Almost all over the world these claims are made when it is alleged that the physician has breached an expressed or implied term of the agreement that arises out of the physician-patient relationship, usually an allegation that the physician failed to achieve the guaranteed result. A claim for violation of contract is also advanced when it is alleged that the physician has disclosed confidential information about the patient without proper authorization and in the absence of being required to disclose the information by law. In Italy, the concept of the medical contract has a general application where a direct physician-patient relationship has been established. The existence of a medical contract does not necessarily impose an obligation of result to the physician, although the physician may have an obligation of means.

It is now widely accepted that clinicians should negotiate rather than dictate what is in the best interests of patients.

Several decades ago, it was common for clinicians to minimize the importance of respecting the autonomy of patients in clinical practice, their ability, and need to make plans about the personal consequences of treatment for them and others.

It is not unusual today for a claim to be asserted on behalf of the plaintiff alleging that, in obtaining consent, the physician failed to provide all the information about the nature and anticipated effect of the proposed procedure, including the significant risks and possible alternatives that a reasonable person would wish to know in determining whether to proceed. The notion of informed consent is entrenched in many codes of ethics and in legislation, in Italy particular in the Civil Code, and gives the tools in current professional and legal guidance about obtaining informed consent from competent patients.

For example, in England a wide range of professional organizations—including the British Medical Association, the Royal Colleges, and the various defense associations—all endorse the same moral principles.

The same can be said of professional and regulatory bodies in other countries.

The law also endorses the moral importance of respect for autonomy within medicine. To avoid a claim of battery, the consent of patients to treatment must be based on information “in broad terms” about the nature of, and reason for, proposed treatment choices. Separate consent must be provided for distinct procedures. Patients should be informed about which procedures within a treatment plan are independent and consent obtained for each component therapy, rather than for the plan as if it were as an indistinguishable whole. This will be so, even if refusal of one component may seriously compromise the patient’s prospects for recovery.

The new standards were worrisome for physicians, creating great uncertainty about what was expected of them. It would appear, however, that physicians have come to appreciate the need for more detailed explanations to be given to their patients and are finding the requirements of informed consent are not imposing as stringent a hardship as once feared. The successful defense of such actions is assisted by the overriding requirement, that to succeed the plaintiff must demonstrate that in the face of full disclosure, a reasonable person in the patient’s place would have refused the procedure.

There is a very basic proposition recognized by the courts all over the world that every human being of adult years and of sound mind has the right to determine what shall be done with his or her own body. This general principle is that of the inviolability of the person mostly in all countries. Therefore, subject to certain exceptions, such as an emergency or a court order, a physician must obtain a valid and informed consent before any treatment is administered to a patient.

An emergency nullifying the requirement to obtain consent only exists where there is imminent and serious danger to the life or health of the patient and it is necessary to proceed immediately to treat the patient. The concept of emergency treatment also extends to instances where the patient requires treatment to alleviate severe suffering. The convenience of the physicians, the healthcare team, and the hospital, however, must not be included as determining factors in declaring proposed treatment to be emergent.

The following suggestions may help physicians meet the legal standards applicable to the law of consent:

In order to avoid a claim of negligence, the information disclosed to patients, when obtaining consent about risks, must be “reasonable” in the eyes of the court, leaving aside breaches of professional duty so obvious that they “speak for themselves.” The care is regarded as appropriate if the experts convince the court that a relevant reasonable body of professional opinion would endorse the course of action that was actually taken. In the case of consent, the issue would be the amount and accuracy of information disclosed by a doctor and contested by a patient.

Being short of suitable action of this will be irrespective of:

Consent assessed as appropriate is judged by a “professional standard” which may be inappropriate outside the profession if it disregards the patient and is based solely on the views of clinicians.

In the past, some patients were not given the information about therapeutic risks when they clearly should have been. Such moral breaches of the duty to respect the patient’s autonomy have recently led the judiciary to question the relevance of the appropriate standard for determining what patients should be told about risks.