Informed Consent: Legal Obligation or Cornerstone of the Care Relationship?

Abstract

The topic of informed consent has become increasingly important in recent decades, both in the ethical-deontological field and as a duty of law. The review covered all sentences issued by the 13th section of the Civil Court of Rome during the period January 2016–December 2020. During this period, 156 judgments were found in which a breach of consent was required; in 24 of these, specific liability was proven, and the corresponding compensation liquidated. Moreover, 80% of the cases concerned the lack of information provided. The most involved branches were those related to surgical areas: general surgery, plastic surgery and aesthetic medicine and orthopaedics. The total amount of compensation paid was EUR 287,144.59. The research carried out has highlighted how, in a broad jurisprudential context, the damage caused by the violation of the right related to informed consent is considered, and how it impacts on the economic compensation of damages. Additionally, it showed that the areas most affected by the information deficit are those related to the performance of surgical activities, which are characterized by greater invasiveness and a higher risk of adverse events. The data reported underline the exigency to consider informed consent not as a mere documentary allegation but as an essential moment in the construction of a valid therapeutic alliance, which is also useful for avoiding unnecessary litigation that is becoming increasingly burdensome for healthcare systems all over the world.

A Survey on Applying Ethics of Informed Consent Among Egyptian Surgeons

“…It is worth mentioning that these surgical areas were the most litigations specialties due to defective informed consent practices as mentioned by Pallocci et al (2023) among malpractice allegations in Italy.…”

“…Ethically, it ensures that medical care complies with the patient's best interest and supports patient autonomy. Legally, it regulates the physician-patient relationship with subsequent protection of patients from being assaulted, and physicians from being accused of malpractice (Pallocci et al, 2023).…”

Collateral Victims of Defensive Medical Practice

“…An analysis carried out in Rome, Italy, during the five years between January 2016–December 2020 showed that the Civil Court of Rome considered 1117 malpractice cases [ 24 ]. From January 2018 to February 2019, 280 cases regarding legal liability for malpractice were submitted to trial, representing about 20% of all national disputes [ 25 ].…”

Nursing Roles in the Quality of Information in Informed Consent Forms of a Spanish County Hospital

“…The lack of information or the difficulty in understanding it means that the informed consent form ceases to be an effective tool and becomes a mere bureaucratic formality aimed at avoiding any legal liability [ 15 ]. Although it is not always possible to achieve these objectives, especially in patients with serious pathologies in whom treatments without sufficient scientific evidence are used as a last resort [ 16 ].…”