Uploaded image for project: 'FHIR Specification Feedback'
  1. FHIR Specification Feedback
  2. FHIR-38969

ResearchSubject - PlanDefinition.actor.option.typeReference

    XMLWordPrintableJSON

Details

    • Icon: Change Request Change Request
    • Resolution: Not Persuasive with Modification
    • Icon: Medium Medium
    • FHIR Core (FHIR)
    • R5
    • Clinical Decision Support
    • PlanDefinition
    • Hide

      ResearchSubject is a linking resource and cannot be itself a Participant. This use case would always handled by identifying a Patient resource (which may be a de-identified resource for the purposes of research participation), rather than trying to use ResearchSubject as the participant directly.

      However, it is reasonable to add other allowable potential participants including:

      Medication

      Specimen - Note some clarifying language needed here to ensure appropriate use (e.g. as a specimen in cell-line research is acceptable, but specimen in clinical research would typically be represented as the focus rather the subject)

      Substance

      BiologicallyDerivedProduct

       

      Show
      ResearchSubject is a linking resource and cannot be itself a Participant. This use case would always handled by identifying a Patient resource (which may be a de-identified resource for the purposes of research participation), rather than trying to use ResearchSubject as the participant directly. However, it is reasonable to add other allowable potential participants including: Medication Specimen - Note some clarifying language needed here to ensure appropriate use (e.g. as a specimen in cell-line research is acceptable, but specimen in clinical research would typically be represented as the focus rather the subject) Substance BiologicallyDerivedProduct  
    • Lloyd McKenzie/Brian Alper: 15-0-0
    • Enhancement
    • Compatible, substantive

    Description

      I know there have been discussions about why ResearchSubject has not been included via PlanDefinition.actor.option.typeReference. However, from the clinical research protocol perspective, the primary reason for using PlanDefinition is to include the ResearchSubject as an actor. Yes, the Patient resource can be used as a traversal method, but the Patient resource may not be accessible in all relevant details at a particular site (e.g., consent into a ResearchStudy may have limited PIIs as part of demographic collection forms). As such, the relevant details would be found in ResearchSubject. Therefore, it would make the process more efficient to include ResearchSubject as a reference here.

      Attachments

        Activity

          People

            Unassigned Unassigned
            mhamidi Mike Hamidi
            Watchers:
            3 Start watching this issue

            Dates

              Created:
              Updated:
              Resolved: