Note: This article is based only on Italian legislation. For other countries check the local regulations.
GENERAL OVERVIEW
When we talk about consent in general, we’re establishing a concordance between the decisions and the ideas of one or more people. We would like to make it clear, based on this definition, that even though the radiologic procedures in the dental field (OPG, ENDORAL, CBCT) involve relatively low radiation doses and are non-invasive, anyone undergoing a treatment or in our case, a diagnostic examination, must be informed with terminology that is as appropriate as it is simple.
The purpose is to make the information more understandable to the patient. By doing so, they will be the ones who decide for themselves whether to perform the exam or not.
By acquiring informed consent, we can obtain the patient’s assent (full or partial), dissent, or revocation, in relation to what was proposed by the physician, thus concluding of the procedure.
Refusal to undergo a certain health treatment is a choice protected by the Constitution Art. 32 on health protection. It will be the responsibility of the specialist to find an alternative way for the treatment plan.
ESSENTIAL ELEMENTS OF INFORMED CONSENT
The person who prepares an informed consent has a complex task as they must consider very specific features. The essential elements are clarity and comprehensibility. In addition, the document must be complete, detailed, and up to date.
In legislative terms, a medical examination must first be justified by the specialist (Art. 3, Legislative Decree 187/2000). Therefore, the individual who signs the form, must be aware of some basic concepts related to radiological exposures, already present in the form, which can sometimes be supplemented by some questions that the patient can ask the doctors or the health professionals involved themselves.
In any case, DentQ reserves the right to carry out all procedures to ensure the optimization of the service, from periodic checks of the instrumentation to the choice of a staff adequately trained to minimize doses, reduce unnecessary exposures, and give any necessary information related to risks as well as, of course, to treat the collected data with the utmost confidentiality (art. 4.8, Legislative Decree 187/2000).
THE FORM
The form itself should not be too long nor technical but explanatory, it should consist of a section to enter personal data and report the type of examination requested by the specialist. It may be either in paper format or submitted through digital systems (computer, tablet, or recognized app). It must anyhow be kept and archived for years in order to be accessible, should it be requested (Art. 12, Legislative Decree 187/2000).
INFORMATIVE NOTATION
Furthermore, the form should contain some informative notations regarding the examination.
Generally, it will have to answer the following questions:
- What is it?
- What is it for?
- How is it performed?
- Are there any complications?
- Does it require specific preparation?
This would be accompanied by brief legislative reminders on radiation protection and topics that will make it possible to perform the exam while maintaining the highest levels of safety.
Informed consent serves to make a particular medical act authorized. Without it, any medical treatment will not be permitted and falls under the law “Except for extraordinary cases”. It is mandatory for the physician to inform and acquire the consent of the patient before performing the procedure. The timing and manner must allow the patient to reflect on the information received and then, as already mentioned earlier, to decide for themselves whether to accept the procedure or not.
SPECIAL AUTHORIZATIONS
- For a minor:
There is also a section on the minor’s authorizations, which must be signed by a parent or those legally responsible.
- For pregnant or presumed pregnant women:
An added notation is made on the possible or presumed pregnant status of the patient, which is an additional element of risk in case of exposure to a radiogenic source.
It is well known how such radiation can cause alterations to cells, particularly those that are in a reproductive activity (such as embryonic and fetal cells); however, it should be emphasized that in most cases, radiological examinations can be carried out under conditions of reasonable safety even in the presence of a pregnant state, in relation to the negligible amount of radiation, the distance from the abdomen of the anatomical part to be examined, and the use of appropriate protection.
PRIVACY
The last section of the informed consent form, equally important, is related to the management of sensitive data. The received data related to the patient and any online uploads performed (image processing, online reports, digital records etc.) must be authorized. The process is reversible and in any case the patient is not obliged to sign anything if they are not fully convinced.
Elaborated by Dr. Enrico Cammarella – Lead Radiographer DentQ Italy
