Revised Policy “Exempt Human Research” – April 13, 2009
The IRB policy that pertains to review and approval of “exempt” research, under the Federal regulations pertaining to human subject protections, has been revised to provide clarifications regarding amendments to protocols that have been previously approved as “Exempt” by the UHCMC IRB.
If an investigator makes changes to a protocol that was previously determined as “exempt” under the Federal regulation, the investigator will need to re-submit the protocol to the IRB for re-consideration and to verify that the protocol still qualifies as “exempt”. Investigators should submit the following to the IRB for review: 1) new Exemption checklist, 2) a copy of the previously approved exempt protocol, 3) a “tracked changes” version (with the change clearly indicated) and 4) a “clean” version with the changes incorporated into the text. In addition, the investigator must provide a memorandum which references the previously approved IRB Exemption number (e.g., EM-08-01) and a summary of the change that is being made.
A designated representative of the UHCMC IRB will review the protocol and the proposed changes. If the protocol continues to qualify as “exempt” under the Federal Regulations, the investigator will receive a notice of approval from the IRB. NOTE: the IRB Exemption number and the expiration date will not change. If the change to the protocol alters the research in a way in which it will no longer qualify as “exempt” under the Federal Regulations, the investigator will be notified and instructed about how to proceed.