Risk Management

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Limited Review letter template

  • 1.  Limited Review letter template

    CAYUSE CHAMPION
    Posted 10-26-2020 12:46
    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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  • 2.  RE: Limited Review letter template

    TEAM CAYUSE
    Posted 11-05-2020 15:46
    Hi Matt,

    I'm going to tag a few members of our Cayuse Community here and see if they might
    be able to share their letters? Hello @Michael Leary​, @Kaitlin Gottuso, and ​@Beth Lynch!
    Do you have any advice for Matt on his question above? If not, no worries!

    Thanks,

    Matty

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    Matty Gilreath
    Customer Success Manager
    Cayuse
    matty.gilreath@cayuse.comCustomer Success Manager
    ------------------------------



  • 3.  RE: Limited Review letter template

    CAYUSE CHAMPION
    Posted 11-06-2020 05:00
    Hi Matt,

    Villanova uses our standard exemption letter mentioning Limited IRB review. We do not include the category selection in the letter.

    Kaitlin

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    Kaitlin Gottuso
    Interim Director
    Villanova University
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  • 4.  RE: Limited Review letter template

    CAYUSE CHAMPION
    Posted 11-06-2020 10:54
    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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  • 5.  RE: Limited Review letter template

    CAYUSE CHAMPION
    Posted 11-11-2020 07:14
    Good Morning Matt,

    We use the same letter we have for the other exempt determinations with the category selection in the letter.

    Regards,

    Tim Deering

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    Tim Deering
    Human Subjects Research Specialist
    Illinois State University
    tjdeeri@ilstu.edu
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