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Accelerating regulatory progress in multi-institutional research.

Andrea R Paolino1, Sherry Lee Lauf2, Lisa E Pieper1

  • 1Kaiser Permanente Colorado Institute for Health Research.

EGEMS (Washington, DC)
|April 8, 2015
PubMed
Summary
This summary is machine-generated.

Novel strategies streamline administrative and regulatory processes for multi-institutional collaborations, accelerating comparative effectiveness research (CER) while ensuring human subject protections. These adaptable approaches foster efficient research oversight and sustainability.

Keywords:
Administrative EfficiencyData agreementInstitutional Review BoardSubawardSubcontract

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Area of Science:

  • Health Services Research
  • Comparative Effectiveness Research
  • Research Administration

Background:

  • Multi-institutional collaborations are crucial for generating robust datasets for comparative effectiveness research (CER).
  • Navigating complex administrative and regulatory requirements can significantly delay research initiation.

Purpose of the Study:

  • To describe novel approaches developed by research, regulatory, and administrative staff to streamline multi-institutional collaborations.
  • To accelerate the process of securing Institutional Review Board (IRB) approvals, enabling data sharing, and expediting subawards for minimal risk studies.

Main Methods:

  • Three Health Maintenance Organization Research Network (HMORN) multi-institutional collaborations implemented innovative strategies.
  • These strategies focused on optimizing IRB approvals, data sharing agreements, and subaward processes.
  • Outcomes were compared to existing literature and previous multisite research practices.

Main Results:

  • Novel approaches successfully accelerated required processes and approvals for multi-institutional studies.
  • These methods maintained essential regulatory, human subjects, and institutional protections.
  • The developed strategies proved effective in managing complex administrative and regulatory hurdles.

Conclusions:

  • Research, regulatory, and administrative staff are vital for successful multi-institutional collaborations.
  • Flexibility, creativity, and communication are key to developing efficient oversight strategies.
  • Adaptable strategies and shared learning systems are essential for sustaining collaborative research efforts.