Biomedical Research Alliance of New York, LLC BRANY

1
Biomedical Research Alliance of New York, LLC
(BRANY)

• A Centralized IRB
• Presentation by
• Eileen Hilton, MD

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Overview and Background

• Initiative of the New York Academy of Medicine in
  1998.

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BRANYs Owner Institutions

• NYU School of Medicine
• Montefiore Medical Center
• Mount Sinai School of Medicine
• North Shore - Long Island Jewish Health System
• St. Vincents Health System

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BRANY IRB

• Functioning as an COMBINED review board since
  1998.
• IRB membership selected with the assistance of
  (OPRR) now OHRP.

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IRB Membership

• 2 IRBS
• 14 Members Committee A
• 17 Members Committee B
• Members from affiliated institutions
• IRB meeting every 2 weeks

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CHALLENGES
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Reluctance to accept the delegation of authority
to another IRB
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Challenge
Solution

• Reluctance to accept the delegation of authority
  to another IRB

• Initiated by institutional leadership
• Modified MPAs and FWAs

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Investigators having to shift to another set of
SOPs
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Challenge
Solution

• Investigators having to shift to another set of
  SOPs

• Affiliated IRBs helped develop SOPs

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Challenge
Solution

• Some IRBs still wanted to re-review everything

• Clarity from administration that rereview is not
  necessary
• Institutions and their interests are already
  represented
• Affiliated IRBs administrators kept in the
  informational loop

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Customizing IRB submission and review while
maintaining consistency
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Challenge
Solution

• Customizing IRB submission and review while
  maintaining consistency

• Experienced writers prepare the ICFs
• Responsive to individual institutional
  requirements while protecting the subjects

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Maintaining investigator involvement in the
consent form preparation
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Challenge
Solution

• Maintaining investigator involvement in the
  consent form preparation

• Writers forward ICFs to investigators for
  comments prior to IRB submission

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HIPAA Issues
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Possible Solutions

• Utilize individual institutions privacy Boards
• Central IRB acts as the privacy board

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Operational Challenges

• Meeting format
• Coordinating multiple site submissions
• Streamlining processes
• Maintaining proactive and cooperative interaction
  with affiliated IRBs

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Quality Assurance

• All protected classes are audited
• All gene therapy audited
• Distant sites audited and assessed by an irb
  member for local research environment
• Problem sites revisited

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The BRANY IRB - a melting pot

• Successful integration of members from various
  institutions with different cultures