What should investigators do if they want to revise an IRB-approved research study?
If investigators wish to modify an ongoing IRB-approved research study, they must submit a request to the IRB and receive IRB approval before implementing the proposed modification, unless the change is designed to eliminate an apparent immediate hazard to subjects (45 CFR 46.103(b)(4)). If the investigators change the research in order to eliminate apparent immediate hazards to subjects without prior IRB approval, they should report those changes promptly to the IRB. The HHS protection of human subjects regulations allow for expedited review and approval of requests for minor changes in previously approved studies (45 CFR 46.110(b)(2)).
