| ARCHETYPE ID | openEHR-EHR-ACTION.kds_informed_consent.v0 |
|---|---|
| Concept | kds_informed_consent |
| Description | 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. |
| Use | Use 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record the status of an order to obtain informed consent, including what is planned, scheduled, requested, provided, or withdrawn.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 The status of the informed consent is reflected by the pathway steps - requested, refused, provided, withdrawn etc. |
| Purpose | To record the status of a request for, or record of, informed consent prior to performing a procedure, clinical trial or healthcare-related activity. |
| 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. |
| Copyright | © openEHR Foundation, HiGHmed |
| Authors | Author name: Heather Leslie Organisation: Atomica Informatics Email: heather.leslie@atomicainformatics.com Date originally authored: 09-10-2012 |
| Other Details Language | Author name: Heather Leslie Organisation: Atomica Informatics Email: heather.leslie@atomicainformatics.com Date originally authored: 09-10-2012 |
| Other Details (Language Independent) |
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| Keywords | consent, informed, caveat |
| Lifecycle | in_development |
| UID | ed7712ae-51c2-4f2a-ba66-b6e91810f761 |
| Language used | en |
| Citeable Identifier | 1246.145.2387 |
| Revision Number | 0.0.1-alpha |
| description | |
| Procedure/Trial/Activity | Procedure/Trial/Activity: 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. |
| Procedure/Trial/Activity description | Procedure/Trial/Activity description: Narrative description of the procedure, clinical trial or healthcare-related activity. |
| Intent | Intent: Description of the intent of the procedure, clinical trial or healthcare-related activity. |
| Consent description | Consent description: Narrative description of the informed consent required or recorded prior to performing the proposed procedure, clinical trial or healthcare-related activity. |
| Details | Details: Additional structured details about the procedure/trial/activity itself or additional structured consent details. For example: intent/purpose; anaesthetic details; disclosure of material risks; and proposed benefits discussed. Include: All not explicitly excluded archetypes |
| Form of consent | Form of consent: Form of the consent sought or provided.
|
| Reason | Reason: Reason that the care pathway step for the identified procedure, clinical trial or healthcare-related activity was carried out. For example, the reason for 'consent refused' or 'consent withdrawn'. |
| Start date | Start date: Date, and optional time, when validity of the informed consent becomes active. |
| End date | End date: Date, and optional time, when validity of the informed consent ceased. |
| Caveat | Caveat: Details of any qualifications or exemptions to the informed consent. |
| Evidence link | Evidence link: Link to evidence of consent. For example, a hyperlink to the evidence held elsewhere in the health record. |
| Comment | Comment: Additional narrative about the informed consent activity, not captured in other fields. |
| Evidence details | Evidence details: Digital representation of the evidence of consent. For example: a PDF of a consent authorisation form; or an audio file. Include: openEHR-EHR-CLUSTER.multimedia.v0 |
| protocol | |
| Consent document used | Consent document used: Identification of the form or document used to obtain consent. |
| Review date | Review date: Date when consent status is due for review. |
| Consent requester | Consent requester: Details about the healthcare provider who is requesting or recording the consent. Insert archetyped demographic details in this SLOT if it is not possible to use other_participations. Include: All not explicitly excluded archetypes |
| Consent provider | Consent provider: Details about the subject (or subject's agent) who is being requested for, or providing, the consent for the procedure, clinical trial or healthcare-related activity. Insert archetyped demographic details in this SLOT if it is not possible to use other_participations. Include: All not explicitly excluded archetypes |
| Patient information | Patient information: Details about Patient Information made available to the subject or subject's agent. |
| Name | Name: Identification of the information made available. For example, the name of the form. |
| Description | Description: Narrative description of the patient information made available. |
| Multimedia representation | Multimedia representation: Digital representation of the evidence of consent. Include: All not explicitly excluded archetypes |
| ism_transition | |
| Planned | Planned: Need for informed consent is identified. Current state: planned |
| Postponed | Postponed: Intent to request informed consent has been postponed. Current state: postponed |
| Cancelled | Cancelled: Intent to request informed consent has been cancelled, prior to requesting consent from patient or patient's agent.. Current state: cancelled |
| Appointment scheduled | Appointment scheduled: An appointment has been scheduled to request consent. Current state: scheduled |
| Informed consent requested | Informed consent requested: Informed consent has been requested from the patient or patient's agent, but no response has been received. Current state: active, planned |
| Informed consent provided | Informed consent provided: Informed consent has been provided by the patient or patient's agent. Current state: active |
| Informed consent not obtained | Informed consent not obtained: Informed consent was not obtainable from either the patient or patient's advocate. Current state: active |
| Informed consent refused | Informed consent refused: In response to a request for informed consent, it has been refused by patient or patient's agent. Current state: aborted |
| Informed consent withdrawn | Informed consent withdrawn: Following initial provision of informed consent, it has been withrawn by the patient or patient's agent. Current state: aborted |
| Completed | Completed: Informed consent has been provided by the patient or patient's agent and the activity is now complete. Current state: completed |
| Other contributors | |
| Translators |
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