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  1. FHIR Specification Feedback
  2. FHIR-29259

Change definition text for ResearchSubject

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    • Icon: Change Request Change Request
    • Resolution: Persuasive with Modification
    • Icon: Medium Medium
    • FHIR Core (FHIR)
    • R4
    • Biomedical Research & Regulation
    • ResearchSubject
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      8.23 Resource ResearchSubject - Content

      A ResearchSubject is a participant or object which is the recipient of investigative activities in a research study

      8.23.1 Scope and Usage
      A research subject is typically a human being or an animal, but can also be a device, drug product or biological product, substance, or a tissue or other sort of sample. Research subject can also be a group or part of any of the above.

      The ResearchSubject resource describes information about the subject in the context of a research study.

      Human research subjects are traceable to a particular person but their identifying characteristics are usually hidden to protect study integrity and to protect the subject’s privacy.

      Note that in a human drug trial the human is the research subject even though the drug is what is being investigated.

      The scope of ResearchSubject is intended to support the following use cases:

      • Humans and Animals for Clinical and Pre-clinical Trials
      • Drug Products for Stability Studies and other Tests
      • Devices for non-clinical laboratory studies - in-vivo and in-vitro
      • Tissue Sample for bench science studies
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      8.23 Resource ResearchSubject - Content A ResearchSubject is a participant or object which is the recipient of investigative activities in a research study 8.23.1 Scope and Usage A research subject is typically a human being or an animal, but can also be a device, drug product or biological product, substance, or a tissue or other sort of sample. Research subject can also be a group or part of any of the above. The ResearchSubject resource describes information about the subject in the context of a research study. Human research subjects are traceable to a particular person but their identifying characteristics are usually hidden to protect study integrity and to protect the subject’s privacy. Note that in a human drug trial the human is the research subject even though the drug is what is being investigated. The scope of ResearchSubject is intended to support the following use cases: Humans and Animals for Clinical and Pre-clinical Trials Drug Products for Stability Studies and other Tests Devices for non-clinical laboratory studies - in-vivo and in-vitro Tissue Sample for bench science studies
    • Brian Alper / Catherine Hosage-Norman : 11 - 0 - 0
    • Clarification
    • Non-substantive
    • R5

    Description

      Current text in 8.23 and 8.23.1 is not a correct definition.  Replace with

      8.23 Resource ResearchSubject - Content

      A ResearchSubject is a participant or object which is the recipient of investigative activites in a research study

      8.23.1 Scope and Usage
      A research subject is typically a human being or an animal, but can also be a device, drug product or biological product, substance, or a tissue or other sort of sample. Research subject can also be a group or part of any of the above.

      (what about environmental studies? location?)

      The ResearchSubject resource describes essential information about the subject in the context of a research study. (maybe use code value pairs)

      Human research subjects are traceable to a particular person but their identifying characteristics are usually hidden to protect study integrity and to protect the subject’s privacy.

      Note that in a human drug trial the human is the research subject even though the drug is what is being investigated.

      This is the start of revision of the Scope and Usage section - there will be further extensions to look at a series of use cases, the initial thought is:

      The scope of ResearchSubject is intended to support the following use cases:
      - Clinical trials (human and vetirinary)
      - Pre-clinical trials
      - Drug Product
      - Stability studies on drug products
      - Device ....
      - Other bench research related to specimen
      - Tissue
      ...

       

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            khalid_shahin Khalid Shahin
            Hugh.Glover Hugh Glover
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