Neil Manson and Onora O’Neill have recently defended an original theory of informed consent in their book Rethinking Informed Consent in Bioethics (2007). The development of their ‘waiver’ model is premised on the failings of the theory of informed consent as disclosure, which is rejected on two counts: firstly, the disclosure model’s implicit reliance upon a ‘conduit-container’ model of communication means that the regulatory requirements of informed consent can rarely be achieved; secondly, the model’s purported ethical justification via a principle (...) of respect for patient autonomy is presented as being vacuous. Despite having laudable motivations for rethinking informed consent, I argue that their theory of informed consent as waiver can be criticised on similar grounds. In order to support this thesis I object that Manson and O’Neill’s developed theory of agential communication is too intricate to easily meet the demands of informed consent as waiver. Secondly, I show that the model appears to be implicitly reliant upon a principle of respect for patient autonomy. Hence, despite improving upon the doctrine of informed consent, the waiver model needs further elucidation in order to avoid the problems mounted against the disclosure model. (shrink)

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 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. (shrink)

In June 1995, the Italian code of medical ethics was revised in order that its principles should reflect the ever-changing relationship between the medical profession and society and between physicians and patients. The updated code is also a response to new ethical problems created by scientific progress; the discussion of such problems often shows up a need for better understanding on the part of the medical profession itself. Medical deontology is defined as the discipline for the study of norms of (...) conduct for the health care professions, including moral and legal norms as well as those pertaining more strictly to professional performance. The aim of deontology is therefore, the in-depth investigation and revision of the code of medical ethics. It is in the light of this conceptual definition that one should interpret a review of the different codes which have attempted, throughout the various periods of Italy's recent history, to adapt ethical norms to particular social and health care climates. (shrink)

The Italian code of medical deontology recently approved stipulates that physicians have the duty to inform the patient of each unwanted event and its causes, and to identify, report and evaluate adverse events and errors. Thus the obligation to supply information continues to widen, in some way extending beyond the doctor-patient relationship to become an essential tool for improving the quality of professional services.

The principle of informed consent obligates physicians to explain possible side effects when prescribing medications. This disclosure may itself induce adverse effects through expectancy mechanisms known as nocebo effects, contradicting the principle of nonmaleficence. Rigorous research suggests that providing patients with a detailed enumeration of every possible adverse event—especially subjective self-appraised symptoms—can actually increase side effects. Describing one version of what might happen (clinical “facts”) may actually create outcomes that are different from what would have happened without this information (another (...) version of “facts”). This essay argues that the perceived tension between balancing informed consent with nonmaleficence might be resolved by recognizing that adverse effects have no clear black or white “truth.” This essay suggests a pragmatic approach for providers to minimize nocebo responses while still maintaining patient autonomy through “contextualized informed consent,” which takes into account possible side effects, the patient being treated, and the particular diagnosis involved. (shrink)

This contribution deals with the issue of the professional autonomy ofthe medical doctor. Worldwide, the physician's autonomy is guaranteedand limited, first of all, by Codes of Medical Ethics. InItaly, the latest version of the national Code of MedicalEthics (Code 1998) was published in 1998 by the Federation ofprovincial Medical Associations (FnomCeO). The Code 1998acknowledges the physician's autonomy regarding the scheduling, thechoice and application of diagnostic and therapeutic means, within theprinciples of professional responsibility. This responsibility has tomake reference to the following (...) fundamental ethical principles:(1) the protection of human life; (2) the protection of thephysical and psychological health of the human being; (3) therelief from pain; (4) the respect for the freedom and the dignityof the human person, without discrimination; (5) an up-to-datescientific qualification (Art. 5). The authors underline that autonomyis an anthropological – and consequently ethical –characteristic of the human person. Different positions on autonomy inbioethics (individualistic, evolutionistic, utilitarian andpersonalistic models) are explained. The relation between theprofessional autonomy of the physician and the autonomy of the patientand of colleagues is discussed. In fact, the medical doctor isobliged: (1) to respect the fundamental rights of the person,first of all his/her life; (2) to ensure the continuity of thecare, even if he can only relieve the patient's suffering; (3) tomaintain, except under certain circumstances, professional secrecy andconfidentiality regarding patients and their medical records. Moreover,the physician cannot deny the patient correct and appropriateinformation. He/she should not perform any diagnostic or therapeuticactivity without the informed consent of the patient and the medicaldoctor must give up medical treatment in case of documented refusal ofthe individual. Furthermore, the medical doctor has the right to raiseconscientious objections if he/she is requested to perform medicalactions that are contrary to his/her conscience or medical opinion,unless this attitude would seriously and immediately harm the patient.Regarding the relationships with colleagues, the physician is obliged tosolidarity, mutual respect, and care of sick colleagues. Finally, theauthors discuss the Italian legislation affecting the physician'sprofessional autonomy: (1) the SSN health care Acts; (2) theso-called Charter for Public Health Care Services; (3) the Acts onprivacy; (4) Good Clinical Practice. (shrink)