ARCHETYPE kds_informed_consent (openEHR-EHR-ACTION.kds_informed_consent.v0)

ARCHETYPE IDopenEHR-EHR-ACTION.kds_informed_consent.v0
Conceptkds_informed_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record the status of an order to obtain informed consent, including what is planned, scheduled, requested, provided, or withdrawn.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 The status of the informed consent is reflected by the pathway steps - requested, refused, provided, withdrawn etc.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, HiGHmed
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 3.0 License. To view a copy of this license, visit http://creativecommons.org/licenses/by-sa/3.0/., custodian_organisation=HiGHmed, 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.highmed, original_publisher=HiGHmed, custodian_namespace=org.highmed, MD5-CAM-1.0.1=C540779A6F4C85B1FDFC8A427971E6A8, build_uid=7e8ec334-e374-429d-9f8b-70e87e9ad779, revision=0.0.1-alpha}
Keywordsconsent, informed, caveat
Lifecyclein_development
UIDed7712ae-51c2-4f2a-ba66-b6e91810f761
Language useden
Citeable Identifier1246.145.2387
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={relationships=[], source=[], capabilities=[], activities=[], details=[], context=[], 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, values=Current state: postponed, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/ism_transition[at0018]_528_at0018, code=at0018, itemType=ISM_TRANSITION, level=1, text=Cancelled, description=Intent to request informed consent has been cancelled, prior to requesting consent from patient or patient's agent.., comment=null, uncommonOntologyItems=null, occurencesFormal=null, occurencesText=null, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=ISM_TRANSITION, bindings=null, values=Current state: cancelled, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/ism_transition[at0027]_529_at0027, code=at0027, itemType=ISM_TRANSITION, level=1, text=Appointment scheduled, description=An appointment has been scheduled to request consent., comment=null, uncommonOntologyItems=null, occurencesFormal=null, occurencesText=null, 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itemType=ISM_TRANSITION, level=1, text=Completed, description=Informed consent has been provided by the patient or patient's agent and the activity is now complete., comment=null, uncommonOntologyItems=null, occurencesFormal=null, occurencesText=null, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=ISM_TRANSITION, bindings=null, values=Current state: completed, extendedValues=null]], other_participations=[], data=[], credentials=[], target=[], items=[], content=[], 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..*, occurencesText=Optional, 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All not explicitly excluded archetypes, 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]], contacts=[], state=[], events=[], provider=[], identities=[], protocol=[ResourceSimplifiedHierarchyItem [path=/protocol[at0024]/items[at0025], code=at0025, itemType=ELEMENT, level=2, text=Consent document used, description=Identification of the form or document used to obtain consent., 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[at0026], code=at0026, itemType=ELEMENT, level=2, text=Review date, description=Date when consent status is due for review., 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=/protocol[at0024]/items[at0028], code=at0028, itemType=SLOT, level=2, text=Consent requester, description=Details about the healthcare provider who is requesting or recording the consent., comment=Insert archetyped demographic details in this SLOT if it is not possible to use other_participations., 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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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:
All not explicitly excluded archetypes, extendedValues=null]], minIndents={}, termBindingRetrievalErrorMessage=null]