[Clinic name]
Controlled document
[Address]
[Registration or licence number]
Consent to treatment form
1About this form
- 1.1This form records the patient's consent to the treatment named below, and the information they were given before they agreed.
- 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
- 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
- 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
- 7.1Consent is confirmed again on the day of treatment, and recorded in the note.
- 7.2A copy of this form is kept on the patient's record, where it can be shown at an MHLW inspection.
8Where this sits in the MHLW framework
- Patient data under the APPI個人情報保護法 第20条 第2項, consent before acquiring 要配慮個人情報
個人情報保護法 第27条 and 第28条, consent before provision to a third party, or to one abroad
AAppendix, Leak response record
- A.1Discovered on ______ By ______
- A.2Data involved ______ Patients affected ______
- A.3First report to the PPC on ______
- A.4Full report due ______ Sent on ______
- A.5Patients told on ______ How ______
- A.6Cause ______ Measures to prevent it ______
