Directions for Modifications of IRB Protocols with Current IRB Approval
When developing a research protocol every attempt should be made to develop the protocol carefully and thoughtfully so that modifications are not necessary; however there are times when an investigator may need to request approval from the IRB to modify the protocol of his or her study. Minor protocol modifications that do not substantially change the study or alter the level of risk of the study in any way may be made using the procedure described below. If the investigator is requesting protocol modifications that substantially change the study or in any way change the level of risk, then a new application for IRB review must be submitted using the appropriate exempt, expedited, or full review forms. Whether requesting minor modifications using the procedure described below or submitting a new application for IRB review, the investigator must submit the request to the IRB and wait for written approval from the IRB before collecting any data using the revised protocol. The procedure for making minor changes to a protocol with existing IRB approval is as follows:
- Complete the Proposal Modification Request form.
- Revise the subject Informed Consent Form so that it reflects the changes you wish to make to your protocol. The content of the subject informed consent form must be modified so that it is consistent with your requested protocol revisions. If the changs affect any recruitment materials such as flyers, please submit these as well.
- E-mail all materials to firstname.lastname@example.org.