There may be a number of reasons to ask for amendments to an IRB approved protocol; change in subject population, research site, research team, research instruments, unexpected results, adverse events, etc. In accordance with 45 CFR 46.103(b)(4) changes to an IRB protocol or its related consent document must be approved by the IRB prior to implementation except where necessary to eliminate apparent immediate hazards to participants.
To request a change in your protocol or consent form please submit the Protocol Amendment Application form. Answer all questions.
Requests for Protocol Amendments are reviewed as they are received and, according to the level of risk to subjects, may be reviewed by one reviewer or by the entire Board. You will be notified in writing when the amendment has been approved and you may then begin your research.
If you have any questions, please do not hesitate to contact the IRB Administrator at 740-427-5748 or firstname.lastname@example.org .