ANVISA, CFM and ONA consent to treatment form template

1About this form

1. 1.1This form records the patient's consent to the treatment named below, and the information they were given before they agreed.
2. 1.2Consent is a conversation before it is a signature, so the clinician records what was discussed, in a language the patient understands.

2The patient

Full name

Date of birth

Record number

Language used

Interpreter, if used

3The treatment

Treatment or procedure

Intended benefit

Clinician

[Name, registration number]

Cost, if any

4What was explained

• The nature of the treatment and what it involves.
• The serious and frequent risks, including [specific risks].
• The alternatives, including no treatment.
• The aftercare, and who to contact if something goes wrong.
• That the patient may withdraw consent at any time before the treatment.
• Any use of software or AI in recording the consultation, and how the record is kept.

5The patient's agreement

1. 5.1I have read this form or had it read to me, my questions have been answered, and I agree to the treatment described.

Patient signature

Date and time

Person with parental responsibility or legal authority, if any

6The clinician's confirmation

1. 6.1I have explained the treatment, its risks and its alternatives, and I believe the patient understands and has capacity to decide.

Clinician signature

Date and time

7Revisiting consent

1. 7.1Consent is confirmed again on the day of treatment, and recorded in the note.
2. 7.2A copy of this form is kept on the patient's record, where it can be shown at an ANVISA, CFM and ONA inspection.

8Where this sits in the ANVISA, CFM and ONA framework

• Telemedicine, AI and health dataResolução CFM 2.314/2022 art. 15, termo de concordância e autorização no prontuário eletrônico
  Resolução CFM 2.454/2026, IA como apoio, paciente informado e registro no prontuário
• The prontuárioCódigo de Ética Médica art. 88, acesso e cópia do prontuário ao paciente