Table 1 Two models of informed consent implementation [36, 41]
Dimensions | Event-based model | Process-based model |
|---|---|---|
Time span | The decision must be regarded as an act placed in a limited and short time span, in which the physician provides the patient with all the information about the diagnosis procedure that he/she intends to adopt. The patient will have to accept it or reject it | The decision is determined and defined continuously throughout the time span of the diagnostic process and therefore of the doctor-patient relationship. The consensus is built on the perspective of an active participation by the patient with the medical decision-making |
Procedure | Informed consent is an additional procedure within the unchanged decision-making process | Informed consent is integrated into the doctor-patient relationship as a transverse component to all the aspects of information/communication and the clinical decision-making processes |
Involved actors | The consent can be gathered from any health operator belonging to the involved staff | The consent is collected by the physician who proposes the diagnostic act |
Central focus | The consent form is considered as the backbone of the event model. The importance of providing complete and accurate information that meets most of the legal requirements of the informed consent process is emphasised | The focus of the “process” model is not so much the module itself, but rather a series of information and communicative acts that—together with the module itself—are performed within the diagnostic process |
Interaction | A more bureaucratic interaction is produced, with two consequences: the perception by physicians of a sense of futility; the perception by patients that their real participation in decision-making is neither sought nor important | The model requires that the doctor and patient enter into an ongoing dialogue, which is defined as “mutual monitoring” |
Perspective | The consent is given as part of the medical act limited to the diagnosis date | Informed consent is an integral part of the therapeutic alliance, as a vision that is generated in the doctor-patient relationship and extends in a broad sense to the structure, the territory and the National Health System |