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. This QuestionnaireResponse is expected to be referenced from a Consent resource which carries the minimal metadata surrounding the consent, as below. Mappings to the HL7v2 Consent segment and how this is expected to be transferred in an OML-O21 message are still pending investigation

Answers are not currently linked to structured identifiers, e.g. for patient and responsible clinician, this will be reviewed in a future release.

Mapping

ID Source Data item Target FHIR Element HL7v2.5.1 Mapping Description
NGRL-1 NGRL consent - Date of NGRL consent Consent.dateTime CON-14 The date NGRL consent was provided.
NGRL-2 NGRL consent - Patient has made their own choice to consent to the NGRL Inferred by Consent.patient != Consent.performer Indicated through multiple CON-24 segments, for subject and performer Confirmation if the patient to be tested has provided NGRL consent themselves.
NGRL-3 NGRL consent - Patient representative name (if patient cannot make their own choice) Consent.performer if not the same as Consent.patient CON-24 for representative The name of the patient representative.
NGRL-4 NGRL consent - I confirm that the patient (or their representative) agree to have their genomic and healthcare data used for research Consent.provision.type=permit CON-11.1=A The outcome of the patient or their representative’s choice in consenting to including their data used for research in the NGRL.
NGRL-5 NGRL consent - NGRL consent document link Consent.sourceReference (if QuestionnaireResponse) or sourceAttachment.url (if binary) CON-4 A URL where a copy of a completed NGRL consent form may be found.

Prior RoD 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.