The Patient Choice Technical Project
Phase 2: Basic Choice for Research Consent Use Case Working Session
March 3rd, 2017
Call Logistics
• If you are not speaking, please keep your phone on mute
• Do not put your phone on hold – if you need to take a call, hang up and dial
in again when finished with your other call
• This meeting is being recorded
• Feel free to use the “Chat” feature for questions, comments or any items
you would like the moderator or participants to know
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Agenda
Topic
Time Allotted
General Announcements
5 minutes
Patient Choice Use Case Development
• Review Draft Use Case Document
• Introduce Sequence Diagrams
• Review User Story 4
50 minutes
Next Steps/Questions
5 minutes
3
General Announcements
• The next Patient Choice Technical Project Use Case Development meeting will
be on Friday, March 10rd, 2017 at 11 am ET
• Josh Mandel will be presenting an overview of Sync for Science on Friday,
March 17th, 2017 at 11am ET.
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Proposed Use Case & Functional
Requirements Development Timeline
Week
Target Date
Working Session Tasks
Review and Provide Comments via Confluence
(due Thursdays @ 12 pm ET)
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2/3
Review: Finalized Pre/Post Conditions and User Stories
Review : Activity Diagrams
Review: Activity Diagrams
15
2/10
Review : Activity Diagram and Finalized User Stories
Introduce: Base Flows
Review: Activity Diagram and Base Flows
16
2/17
Review: User Stories, Activity Diagram, and Base Flows
Review: User Stories, Activity Diagram and
Base Flows
17
2/24
CANCELLED (HIMSS)
Review: User Stories, Activity Diagram and
Base Flow
18
3/3
Review: Finalized Activity Diagrams, Finalized Base Flows
Introduce: Sequence Diagrams
Review: Sequence Diagrams
19
3/10
Review: Finalized Sequence Diagrams
Introduce: Functional Requirements & Dataset
Considerations, and Risks & Issues
Review: Functional Requirements, Dataset
Considerations, and Risks & Issues
20
3/17
Review: Finalized Functional Requirements & Sequence
Diagrams, Dataset Considerations, and Risks & Issues
Review: Dataset Considerations, and Risks
& Issues
21
3/24
Review: Finalized Data Requirements, and Finalized Risks &
Issues
End to End Review
5
6
Section Review
1.
Review the following sections:
1.
2.
User Story 4
Introduce the following sections:
1.
Sequence Diagrams
Click the icon to
open the
Word Document
7
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User Story 4 - Retina Translational Research
•
Alice Recruit sustains poly-traumatic injuries following an improvised explosive device (IED)
exposure during a recent tour of duty. She’s been taking an antioxidant to lower risk of ocular
blast trauma. She is now being cared for by a VA Ophthalmologist who recommends that she
join a VA Ocular Blast Trauma (OBT) and Opiate Pain Management (OPM) Translational Clinical
Trials. The VA Ophthalmologist is coordinating her care for chronic pain with her Community
Pain Management Specialist.
•
Alice meets with the VA OBT Recruitment Counselor. Since the VA does not permit compound
HIPAA Research Authorization and Informed Consent forms, the Counselor has Alice sign two
consent directives.
»
VA’s HIPAA and Title 38 Authorization to Disclose for Research, which will be sent to
Alice’s VA Ophthalmologist and her Pain Management Provider so that they can send her
records on a regular basis to the OBT Clinical Trial. Her VA Ophthalmologist will be
regularly sending her de-identified retinal scans as input to an artificial intelligence super
computer capable of machine learning to monitor any degradation of her ocular health.
Her Pain Management Specialist will be sending de-identified opiate pain management
information to the same super computer to monitor her susceptibility to opiate addiction.
»
VA’s Informed Consent to participate in the OBT and OPM Clinical Trials.
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User Story 4 - Retina Translational Research Cont.
•
Both consent directive forms give Alice the option of donating de-identified health information
disclosed to the OBT and OPM Clinical Trials, research data generated during the trial, and
biospecimens to the NIH for secondary research purposes limited to ocular and opiate
management research.
•
Both consent directives give Alice the option to be recontacted for follow up care with her
providers if the Clinical Trials detect any opportunities or concerns. Both also give Alice the
option to be recontacted for secondary research purposes or clinical trials related to OBT or
OPM. All recontacting is to be channeled through her OBT/OPM Recruitment Counselor.
•
Alice signs both consent directives, and selects secondary research and recontacting for
OBT/OPM.
•
Based on Alice’s consent for secondary research, the OBT/OPM Recruitment Counselor
registers her informed consent in the NIH Genomic Data Repository along with her NIH Data
Use Limitations [DULs] and agreement to be recontacted. The Counselor also registers her
informed consent to secondary use of her ocular biospecimens in the NIH/National Eye
Institute (NEI) EyeGENE Biorepository.
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User Story 4 - Retina Translational Research Cont.
•
Based on Alice’s secondary computable informed consent directives, only researchers who have
credentials for verifiable research protocols related to OBT/OPM are authorized to access Alice’s
de-identified ocular and opiate management health, clinical trial, and genomic information in the
NIH Genomic Data Repository or the NIH EyeGENE Biorepository via these repositories Access
Control Systems.
•
Later in this User Story, we will see Alice being recontacted via her OBT/OPM Recruitment
Counselor by several downstream secondary research studies including Rare Disease Registry, and
she will need to provide additional computable informed consent in order to participate in those
studies.
•
The main take-away is to illustrate some of the secondary use pathways that computable research
consent may take Alice, and to distill the data requirements for making this technically possible.
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User Story 4 - Retina Translational Research Cont.
• Today we are looking for initial thoughts about this user story and the
community’s reaction to exploring other aspects of the research consent
ecosystem such as:
» translational clinical trials,
» separate HIPAA Authorization and Informed Consent directives,
» multi-node secondary research uses,
» computable codes for encoding informed consent and enabling enforcement of
access control to research data.
• Based on your feedback, we will pull additional background information
forward to elaborate on this user story as needed while keeping the
workflow and interoperable consent directive exchanges front and center.
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Next Steps
• Review and provide feedback to posted materials by the following Thursday
at 12pm ET
» http://confluence.siframework.org/display/PATCH/Phase+2%3A+Basic+Choice+f
or+Research+Consent+Use+Case+Development
• Next meeting is Friday, March 10th, 2017 at 11 am ET
• Reminder: All Patient Choice Announcements, Schedules, Project Materials,
and Use Case will be posted on the Patient Choice Confluence page
» http://confluence.siframework.org/display/PATCH/
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Project Contact Information
OCPO-ONC Lead
Rose-Marie Nsahlai
[email protected]
Project Coordinator
Johnathan Coleman
[email protected]
Project Manager
Ali Khan
[email protected]
Project Support
Taima Gomez
[email protected]
Staff SME
Kathleen Connor
[email protected]
Staff SME
Amber Patel
[email protected]
Staff SME
David Staggs
[email protected]
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Thank you for joining!
@ONC_HealthIT
@HHSONC