We continue to struggle after a year from "go-live" with the iMedris iRIS IRB module for what seems like routine, standard IRB practices. I'm writing to see if anyone else has this problem in their system or if not, how did they accomplish the business process.
Meeting Issue: Calculating Quorum
iRIS has a merge code in provided mail merge [%quorum%].
Desired process: The merge code produces the correct number for quorum.
Current process: iRIS produces the incorrect quorum number when the mail merge is used. The issue is the formula used by iRIS to calculate quorum is based on all members (full and alternate), not just full board members.
Our roster has 12 full board members (9 listed as full board, 1 chair and 2 vice -chairs). 12/2 = 6 + 1 = 7 for quorum.
However, the merge code iRIS produces is 10 .The number 10 seems to be because it is calculating the total number of members and then 1/2 + 1. Our roster has a total of 18 IRB members (9 full board members + 1 Chair + 2 Vice Chair + 6 alternate members). So 18/2 = 9 + 1 = 10.
Current process: If the formula is calculating alternate members, this is an incorrect interpretation of the regulations as alternate members do NOT count towards the quorum. Including alternate members as part of the quorum count defeats the purpose of even having alternate members.
I've provided iRIS the regulations and OHRP guidance on how to calculate quorum, noting the calculation is not correct.
iRIS response: Current/expected system functionality: The quorum formula that was coded in the system was designed based on, IRB Research Standards and the FDA's recommend formula as per their FDA Website.
Question: How does your iRIS system calculate quorum? Is it correct? Or did you do like what we did and abandon and not use the mail merge for the quorum field? If you are using and it is correctly calculating quorum, can you share how you accomplished this?
Rebecca A Ballard
Director, Research Compliance
Texas A&M University-Corpus Christi