Rethinking Informed Consent in Bioethics

  • By Neil C. Manson

    By Onora O'Neill

  • Publisher: Cambridge University Press

    Online Publication Date:June 2012

    Online ISBN:9780511814600

    Hardback ISBN:9780521874588

    Paperback ISBN:9780521697477

  • Book DOI:

    Subjects: Ethics

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.


"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

'This is a ground-breaking book. The idea that information is dynamic, that what, in this genetic age, even comprises information, receives intelligent, thorough, and necessary reflection. The focus on the activity of communicating as opposed to what is being communicated holds great promise. Such a move opens up a perspective where obligations do not attach a priori to certain kinds of information, but to the manner in which actual engagement with such information occurs. This begins to get at a complexity, in the area of informed consent, that has been missed.' Mark Sheldon, Professor of Philosophy, Northwestern University

Reference Title: Bibliography

Reference Type: bibliography

Reference Type: bibliography

Annas, G. J., Glantz, L. H. and Roche, P. A., 1995, ‘Drafting the Genetic Privacy Act: Science, Policy, and Practical Considerations’, Journal of Law and Medical Ethics 23, 360–6.
Annas, G. and Grodin, M., 1992, The Nazi Doctors and the Nuremberg Code, Oxford: Oxford University Press.
Anscombe, Elizabeth, 1957, Intention, Oxford: Blackwell.
Austin, J. L., 1962, How to Do Things With Words, Oxford: Clarendon Press.
Austin, J. L., 1962, Collected Philosophical Papers, Oxford: Clarendon Press.
Baier, Annette, 1986, ‘Trust and Anti-Trust’, Ethics, 96, 231–60.
Baier, Annette, 1991, ‘Trust’, Tanner Lectures on Human Values, vol. 13, Salt Lake City: University of Utah Press.
Beauchamp, Tom L., and Childress, James F., 1994, Principles of Biomedical Ethics, 4th edn, New York: Oxford University Press.
Bennett, Colin J., 1992, Regulating Privacy: Data Protection and Public Policy in Europe and the United States, Ithaca, NY: Cornell University Press.
Berg, Paul, and Singer, Maxine, 1992, Dealing with Genes: The Language of Heredity, Mill Valley, CA: University Science Books.
Beyleveld, Deryck, and Brownsword, Roger, 2001, Human Dignity in Bioethics and Biolaw, Oxford: Oxford University Press.
Blakemore, Colin, 2005, ‘Cultivating a thousand flowers’, Journal of the Foundation for Science and Technology, 18, 10–11.
Brody, B., 1998, The Ethics of Biomedical Research: an International Perspective, New York: Oxford University Press.
Brownsword, Roger, 2004, ‘The Cult of Consent: Fixation and Fallacy’, King's College Law Journal, 15, 223–51.
Buchanan, Allen, 1978, ‘Medical Paternalism’, Philosophy and Public Affairs, 7, 70–390.
Burleigh, Michael, 1994, Death and Deliverance: ‘Euthanasia’ in Germany, c.1900–1945, Cambridge: Cambridge University Press.
Burleigh, Michael, 1997, Ethics and Extermination: Reflections on Nazi Genocide, Cambridge: Cambridge University Press.
Burton, Hilary, 2003, Addressing Genetics Delivering Health: A Strategy for Advancing the Dissemination and Application of Genetics Knowledge Throughout our Health Professionals, Cambridge: Public Health Genetics Unit.
Callahan, Daniel, 1996, ‘Can the Moral Commons Survive Autonomy?’, Hastings Center Report, 26, 41–2.
Carey, James, 1990, Communication as Culture, New York: Routledge.
Carlson, Robert V., Boyd, Kenneth M., and Webb, David J., 2004, ‘The Revision of the Declaration of Helsinki: Past, Present and Future’, British Journal of Clinical Pharmacology, 57, 695–713.
Christman, John, 1988, ‘Constructing the Inner Citadel: Recent Work on the Concept of Autonomy’, Ethics, 99, 109–24.
Christman, John, ed., 1989, The Inner Citadel: Essays on Individual Autonomy, New York: Oxford University Press.
Coady, C. A. J., 1992, Testimony: A Philosophical Study, Oxford: Clarendon Press.
Cox, K., 2002, ‘Informed Consent and Decision-making: Patients’ Experiences of the Process of Recruitment to Phases I and II Anti-cancer Drug Trial', Patient Education and Counselling, 46 (1), 31–8.
Crick, Francis, 1958, ‘On Protein Synthesis’, Symposium of the Society of Experimental Biology, 12, 138–63.
Crick, Francis, 1970, ‘Central Dogma of Molecular Biology’, Nature, 227, 561–3.
Dalla-Vorgia, P., Lascaratos, J., Skiadia, P., and Garanis-Papadotos, T., 2001, ‘Is Consent in Medicine a Concept Only of Modern Times?’, Journal of Medical Ethics, 27 (1), 59–61.
Dawson, Angus, 2004, ‘What Should We Do About It? Implications of the Empirical Evidence in Relation to Comprehension and Acceptability of Randomisation?’, in Holm, S. and Jonas, M., eds., Engaging the World: The Use of Empirical Research in Bioethics and the Regulation of Biotechnology, Netherlands: IOS Press, pp. 41–52.
Day, Ronald E., 2000, ‘The “Conduit Metaphor” and The Nature and Politics of Information Studies’, Journal of the American Society for Information Science, 9, 805–11.
Descartes, Rene, 1988, Rules for the Direction of our Native Intelligence, in Selected Philosophical Writings, ed. and trans. Cottingham, J., Stoothoff, R., and Murdoch, D., Cambridge: Cambridge University Press.
Dretske, Fred, 1981, Knowledge and the Flow of Information, Cambridge, MA: MIT Press.
Dworkin, Gerald, 1972, ‘Paternalism’, The Monist, 56, 64–84.
Eckstein, Sue, ed., 2003, Manual for Research Ethics Committees, 6th edn, Cambridge: Cambridge University Press.
Elster, Jon, 1989, The Cement of Society: A Study of Social Order, Cambridge: Cambridge University Press.
Faden, Ruth R., and Beauchamp, Tom L., 1986, A History and Theory of Informed Consent, New York: Oxford University Press.
Fiske, John, 1990, Introduction to Communication Studies, 2nd edn, London: Routledge.
Fletcher, George P., 1996, Basic Concepts of Legal Thought, Oxford: Oxford University Press.
Fukuyama, Francis, 1995, Trust: The Social Virtues and the Creation of Prosperity, New York: Free Press.
Geach, Peter, 1965, ‘Assertion’, Philosophical Review, 74, 4, 449–65.
Godard, Raeburn et al., 2003, ‘Genetic Information and Testing in Insurance and Employment: Technical, Social and Ethical Issues’, European Journal of Human Genetics 11, 123–142.
Gostin, L. O., 1995, ‘Genetic privacy’, Journal of Law and Medical Ethics, 23, 320–30.
Griffiths, Anthony J. F., et al., 2000, An Introduction to Genetic Analysis, New York: W. H. Freeman.
Griffiths, P. E., and Gray, R. D., 2004, ‘Developmental Systems and Evolutionary Explanation’, Journal of Philosophy, 91, 277–304.
Hardwig, John, 1985, ‘Epistemic Dependence’, Journal of Philosophy, 82, 335–49.
Hardwig, John, 1991, ‘The Role of Trust in Knowledge’, Journal of Philosophy, 88, 693–708.
Hayes, Brian, 1998, ‘The Invention of the Genetic Code’, American Scientist, 86, 8–14.
Hill, Thomas E., Jnr, 1992, ‘The Kantian Conception of Autonomy’, in Hill, Thomas E., Jnr, Dignity and Practical Reason, Ithaca, NY: Cornell University Press, pp. 76–96.
Holton, Richard, 1994, ‘Deciding to Trust, Coming to Believe’, Australasian Journal of Philosophy, 72, 63–76.
Jones, James H., 1993, Bad Blood: The Tuskegee Experiment, New York: Free Press.
Jones, Karen, 1996, ‘Trust as an Affective Attitude’, Ethics, 107, 4–25.
Kant, Immanuel, 1996, Critique of Practical Reason, in Kant, Immanuel, Practical Philosophy, tr. Gregor, Mary, Cambridge: Cambridge University Press.
Kass, Leonard R., 2002, Life, Liberty and the Defence of Dignity: The Challenge for Bioethics, New York: Encounter Books.
Kay, Lily E., 2000, Who Wrote the Book of Life: A History of the Genetic Code, Stanford, CA: Stanford University Press.
Kegley, J. A., 2002, ‘Genetics Decision-making: a Template for Problems With Informed Consent’, Medical Law 21(3), 459–71.
Kleinig, John, 1983, Paternalism, Manchester: Manchester University Press.
Lakoff, George, and Johnson, Mark, 1980, Metaphors We Live By, Chicago: University of Chicago Press.
Laurie, Graeme T., 2002, Genetic Privacy: A Challenge to Medico-Legal Norms, Cambridge: Cambridge University Press.
Liddell, Kathleen, and Hall, Alison, 2005, ‘Beyond Bristol and Alder Hey: The Future Regulation of Human Tissue’, Medical Law Review 15, 170–223.
Manson, Neil C., 2006, ‘What is Genetic Information and Why is it Significant? A Contextual, Contrastive Approach’, Journal of Applied Philosophy 23, 1–16.
Maynard Smith, John, 2000, ‘The Concept of Information in Biology’, Philosophy of Science, 67, 177–94.
Mill, John Stuart, 1962, On Liberty, London: Fontana.
Mill, John Stuart,1989, On Liberty, and Other Writings, ed. Collini, Stefan, Cambridge: Cambridge University Press.
Moran, Michael, 2003, The British Regulatory State: High Modernism and Hyper-innovation, Oxford: Oxford University Press.
Moreno, Jonathan D., 2000, Undue Risk: Secret State Experiments on Humans, London: Routledge.
O'Neill, Onora, 2000, ‘Kant and the Social Contract Tradition’, in Duchesneau, François, Lafrance, Guy, and Piché, Claude, eds., Kant Actuel: Hommage à Pierre Laberge, Montreal: Bellarmin, pp. 185–200.
O'Neill, Onora, 2000, The Bounds of Justice, Cambridge: Cambridge University Press.
O'Neill, Onora, 2002, Autonomy and Trust in Bioethics, Cambridge: Cambridge University Press.
O'Neill, Onora, 2003, ‘Autonomy: The Emperor's New Clothes, The Inaugural Address’, Proceedings of the Aristotelian Society, supp. vol. 77, 1–21.
O'Neill, Onora,2004, ‘Self-Legislation, Autonomy and the Form of Law’, in Recht, Geschichte, Religion: Die Bedeutung Kants für die Gegenwart, eds. Nagl-Docekal, Herta, and Langthaler, Rudolf, Sonderband der Deutschen Zeitschrift für Philosophie, Berlin: Akademie Verlag, pp. 13–26.
O'Neill, Onora, 2004, ‘Informed Consent and Public Health’, Philosophical Transactions: Biological Sciences, vol. 359, no. 1447, 1133–6.
O'Neill, Onora, 2005, ‘The Dark Side of Human Rights’, International Affairs, 81, 427–39.
O'Neill, Onora,2006, ‘Transparency and the Ethics of Communication’, in Transparency: The Key to Better Governance?, eds. Heald, David, and Hood, Christopher, Proceedings of the British Academy 135, Oxford: Oxford University Press, pp. 75–90.
Oyama, Susan, 2000, The Ontogeny of Information, 2nd edn, Durham, NC: Duke University Press.
Parent, W. A., 1983, ‘Privacy, Morality and the Law’, Philosophy and Public Affairs, 12, 269–88.
Phillipson, Gavin, 2003, ‘Transforming Breach of Confidence? Towards a Common Law Right of Privacy under the Human Rights Act’, Modern Law Review 66, 726–58.
Phillipson, Gavin and Fenwick, Helen, 2000, ‘Breach of confidence as a Privacy Remedy in the Human Rights Act Era’, Modern Law Review, 63, 660–93.
Power, Michael, 1994, The Audit Explosion, London: Demos.
Power, Michael, 1997, The Audit Society: Rituals of Verification, Oxford: Oxford University Press.
Power, Michael, 2004, The Risk Management of Everything: Rethinking the Politics of Uncertainty, London: Demos.
Putnam, Robert, 1995, ‘Bowling Alone: America's Declining Social Capital’, The Journal of Democracy, 6, 65–78.
Putnam, Robert, 2000, Bowling Alone: The Collapse and Revival of American Community, New York: Simon & Schuster.
Raymont, Vanessa, et al., 2004, ‘Prevalence of Mental Incapacity in Medical Inpatients and Associated Risk Factors: Cross Sectional Study’, The Lancet, 364, 1421–7.
Reddy, Michael, 1979, ‘The Conduit Metaphor: A Case of Frame Conflict in our Language about Language’, in Ortony, A., ed., Metaphor and Thought, Cambridge: Cambridge University Press, pp. 284–324.
Rhodes, Rosamond, Batting, Margaret P., and Silvers, Anita, eds., 2002, Medicine and Social Justice: Essays on the Distribution of Health Care, New York: Oxford University Press.
Rothstein, Mark A., 2005, ‘Genetic Exceptionalism and Legislative Pragmatism’, Hastings Center Report, 35, 4, 2–8.
Sankar, Pamela, 2003, ‘Genetic Determinism Provides the Foundation of Arguments Supporting Genetic Exceptionalism’, Annual Review of Medicine 54, 393–407.
Sarkar, Sahotra, 1996, ‘Biological Information: A Sceptical Look at Some Central Dogmas of Molecular Biology’, in Sarkar, Sahotra, ed., The Philosophy and History of Molecular Biology: New Perspectives, Dordrecht: Kluwer, pp. 187–232.
Schneider, Carl E., 1998, The Practice of Autonomy, New York: Oxford University Press.
Searle, John, 1969, Speech Acts: An Essay in Philosophy of Language, Cambridge: Cambridge University Press.
Sugarman, Jeremy, et al., 1999, ‘Empirical Research on Informed Consent: An Annotated Bibliography’, Hastings Center Report, Special Supplement, January–February, 1–42.
Thompson, Mark, 1990, ‘Breach of Confidence and Privacy’, in Clarke, Linda, ed., Confidentiality and the Law, London: Lloyds of London, pp. 65–79.
Wacks, Raymond, 1993, Personal Information: Privacy and the Law, Oxford: Clarendon Press.
Warlow, Charles, 2005, ‘Over-regulation of Clinical Research: a Threat to Public Health’, Clinical medicine, 5, 1, 33–8.
Warren, Samuel D., and Brandeis, Louis D., 1890, ‘The Right to Privacy’, Harvard Law Review, 4, 193–220.
Weinreb, Lloyd L., 2000, ‘The Right to Privacy’, in Frankel Paul, Ellen, Miller, Fred D., Jnr., and Paul, Jeffrey, eds., The Right to Privacy, Cambridge: Cambridge University Press.
Welbourne, Michael, 2001, Knowledge, Chesham: Acumen.
Westin, Alan, 1967, Privacy and Freedom, New York: Atheneum.
Weston, J., Hannah, M., and Downes, J., 1997, ‘Evaluating the benefits of a patient information video during the informed consent process’, Patient Education and Counselling, 30 (3), 239–45.
Wilkinson, T. M., 2001, ‘Research, Informed Consent, and the Limits of Disclosure’, Bioethics, 15, 4, 341–63.
Williams, Bernard, 1985, Ethics and the Limits of Philosophy, London: Fontana.
Willis, Rebecca, and Wilsdon, James, 2004, See-through Science: Why Public Engagement Needs to Move Upstream, London: Demos.
Wolpe, P., 1998, ‘The Triumph of Autonomy in American Bioethics’, in Devries, R., and Subedi, J., eds., Bioethics and Society: Constructing the Ethical Enterprise, Englewood Cliffs, NJ: Prentice Hall, pp. 38–59.