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sIRB Project
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No
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No
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1f. Name of standard being reaffirmed
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N/A
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1h. ISO/IEC Standard to Adopt
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Biomedical Research & Regulation
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Request periodic project updates; specify period in text box below (e.g. 'Monthly', 'At WGMs', etc.)
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Request periodic project updates; specify period in text box below (e.g. 'Monthly', 'At WGMs', etc.)
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Monthly, at WGMs, ETC
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Anita Walden and Ed Hammond
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National Institute of Health-NCATS Will provide guidance on project direction and scope
Federal Drug Administration (FDA): conduct audit of the sites to evaluate the methodology of using FHIR to collect data for clinical research.
Vanderbilt will participate on pilot demonstration project
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Michael Rutherford
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James Topping
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Julie James
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2i. Domain Expert Representative
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Meredith Zozus
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Anita Walden
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Michael rutherford
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Ed Hammond (Jean Duteau)- FHIR Facilitator
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Duke University
University of Arkansas for Medical Sciences
Vanderbilty University
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We will develop, test and evaluate data standards to move data and documents from clinical research sites to a single ethics review board in support of the "NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research.” The scope of this project will consist of two phases.
Phase I – While some standards exist and will be leveraged, significant gaps remain. We will perform an analysis identifying and addressing standards gaps to support comprehensive data and document exchange between sites and sIRBs and providing for re-use of data and documents within clinical studies. Stakeholders from the public and private sectors will vet the analysis through the IRB vendors administrators using the balloting process.
Phase II - Develop standards, prototype and demonstrate automated single internal review board (sIRB) data and document exchange. Where needed the following standards will be developed. Existing FHIR resources will be utilized when appropriate, FHIR documents to support the following data collection and exchange (1) Structured (IRB) Reliance Agreement based on National IRB reliance models, (2) Study protocols, (3) Structured recruitment materials and (4) Structured informed consent documents and (5) Reportable medical (Unanticipated events, Adverse Events and Serious Adverse Events) and non-medical events and (6) Continuing Review and Final Progress Report form. FHIR resources will be utilized when appropriate. Implementation Guides will be created.
We will review and consider existing standards such as ICSR, other Adverse Event standards (CDISC, ICH E2B) and BRIDG.
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The Common Rule was updated and the necessary standards do not exist to support required data exchange. The vast majority of federally funded research in the United States will require use of a single IRB and will be impacted by the new sIRB Policy. Currently, independent IRB reviews involve redundant work at the local site and local IRB level and inviting the potential for conflicting decisions, requirements and oversight. The new NIH sIRB policy changes this by eliminating the redundancy and opportunity for conflicting reviews, ultimately increasing the efficiency of clinical studies. The creation and implementation of standards will support the new policy. These standards are needed to maintain the rigor of the ethics review while reducing regulatory burden and research costs.
Funding provided by National Center for Advancing Translational Sciences (NCATS)
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No
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Federal Policy Change- The Common Rule
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Submit Project Scope Statement -2019 May 23
Gap analysis between needs and existing standards-
2019 March
Development of Implementation Guide/s-
2020 February
Notification of Intent to STU Ballot of Implementation Guide- 2019 December
Ballot Implementation Guide STU- 2020 Jan/May
Ballot Reconciliation- 2020 Jan/May
Request for Publication- 2020 June
Project End Date (all objectives have been met)- 2020 June
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sIRB Project
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N/A
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N/A
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https://confluence.hl7.org/display/BRR/sIRB+Project+Page
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N/A
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N/A
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Unknown
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FHIR Extensions, FHIR Implementation Guide, FHIR Profiles, White Paper
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Not Sure at this Time
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White Paper, Implementation Guide (IG) will be created/modified
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Non-balloted WG White Paper
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5a. Revising Current Standard Info
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STU to Normative
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No
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no
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National Institute of Health
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Yes
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Regulatory Agency, Standards Development Organizations (SDOs)
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Pharmaceutical
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Healthcare Institutions (hospitals, long term care, home care, mental health), Other
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Academic Medical Centers (clinical sites) Electronic Data Capture vendors eIRB System vendors, IRB accreditors, IRB Reliance Organizations, Commercial IRBs
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U.S. Realm Specific
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Jun 18, 2019
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FHIR
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May 22, 2019
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