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IRB Revised Standard Operating Procedures and Revised Common Rule Resources

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The Institutional Review Board (IRB) will have revised Standard Operating Procedures (SOPs), researcher tools & guides, and board member tools & guides available on our website on January 22, 2019, the day after the general compliance date (1/21/19) of the revised Common Rule (DHHS federal regulations for the protection of human subjects).

You can find a summary of the major regulatory and associated IRB policy changes on our Revised Common Rule webpage at
https://www.uthsc.edu/research/compliance/irb/training-and-education/revised-common-rule.php

More details regarding the changes can be found in the slides (with notes) from the October 31, 2018 IRB Insights training on the Revised Common Rule at
https://www.uthsc.edu/research/compliance/irb/training-and-education/irb-insights.php

Visit our website to download the new consent form templates in order to draft consent forms for new study application submissions to the IRB: https://www.uthsc.edu/research/compliance/irb/researchers/consent-forms.php

**Please note the following:

• Consent forms for studies that are/were UTHSC IRB-approved BEFORE January 21, 2019 do NOT have to be revised according to the new consent form templates.

• Currently approved studies will NOT be affected by the revised Common Rule.

• A revised study application in iMedRIS will be published due to the revised Common Rule (accordingly, the exempt application will contain the most changes).
Therefore, any new study applications (i.e., requesting initial IRB approval) that are not reviewed and approved (or approved pending a satisfactory response to provisos) BEFORE January 21, 2019 will be returned to you in iMedRIS if the consent form does not follow the new template (see above for the link) and/or if the study application needs to be revised in order for you to receive and answer the new questions required by the revised Common Rule.

Please give us a call with any questions! (901) 448-4824

Thank you,
IRB Administration