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.
- The revised protocol, consent form, and/or survey instruments should be sent electronically to peelle@kenyon.edu with changes highlighted. Include the IRB protocol number in the subject line of your email.
- If you are adding a study site, you may need to provide additional documentation, depending on the type of site. If you are adding a research site at another college or university, an approval letter from that institution's IRB must be submitted. Research conducted at public schools or other institutions without IRBs requires a letter of permission from the school's principal or an official of the school district.
- If you are adding additional study personnel, all must be CITI-certified before the amendment will be approved. Please note that it is not necessary to send CITI certificates for Kenyon students or employees; the IRB administrator has access to all Kenyon CITI training records.
- Details of your request and a justification for all changes should be provided in section 4 of the Amendment Application.
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.
Protocol Amendment Application form.
If you have any questions, please do not hesitate to contact the IRB Administrator at 740-427-5748 or peelle@kenyon.edu .