Basic elements of a declaration of consent: consent to the investigation, processing or operational procedure (1) I,__________________________________________________________________________Dr.____ (3) I also agree with additional or alternative examinations, treatments or operating procedures which, according to Dr.________________________, are immediately necessary. (4) Furthermore, I agree that Dr._______________________ may, at its discretion, benefit from the assistance of other surgeons, physicians and hospital staff (including trainees) and allow them to order or perform all or part of the examination, treatment or surgery, and I agree: that they have the same discretion in my examination and treatment as Dr____ ___Dated_________________________ Day/month/year Patient______________________ Although the legal and ethical debate continues, most stakeholders agree on at least four fundamental elements of discussion on informed consent: the decision-maker (i.e. The patient or a surrogate mother) should have the ability to make decisions; the physician must provide sufficient information to enable the decision-maker to make an informed decision; the decision-maker must demonstrate an understanding of the information disclosed; and the decision-maker should freely approve the treatment plan. Who is the right person to obtain consent? It is always preferable that the person who actually cares for the patient has the patient`s agreement. However, you can obtain the agreement on behalf of colleagues if you are able to perform the procedure in question or if you have received specific training to obtain the agreement of this procedure. WRITTEN CONSENT Consent is often mistakenly equated with a patient`s signature on a declaration of consent. A signature on a form is proof that the patient has given consent, but not proof of valid consent. If a patient is required to sign a form due to a lack of information, the consent may not be valid despite the signature. If a patient has given valid oral consent, the fact that they are not physically able to sign the form is not a means of blocking treatment. Patients can, if they wish, revoke their consent after signing a form: the signature is proof of the consent process, not a binding contract. Surgical procedures and invasive procedures must be subject to explicit written consent. It is advisable to obtain written consent, even if painkillers, anesthetics or anesthetics significantly affect the patient`s consciousness during treatment. It is always necessary to explain fairly what is proposed, its risks and complaints, the benefits that could arise, if any, and, if so, the appropriate alternative treatments or procedures that could be proposed.
If this is a blinded study, patients should be aware that they cannot benefit from it. Researchers should offer and make themselves available to respond to requests regarding what is being proposed and should emphasize to patients or subjects that they are free to revoke their consent at any time without prejudice and to stop participating in the project. .