Informed Consent in Orofacial Harmonization and Legal Defense

Few documents create as much false security as the consent form. The professional prints the template, collects the signature and believes they are protected. When a conflict arises, they discover that the paper alone proves less than they imagined. Informed consent is not a form: it is a process of information, listening and decision, and the form is the record of it.

Here you will see what the form proves and does not prove, how to run the process so that it is real, what makes the record solid and how to organize the documentation. It does not replace legal advice or your professional board's rules. For the concept, see the glossary entry informed consent and the page consent and LGPD in photos (LGPD is Brazil's data protection law).

What exactly is informed consent?

It is the patient's free and informed decision to undergo a procedure, after receiving, in language they understand, information about what will be done, the expected benefits, the risks, the alternatives and the limits. It has three elements:

1. Information: the patient receives what they need to decide.
2. Understanding: they grasp what was said, not just hear it.
3. Voluntariness: they decide without coercion or pressure.

The written form is the evidence of this process. If the process did not happen in practice, the paper is fragile.

What does the form prove, and what does it not?

In other words: the form is one piece of a whole. A professional's defense also depends on a complete patient record, a justified indication, an appropriate technique, aftercare instructions and communication over time. See patient record and documentation in HOF and lawsuits over harmonization: how to prevent them.

How do I run the process so that it is real?

The best form is one that records a conversation that actually took place. A practical sequence:

If the patient wants to think it over, respect that. If they hesitate, do not force it. See how to explain the consent form, how to ask the patient to read the form and patient who does not want to sign the form.

What should a well-made form include?

Each form must be specific to the procedure and adapted to the patient. Common elements, to be reviewed with a lawyer:

• Identification of the patient and the professional, with their professional board registration.
• Description of the procedure in accessible language.
• Purpose and expected results, without promises.
• Risks and possible complications, including rare and serious ones, in proportion.
• Alternatives, including doing nothing.
• Limits: the result varies, a touch-up may be needed, duration varies.
• Care before and after, and what to do in case of a complication, with a contact channel.
• Patient's statement about health conditions, medication use and allergies.
• Image authorization, separate by purpose.
• Place, date and signatures.

See the templates for the botulinum toxin consent form, lip filler, biostimulator and hyaluronidase. Each offers a starting point that must be adapted and legally reviewed.

Which mistakes weaken the form the most?

• A generic form for every procedure.
• Handing it over at the last minute, with the patient already lying down and no time to read.
• Language that is too technical, which the patient does not understand.
• A blank form signed before being filled in.
• Missing date and identification of the patient.
• A promise of results in the text, which contradicts the principle of informing.
• No copy given to the patient.
• An old form reused after a change of procedure or product.
• Loss of the file: paper misplaced or digital with no backup.

How do I document beyond the form?

The form is one part. Strengthen the record with:

1. Complete medical history, dated and signed. See medical history in HOF and the medical history form template.
2. Lot record of the product applied. See traceability of injectables.
3. Progress notes on the appointment, with what was done and the instructions given.
4. Standardized photographs, with proper authorization.
5. Record of risk communications and instructions. See recording the risk communication.
6. Record of complications and the actions taken. See recording a complication in HOF.
7. Refusal document, when the patient declines the recommended course. See the procedure refusal form template.

It is also worth having a retention policy defined. See retention period for patient records in HOF and digital signature of forms in HOF.

How does the simulation relate to consent?

Showing a projection is part of communicating expectations, but it does not replace consent. The simulation is illustrative and does not guarantee a result, and the patient must be told so. Avoid having the image understood as a commitment. See a simulation is not a guarantee and difference between simulation and actual result.

What should I do if the patient changes their mind or revokes consent?

The patient may change their mind before the procedure, and that must be respected and recorded. They may also revoke image-use authorizations. Document the decision, stop the use as appropriate and advise on any effects. See patient wants to revoke image authorization and patient who changed their mind midway through the plan.