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

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 st

SUBMITTER: Hamilton MD 

PROVIDER: S-EPMC4331110 | biostudies-literature | 2011 Sep-Oct

REPOSITORIES: biostudies-literature