| ARCHETYPE ID | openEHR-EHR-INSTRUCTION.informed_consent.v1 |
|---|---|
| Concept | 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). |
| 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. |
| 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. |
| 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 |
| Authors | Author name: Heather Leslie Organisation: Ocean Informatics Email: heather.leslie@oceaninformatics.com Date originally authored: 2012-10-09 |
| Other Details Language | Author name: Heather Leslie Organisation: Ocean Informatics Email: heather.leslie@oceaninformatics.com Date originally authored: 2012-10-09 |
| Other Details (Language Independent) |
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| Keywords | consent, informed, trial, procedure, operation |
| Lifecycle | CommitteeDraft |
| Language used | en |
| Citeable Identifier | 1013.1.1408 |
| activities | |
| Current Activity | Current Activity: Current Activity. Action Archetype ID: openEHR-EHR-ACTION.informed_consent.v1 |
| Proposed Procedure/Trial/Activity | Proposed Procedure/Trial/Activity: Identification of the index proposed procedure/trial/activity (including correct side/correct site, where appropriate). |
| Procedure/Trial/Activity Description | Procedure/Trial/Activity Description: Narrative description of the proposed procedure, clinical trial or healthcare-related activity. |
| Intent | Intent: Description of the intent of the proposed procedure, clinical trial or healthcare-related activity. |
| Consent Description | Consent Description: Narrative description of the informed consent required before performing the proposed procedure, clinical trial or healthcare-related activity. |
| Details | Details: Detailed information on the proposed procedure, clinical trial or healthcare-related activity, or indiviual component activities of the index procedure/trial/activity. For example: intent/purpose; anaesthetic details; disclosure of material risks; and proposed benefits discussed. Include: openEHR-EHR-CLUSTER.consent_ openEHR-EHR-CLUSTER.procedure_ |
| Start Date | Start Date: Proposed start date, and optional time, for the proposed index procedure, clinical trial or healthcare-related activity. |
| Date Consent Required | Date Consent Required: Date, and optional time, by which the consent is required. |
| protocol | |
| Proposed Consent Document | Proposed Consent Document: Identification of the consent form or document proposed for use. |
| Responsible Provider | Responsible Provider: Healthcare provider who has oversight and responsibility for the procedure, clinical trial or healthcare-related activity. Include: All not explicitly excluded archetypes |
| Proposed Requester | Proposed Requester: Healthcare provider who is proposed to request consent from the subject. Include: All not explicitly excluded archetypes |
| Patient Information | Patient Information: Details about Patient Information proposed to be made available to the subject or subject's agent. |
| Name | Name: Identification of the information to be made available. |
| Description | Description: Narrative description of the patient information to be made available. |
| Multimedia Representation | Multimedia Representation: Digital representation of the Patient Information to be made available. |
| Other contributors | |
| Translators |