10/19/2011: Form changes!
IRB-01 voted to approve multiple form changes at the 10/19/2011 meeting. The following forms were changed:
-
Introductory Questionnaire for Full Board and Expedited Studies
(What’s different?)- revised primarily to solicit better information about DSMB’s
-
Continuing Review/Study Closure Report (What’s different)
- help us process your submission faster by submitting it in a pre-sorted order. Tabbing documents also facilitates faster review.
-
Revision
(What’s different?)- inform researchers that revisions will not be processed on expired studies
- remind researchers to update study listings on the newest Addendum A if making changes to the PI or other study personnel.
- Full consent: UF/Shands + HIPAA (What’s different?)
- Full consent: VA for all NEW STUDIES with HIPAA* (What’s different?)
- Full consent: VA + HIPAA – for studies originally approved before 3/31/2011 (What’s different?)
- Full consent: UF/Shands without HIPAA (What’s different?)
-
Full consent: VA template without HIPAA
(What’s different?)- consents were revised to eliminate redundant information / data entry
- more clearly identify who the PI is and list other pertinent study staff (if applicable)
At the request of researchers we’ve provided links to documents showing what has changed.
Researchers should always download and use the newest versions of IRB paperwork. IRB-01 will continue to accept the prior version of these forms until 12/01/2011, after which time only the newest versions will be accepted and processed.