Smart Irb Master Common Reciprocal Institutional Review Board Authorization Agreement

Recommendations and reflections on verifying non-compliance and unforeseen problems and ensuring a prompt report. To address these challenges, the National Institutes of Health (NIH) National Center for Advancing Translational Sciences (NCATS) funded a project 3 in September 2014 to develop an IRB confidence agreement to support the sIRB review of multisite research across the Clinical and Translational Science Awards (CTSA) consortium. This first project culminated in April 2016 with the development of a prototype national trust agreement and IRB, informed by contributions from 115 institutions, including the current 62 CTSA centres [6] in 33 countries, as well as public and private universities, university health centres, municipal hospitals, IRBs and NIH agencies. Cooperation and engagement have been essential elements of the process; Stakeholders have contributed to a wide range of issues such as minimum insurance coverage, the applicability of an institution`s Federalwide Insurance (FWA), compensation and the performance of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Board. The resulting agreement was not limited to one type of research, but applied to a broad spectrum of human research (minimal risk and greater than minimal risk; large and small studies; biomedical and social and behavioural studies; funded by federal, academic and industrial funds; initiated by researchers and others). Although the agreement can be used in situations requiring access to information and security agreements (for example. B by policy or obligation to participate in a network), it also provided for the voluntary decision to rely on trust. The agreement defined the roles and responsibilities of the “participating institutions” as well as the “revision of IRBs and relying institutions” for the research covered by the agreement. In addition, complementary standard operating procedures (SOPS) have been developed to guide the implementation of the specific framework agreement under consideration; these SOPs must be defaulted, unless other provisions have been agreed and documented as a condition of reliability. In July 2016, NCATS funded the Streamlined, Multisite, Accelerated Resources for Trials (SMART) IRB Platform [7] to facilitate the dissemination, adoption and implementation of this consensual national agreement; developing processes, workflows and tools to enable dependence on the IRB at the national level; and support compliance with the single NIH IRB policy (effective date: 25 January 2018) [8] and other sIRB agreements.

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