Lacy Clegg is our new IRB coordinator for Panel 3. Her first day is March 27 th . Please help us welcome her to our staff!

IRB Requirements: A reminder that for studies involving INDs the IRB now requires the FDA 1572 Form as well as the FDA Letter of Receipt of the IND. These should be attached in the Other Documents section of the “Documents and Attachments” page.

IRB Requirements: The Clinical Trials Facilitator now requires that a Patient Care Classification Form be completed to clarify costs of standard-of-care procedures versus research-related procedures. If you are required to complete this form for the research project, this form will also be requested as an attachment in all IRB new study applications. You will be reminded in section 6.3 of the application to attach the document to the “Documents and Attachments” page.

ERICA Updates: The Amendment Application will have some changes forthcoming in the next few weeks. Please watch for those and contact the IRB if you have any questions.

IRB Templates: The Parental Permission Form (HIPAA) has been revised. The signature page now defaults to two parental signatures along with a section to complete if one parent is not available to grant permission. Studies which are found to be greater than minimal risk will require this new signature block of two parents. The IRB may find that one parental permission is sufficient if the research is no more than minimal risk (45 CFR 46.408(b)). If the IRB finds one parental permission is sufficient, you will be notified via a revisions memo to revise the signature page.