A Study to Evaluate the Effect of Investigator Attendance on the Efficiency of IRB Review (Institutional Review Boards) (Report‪)‬

Institutional Review Boards (IRBs) are challenged to review increasing volumes of proposed research studies while meeting high ethical and regulatory standards. (1) A growing literature has documented concerns about the IRB review process, including administrative delays, (2) inadequate institutional support, (3) and poor investigator-IRB relations. (4) IRBs also carry significant operational costs, (5) creating a strong incentive for institutions to identify mechanisms to improve the efficiency of the review process. Some suggest that IRBs can become more efficient and decrease misunderstandings with principal investigators (PIs) by inviting them to attend IRB meetings when their protocols are scheduled for review and discussion. (6) IRBs can involve investigators in the review of protocols in a number of ways: 1) invite PIs to meetings whenever new protocols are reviewed; 2) invite PIs on an as needed basis, often when the IRB has particularly deep concerns about a protocol; or 3) never invite PIs to attend meetings. In addition, we know from anecdotal evidence that some IRBs (or individual IRB members) communicate with PIs after the submission of their protocol but prior to the full committee meeting to gather additional information regarding particular concerns or issues that they identify in their review of protocols.