Grants and Contracts Details
To launch a multi-site human clinical research study, the IRB at each participating institution must review and independently approve the research study. This process is not only laborious and expensive but, more importantly, it impedes medical progress and limits access to medical advances for patients in need. Over the past decade, we and others have experimented with an alternative approach to IRB review for multi-site clinical studies. This approach is termed IRB reliance where a single IRB reviews the protocol and all other research sites wishing to participate rely on the reviewing IRB. The contractual agreement that enables this process is termed an IRB Master Reliance Agreement. The Master Reliance Agreement is a “treaty” shared by sites where they contractually agree to serve as the Reviewing or Relying IRB and to conform to the terms of the agreement. Several Hubs implemented this approach locally and then progressed to the establishment of regional Reliance Networks that demonstrated that IRB reliance was feasible, safe, compliant, and could speed the review of multi-site clinic studies. With support from NCATS, these Regional Reliance Hub Networks came together in 2014 to develop IRBrely to determine whether a national reliance agreement could be forged and infrastructure defined and built. By April 2016, IRBrely had achieved its goals and in May 2016 the next stage of the National Single IRB Reliance Network was named SMART IRB. This proposal is committed to implement SMART IRB as a national single IRB reliance platform to support all types of multi-site human research studies. To achieve this goal, we propose three specific aims. Aim 1: JOIN SMART IRB proposes to recruit all CTSA Hubs and the majority of their affiliates to join the SMART IRB reliance agreement to establish SMART IRB as the model for IRB reliance across the CTSA consortium and the nation. Aim 2: ENABLE MULTISITE STUDIES will leverage the expertise across the CTSA consortium to collect, develop, implement, and disseminate educational and support tools and resources to enable the conduct of all multi-site studies using SMART IRB. Aim 3: HARMONIZE will bring together all stakeholders to examine regulatory methods, processes and definitions with the goal of standardizing as many as of them as possible to accelerate post-IRB approval. Success will require education, team building at all levels, IT infrastructure, development of trust and community, and demonstration that SMART IRB meets the needs of all of its customers. We have proposed a highly experienced and nimble management and governance structure that will not only collaborate closely with NCATS but is also dedicated to bi-directional communication and collaboration with Hubs, their affiliates, their home institutions, NIH ICs, Industry, Foundations, patient advocates, and patients. SMART IRB will ensure that multi-site clinical research studies better serve our diverse patient populations with the commitment to ensure availability of clinic research studies to all in need.
|Effective start/end date||11/1/16 → 4/30/18|
Explore the research topics touched on by this project. These labels are generated based on the underlying awards/grants. Together they form a unique fingerprint.