I must admit I am a bit disappointed in the agenda/minutes, as this wasn't my understanding during the demo. I have been through an FDA audit and the really scrutinize the agenda an especially the minutes. Below are screenshots of what my previous system generated.
St. Luke's University Hospital and Health Network
Original Message:
Sent: 12-13-2023 07:19
From: Darcy Hammar
Subject: Agenda
Sharla,
You are not alone. We too, would like more detail in the Agenda/Minutes for Exempt and Expedited. We'd like NHSR to be reported as well.
Regards,
Darcy
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Darcy Hammar
Director, HRPP
Rocky Mountain University of Health Professions
Original Message:
Sent: 12-13-2023 07:13
From: Sharla Miles
Subject: Agenda
While Leigh describes this perfectly, I have always wondered if anyone in this community wanted to see more information in the agenda regarding studies that were approved outside of a meeting. Before we launched Human Ethics in 2018, I prepared minutes and agendas manually. The following is a template of information that I included for each study:
Protocol Number
Protocol Title
PI
Reviewers (members' initials only)
Review Type
Approval/Decision Date
Expiration Date (before 2018 CR was implemented)
Justification (i.e., category under which study was reviewed)
I wish the Human Ethics agendas would include additional information. I would think if the approval letter could pull in these variables, the agenda/minutes would be able to do this as well. Thoughts anyone?
Sharla
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Sharla Miles, M.Ed., CIP
Director, Research Compliance
Sam Houston State University
Huntsville, TX
(936) 294-4875
sharla_miles@shsu.edu
Original Message:
Sent: 12-12-2023 07:51
From: Leigh Schectman
Subject: Agenda
Hi Jayne,
Any studies that are conducted via an Expedited review by one member of the IRB Committee, once approved, will get put on to the next Meeting's agenda so that all members are aware and can see what studies have recently been approved since the last meeting. Any submissions that require a Full Board Review get assigned to the Full Board and then you need to add it to an IRB Meeting. The meeting needs to be on the calendar first in order to add the submission or assign the meeting to the submission.
Are you conducting Expedited Reviews where either the IRB Chair or a designated reviewer can review/approve submissions? Or are you requiring a review by the IRB Committee for every submission? If you are wanting the Full Board to make the ultimate decision on every submission, then they have to be assigned to the Full Board for review and assigned a meeting date.
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Leigh Schectman, MPH
Research Protections Coordinator
California Lutheran University
Thousand Oaks, CA
lschectman@callutheran.edu
Original Message:
Sent: 12-08-2023 07:13
From: Jayne Silva
Subject: Agenda
Hello,
We are new o Cayuse Human Ethics and have learned that only when a study is approved does it get pulled into the agenda. This creates a problem, as some of my reviewers on the committee do not give final approval or conditional approval until the full board meeting is taking place. All studies for a scheduled meeting should be on the agenda whether approved or not along with the reviewer/reviewer's name.
I did put in a ticket and there is no work around. This would be a great enhancement.
How do other institutions handle this, any feedback would be greatly appreciated.
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Jayne Silva
Manager, Human Research Protections
St. Luke's University Hospital and Health Network
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