Note that the sIRB team will be convening Friday, May 15 at 9AM ET to provide test scripts and setup.
Submitting WG/Project/Implementer Group
Biomedical Research and Regulation /sIRB
Justification and Objectives
For this track, we plan to have participants step through the generalized workflow of the sIRB process including use of a standardized form, collection of data, and transmission and retrieval of these data using FHIR standards to simulate the sharing of data between reviewing and relying IRB vendor software.
This track will use R4 version of FHIR.
Clinical input requested (if any)
No specific clinical input is requested, although we are open to feedback on the content of the forms as well as the technical infrastructure.
(used to help guide seating arrangements and possibly drive track consolidation)
Proposed Track Lead
James Topping, Duke University email@example.com
We currently expect 2 academic members and possibly 1 or 2 representatives from the IRB vendor community.
System Role 1: A server containing the proposed forms will be provided.
System Role 2: The NLM LHC Forms website will be available for form completion. This role could also be fulfilled in the future using IRB vendor software.
System Role 3: A test FHIR server for saving and retrieval of data will be provided.
Role 1 Name
Participants will asked to replicate a standard scenario where a PI retrieves a standard form (there will be multiple), completes it based on supporting documents and the needs of their project (as would occur at the reviewing IRB) and transmits it using FHIR standards to a FHIR server. This form will then be retrieved and rendered (as would occur at the relying IRB).
Scenario Step 1 Name
Action: Retrieval of forms, Completion and Submission using FHIR standards, retrieval and rendering.
Precondition: Provided forms, provided test server.
Success Criteria: Successful completion of the full pathway from blank forms to retrieved data.
Indicate any test scripts that will be used to help verify system behavior
Security and Privacy Considerations
Identify any expectations around security (e.g. will TLS, mutual-TLS, OAuth, etc. be required to participate