Informed Consent and Genetic Information

Abstract

In the last 25 years writing in bioethics, particularly in medical ethics, has generally claimed that action is ethically acceptable only if it receives informed consent from those affected. However, informed consent provides only limited justification, and may provide even less as new information technologies are used to store and handle personal data, including personal genetic data. The central philosophical weakness of relying on informed consent procedures for ethical justification is that consent is a propositional attitude, so referentially opaque: consent is given to specific propositions describing limited aspects of a situation, and does not transfer even to closely related propositions. Assembling genetic data in databases creates additional difficulties for ethical justification. This is not because genetic information is intrinsically exceptional, but because the merger of genetic and information technologies make it possible to assemble massive quantities of complex information that defeat individuals' best efforts to grasp what is at stake, or to give or withhold informed consent. The future agenda for bioethics will need to take account of both these limitations of appeals to informed consent.

Introduction

In the mid 1970s a group of physicians and philosophers met in New York City under the auspices of the Society for Philosophy and Public Affairs to discuss ethical issues raised by the creation of genetically modified organisms: an exotic theme at the time. The topic and the ethical issues discussed were unfamiliar to everybody present. Towards the end of the evening, an elderly doctor remarked—with mild regret—that when he had been at medical school, medical ethics had been more manageable and had covered only referrals, confidentiality and billing. By contrast, we were talking about informed consent and the imposition of risk, about the rights of research subjects and of patients, about designer organisms and the implications of new technologies for human life and the natural environment. The themes that were so new that evening have been formative for medical ethics, and more widely for bioethics, across the subsequent quarter of a century.

I believe that this period of work may now be drawing to a close, and that we can expect rather different themes and philosophical issues to be central in future discussions, and that certain philosophical difficulties that these discussions have constantly shelved rather than resolved over recent years will now command more attention. The basic problem can be stated in simple terms. Bioethics, and more specifically medical ethics, has often viewed action and interventions as ethically acceptable only if they receive the informed consent of those to be affected.¹ Yet this demand will become less and less easy to satisfy if individuals are swamped with information so complex in content and in organisation that few people will be in a position to provide genuinely informed consent, or informed dissent. Yet this is happening in multiple ways.

These problems arise, I shall suggest, not because most members of the public have limited understanding of science, nor because most scientists are poor communicators, but rather because the matters to which consent is sought are more numerous and more complex, and sometimes rendered increasingly opaque by the very structures of accountability that are supposed to protect the public. Even those with a high level of scientific training and culture are challenged by the ways in which information is now organised. The answer to this problem cannot be to provide more information, more regulation and more fine print: there is often all too much information provided, and more fine print around than anyone has time to deal with.

My prime illustration of changes that are now bringing this problem to a head will be the incipient uses of personal genetic data in medical and other practices, and the possibility of presenting, manipulating and using ever larger arrays of genetic data. However, this is only an illustration: many other changes, including the spread of high-tech medicine and the emergence of evidence-based medicine, raise analogous problems for current reliance on informed consent procedures.