuals against invasive action, and have classically been seen as elements of a ‘right to be let alone’. In public debate in the UK privacy is typically understood in a more restricted way, as a right against action that is intrusive, but may not be invasive (consequently many of the actions characterised as invasions of privacy in US debates are seen in Millian terms as violations of liberty rather than of privacy in the UK).

Informed consent is now widely seen as fundamental to medical and research ethics. This has not always been the case. Informed consent first rose to prominence in biomedical practice with the Nuremberg Code of 1947, which responded to the abusive treatment of human beings by Nazi medical researchers. Consent requirements were subsequently extended from research to clinical ethics, and more recently to procedures regulating the acquisition, possession and use of personal information, including genetic and medical information. Across the last fifty years informed consent requirements have also supposedly been made more rigorous: standards for ‘consent disclosures’ are now more exacting; demands for more explicit and more specific consent are widely endorsed; ever more elaborate consent forms are increasingly devised and required. This huge expansion and elaboration of informed consent requirements is generally seen as indispensable if we are to respect individual autonomy. Informed consent, it is argued, ensures that patients and research subjects can decide autonomously whether to permit or refuse actions that affect them.

Yet current approaches to informed consent have led to many problems. If patients and research subjects consent without reading or understanding informed consent ‘disclosures’ – and it is clear that they do – is their consent inadequate? If consent ‘disclosures’ omit certain information – and it is clear that they do – is consent given on the basis of such disclosures inadequate? Should we forbid medical treatment and research whenever informed consent is defective?

We have seen that the conduit and container metaphors emphasise some elements of information and communication whilst downplaying others. We suggested that this happens when we rely too much on conceptions of ‘information’ that are detached from action. A ‘drift from agency’ easily happens if we think of information as a kind of quasi-spatial semantic stuff – stuff that is about things – that can be possessed, conveyed, disclosed, acquired, used, and so on. In Chapter 2 we exposed the ‘highlighting’ and ‘hiding’ effects of these metaphors; in this chapter we aim to say something more about the key elements and aspects of communication that tend to be ‘hidden’ by incautious use of the conduit and container metaphors. By the end of this chapter we will have two ‘models’ of information and communication in play: the conduit/container model and what we shall call ‘the agency model’. We hope then to be well placed to rethink informed consent, and to discuss certain other normative questions that bear on ‘informational’ issues.

AGENCY

There are many kinds of communicative behaviour, and we shall not discuss the full range. For example, we shall not discuss unintentional communication, important as it often is. The clothes that we wear, our posture, certain hand gestures or movements of the eyes may be viewed as ‘communicating’ something about our social status, our interests, our emotional states, our trustworthiness, and so on. The person wearing no-longer-fashionable shoes may not intend to communicate anything at all by wearing them.

CONSENT, PATERNALISM AND TRUST

Informed consent cannot, we have argued, serve as an ethical panacea in biomedicine. It is inapplicable where public rather than private goods are to be provided. It fails where individual capacities to consent are not adequate for grasping the relevant information. Even where capacities are adequate, it fails where consent transactions are defective; and consent transactions can fail in many ways. These failures are exacerbated rather than remedied by attempts to set higher and supposedly better standards for consent, for example, by gesturing to excessive and impractical conceptions of ‘fully explicit’ or ‘fully specific’ consent. The difficulties cannot be remedied by invoking implausible or ungrounded conceptions of individual autonomy or of informational privacy.

These realities cast a sobering light on attempts to make informed consent the key to justifiable clinical and research interventions. Where consent transactions fail, any ostensible consent will be bogus; and bogus consent can offer only bogus justification. Even when more limited forms of consent can be sought and given, they will not by themselves provide a sufficient ethical justification. Since consent works by waiving other norms and standards in specific ways for specific purposes, it has to be understood against the background of a wider range of normative standards, including ethical standards. Informed consent is never more than a part of any justification for medical and research interventions.

These are challenging conclusions. If informed consent can play only a limited part in justifying clinical or research practice, we face serious problems.