If changes are required to a study, an amendment must be submitted for review utilizing the IRB Amendment Form in IRIS. The amendment and any required modifications to the protocol, consent or other study documentation are submitted at the same time. The federal regulations specifically require the IRB to review proposed changes in a research activity, and to ensure that such changes in approved research are not initiated without IRB review and approval except when necessary to eliminate apparent immediate hazards to the subject [45CFR46.103(b)(4)(iii) and 21CFR56.108(a)(4)]. Research activity includes all aspects of the conduct of the research study, e.g., recruitment methods, consent process, procedures used to protect privacy and confidentiality, etc. Noncompliance with these regulations, or UofL IRB policies and procedures, during the conduct of a research study results in a protocol violation, and as such must be reported to the IRB by using the IRB Deviation/Violation/Misc. form.
If approved research is changed to eliminate an apparent immediate hazard(s) to the subject, the investigator is required to notify the IRB of the change(s) promptly (within five (5) business days). The IRB will review at the next convened meeting to determine if the change(s) instituted were consistent with the subject’s continued welfare.