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 committees 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 PIs
• 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