Hi Matt,
We do toggle that "Exempt - Limited IRB" decision category and have the Exempt language auto-populate in the Letter. We then have a templated rationale we revise on a case by case basis to substantiate the determination. Here is the gist of it:
- The IRB has conducted a Limited IRB Review to ensure that while these data are [potentially or readily] identifiable, given that [description of identifiability], it is necessary to capture data in this manner, as [rationale for necessity of identifiable data]. The PI has an adequate plan to protect the privacy and confidentiality of research subjects, including technical safeguards for the security of [data types] outlined in the IRB application.
Our aim is to provide a clear determination specific to the study, as a matter of record. Using the above template makes these consistent each time - and expand it to capture privacy safeguards as needed.
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Michael Leary
Director of Research and Compliance, IRB
Lindenwood University
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Original Message:
Sent: 10-26-2020 12:45
From: Matt Zembrzuski
Subject: Limited Review letter template
Hi everyone. I was wondering if anyone would be willing to share the letter template used for Limited Review approvals. Is it any different than your exemption approval, aside from explicitly stating it was approved using Limited Review procedures?
Do you include the category selection in the letter?
Thanks!
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Matt Zembrzuski
Research Compliance Manager
American University
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