Amending an Active Study

For any study that was previously approved by expedited or full board review, any and all proposed changes to the study, no matter how minor (including changes to personnel, methodology, or consent forms), must receive prior approval by the IRB before being implemented (45 CFR #46.103(b)(4); Investigator Responsibilities) (except when the change was made to eliminate an apparent immediate hazard to the participants, in which case an unanticipated problem report should be filed in addition to the amendment form).

For studies previously determined to be non-research, non-human research, or exempt, if the changes to the study may cause a classification change, such that it no longer qualifies for exemption, please submit the amendment for review.

Please complete the forms below and any other requested items and submit to orsp@acu.edu per the submission instructions.

Forms