Informed Consent by Procedure: Essential Items

The consent form is one of the most cited documents in HOF and one of the least understood. Many offices use a generic template, downloaded from the internet, that the patient signs in the chair without reading. That checks the routine box but protects little and informs little. A good form is the result of a good conversation, not a substitute for it.

This text lists the essential items for organizing a consent form by procedure. It is not a ready-made document or legal opinion. The final wording should be reviewed by a lawyer you trust and checked against the rules of your professional board (in Brazil, the CFM, CFO and the other councils of each profession).

What is the form for?

Under the principle of informed consent, the patient has the right to know what will be done, what the risks and alternatives are, and to decide freely. The form records that this happened. In essence, it serves four roles:

1. Inform: it is a written summary of what was discussed, for the patient to reread.
2. Respect autonomy: it formalizes that the decision was the patient's.
3. Document: it becomes part of the patient record and helps reconstruct what was said in case of doubt.
4. Align expectations: it makes clear what can and cannot be expected.

It does not create new rights, limit the patient's rights or reverse responsibilities. The duty to inform exists with or without a signed paper, and a failure to inform is not fixed by a signature.

Why one form per procedure?

Toxin, hyaluronic acid, biostimulator, threads and hyaluronidase have different risks, complication profiles and aftercare. A text that tries to cover everything ends up long, vague and rarely read. The most workable pattern is usually:

• Common core: identification, statement of information, images, data and general responsibilities.
• Appendix per procedure: risks, alternatives, aftercare and expectations specific to that procedure.

That way the patient reads what really applies and the professional updates only the appendix when the literature or the product label changes.

Essential items of the common core

1. Identification

• Patient's full name, ID and contact.
• Professional's name, board registration number and place of care.
• Date and, when applicable, identification of the legal guardian.

2. Statement of information

The patient states that they received explanations about the condition, the proposed procedure, the alternatives (including not doing it), the risks and the aftercare. The wording must be understandable and avoid unnecessary jargon.

3. Expectations and limits

Make clear that the result varies, that there is no guarantee of results and that the professional commits to good practice. The discussion of obligation of means versus obligation of result is legal and deserves specialized advice, but the text must not promise what it cannot deliver.

4. Images and data

• Authorization, or not, for photographic records in the patient file.
• Specific, separate authorization for any use in marketing, with clear scope and time limit.
• Information on the processing of personal and sensitive data, under LGPD (Brazil's data protection law) and sensitive personal data.

See also consent and LGPD for photos. Consent for the use of an image in marketing should not be built into the same acceptance as the procedure.

5. Patient responsibilities

Report their history, medications and allergies correctly; follow the aftercare instructions; attend the follow-up; report warning symptoms.

6. Contact channel

A phone number or emergency channel, and what to do in case of a complication outside business hours.

7. Signatures and date

Patient, professional and, if needed, a witness or legal guardian. The date must reflect the moment the patient read and signed.

Items of the appendix per procedure

Each appendix must answer the same questions, adapted to the procedure:

For hyaluronic acid, the appendix should mention the possibility of vascular occlusion and the availability of hyaluronidase. For toxin, the possibility of asymmetry, ptosis and diffusion. For biostimulators and threads, nodules and other specific events. The exact wording is the professional's decision with legal support.

What to avoid in the form

• Clauses that try to release the professional from liability for error or negligence.
• Promises of results, of no pain or of "guaranteed natural look."
• Overly technical language or fine print.
• Authorization for image use in marketing built into the procedure acceptance.
• Generic phrases like "I am aware of all the risks" without specifying them.
• Mixing a service contract, a quote and consent in one confusing document. The contract has its own function, as in service contract in HOF.

How to hold the consent conversation

1. Before the day of the procedure, send the form or appendix to be read.
2. At the consultation, explain in plain words and use the form as a script.
3. Ask the patient to explain it back in their own words, to check understanding.
4. Answer questions without hurry and record the relevant ones.
5. Give a copy to the patient.
6. Reconfirm on the day, if anything changed.

Structure template (item organization only)

Storage, updates and versions

The signed form should be kept with the patient record, for the period the applicable rule requires, and the patient should receive a copy. Keep version control of the template, with a revision date, so you know which text was used in each visit. Review the document when rules, product labels or practice change.

Storage and disposal follow the rules of patient record retention, and the organization of the clinical record is in patient records and documentation in HOF.

Relationship with visual planning

In clinics that show the patient a simulation, the form or appendix can mention that the image is illustrative, that it is not a promise of results and that the final decision depends on clinical assessment. This aligns expectations and avoids misunderstandings.

Quick review

A good consent form is short enough to be read, specific enough to be useful and honest enough not to promise what no one can guarantee. Written with legal support and used as a script for the conversation, it stops being bureaucracy and becomes part of care.