Investigators are required to obtain a prospective IRB review and approval if any of the following criteria exist:
If an investigator submits a protocol to a University of Virginia IRB or to another IRB outside the University and the reviewing IRB disapproves the study, and it is subsequently sent to another IRB for review, that IRB must be informed by the PI of the original disapproval.
When an IRB disapproves a study, it must provide a written statement of the reasons for its decision to the investigator and the institution. If the study is submitted to a second IRB, a copy of this written statement should be included with the study documentation so that it can make an informed decision about the study. Federal regulations require an IRB to "... review ... all research activities...." The FDA regulations do not prohibit submission of a study to another IRB following disapproval. However, all pertinent information about the study should be provided to the second IRB.
The IRB is required to review all research instruments including standardized instruments such as surveys, questionnaires, inventories and assessments to be used in the proposed research. Please include the instruments, if available, with your initial application. Investigators may submit draft versions of investigator initiated study instruments for the IRB to review. The IRB is required to review any modifications to research instruments. Please submit a modification to the IRB when requesting changes to previously approved instruments. If draft instruments are submitted, the instruments cannot be used until they are approved by the IRB.
Investigators who transfer research to University of Virginia from their previous institution are required to submit the protocols to the IRB for review and approval in order to continue the study. See the information listed above. Please feel free to contact the IRB's for further information. See IRB Contacts.
For information on submissions required after initial protocol approval see: Maintaining a Protocol After Initial Approval