<status value="draft" /> <date value="2024-06-18" /> <publisher value="openEHR" /> <contact> <telecom> <system value="url" /> <value value="http://www.veratech.es" /> </telecom> </contact> <description value="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." /> <purpose value="To record the status of a request for, or record of, informed consent prior to performing a procedure, clinical trial or healthcare-related activity." /> <fhirVersion value="4.0.0" /> <mapping> <identity value="openEHR" /> <uri value="http://openehr.org" /> <name value="openEHR Mapping" /> </mapping> <mapping> <identity value="openEHR-natural" /> <uri value="http://openehr.org" /> <name value="openEHR natural path" /> </mapping> <kind value="logical" /> <abstract value="false" /> <type value="StructureDefinition" /> <baseDefinition value="http://hl7.org/fhir/StructureDefinition/Element" /> <snapshot> <element id="Informed_consent"> <path value="Informed_consent" /> <short value="Informed consent" /> <definition value="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." /> <min value="1" /> <max value="1" /> <base> <path value="Informed_consent" /> <min value="1" /> <max value="1" /> </base> <type> <code value="BackboneElement" /> </type> <mustSupport value="true" /> <isModifier value="false" /> <isSummary value="true" /> </element> <element id="Informed_consent.protocol"> <path value="Informed_consent.protocol" /> <short value="Tree" /> <definition value="@ internal @" /> <min value="0" /> <max value="1" /> <base> <path value="Informed_consent.protocol" /> <min value="0" /> <max value="1" /> </base> <type> <code value="BackboneElement" /> </type> <mustSupport value="false" /> <isModifier value="false" /> <isSummary value="true" /> </element> <element id="Informed_consent.protocol.Consent_document_used"> <path value="Informed_consent.protocol.Consent_document_used" /> <short value="Consent document used" /> <definition value="Identification of the form or document used to obtain consent." /> <min value="0" /> <max value="1" /> <base> <path value="Informed_consent.protocol.Consent_document_used" /> <min value="0" /> <max value="1" /> </base> </element> <element id="Informed_consent.protocol.Consent_document_used.value"> <path value="Informed_consent.protocol.Consent_document_used.value" /> <short value="Consent document used" /> <definition value="Identification of the form or document used to obtain consent." /> <min value="0" /> <max value="1" /> <base> <path value="Informed_consent.protocol.Consent_document_used.value" /> <min value="0" /> <max value="1" /> </base> <type> <code value="CodeableConcept" /> </type> <mustSupport value="false" /> <isModifier value="false" /> <isSummary value="true" /> </element> <element id="Informed_consent.protocol.Review_date"> <path value="Informed_consent.protocol.Review_date" /> <short value="Review date" /> <definition value="Date when consent status is due for review." /> <min value="0" /> <max value="1" /> <base> <path value="Informed_consent.protocol.Review_date" /> <min value="0" /> <max value="1" /> </base> </element> <element id="Informed_consent.protocol.Review_date.value"> <path value="Informed_consent.protocol.Review_date.value" /> <short value="Review date" /> <definition value="Date when consent status is due for review." /> <min value="0" /> <max value="1" /> <base> <path 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<element id="Informed_consent.protocol.Patient_information.Name"> <path value="Informed_consent.protocol.Patient_information.Name" /> <short value="Name" /> <definition value="Identification of the information made available." /> <min value="0" /> <max value="1" /> <base> <path value="Informed_consent.protocol.Patient_information.Name" /> <min value="0" /> <max value="1" /> </base> </element> <element id="Informed_consent.protocol.Patient_information.Name.value"> <path value="Informed_consent.protocol.Patient_information.Name.value" /> <short value="Name" /> <definition value="Identification of the information made available." /> <min value="0" /> <max value="1" /> <base> <path value="Informed_consent.protocol.Patient_information.Name.value" /> <min value="0" /> <max value="1" /> </base> <type> <code value="CodeableConcept" /> </type> <mustSupport value="false" /> <isModifier value="false" /> <isSummary value="true" /> </element> <element 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value="true" /> </element> <element id="Informed_consent.protocol.Patient_information.Multimedia_representation"> <path value="Informed_consent.protocol.Patient_information.Multimedia_representation" /> <short value="Multimedia representation" /> <definition value="Digital representation of the evidence of consent." /> <min value="0" /> <max value="*" /> <base> <path value="Informed_consent.protocol.Patient_information.Multimedia_representation" /> <min value="0" /> <max value="*" /> </base> <type> <code value="BackboneElement" /> </type> <mustSupport value="false" /> <isModifier value="false" /> <isSummary value="true" /> </element> <element id="Informed_consent.description"> <path value="Informed_consent.description" /> <short value="Tree" /> <definition value="@ internal @" /> <min value="0" /> <max value="1" /> <base> <path value="Informed_consent.description" /> <min value="0" /> <max value="1" /> </base> <type> <code value="BackboneElement" /> </type> <mustSupport value="false" /> <isModifier value="false" /> <isSummary value="true" /> </element> <element id="Informed_consent.description.Procedure_Trial_Activity"> <path value="Informed_consent.description.Procedure_Trial_Activity" /> <short value="Procedure/Trial/Activity" /> <definition value="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." /> <min value="1" /> <max value="*" /> <base> <path value="Informed_consent.description.Procedure_Trial_Activity" /> <min value="1" /> <max value="*" /> </base> </element> <element id="Informed_consent.description.Procedure_Trial_Activity.value"> <path value="Informed_consent.description.Procedure_Trial_Activity.value" /> <short value="Procedure/Trial/Activity" /> <definition value="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." /> <min value="0" /> <max value="1" /> <base> <path value="Informed_consent.description.Procedure_Trial_Activity.value" /> <min value="0" /> <max value="1" /> </base> <type> <code value="CodeableConcept" /> </type> <mustSupport value="false" /> <isModifier value="false" /> <isSummary value="true" /> </element> <element id="Informed_consent.description.Procedure_Trial_Activity_description"> <path value="Informed_consent.description.Procedure_Trial_Activity_description" /> <short value="Procedure/Trial/Activity description" /> <definition value="Narrative description of the procedure, clinical trial or healthcare-related activity." /> <min value="0" /> <max value="1" /> <base> <path value="Informed_consent.description.Procedure_Trial_Activity_description" /> <min value="0" /> <max value="1" /> </base> </element> <element id="Informed_consent.description.Procedure_Trial_Activity_description.value"> <path value="Informed_consent.description.Procedure_Trial_Activity_description.value" /> <short value="Procedure/Trial/Activity description" /> <definition value="Narrative description of the procedure, clinical trial or healthcare-related activity." /> <min value="0" /> <max value="1" /> <base> <path value="Informed_consent.description.Procedure_Trial_Activity_description.value" /> <min value="0" /> <max value="1" /> </base> <type> <code value="CodeableConcept" /> </type> <mustSupport value="false" /> <isModifier value="false" /> <isSummary value="true" /> </element> <element id="Informed_consent.description.Intent"> <path value="Informed_consent.description.Intent" /> <short value="Intent" /> <definition value="Description of the intent of the procedure, clinical trial or healthcare-related activity." /> <min value="0" /> <max value="1" /> <base> <path value="Informed_consent.description.Intent" /> <min value="0" /> <max value="1" /> </base> </element> <element id="Informed_consent.description.Intent.value"> <path value="Informed_consent.description.Intent.value" /> <short value="Intent" /> <definition value="Description of the intent of the procedure, clinical trial or healthcare-related activity." /> <min value="0" /> <max value="1" /> <base> <path value="Informed_consent.description.Intent.value" /> <min value="0" /> <max value="1" /> </base> <type> <code value="CodeableConcept" /> </type> <mustSupport value="false" /> <isModifier value="false" /> <isSummary value="true" /> </element> <element id="Informed_consent.description.Consent_description"> <path value="Informed_consent.description.Consent_description" /> <short value="Consent description" /> <definition value="Narrative description of the informed consent required or recorded prior to performing the proposed procedure, clinical trial or healthcare-related activity." /> <min value="0" /> <max value="1" /> <base> <path value="Informed_consent.description.Consent_description" /> <min value="0" /> <max value="1" /> </base> </element> <element id="Informed_consent.description.Consent_description.value"> <path value="Informed_consent.description.Consent_description.value" /> <short value="Consent description" /> <definition value="Narrative description of the informed consent required or recorded prior to performing the proposed procedure, clinical trial or healthcare-related activity." /> <min value="0" /> <max value="1" /> <base> <path value="Informed_consent.description.Consent_description.value" /> <min value="0" /> <max value="1" /> </base> <type> <code value="CodeableConcept" /> </type> <mustSupport value="false" /> <isModifier value="false" /> <isSummary value="true" /> </element> <element id="Informed_consent.description.Details"> <path value="Informed_consent.description.Details" /> <short value="Details" /> <definition value="Additional structured details about the procedure/trial/activity itself or additional structured consent details." /> <min value="0" /> <max value="*" /> <base> <path value="Informed_consent.description.Details" /> <min value="0" /> <max value="*" /> </base> <type> <code value="BackboneElement" /> </type> <mustSupport value="false" /> <isModifier value="false" /> <isSummary value="true" /> </element> <element id="Informed_consent.description.Form_of_consent"> <path value="Informed_consent.description.Form_of_consent" /> <short value="Form of consent" /> <definition value="Form of the consent sought or provided." /> <min value="0" /> <max value="1" /> <base> <path value="Informed_consent.description.Form_of_consent" /> <min value="0" /> <max value="1" /> </base> </element> <element id="Informed_consent.description.Form_of_consent.value"> <path value="Informed_consent.description.Form_of_consent.value" /> <short value="Form of consent" /> <definition value="Form of the consent sought or provided." /> <min value="0" /> <max value="1" /> <base> <path value="Informed_consent.description.Form_of_consent.value" /> <min value="0" /> <max value="1" /> </base> <type> <code value="CodeableConcept" /> </type> <mustSupport value="false" /> <isModifier value="false" /> <isSummary value="true" /> </element> <element id="Informed_consent.description.Reason"> <path value="Informed_consent.description.Reason" /> <short value="Reason" /> <definition value="Reason that the care pathway step for the identified procedure, clinical trial or healthcare-related activity was carried out." /> <min value="0" /> <max value="1" /> <base> <path value="Informed_consent.description.Reason" /> <min value="0" /> <max value="1" /> </base> </element> <element id="Informed_consent.description.Reason.value"> <path value="Informed_consent.description.Reason.value" /> <short value="Reason" /> <definition value="Reason that the care pathway step for the identified procedure, clinical trial or healthcare-related activity was carried out." /> <min value="0" /> <max value="1" /> <base> <path value="Informed_consent.description.Reason.value" /> <min value="0" /> <max value="1" /> </base> <type> <code value="CodeableConcept" /> </type> <mustSupport value="false" /> <isModifier value="false" /> <isSummary value="true" /> </element> <element id="Informed_consent.description.Start_date"> <path value="Informed_consent.description.Start_date" /> <short value="Start date" /> <definition value="Date, and optional time, when validity of the informed consent becomes active." /> <min value="0" /> <max value="1" /> <base> <path value="Informed_consent.description.Start_date" /> <min value="0" /> <max value="1" /> </base> </element> <element id="Informed_consent.description.Start_date.value"> <path value="Informed_consent.description.Start_date.value" /> <short value="Start date" /> <definition value="Date, and optional time, when validity of the informed consent becomes active." /> <min value="0" /> <max value="1" /> <base> <path value="Informed_consent.description.Start_date.value" /> <min value="0" /> <max value="1" /> </base> <type> <code value="dateTime" /> </type> <mustSupport value="false" /> <isModifier value="false" /> <isSummary value="true" /> </element> <element id="Informed_consent.description.End_date"> <path value="Informed_consent.description.End_date" /> <short value="End date" /> <definition value="Date, and optional time, when validity of the informed consent ceased." /> <min value="0" /> <max value="1" /> <base> <path value="Informed_consent.description.End_date" /> <min value="0" /> <max value="1" /> </base> </element> <element id="Informed_consent.description.End_date.value"> <path value="Informed_consent.description.End_date.value" /> <short value="End date" /> <definition value="Date, and optional time, when validity of the informed consent ceased." /> <min value="0" /> <max value="1" /> <base> <path value="Informed_consent.description.End_date.value" /> <min value="0" /> <max value="1" /> </base> <type> <code value="dateTime" /> </type> <mustSupport value="false" /> <isModifier value="false" /> <isSummary value="true" /> </element> <element id="Informed_consent.description.Caveat"> <path value="Informed_consent.description.Caveat" /> <short value="Caveat" /> <definition value="Details of any qualifications or exemptions to the informed consent." /> <min value="0" /> <max value="*" /> <base> <path value="Informed_consent.description.Caveat" /> <min value="0" /> <max value="*" /> </base> </element> <element id="Informed_consent.description.Caveat.value"> <path value="Informed_consent.description.Caveat.value" /> <short value="Caveat" /> <definition value="Details of any qualifications or exemptions to the informed consent." /> <min value="0" /> <max value="1" /> <base> <path value="Informed_consent.description.Caveat.value" /> <min value="0" /> <max value="1" /> </base> <type> <code value="CodeableConcept" /> </type> <mustSupport value="false" /> <isModifier value="false" /> <isSummary value="true" /> </element> <element id="Informed_consent.description.Evidence_link"> <path value="Informed_consent.description.Evidence_link" /> <short value="Evidence link" /> <definition value="Link to evidence of consent." /> <min value="0" /> <max value="1" /> <base> <path value="Informed_consent.description.Evidence_link" /> <min value="0" /> <max value="1" /> </base> </element> <element id="Informed_consent.description.Evidence_link.value"> <path value="Informed_consent.description.Evidence_link.value" /> <short value="Evidence link" /> <definition value="Link to evidence of consent." /> <min value="0" /> <max value="1" /> <base> <path value="Informed_consent.description.Evidence_link.value" /> <min value="0" /> <max value="1" /> </base> <type> <code value="string" /> </type> <mustSupport value="false" /> <isModifier value="false" /> <isSummary value="true" /> </element> <element id="Informed_consent.description.Comment"> <path value="Informed_consent.description.Comment" /> <short value="Comment" /> <definition value="Additional narrative about the informed consent activity, not captured in other fields." /> <min value="0" /> <max value="1" /> <base> <path value="Informed_consent.description.Comment" /> <min value="0" /> <max value="1" /> </base> </element> <element id="Informed_consent.description.Comment.value"> <path value="Informed_consent.description.Comment.value" /> <short value="Comment" /> <definition value="Additional narrative about the informed consent activity, not captured in other fields." /> <min value="0" /> <max value="1" /> <base> <path value="Informed_consent.description.Comment.value" /> <min value="0" /> <max value="1" /> </base> <type> <code value="CodeableConcept" /> </type> <mustSupport value="false" /> <isModifier value="false" /> <isSummary value="true" /> </element> <element id="Informed_consent.description.Evidence_details"> <path value="Informed_consent.description.Evidence_details" /> <short value="Evidence details" /> <definition value="Digital 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value="Informed_consent.ism_transition_Postponed.careflow_step" /> <short value="Postponed" /> <definition value="Intent to request informed consent has been postponed." /> <min value="0" /> <max value="1" /> <base> <path value="Informed_consent.ism_transition_Postponed.careflow_step" /> <min value="0" /> <max value="1" /> </base> <type> <code value="CodeableConcept" /> </type> <mustSupport value="false" /> <isModifier value="false" /> <isSummary value="true" /> </element> <element id="Informed_consent.Cancelled"> <path value="Informed_consent.Cancelled" /> <short value="Cancelled" /> <definition value="Intent to request informed consent has been cancelled, prior to requesting consent from patient or patient's agent.." /> <min value="0" /> <max value="1" /> <base> <path value="Informed_consent.Cancelled" /> <min value="0" /> <max value="1" /> </base> <type> <code value="BackboneElement" /> </type> <mustSupport value="false" /> <isModifier value="false" /> <isSummary value="true" /> 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