Lessons Learned: The IRB and Contracts Process

1. Lessons Learned: The IRB and Contracts Process Einstein-Montefiore Institute for Clinical and Translational Research Brian Currie, MD MPH – Champion of Change Eileen Shore, Barbara Levy, David Wallach, John Harb, Victor Hatcher PhD Background Cooperative Agreement Creating a Common e-Platform The Albert Einstein College of Medicine and Montefiore Medical Center (MMC) were awarded a Clinical and Translational Science Award (CTSA) in May 2008, forming the new Institute for Clinical and Translational Research (ICTR) in the process. The mission of the ICTR is to enhance the discipline of clinical and translational research by promoting multidisciplinary collaboration, addressing translational 'blocks' in research, providing infrastructure and collaborative support, and enhancing training, education, and career development. Among the many areas where efficiency can be increased and redundancy reduced are the protocol review (IRB) and contracts processes. • The Cooperative Agreement has been modified to implement a streamlined review process with a single review, approval and monitoring of protocols. • The Federalwide Assurances delineate their authority to review research protocols for studies to be conducted at Einstein and MMC. • The joint IRB Executive Committee implemented a new policy wherein it designated one review committee (“the primary review committee”) to conduct the review, approval and monitoring of a protocol. The secondary IRB would rely solely on the primary review committee’s findings – i.e. complete reciprocity. • Coordinate submission with multiple committees • Manage all IRB functions and meetings • Automatically generate notification • Customize help files, forms and links • Direct correspondence between IRB and PI’s • Provide templates (e.g. consent form building) • Paperless submission and review IRB Process Improvements Expected Benefits A Tale of Two Committees • Streamlined adverse event reporting • Practical educational sessions • Staff assists investigators with issues of protocol implementation • Web-based access to forms and procedures • Protocol audit process of IRB-approved protocols after implementation • Facilitate process of creating a single IRB across multiple institutions with two review committees • Remove duplication in applications, tracking & Serious Adverse Event reporting • Reduce time from submission to final approval • Facilitate regulatory reporting Common Platform - iMedRIS 2009 The joint IRB Executive Committee will oversee a planned IRB merger. This will result in one IRB that subsumes the existing personnel and will be directed by one individual. Two committees with staggered monthly meetings will greatly improve efficiency. Contracts and grants will be managed through one entity as well. A closer collaboration with the Biomedical Research Alliance of New York (BRANY) for review of Phase III & IV industry- sponsored studies will ease some of the pressures that the IRBs currently face. Removing Redundancy • Einstein (FWA00000140) and MMC (FWA00002558) are affiliated at the IRB level • At Einstein, the Committee on Clinical Investigations (CCI) is the Institutional Review Board • The IRB for MMC is the Institutional Review Board (MMC-IRB) • The CCI and MMC-IRB are governed by a Cooperative Agreement under both institutions’ Federalwide Assurances • Under the cooperative Agreement, an ad hoc review process had been in place for the past 15 years to reduce duplication of effort and facilitate project initiation • An Executive Committee including the Chairs and co-chairs of both IRB & CCI and their respective administrators met as needed to coordinate protocol reviews. CURRENT FUTURE