II. Definitions

  1. Informed Consent
    1. Patient willingly participates in medical therapy
    2. Requires understanding what is involved with the proposed therapy
  2. Personal Autonomy
    1. Given capacity, patients may make medical decisions for themselves
    2. Patients are given adequate information about their condition and treatment options to make an informed decision
  3. Beneficence
    1. Medical care given provides more benefit than harm
  4. Nonmaleficence
    1. Avoiding both intentional and unintentional harm to patients
  5. Social Justice
    1. Medical professional duty to promote fair health care resource allocation and delivery

III. Protocol: Requirements for valid Informed Consent

  1. Informed Consent should be obtained by the provider performing the procedure
  2. 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
  3. Patient must be given sufficient information including treatment risks and benefits
  4. Patient makes decision without coercion and with adequate information about alternatives to proposed procedure
  5. Decision must be stable over time with the patient likely to consistently make the same decision if asked a second time

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

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

V. 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

VI. References

  1. Seeyave, Sherman and Ward (2020) Crit Dec Emerg Med 34(1): 19-25
  2. Weinstock and Henry in Herbert (2018) EM:Rap 18(1): 19-21
  3. Bradford-Saffles and Arambasick (2013) Crit Dec Emerg Med 27(6): 11-5
  4. Henry (2013) Avoid Being Sued, EM Bootcamp, CEME

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Ontology: Beneficence (C0004978)

Definition (MSH) The state or quality of being kind, charitable, or beneficial. (from American Heritage Dictionary of the English Language, 4th ed). The ethical principle of BENEFICENCE requires producing net benefit over harm. (Bioethics Thesaurus)
Concepts Idea or Concept (T078)
MSH D026686
English Beneficence, beneficence, Benevolence
Swedish Välgörenhet
Czech dobročinnost
Finnish Hyvän tekeminen
Italian Benevolenza, Beneficienza
Russian MILOSERDIE, МИЛОСЕРДИЕ
Japanese 道徳律, 善行, 慈恵
Polish Dobroczynność
Norwegian Velgjørenhet, Vennlighet
French Bienfaisance
German Benefizienz, Nutzen, Wohlwollen
Dutch Weldadigheid
Portuguese Beneficência
Spanish Beneficencia

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

Ontology: Social Justice (C0037422)

Definition (MSH) An interactive process whereby members of a community are concerned for the equality and rights of all.
Concepts Qualitative Concept (T080)
MSH D012935
English Justice, Social, Social Justice, social justice, Social justice
Swedish Social rättvisa
Czech sociální spravedlnost
Finnish Yhteiskunnallinen oikeudenmukaisuus
Russian SOTSIAL'NAIA SPRAVEDLIVOST', СОЦИАЛЬНАЯ СПРАВЕДЛИВОСТЬ
Japanese 社会正義
Polish Sprawiedliwość społeczna
Norwegian Sosial rettferdighet
French Justice sociale
German Soziale Gerechtigkeit
Italian Giustizia sociale
Dutch Sociale gerechtigheid
Portuguese Justiça Social
Spanish Justicia Social

Ontology: Personal Autonomy (C0949760)

Definition (MSH) Self-directing freedom and especially moral independence. An ethical principle holds that the autonomy of persons ought to be respected. (Bioethics Thesaurus)
Definition (NOC) Personal actions of a competent individual to exercise governance in life decisions
Concepts Idea or Concept (T078)
MSH D026684
Swedish Personlig autonomi
Czech osobní nezávislost, osobní autonomie
Finnish Yksilön autonomia
Russian NEZAVISIMOST' LICHNOSTI, LICHNOSTI NEZAVISIMOST', ЛИЧНОСТИ НЕЗАВИСИМОСТЬ, НЕЗАВИСИМОСТЬ ЛИЧНОСТИ
Japanese 自律性-個人, 自発的決定, 個人の自律, 自己決定, 自由意志, 個人の自律性, 意志の自由
French Autonomie personnelle, Autonomie individuelle
Croatian OSOBNA NEOVISNOST
Polish Wolność woli, Niezależność moralna, Samookreślenie, Wolność osobista, Samostanowienie, Autonomia osobista
Norwegian Personlig autonomi, Personlig selvstendighet
English Autonomy, Personal, Personal Autonomy
German Autonomie, persönliche, Persönliche Autonomie
Italian Autonomia della persona
Dutch Autonomie, persoonlijk, Persoonlijke autonomie
Portuguese Autonomia Pessoal
Spanish Autonomía Personal

Ontology: Nonmaleficence (C0949761)

Definition (MSH) In ethics, the principle that requires avoiding the causation of harm.
Concepts Idea or Concept (T078)
MSH D026686
German Schadensvermeidung
English nonmaleficence, Nonmaleficence
French Non-malfaisance
Norwegian Prinsippet om å ikke skade