Non-federally funded/supported research and non-FDA regulated minimal risk research that qualifies for expedited review will be approved for either the anticipated time frame of the project or one year from the date of approval, whichever is greater. Unless specifically required by the IRB, annual re-approval review will no longer be required for this type of research.
As the anticipated completion date of the research draws near, investigators may extend the expected completion date if necessary through an IRB-3 amendment. Research cannot be conducted beyond the approval period. If any federal support is obtained after the initial approval the investigator is obligated to inform the IRB, via an amendment, and annual re-approval review will become required.
For studies previously approved through the expedited review process, investigators may request transition to this new policy at the time the next re-approval review is due or sooner by submitting an amendment. Any document currently stamped with an expiration date that is still used in the research would need to be attached to the submission to allow for removal of the expiration date.
Information to include in the IRB-3:
“Request extension of the protocol through XX/XX/XXXX (anticipated end-date)”
For more information, contact: Doug Bradway/Research Compliance at 6-0986/doug.bradway@uconn.edu