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. 2011 Sep-Oct;24(5):605-9.
doi: 10.3122/jabfm.2011.05.110034.

A novel protocol for streamlined IRB review of Practice-based Research Network (PBRN) card studies

Michelle D Hamilton  1 , Philip A Cola, Joshua J Terchek, James J Werner, Kurt C Stange
Affiliations

A novel protocol for streamlined IRB review of Practice-based Research Network (PBRN) card studies

Michelle D Hamilton et al. J Am Board Fam Med. 2011 Sep-Oct.

Abstract

Purpose: The "card study," in which clinicians record brief information about patient visits during usual clinical care, has long been a rapid method for conducting descriptive studies in practice-based research networks. Because an increasingly stringent regulatory environment has made conducting card studies difficult, we developed a streamlined method for obtaining card study institutional review board (IRB) approval.

Methods: We developed a protocol for a study of the card study method, allowing new card study proposals of specific research questions to be submitted as addenda to the approved Card Study Protocol.

Results: Seven card studies were proposed and approved under the Card Study Protocol during the first year after implementation, contrasted with one-card study proposed in the previous year. New card study ideas submitted as addenda to an approved protocol appeared to increase IRB comfort with the card study as a minimal risk method while reducing the hurdles to developing new study ideas.

Conclusions: A Card Study Protocol allowing new study questions to be submitted as addenda decreases time between idea generation and IRB approval. Shortened turn-around times may be useful for translating ideas into action while reducing regulatory burden.

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Conflict of interest statement

There are no conflicting or competing interests.

Figures

Figure 1
Figure 1
Identification of developmental delays card study data collection card.
See this image and copyright information in PMC

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