RT Journal Article
SR Electronic
T1 A Novel Protocol for Streamlined IRB Review of Practice-based Research Network (PBRN) Card Studies
JF The Journal of the American Board of Family
                Medicine
JO J Am Board Fam Med
FD American Board of Family Medicine
SP 605
OP 609
DO 10.3122/jabfm.2011.05.110034
VO 24
IS 5
A1 Hamilton, Michelle D.
A1 Cola, Philip A.
A1 Terchek, Joshua J.
A1 Werner, James J.
A1 Stange, Kurt C.
YR 2011
UL http://www.jabfm.org/content/24/5/605.abstract
AB 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.