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16 HEC F. 1 (2004)

handle is hein.journals/hecforum16 and id is 1 raw text is: HE C FORUM O 2004 Kluwer Academic Publishers. 2004; 16(1): 1-5. Printed in The Netherlands. INTRODUCTION: ON THE EDGES OF INFORMED CONSENT CHRISTOPHER TOLLEFSEN Few concepts are more familiar to medical and research ethicists than that of informed consent. The requirement is relatively easily stated: before engaging in any intervention upon another human being, an agent must inform the patient concerning what she is going to do, and obtain permission from the patient to perform the intervention. Moreover, the practice of obtaining informed consent is one which is now so deeply embedded the world of hospitals, clinics and laboratories that it can almost seem passe; what possible reasons could there still be for discussing informed consent? Appearances to the contrary, there is still much to discuss. For while it is easy enough to identify the paradigm cases of informed consent, and the paradigm cases of its neglect, much else about the concept remains unclear. Onora O'Neill, for example, has recently written that despite 25 years of work on the nature of informed consent, some commonly cited reasons for thinking that informed consent is of great importance are quite unconvincing: informed consent has been supported by poor arguments and lumbered with exaggerated claims (1, p. 4). So there remains a need for work on informed consent that explores the depth of the concept - work that explores its conceptual and normative foundations. There is also, however, and here we must mix metaphors a bit, a need for work at the periphery, or edge of the concept. If there is a map of the paradigm cases, in which an intelligent, sensitive patient is given all the facts, and comes to a reasoned decision to endorse or refuse some suggestion of her doctor, it is still the case that at the margins of the map lie insufficiently charted regions. What, for example, are we to think of informed consent for patients who are less than fully competent, intelligent, or morally sensitive? What of those who will be affected by some medical intervention or research project but who are not yet capable of consent, or perhaps do not even yet exist? What are we to make of the previously and perhaps only partially expressed wishes of those no longer able to express them - did those wishes amount to a consent, or a refusal to consent to some 1

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