A Novel Protocol for Streamlined IRB Review of Practice-based Research Network (PBRN) Card Studies

Journal Name: 
The Journal of the American Board of Family Medicine
Hamilton,Michelle D.
Cola,Philip A.
Terchek,Joshua J.
Werner,James J.
Stange,Kurt C.

PurposeThe "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. MethodsWe 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. ResultsSeven 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. ConclusionsA 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