ARCHETYPE Informed consent (openEHR-EHR-ACTION.informed_consent.v0)

ARCHETYPE IDopenEHR-EHR-ACTION.informed_consent.v0
ConceptInformed consent
DescriptionRecord of status and details of informed consent from an individual (or the individual's agent/proxy) for a proposed procedure, trial or other healthcare-related activity (including treatments and investigations), based upon a clear appreciation and understanding of the facts, implications, and possible future consequences by the consenting party.
UseUse to record the status of an order to obtain informed consent, including what is planned, scheduled, requested, provided, or withdrawn. This archetype has been designed to be a framework that will be adequate for requesting and recording a simple consent, but allow for additional details to be optionally added within the 'Details' SLOT to meet the specific requirements of a more complex clinical scenario. For example, additional consent details can be included using the CLUSTER.consent_details archetype. Other archetypes can be developed and optionally included in the same SLOT for the purpose of recording specific details about the procedure, trial or activity. The status of the informed consent is reflected by the pathway steps - requested, refused, provided, withdrawn etc.
PurposeTo record the status of a request for, or record of, informed consent prior to performing a procedure, clinical trial or healthcare-related activity.
ReferencesASTM Standard E2369 - 05, "Standard Specification for Continuity of Care Record (CCR)", ASTM International, West Conshohocken, PA, 2003, DOI: 10.1520/E2369-05E02, www.astm.org.
Copyright© openEHR Foundation
AuthorsAuthor name: Heather Leslie
Organisation: Atomica Informatics
Email: heather.leslie@atomicainformatics.com
Date originally authored: 09-10-2012
Other Details LanguageAuthor name: Heather Leslie
Organisation: Atomica Informatics
Email: heather.leslie@atomicainformatics.com
Date originally authored: 09-10-2012
OtherDetails Language Independent{licence=This work is licensed under the Creative Commons Attribution-ShareAlike 4.0 International License. To view a copy of this license, visit http://creativecommons.org/licenses/by-sa/4.0/., custodian_organisation=openEHR Foundation, references=ASTM Standard E2369 - 05, "Standard Specification for Continuity of Care Record (CCR)", ASTM International, West Conshohocken, PA, 2003, DOI: 10.1520/E2369-05E02, www.astm.org., current_contact=Heather Leslie, Atomica Informatics, heather.leslie@atomicainformatics.com, original_namespace=org.openehr, original_publisher=openEHR Foundation, custodian_namespace=org.openehr, MD5-CAM-1.0.1=7229DFAFA43B2D9ABD13B0228E2F0181, build_uid=3be1588a-c4f0-4ef3-8bd3-0a3e7a0c7585, revision=0.0.1-alpha}
Keywordsconsent, informed, caveat
Lifecyclein_development
UIDb016cdb3-d685-4f86-a623-dba44ebe1586
Language useden
Citeable Identifier1013.1.1303
Revision Number0.0.1-alpha
AllArchetype [runtimeNameConstraintForConceptName=null, archetypeConceptBinding=null, archetypeConceptDescription=Record of status and details of informed consent from an individual (or the individual's agent/proxy) for a proposed procedure, trial or other healthcare-related activity (including treatments and investigations), based upon a clear appreciation and understanding of the facts, implications, and possible future consequences by the consenting party., archetypeConceptComment=null, otherContributors=, originalLanguage=en, translators=
  • German: Aurelie Tomczak, Natalia Strauch, Institute of Pathology, University Hospital Heidelberg, Germany, Medizinische Hochschule Hannover, au.tomczak@yahoo.com, Strauch.Natalia@mh-hannover.de
  • Russian: Art Latyp; Латыпов Артур Шамилевич, RusBITech РусБИТех, hmm
  • Norwegian Bokmål: Kanika Kuwelker, Helse Vest IKT, kanika.kuwelker@helse-vest-ikt.no
, subjectOfData=unconstrained, archetypeTranslationTree=null, topLevelToAshis={events=[], content=[], identities=[], description=[ResourceSimplifiedHierarchyItem [path=/description[at0001]/items[at0002], code=at0002, itemType=ELEMENT, level=2, text=Procedure/Trial/Activity, description=Identification of the procedure, clinical trial or healthcare-related activity (including correct side/correct site, where appropriate) against which the consent status and details are recorded., comment=null, uncommonOntologyItems=null, occurencesFormal=1..*, occurencesText=Mandatory, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/description[at0001]/items[at0030], code=at0030, itemType=ELEMENT, level=2, text=Procedure/Trial/Activity description, description=Narrative description of the procedure, clinical trial or healthcare-related activity., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/description[at0001]/items[at0031], code=at0031, itemType=ELEMENT, level=2, text=Intent, description=Description of the intent of the procedure, clinical trial or healthcare-related activity., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/description[at0001]/items[at0011], code=at0011, itemType=ELEMENT, level=2, text=Consent description, description=Narrative description of the informed consent required or recorded prior to performing the proposed procedure, clinical trial or healthcare-related activity., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/description[at0001]/items[at0003], code=at0003, itemType=SLOT, level=2, text=Details, description=Additional structured details about the procedure/trial/activity itself or additional structured consent details., comment=For example: intent/purpose; anaesthetic details; disclosure of material risks; and proposed benefits discussed., uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=Include:
openEHR-EHR-CLUSTER.consent_details.v1 and specialisations or
openEHR-EHR-CLUSTER.procedure_details.v1 and specialisations, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/description[at0001]/items[at0004], code=at0004, itemType=ELEMENT, level=2, text=Form of consent, description=Form of the consent sought or provided., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values=
  • Written [Format of the consent is written.]
  • Verbal [Format of the consent is verbal.]
, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/description[at0001]/items[at0007], code=at0007, itemType=ELEMENT, level=2, text=Reason, description=Reason that the care pathway step for the identified procedure, clinical trial or healthcare-related activity was carried out., comment=For example, the reason for 'consent refused' or 'consent withdrawn'., uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/description[at0001]/items[at0008], code=at0008, itemType=ELEMENT, level=2, text=Start date, description=Date, and optional time, when validity of the informed consent becomes active., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_DATE_TIME, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/description[at0001]/items[at0009], code=at0009, itemType=ELEMENT, level=2, text=End date, description=Date, and optional time, when validity of the informed consent ceased., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_DATE_TIME, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/description[at0001]/items[at0010], code=at0010, itemType=ELEMENT, level=2, text=Caveat, description=Details of any qualifications or exemptions to the informed consent., comment=null, uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/description[at0001]/items[at0012], code=at0012, itemType=ELEMENT, level=2, text=Evidence link, description=Link to evidence of consent., comment=For example, a hyperlink to the evidence held elsewhere in the health record., uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_URI, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/description[at0001]/items[at0036], code=at0036, itemType=ELEMENT, level=2, text=Comment, description=Additional narrative about the informed consent activity, not captured in other fields., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/description[at0001]/items[at0037], code=at0037, itemType=SLOT, level=2, text=Evidence details, description=Digital representation of the evidence of consent., comment=For example: a PDF of a consent authorisation form; or an audio file., uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=Include:
openEHR-EHR-CLUSTER.multimedia.v0, extendedValues=null]], relationships=[], target=[], ism_transition=[ResourceSimplifiedHierarchyItem [path=/ism_transition[at0013]_526_at0013, code=at0013, itemType=ISM_TRANSITION, level=1, text=Planned, description=Need for informed consent is identified., comment=null, uncommonOntologyItems=null, occurencesFormal=null, occurencesText=null, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=ISM_TRANSITION, bindings=null, values=Current state: planned, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/ism_transition[at0019]_527_at0019, code=at0019, itemType=ISM_TRANSITION, level=1, text=Postponed, description=Intent to request informed consent has been postponed., comment=null, uncommonOntologyItems=null, occurencesFormal=null, occurencesText=null, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=ISM_TRANSITION, bindings=null, 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All not explicitly excluded archetypes, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/protocol[at0024]/items[at0033], code=at0033, itemType=CLUSTER, level=2, text=Patient information, description=Details about Patient Information made available to the subject or subject's agent., comment=null, uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=1..*, cardinalityText=, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/protocol[at0024]/items[at0033]/items[at0032], code=at0032, itemType=ELEMENT, level=3, text=Name, description=Identification of the information made available., comment=For example, the name of the form., uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/protocol[at0024]/items[at0033]/items[at0035], code=at0035, itemType=ELEMENT, level=3, text=Description, description=Narrative description of the patient information made available., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/protocol[at0024]/items[at0033]/items[at0038], code=at0038, itemType=SLOT, level=3, text=Multimedia representation, description=Digital representation of the evidence of consent., comment=null, uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=Include:
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All not explicitly excluded archetypes, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/protocol[at0024]/items[at0033], code=at0033, itemType=CLUSTER, level=2, text=Patient information, description=Details about Patient Information made available to the subject or subject's agent., comment=null, uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=1..*, cardinalityText=, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/protocol[at0024]/items[at0033]/items[at0032], code=at0032, itemType=ELEMENT, level=3, text=Name, description=Identification of the information made available., comment=For example, the name of the form., uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/protocol[at0024]/items[at0033]/items[at0035], code=at0035, itemType=ELEMENT, level=3, text=Description, description=Narrative description of the patient information made available., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/protocol[at0024]/items[at0033]/items[at0038], code=at0038, itemType=SLOT, level=3, text=Multimedia representation, description=Digital representation of the evidence of consent., comment=null, uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=Include:
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