Resource Title

Accelerating Regulatory Progress in Multi-Institutional Research

Abstract

Purpose: 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.

Innovation: 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.

Credibility: 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.

Conclusion and Discussion: 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.

Publication Date

7-10-2014

Type of Governance Resource

Publication

Other Type of Governance Resource

Case Study

Generalizability to Other Settings

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.

Geographic scope type

Multi-State

Acknowledgement of Funders

Support provided by the AcademyHealth Electronic Data Methods (EDM) Forum, a project supported by the Agency for Healthcare Research and Quality (AHRQ) through the American Recovery & Reinvestment Act of 2009, Grant U13 HS19564-01. Additional support provided by Grants R01HS019912 and R01HS019859 from the Agency for Healthcare Research and Quality. The content is solely the responsibility of the authors and does not necessarily represent the official views of the Agency for Healthcare Research and Quality. Initial data collection from the Cancer Research Network across Health Care Systems project (CRN3) was supported by Grant U19 CA079689 from the National Cancer Institute.

Additional Information

Engaging research, regulatory, and administrative staff is essential to the success of multi-institutional collaborations. Their flexibility, creativity, and effective communication skills are essential to the development of efficient approaches to achieving the necessary oversight for these complex projects.

Creative Commons License


This work is licensed under a Creative Commons Attribution-Noncommercial-No Derivative Works 3.0 License.