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(Content brought in from the PSS -- needs review by the sIRB team)

Background

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).

Scope

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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