title: Accelerating regulatory progress in multi-institutional research.
abstract: OBJECTIVE
  Multi-institutional collaborations are necessary in order to create large and robust data sets that are needed to answer important comparative effectiveness research (CER) questions. Before scientific work can begin, a complex maze of administrative and regulatory requirements must be efficiently navigated to avoid project delays.
  
  
  METHODS
  Staff from research, regulatory, and administrative teams involved in three HMO Research Network (HMORN) multi-institutional collaborations developed and employed novel approaches: to secure and maintain Institutional Review Board (IRB) approvals; to enable data sharing, and to expedite subawards for two data-only minimal risk studies. These novel approaches accelerated required processes and approvals while maintaining regulatory, human subjects, and institutional protections.
  
  
  METHODS
  Outcomes from the processes described here are compared with processes outlined in the research and regulatory literature and with processes that have been used in previous multisite research collaborations.
  
  
  CONCLUSIONS
  Research, regulatory, and administrative staff are essential contributors to the success of multi-institutional collaborations. Their flexibility, creativity, and effective communication skills can lead to the development of efficient approaches to achieving the necessary oversight for these complex projects. Elements of these specific strategies can be adapted and used by other research networks. Other efforts in these areas should be evaluated and shared. The processes that help develop a "learning research system" play an important and complementary role in sustaining multi-institutional research collaborations.
authors.affiliation: Kaiser Permanente Colorado Institute for Health Research.
authors.forename: Andrea R
authors.initials: AR
authors.lastname: Paolino
authors.affiliation: Group Health Research Institute Cancer Research Network.
authors.forename: Sherry Lee
authors.initials: SL
authors.lastname: Lauf
authors.affiliation: Kaiser Permanente Colorado Institute for Health Research.
authors.forename: Lisa E
authors.initials: LE
authors.lastname: Pieper
authors.affiliation: Kaiser Permanente Colorado Compliance Department.
authors.forename: Jared
authors.initials: J
authors.lastname: Rowe
authors.affiliation: Kaiser Permanente Colorado Compliance Department.
authors.forename: Ileana M
authors.initials: IM
authors.lastname: Vargas
authors.affiliation: Kaiser Permanente Colorado Compliance Department.
authors.forename: Melissa A
authors.initials: MA
authors.lastname: Goff
authors.affiliation: Kaiser Permanente Colorado Institute for Health Research.
authors.forename: Matthew F
authors.initials: MF
authors.lastname: Daley
authors.affiliation: Group Health Research Institute Cancer Research Network.
authors.forename: Leah
authors.initials: L
authors.lastname: Tuzzio
authors.affiliation: Kaiser Permanente Colorado Institute for Health Research.
authors.forename: John F
authors.initials: JF
authors.lastname: Steiner
keywords: Administrative Efficiency; Data agreement; Institutional Review Board; Subaward; Subcontract
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