Notice
- Important: This guidance is under active development by NHS England and content may be added or updated on a regular basis.
- This Implementation Guide is currently in Draft and SHOULD NOT be used for development or active implementation without express direction from the NHS England Genomics Unit.
Record of Discussion
Purpose
For recording consent of patient data for research, based off the paper form available from the Genomics GitHub repository
Notes
WGS Only RoD forms will be stored as QuestionnaireResponse resources following the structure of the RoD Questionnaire resource, Questionnaire-Genomic Testing. Answers are not currently linked to structured identifiers, e.g. for patient and responsible clinician, this will be reviewed in a future release.
Mapping
| Source Data item | Target FHIR Element | HL7v2.5.1 Mapping | Description |
|---|---|---|---|
| RoD - Included | N/A - Inferred through inclusion of RoD Questionnaire Response | N/A - Inferred through inclusion of NTE segment attached to patient with NTE-4=PI | Has RoD been included with request. |
| RoD - Patient category | Answer to RoD question with linkId patientCategory | CON-16 (for OML, included in RoD, referenced from NTE-3) | Confirmation of who made the RoD decisions. |
| RoD - Recording clinician name | Answer to RoD question with linkId healthcareProfessionalName | STF segment attached to CON (for OML, included in RoD, referenced from NTE-3) | Name of the clinician who recorded the RoD details. |
| RoD - Record of discussion form - copy attached | Consent.sourceAttachment (or QuestionnaireResponse attached directly to message, TBC) | CON-19 (for OML, included in RoD, referenced from NTE-3) | Marker to confirm on a test request form that an RoD has been included. |
| RoD - Patient choice status | Answer to RoD question with linkId researchConfirmation2 | CON-11 (for OML, included in RoD, referenced from NTE-3) | Indication of the patient consenting to the genomic test request. |
| RoD - Has research participation been discussed | Answer to RoD question with linkId researchConfirmation1 | Inferred through CON-12 (for OML, included in RoD, referenced from NTE-3) | Marker to confirm RoD conversation has taken place. |
| RoD - Remote consent | Answer to RoD question with linkId remoteConsent | CON-10 (for OML, included in RoD, referenced from NTE-3) | Where consent has been recorded on behalf of the patient via remote confirmation. |
| RoD - Test type | Answer to RoD question with linkId testType | CON-2 (for OML, included in RoD, referenced from NTE-3) | If the test is WGS Cancer or WGS rare disease. |
| RoD - Research opt out reason | Answer to RoD question with linkId reasonsforChoiceA | CON-22 (for OML, included in RoD, referenced from NTE-3) | Why patient has opted out of research. |
| RoD - Responsible clinician name | Answer to RoD question with linkId responsibleClinician | STF segment attached to CON (for OML, included in RoD, referenced from NTE-3) | Name of the clinician who is responsible for the patient's genomic test request. |
| RoD - Patient conversation taken place, ROD form to follow | Consent.status (TBC) | Inferred through CON-19 value (for OML, included in RoD, referenced from NTE-3) | Marker to confirm RoD conversation has taken place but will be sent separately. |
| RoD - Signature | Answer to RoD question with linkId patientSignature | N/A not in scope for HL7v2 | Copy of wet signature or valid e-signature. |
| RoD - Document/Link | N/A - Presence of DiagnosticReport in message | N/A not in scope for HL7v2 | A copy of/or link to the previous genomic or non genomic report. |