Approaches to facilitate institutional review board approval of multicenter research studies.

Published

Journal Article

BACKGROUND AND OBJECTIVES: Gaining Institutional Review Board (IRB) approval for a multicenter research study can be a lengthy and time-consuming process. It can increase the complexity of consent forms, decreasing patient understanding and lowering recruitment numbers. It also leads to increased costs through the duplication of effort. This paper examines some of the strategies used to streamline the IRB review process for multicenter studies and provides examples used by 2 existing multicenter comparative effectiveness research networks. METHODS: A literature search was conducted to identify sources that described the challenges and potential strategies to facilitate multicenter IRB approval. The most promising avenues were identified and included in this review. Phone interviews were conducted with the Principal Investigators and Project Managers of 2 successful multicenter research networks to learn their "keys to success" and their lessons learned. RESULTS: Three strategies were identified that held the most promise: working with IRBs before submission, the use of central and/or federated IRBs, and the establishment of an umbrella protocol. Each of these strategies was used to some degree by the case study projects. CONCLUSIONS: Although the approaches documented here can help streamline the IRB approval process, they are not a "silver bullet." Because some of these approaches are still relatively new, empirical data are sparse. However, it is believed that they will significantly reduce the administrative burden of the project as a whole and lead to a decrease in the overall time to protocol approval.

Full Text

Duke Authors

Cited Authors

  • Marsolo, K

Published Date

  • July 2012

Published In

Volume / Issue

  • 50 Suppl /

Start / End Page

  • S77 - S81

PubMed ID

  • 22692264

Pubmed Central ID

  • 22692264

Electronic International Standard Serial Number (EISSN)

  • 1537-1948

Digital Object Identifier (DOI)

  • 10.1097/MLR.0b013e31825a76eb

Language

  • eng

Conference Location

  • United States