archetype (adl_version=1.4; uid=14688987-592c-48c7-9b23-c474181de623) openEHR-EHR-INSTRUCTION.informed_consent_request.v1 concept [at0000] -- Informed Consent Request language original_language = <[ISO_639-1::en]> description original_author = < ["name"] = <"Heather Leslie"> ["organisation"] = <"Ocean Informatics"> ["email"] = <"heather.leslie@oceaninformatics.com"> ["date"] = <"2012-10-09"> > details = < ["en"] = < language = <[ISO_639-1::en]> purpose = <"To record a formal request or instruction to gain and record informed consent from a subject (or the subject's agent) for a proposed procedure, trial or other healthcare-related activity."> use = <"Use to record a formal request or instruction to gain and record informed consent from a subject (or the subject's agent) for a proposed procedure, trial or other healthcare-related activity. This may need to be recorded as a formal instruction when part of a care plan or ahead of time when there is a distributed care team preparing a patient for a procedure, trial or activity to be performed in a different physical environment. This archetype has been designed to be a framework that will be adequate for ordering or requesting a simple informed 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 including specific details about the procedure, trial or activity."> keywords = <"consent", "informed", "trial", "procedure", "operation"> misuse = <""> copyright = <"© openEHR Foundation"> > > lifecycle_state = <"published"> other_contributors = <> other_details = < ["licence"] = <"This work is licensed under the Creative Commons Attribution-ShareAlike 4.0 License. To view a copy of this license, visit http://creativecommons.org/licenses/by-sa/4.0/."> ["custodian_organisation"] = <"Ocean Informatics"> ["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, Ocean Informatics, heather.leslie@oceaninformatics.com"> ["original_namespace"] = <"com.oceaninformatics"> ["original_publisher"] = <"Ocean Informatics"> ["custodian_namespace"] = <"com.oceaninformatics"> ["MD5-CAM-1.0.1"] = <"246656E87252BB7962A0EB9626505424"> ["build_uid"] = <"f1bb6d30-a934-40f1-8f95-6dbe95e21266"> ["revision"] = <"1.0.0"> > definition INSTRUCTION[at0000] matches { -- Informed Consent Request activities cardinality matches {0..*; unordered} matches { ACTIVITY[at0002] occurrences matches {0..1} matches { -- Current Activity action_archetype_id matches {/openEHR-EHR-ACTION\.informed_consent\.v1/} description matches { ITEM_TREE[at0003] matches { -- Tree items cardinality matches {0..*; unordered} matches { ELEMENT[at0004] occurrences matches {0..1} matches { -- Proposed Procedure/Trial/Activity value matches { DV_TEXT matches {*} } } ELEMENT[at0016] occurrences matches {0..1} matches { -- Procedure/Trial/Activity Description value matches { DV_TEXT matches {*} } } ELEMENT[at0017] occurrences matches {0..1} matches { -- Intent value matches { DV_TEXT matches {*} } } ELEMENT[at0005] occurrences matches {0..1} matches { -- Consent Description value matches { DV_TEXT matches {*} } } allow_archetype CLUSTER[at0008] occurrences matches {0..*} matches { -- Details include archetype_id/value matches {/openEHR-EHR-CLUSTER\.consent_details(-[a-zA-Z0-9_]+)*\.v1|openEHR-EHR-CLUSTER\.procedure_details(-[a-zA-Z0-9_]+)*\.v1/} } ELEMENT[at0009] occurrences matches {0..1} matches { -- Start Date value matches { DV_DATE_TIME matches {*} } } ELEMENT[at0015] occurrences matches {0..1} matches { -- Date Consent Required value matches { DV_DATE_TIME matches {*} } } } } } } } protocol matches { ITEM_TREE[at0012] matches { -- Tree items cardinality matches {0..*; unordered} matches { ELEMENT[at0018] occurrences matches {0..1} matches { -- Proposed consent document value matches { DV_TEXT matches {*} } } allow_archetype CLUSTER[at0013] occurrences matches {0..*} matches { -- Responsible provider include archetype_id/value matches {/.*/} } allow_archetype CLUSTER[at0014] occurrences matches {0..*} matches { -- Proposed requester include archetype_id/value matches {/.*/} } CLUSTER[at0019] occurrences matches {0..*} matches { -- Supporting information items cardinality matches {1..*; unordered} matches { ELEMENT[at0020] occurrences matches {0..1} matches { -- Information name value matches { DV_TEXT matches {*} } } ELEMENT[at0023] occurrences matches {0..1} matches { -- Information type value matches { DV_TEXT matches {*} } } ELEMENT[at0021] occurrences matches {0..1} matches { -- Description value matches { DV_TEXT matches {*} } } allow_archetype CLUSTER[at0022] occurrences matches {0..*} matches { -- Multimedia representation include archetype_id/value matches {/.*/} } } } } } } } ontology term_definitions = < ["en"] = < items = < ["at0000"] = < text = <"Informed Consent Request"> description = <"Request or instruction to gain and record informed consent from a subject (or the subject's agent) 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 subject (or the subject's agent)."> > ["at0002"] = < text = <"Current Activity"> description = <"Current Activity."> > ["at0003"] = < text = <"Tree"> description = <"@ internal @"> > ["at0004"] = < text = <"Proposed Procedure/Trial/Activity"> description = <"Identification of the index proposed procedure/trial/activity (including correct side/correct site, where appropriate)."> > ["at0005"] = < text = <"Consent Description"> description = <"Narrative description of the informed consent required before performing the proposed procedure, clinical trial or healthcare-related activity."> > ["at0008"] = < text = <"Details"> description = <"Detailed information on the proposed procedure, clinical trial or healthcare-related activity, or indiviual component activities of the index procedure/trial/activity."> comment = <"For example: intent/purpose; anaesthetic details; disclosure of material risks; and proposed benefits discussed."> > ["at0009"] = < text = <"Start Date"> description = <"Proposed start date, and optional time, for the proposed index procedure, clinical trial or healthcare-related activity."> > ["at0012"] = < text = <"Tree"> description = <"@ internal @"> > ["at0013"] = < text = <"Responsible provider"> description = <"Healthcare provider who has oversight and responsibility for the procedure, clinical trial or healthcare-related activity."> > ["at0014"] = < text = <"Proposed requester"> description = <"Healthcare provider who is proposed to request consent from the subject."> > ["at0015"] = < text = <"Date Consent Required"> description = <"Date, and optional time, by which the consent is required."> > ["at0016"] = < text = <"Procedure/Trial/Activity Description"> description = <"Narrative description of the proposed procedure, clinical trial or healthcare-related activity."> > ["at0017"] = < text = <"Intent"> description = <"Description of the intent of the proposed procedure, clinical trial or healthcare-related activity."> > ["at0018"] = < text = <"Proposed consent document"> description = <"Identification of the consent form or document proposed for use."> > ["at0019"] = < text = <"Supporting information"> description = <"Details about supporting information proposed to be made available to the subject or subject's agent to support or inform the consent process."> > ["at0020"] = < text = <"Information name"> description = <"Identification of the information to be made available."> > ["at0021"] = < text = <"Description"> description = <"Narrative description of the information to be made available."> > ["at0022"] = < text = <"Multimedia representation"> description = <"Digital representation of the information to be made available."> > ["at0023"] = < text = <"Information type"> description = <"Type of information made available."> > > > >