Informed consent: elements and how to obtain it
- Procedure
Before a treatment, a patient with capacity gets clear information and freely decides whether to accept or refuse it.
What it is
Informed consent is a conversation, not a signature. The doctor explains the nature of the intervention, its risks, benefits and alternatives (including no treatment), checks that the patient understood, and respects the patient's free decision. In Colombia it is required by Law 23 of 1981 (arts. 15 and 16), its Decree 3380 of 1981 and Statutory Law 1751 of 2015 (art. 10, item d). The Constitutional Court asks for a «qualified» consent when the treatment is very invasive or risky.
What it must include
- The nature of the decision or procedure, in plain words.
- Foreseeable risks, expected benefits and uncertainties.
- Reasonable alternatives, including doing nothing, with their own risks and benefits.
- The doctor's recommendation and the reasons for it.
- A check that the patient understood.
- Free acceptance or refusal, without pressure.
How it is done
- Confirm the patient has capacity for this specific decision; if not, identify who decides for them.
- Find a private place and unhurried time; ask whom the patient wants present.
- Explain what you propose to do, what it is for and how it is done, without jargon.
- Explain the foreseeable risks, the benefits and the alternatives, including no treatment.
- Ask the patient to explain in their own words what they understood, and answer questions.
- Give your recommendation; make clear the decision is the patient's and can be changed.
- Record in the medical record the information given, the decision and, if used, the signed form.
How much to disclose: the three standards
| Standard | Question it asks | Comment |
|---|---|---|
| Reasonable physician | What would a typical doctor say? | Doctor-centred; now seen as inadequate |
| Reasonable patient | What would an average patient need to know? | The one most used in law and in exams |
| Subjective | What does this particular patient need to know? | The most demanding: tailors the information to the person's values |
In clinical practice
- A blood draw in a patient who has had one before allows basic or implied consent, but you still explain what you will do.
- Surgery, anaesthesia and invasive procedures usually need written consent under each institution's policy.
- The riskier or more invasive the intervention, the more information and autonomy are required (qualified consent).
- A refusal does not mean the patient lacks capacity: it is a cue to talk again about their reasons.
Common mistakes
- Treating the signed form as if it were the consent.
- Using medical jargon or giving all the information at once.
- Leaving out the option of no treatment.
- Asking for the signature just before the procedure, with the patient sedated or under pressure.
- Not recording it in the medical record.
Test yourself
Think of the answer, then tap the question to see it.
What makes informed consent valid?
A patient with capacity for that decision, enough information, understanding of that information and a voluntary decision, free of coercion.
Which alternative must always be mentioned when asking for consent?
Receiving no treatment at all, with its risks and benefits. The Constitutional Court said so in ruling T-551 of 1999.
Which article of Law 23 of 1981 requires consent for treatments that may affect the patient?
Article 15: the doctor asks for consent and explains the consequences beforehand, unless that is not possible.
Which disclosure standard asks what an average patient would need to know?
The reasonable patient standard.
Connections
Educational content on ethics and health law; not legal advice. Laws and case law change: each page links the official text and says when it was last checked. For a real case, read the text in force and ask a lawyer or the medical ethics tribunal.
Sources: Ley 23 de 1981, por la cual se dictan normas en materia de ética médica (Función Pública, Gestor Normativo, 1981); Decreto 3380 de 1981, por el cual se reglamenta la Ley 23 de 1981 (Función Pública, Gestor Normativo, 1981); Ley Estatutaria 1751 de 2015, que regula el derecho fundamental a la salud (Función Pública, Gestor Normativo, 2015); Sentencia T-551 de 1999 (Corte Constitucional de Colombia, 1999); Informed Consent (University of Washington, Department of Bioethics & Humanities, 2018).
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Representative model, for educational purposes only.