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					                                                                       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           • The Cooperative Agreement has been modified to implement a streamlined review           • Coordinate submission with multiple committees
(MMC) were awarded a Clinical and Translational Science Award (CTSA) in           process with a single review, approval and monitoring of protocols.
May 2008, forming the new Institute for Clinical and Translational Research                                                                                               • Manage all IRB functions and meetings
(ICTR) in the process.                                                          • The Federalwide Assurances delineate their authority to review research protocols for
                                                                                  studies to be conducted at Einstein and MMC.                                            • Automatically generate notification
The mission of the ICTR is to enhance the discipline of clinical and
translational research by promoting multidisciplinary collaboration,            • The joint IRB Executive Committee implemented a new policy wherein it designated        • Customize help files, forms and links
addressing translational 'blocks' in research, providing infrastructure and       one review committee (“the primary review committee”) to conduct the review,
collaborative support, and enhancing training, education, and career              approval and monitoring of a protocol. The secondary IRB would rely solely on the       • Direct correspondence between IRB and PI’s
development.                                                                      primary review committee’s findings – i.e. complete reciprocity.
                                                                                                                                                                          • Provide templates (e.g. consent form building)
Among the many areas where efficiency can be increased and redundancy
reduced are the protocol review (IRB) and contracts processes.                                                                                                            • Paperless submission and review
                                                                                                          IRB Process Improvements
                     A Tale of Two Committees                                   • Streamlined adverse event reporting                                                                                   Expected Benefits
                                                                                • Practical educational sessions                                                          • Facilitate process of creating a single IRB across multiple institutions with two
                                                                                • Staff assists investigators with issues of protocol implementation                        review committees

                                                                                • Web-based access to forms and procedures                                                • Remove duplication in applications, tracking & Serious Adverse Event reporting

                                                                                • Protocol audit process of IRB-approved protocols after implementation                   • 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
                       Removing Redundancy                                                                                                                                improve efficiency. Contracts and grants will be managed through one entity as
                                                                                                                                                                          well. A closer collaboration with the Biomedical Research Alliance of New York
• Einstein (FWA00000140) and MMC (FWA00002558) are affiliated at the                                                                                                      (BRANY) for review of Phase III & IV industry- sponsored studies will ease some of
  IRB level                                                                                                                                                               the pressures that the IRBs currently face.
• 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

				
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