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

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.