Abstract

We conducted a retrospective review of research protocols from four IRBs at one large academic medical institution. The project examined whether having the Principal Investigator attend the initial IRB review of his or her study improves the efficiency of the review. We measured efficiency by the number of days from protocol submission to approval, volume of correspondence exchanged between investigator and IRB prior to approval, and the number of convened IRB meetings required prior to approval. We assessed two samples of research records. The first cross-sectional sample was drawn concurrently from four IRBs—two that routinely invite PIs to be present when their protocols are reviewed, and two that do not. No statistical differences in review efficiency were found between these groups. The second sample was a historical comparison in which protocols from an IRB that initially did not invite PIs to attend review were compared to protocols from the same IRB after it had changed its policy to encourage PI attendance. This sample revealed that the protocols for which the PI attended were reviewed in fewer days and with fewer meetings. Further research is needed to explore whether PI attendance and other strategies may increase the efficiency of IRB review, and whether PI attendance may have other benefits besides efficiency that would make the investigator’s presence at review desirable