II. Definitions
- Informed Consent
- Patient willingly participates in medical therapy
- Requires understanding what is involved with the proposed therapy
- Personal Autonomy
- Given capacity, patients may make medical decisions for themselves
- Patients are given adequate information about their condition and treatment options to make an informed decision
- Beneficence
- Medical care given provides more benefit than harm
- Nonmaleficence
- Avoiding both intentional and unintentional harm to patients
- Social Justice
- Medical professional duty to promote fair health care resource allocation and delivery
III. Protocol: Requirements for valid Informed Consent
- Informed Consent should be obtained by the provider performing the procedure
- Patient (or their proxy) must have Medical Decision-Making Capacity
- See Medical Decision-Making Capacity
- See CURVES Mnemonic for Capacity Assessment
- Communicates choices
- Understands relevant information
- Reasons with logical, rational choices
- Values of patients are consistent with their choices
- Patient must be given sufficient information including treatment risks and benefits
- Patient makes decision without coercion and with adequate information about alternatives to proposed procedure
- 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)
- Patient does not have adequate Decision-Making Capacity (e.g. unconscious or Delirium) AND
- No surrogate decision maker or legal document is available AND
- Situation is true emergency with threat to life or limb
V. Protocol: Approach to documentation
- See Medical Documentation
- Obtain written Informed Consent for procedures including contingency plans and document that consent was obtained
- Document patient refusal of recommended important clinical interventions in high risk conditions
- Obtain signature for refusal Against Medical Advice
VI. References
- Seeyave, Sherman and Ward (2020) Crit Dec Emerg Med 34(1): 19-25
- Weinstock and Henry in Herbert (2018) EM:Rap 18(1): 19-21
- Bradford-Saffles and Arambasick (2013) Crit Dec Emerg Med 27(6): 11-5
- Henry (2013) Avoid Being Sued, EM Bootcamp, CEME
Images: Related links to external sites (from Bing)
Related Studies
| 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 |
