EM-HCP-07 · Subject model · W-IND
Informed consent record
A patient's or representative's recorded decision to accept or refuse a treatment, a procedure, research participation or information sharing, with its scope, form version, information given, signatories, validity and withdrawal. Legal bases for processing personal data are a separate contour.
Partially published; research continues
Claude: initial-industry-contour-and-card-supplement; Grok: not-started.
Published results
The independent second-provider study, fixtures and the full research protocol remain open. Runtime promotion is governed by the package allocation holds.
Subject boundary and candidate types
- ConsentRecord
- ConsentScope
- ConsentFormVersion
- Signatory
- ConsentWithdrawal
Deep research questions
- How is consent to a procedure distinguished from consent to data sharing?
- Which version of the information sheet did the patient receive?
- How does a withdrawal take effect on records and on planned activities?
Verifiable invariants
- A consent record names its scope, decision and date
- Consent given by a representative records the basis of authority
- A withdrawal never deletes the original consent record
End-to-end acceptance scenario
For a synthetic surgical case, record procedure consent signed by a representative, a refusal of research use, and a later withdrawal of data sharing consent, and show what each record permits.
Negative case
A general admission form is treated as consent to a specific surgical procedure and to research use of samples.
Approaches to compare
- HL7 FHIR: Consent resource
- IHE privacy consent profiles for health information exchange
- Research ethics and research consent practice
Candidates in the live catalogue
- WM-XCT-002 · Access Contract / Consent · 0.3.0-research.1 · installable
Semantic fit requires boundary research; a published model does not by itself complete this card. - WM-REC-010 · Decision / Approval Record · 0.3.0-research.1 · installable
Semantic fit requires boundary research; a published model does not by itself complete this card.
Result requirements
Every card is executed together with the full research contract: definitions, fields and cardinalities, lifecycle, sources, data mastership, rights, the five object facets, at least eight invariants, positive and negative examples, dependencies, migration and applicability limits.