Rethinking Informed Consent in Bioethics / Edition 1

by Neil C. Manson, Onora O'Neill

Overview

Informed consent is a central topic in contemporary biomedical ethics. Yet attempts to set defensible and feasible standards for consenting have led to persistent difficulties. In Rethinking Informed Consent in Bioethics, first published in 2007, Neil Manson and Onora O'Neill set debates about informed consent in medicine and research in a fresh light. They show why informed consent cannot be fully specific or fully explicit, and why more specific consent is not always ethically better. They argue that consent needs distinctive communicative transactions, by which other obligations, prohibitions, and rights can be waived or set aside in controlled and specific ways. Their book offers a coherent, wide-ranging and practical account of the role of consent in biomedicine which will be valuable to readers working in a range of areas in bioethics, medicine and law.

Product Details

ISBN-13:	9780521697477
Publisher:	Cambridge University Press
Publication date:	03/29/2007
Edition description:	New Edition
Pages:	228
Product dimensions:	6.34(w) x 8.94(h) x 0.55(d)

About the Author

Neil C. Manson is Lecturer in Philosophy at the Institute for Philosophy and Public Policy, Lancaster University.

Onora O'Neill is Professor of Philosophy at the University of Cambridge. Her most recent publications include A Question of Trust: The BBC Reith Lectures 2002 (2002) and Autonomy and Trust in Bioethics (2002).

Read an Excerpt

Cambridge University Press
9780521874588 - Rethinking Informed Consent in Bioethics - by Neil C. Manson and Onora O’Neill
Excerpt

CHAPTER 1
Consent: Nuremberg, Helsinki and beyond

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.¹ 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 medicalinformation 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. We begin with an overview of ways in which conceptions of informed consent and its role have developed in biomedicine. In this chapter we sketch changes in received views of the scope, the standards, the justification and the regulatory use of informed consent. All four have been transformed over the last thirty years.

These changes are generally seen as improvements. We shall argue that the quest for wider scope, for higher standards, for better justifications and for regulatory reinforcement, which aimed to make consent the lynchpin of biomedical ethics, has created intractable problems. We do not conclude that informed consent is unimportant in biomedicine, or that there is a case for reverting to a paternalistic medical or research culture. Rather we argue that received views of informed consent and of its role in biomedicine need fundamental rethinking.

BEGINNING AT NUREMBERG

The Nuremberg Code of 1947 is generally seen as the first authoritative statement of consent requirements in biomedical ethics. The issues that it was designed to settle were stark and horrifying. Human beings had been callously abused and murdered in the name of medical research, both in pre-war Nazi Germany and subsequently in the concentration camps.² During the Nuremberg trials of the doctors charged with these crimes, the defence argued that the Nazi experiments had been no worse than medical research elsewhere. The Code was drafted to help the prosecution by setting out some of the differences. It asserts emphatically that in all research on human beings: ‘The voluntary consent of the human subject is absolutely essential.’³ It glosses the phrase ‘voluntary consent’ in these words:

This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision. This latter element requires that before the acceptance of an affirmative decision by the experimental subject there should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonably to be expected; and the effects upon his health or person which may possibly come from his participation in the experiment.⁴

The Nuremberg Code’s reasons for requiring ‘voluntary consent’ echo those traditionally offered by political philosophers for grounding the obligations of citizens in consent. The basic idea of the social contract tradition can be encapsulated in the old tag volenti non fit iniuria: no injury is done where the subject is willing. The Nuremberg Code elaborates this thought in a quite traditional way by viewing informed consent as providing assurance and evidence that there has been no ‘force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion’. Codes don’t usually offer explicit justifications, but we can find in the text of the Nuremberg Code an appeal to these widely accepted ethical standards, which would form part of virtually any ethical system or outlook. In effect, the Code forbids research that is based on overwhelming or undermining the will, or on forcing the body. Hence it forbids research on those who lack ‘sufficient knowledge and comprehension of the elements of the subject matter involved … to make an understanding and enlightened decision’, and forbids force and duress of all sorts. However, the Code says nothing more explicit about consent, and never mentions information or autonomy.

Contemporary discussions insist that informed consent should play a wider role in biomedicine than was envisaged at the time of the Nuremberg Code. Informed consent requirements have been extended from research to clinical ethics, and standards for seeking and giving informed consent have been made more explicit and more demanding. The justifications given for requiring informed consent have supposedly been strengthened by appeals to various conceptions of autonomy. Finally, informed consent requirements have been extended from medical treatment and research to the secondary use of information and tissues, by incorporating them into the regulation governing data protection, uses of human tissues and genetic technologies. Each of these four developments creates significant problems, which we discuss in the following sections of this chapter.

EXTENDING SCOPE: FROM RESEARCH ETHICS TO CLINICAL ETHICS

Contemporary discussions of informed consent in biomedicine may have started with the Nuremberg focus on research ethics, but they are now taken to apply equally to clinical ethics. The transformation of medical ethics that began in the late 1960s, and has continued since then, seeks to protect patients by requiring their consent for all medical interventions. This was often justified by claiming that it was important not to treat patients paternalistically, on the basis of a physician’s estimate of their best interests, and that informed consent requirements would ensure that the patient rather than the doctor was in control.

The extension of informed consent requirements from research ethics to clinical practice proved highly problematic from the start. The Nuremberg Code demands that research not be done without informed consent: this is a coherent requirement.⁵ A parallel demand that medical treatment not be given without the patient’s informed consent is clearly unacceptable. Patients who cannot give informed consent can hardly be denied treatment, and medical ethics cannot parallel research ethics by making informed consent a universal, or even a normal, requirement.

This is not a minor problem.⁶ Incompetence and impaired competence to consent are more common in medical practice than elsewhere, since impaired cognitive capacities are a common effect of illness and injury. Very many patients are unconscious or too ill, cognitively impaired or mentally confused, too young or too frail to grasp the relevant information, so cannot give informed consent to their medical treatment. Few of them are likely to (re)gain competence in time to consent. Even those ‘in the maturity of their faculties’⁷ find it hard to grasp information about complex diagnoses or treatments, or severe outcomes. They may ignore or fail to grasp information they are given, mistakenly dismiss important information as routine or trivial, or react to routine information with misplaced or disproportionate dread or fear. Mustering the cognitive grasp and emotional strength to give or refuse informed consent to complex or threatening proposals taxes even the most competent of us. These problems have become more intractable as medical interventions have become more complex, thereby adding to the cognitive demands of giving informed consent.

A vast and often repetitive literature, as noted above, has addressed these unpromising realities by using two strategies. Some writers argue that supposedly near alternatives to consent, such as proxy consent or hypothetical consent, can justify interventions where patients lack (full) competence to consent. In doing so they come close to disregarding or short-changing the very standards to which proponents of consent requirements aspire: actual consent is set aside in favour of somebody else’s consent, or of consent that might be given under different conditions, or by somebody with different capacities. Others propose ways of making consenting easier and more user-friendly for marginally competent patients, for example by improving procedures for providing information (e.g., better information leaflets) or by using intermediaries (e.g., counsellors) to help those whose capacities are challenged.⁸ Unfortunately gaps between actual cognitive and decision-making capacities and the capacities needed for informed consent to proposed action often cannot be bridged by these methods. Attempts to make informed consent the guiding principle of medical ethics have proved, and are bound to prove, uphill work.

RAISING STANDARDS: EXPLICIT AND SPECIFIC CONSENT

Contemporary discussions of informed consent requirements not only extend their scope from research to medical practice, but seek to raise standards. The Nuremberg standards were open to a range of criticisms. Was it enough to ensure that research subjects – or for that matter patients – ‘have legal capacity to give consent’ and are ‘so situated as to be able to exercise free power of choice’? Or were these requirements too weak, or too vague? On a natural reading, tacit or implicit consent would meet these standards, provided that those to whom it was ascribed had legal capacity and could exercise ‘free power of choice’. And were the standards clear enough to ensure that those whose consent was sought understood what they were consenting to? The Code requires only that anyone whose consent is sought should have ‘sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision’. It does not require that they actually make ‘an understanding and enlightened decision’. Should adequate standards for informed consent in biomedicine be clearer about the level of information to be provided and understood, and about the quality of the consent actually given?

Once again discussions of standards for consent to research interventions led the way. Contemporary discussions of research ethics commonly refer not to the Nuremberg Code but to successive versions of the Declaration of Helsinki, and to a range of congruent conventions and reports.⁹ The most recent version of the Declaration of Helsinki, approved in 2004, sets out strict and strong requirements for (highly) explicit and (fairly) specific consent. Similar demands are often set out in other codes for research ethics.

The relevant articles of the Declaration of Helsinki read:

20. The subjects must be volunteers and informed participants in the research project.

22. In any research on human beings, each potential subject must be adequately informed of the aims, methods, sources of funding, and any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and potential risks of the study and the discomfort it may entail. The subject should be informed of the right to abstain from participation in the study or to withdraw consent to participate at any time without reprisal. After ensuring that the subject has understood the information, the physician should then obtain the subject’s freely given informed consent, preferably in writing. If the consent cannot be obtained in writing, the non-written consent must be formally documented and witnessed.

Setting aside the Declaration’s careless habit of conflating physicians with researchers, we can see that it promulgates more exacting standards and processes for seeking and obtaining informed consent from research subjects than those set out in the Nuremberg Code. In effect, Helsinki 2004 requires researchers to use explicit written and documented procedures in requesting and obtaining consent, and to seek specific consent to envisaged research projects. It repeatedly emphasises the information that researchers are to provide to research subjects. It goes beyond the Nuremberg demand that research subjects grasp in a general way what is proposed, and its likely effects and risks for them, and requires researchers to inform them about a range of scientific and institutional matters, including ‘the aims, methods, sources of funding, and any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and potential risks of the study’. Asking research subjects to grasp this complex of scientific and institutional information is highly demanding, even in the ‘best’ case where highly competent research subjects are recruited for a prospective study. And some seek to raise the standards even higher.¹⁰

These standards may demand too much. Many research subjects fail to understand common features of prospective research design, such as the use of randomised trials and placebos.¹¹ Where they fail, their consent will not meet the Helsinki standards. Does this show that such research should not be done? In other cases, where research is not prospective, but rather based on further analysis of existing data or tissues, it is even harder – indeed often impossible – to see how Helsinki standards could be applied. Research proposals for secondary data analyses, population studies or epidemiological investigations may not be formulated until well after information was recorded or the tissues were removed. The ‘research subjects’ (if that is how they are best thought of) would have to be recontacted if explicit and specific prior consent were required. Doing so is often impossible. Does this show that retrospective research should not be done, because it cannot meet the Helsinki standards? If it does, and we prohibit all research that does not meet the Helsinki standards, many sorts of medical research will not pass muster and will have to be abandoned.

The quest for higher standards for informed consent has also become vigorous in clinical ethics. In the very years in which some have tried to make consenting easier in order to accommodate patients’ cognitive limitations, others have tried to make it more exacting. The desire to make consent and consenting rigorous is understandable, but has raised many problems. Even if past standards had been good enough – and there may be reasons to doubt that they were – the growing complexity both of the information relevant to specific clinical interventions and research protocols and of their medical and scientific settings, may now require more exacting procedures.¹² However, simultaneous attempts to make informed consent easier for patients and to make it more exacting are likely to backfire.

In effect attempts to make informed consent more rigorous argue for two distinct types of improvement. They claim that acts of consenting should be explicit, rather than implied (tacit, presumed), and they claim that adequate consent should be specific rather than generic (general). In effect, they generalise the position taken in the Declaration of Helsinki, and extend it from research into clinical practice. Demands for explicit and specific consent may have started in research ethics, but have now penetrated into clinical practice, into medical ethics and into regulatory requirements. One result has been the development of increasingly complex, lengthy and (at worst) incomprehensible consent forms – and a large literature lamenting the fact!

The distinction between explicit and implied consent contrasts ways of consenting. Explicit consenting is a two way process. Those who request consent must provide an explicit statement of the nature and purposes of a proposed course of action, its effects, risks and other features, to those whose consent is sought. Those who are asked to consent must show explicitly that they understand

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© Cambridge University Press

Table of Contents

1. Consent: Nuremburg, Helsinki and beyond; 2. Information and communication: the drift from agency; 3. Informing and communicating: back to agency; 4. How to rethink informed consent; 5. Informational privacy and data protection; 6. Genetic information and genetic exceptionalism; 7. Trust, accountability and transparency; Some conclusions and proposals.

Editorial Reviews

"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 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." - Metapsychology Online Reviews

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