II. Protocol: Requirements for valid Informed Consent

  1. Patient (or their proxy) must have Medical Decision-Making Capacity
    1. See Medical Decision-Making Capacity
    2. See CURVES Mnemonic for Capacity Assessment
    3. Communicates choices
    4. Understands relevant information
    5. Reasons with logical, rational choices
    6. Values of patients are consistent with their choices
  2. Patient must be given sufficient information including treatment risks and benefits
  3. Patient makes decision without coercion and with adequate information about alternatives to proposed procedure
  4. Decision must be stable over time with the patient likely to consistently make the same decision if asked a second time

III. Protocol: Criteria for treating a patient without Informed Consent (all must be present)

  1. Patient does not have adequate Decision-Making Capacity AND
  2. No surrogate decision maker or legal document is available AND
  3. Situation is true emergency with threat to life or limb

IV. Protocol: Approach to documentation

  1. See Medical Documentation
  2. Obtain written Informed Consent for procedures including contingency plans and document that consent was obtained
  3. Document patient refusal of recommended important clinical interventions in high risk conditions
    1. Obtain signature for refusal Against Medical Advice

V. References

  1. Bradford-Saffles and Arambasick (2013) Crit Dec Emerg Med 27(6): 11-5
  2. Henry (2013) Avoid Being Sued, EM Bootcamp, CEME

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Ontology: Informed Consent (C0021430)

Definition (NCI_CDISC) Consent by a patient for participation in a clinical study after achieving an understanding of the relevant medical facts and the risks involved.
Definition (NCI_NCI-GLOSS) A process in which a person is given important facts about a medical procedure or treatment, a clinical trial, or genetic testing before deciding whether or not to participate. It also includes informing the patient when there is new information that may affect his or her decision to continue. Informed consent includes information about the possible risks, benefits, and limits of the procedure, treatment, trial, or genetic testing.
Definition (NCI) Consent by a patient to a surgical or medical procedure or participation in a clinical study after achieving an understanding of the relevant medical facts and the risks involved.
Definition (MSH) Voluntary authorization, by a patient or research subject, with full comprehension of the risks involved, for diagnostic or investigative procedures, and for medical and surgical treatment.
Definition (PSY) Process of making rational decisions regarding one's treatment or participation in experimental procedures.
Definition (CSP) voluntary authorization, by a patient or research subject, with full comprehension of the risks involved, for diagnostic or investigative procedures, and for medical and surgical treatment.
Concepts Regulation or Law (T089)
MSH D007258
English Consent, Informed, Informed Consent, informed consent, INFORMED CONSENT OBTAINED
Swedish Informerat samtycke
Finnish Tietoon perustuva suostumus
Russian BOL'NOI, RAZRESHENIE NA LECHENIE, INFORMIROVANNOE SOGLASIE BOL'NOGO NA LECHENIE, BOL'NOGO DOBROVOL'NOE SOGLASIE NA LECHENIE, БОЛЬНОГО ДОБРОВОЛЬНОЕ СОГЛАСИЕ НА ЛЕЧЕНИЕ, БОЛЬНОЙ, РАЗРЕШЕНИЕ НА ЛЕЧЕНИЕ, ИНФОРМИРОВАННОЕ СОГЛАСИЕ БОЛЬНОГО НА ЛЕЧЕНИЕ
Portuguese Consentimento Livre e Esclarecido, Autorização Consciente, Consentimento Esclarecido, Consentimento Informado, Consentimento Consciente
Croatian PRISTANAK INFORMIRANOG BOLESNIKA/ISPITANIKA, INFORMIRANI PRISTANAK
Czech souhlas informovaného pacienta, informovaný souhlas pacienta
Polish Zgoda pacjenta odpowiednio poinformowanego, Zgoda świadoma, Zgoda pacjenta na leczenie
French Consentement libre et éclairé, Consentement éclairé
Norwegian Informert samtykke
Spanish Consentimiento Consciente, Autorización Consciente, Consentimiento Informado
German Einverständniserklärung
Italian Consenso informato
Dutch Informed Consent