Often during the research process, the original protocol needs to be changed in order to accommodate needed adjustments that are essential to the study’s success. The approved protocol needs to reflect the most current changes and any new procedures need to be communicated to the IRB-SBS through a modification submission and approved through a modification review. Often changes are minor and don’t affect the overall scope and intent of the study (but even minor changes need to be submitted for review); such changes are often reviewed administratively or through the expedited/exempt review process. However, some changes can affect the level of risk; they may alter the requirements that the IRB-SBS Board has for the study and may require full board review even if the protocol was not reviewed by the full board originally. If the change is significant, anticipate that the Board may need to spend time evaluating the study in a way that was similar to the original review.
Once a protocol is approved, that version is “locked” and can’t be edited. In order to submit a modification, you need to “create a copy” of the protocol which will create a new version of the protocol that can be edited. Once you have made any changes to the protocol’s contents (including documents) and answered the “modifications” question, the protocol should be ready to submit. Modifications can be submitted at any time (though please consider grouping modifications into one submission where possible to reduce administrative burden).
The one change that does not require a modification is adding or removing Personnel from an approved protocol. Please see Personnel Management Tool for more information.
- Locate the protocol that you want to modify in the iProtocol Protocol Management and Document Storage page. Select the "create a copy" link below the protocol's title.
- Select the first radio button "I am copying in order to submit a Modification..."
- You will see a “Protocol was successfully updated” message. Click on the “return to protocol management” link to return to the Protocol Management page to find the new copy of the protocol.
- Select "edit" below the new copy of the protocol.
- Edit the protocol.
- In the "Modification" section near the end, complete the questions regarding the modification.
- When you are done making edits, select "submit" at the bottom of the page. In order for the submit button to be revealed, all of the "required" fields must be complete.
Trying to make a copy of the protocol for a modification but iProtocol won't allow it? iProtocol only allows one "in development" copy of the protocol for the same protocol number. Look for the protocol copy in the Protocol Management page. If you don't see it in your Protocol Management page, check the Trash/Recycle Bin for a copy of the protocol. Once you locate the modification copy, you have two options:
- Revise the copy that you already made for your current modification needs and submit it.
- Move the copy to the "Trash/Recycle Bin" and select the "permanent delete" button to delete the version (see Trash/Recycle Bin for directions). Once the copy is deleted, you can create a new copy from the most recently approved version of the protocol.
In this section of the protocol form, you will describe the changes that you made to the protocol. Our program is able to detect and highlight changes that are made between versions (up to three versions). The reviewers will be able to see changes made directly in the text which will help them to quickly assess what changes have been made. In addition, the questions in this section will help to highlight underlying reasons for making changes.
Does this protocol version include any changes that were made to the previously approved protocol (protocol form, consent documents, etc)
If you are completing the protocol for the first time and it has no previously approved word document version, you should mark “no” to this question. A “modification” is a change made to the protocol only after the protocol is approved. If the pre-reviewer or the Board request revisions to the protocol during the review process, this is not considered a modification.
If you made changes to the previously approved protocol, even minor changes, you should mark this question as yes.
Has the level of risk changed (either increased or decreased) since the last submission?
If you select “yes” you need to go to the Risk and Benefits section and update your response to address additional risks and/or new information about risks to participants in this study.
Provide the rationale for changing the protocol described in this study.
As previously stated, the program is able to detect changes made in the text boxes so it is not necessary to report every edit. Use this box to provide an overall summary of the changes and the rationale for making the changes. Make sure that the content in this section applies to the modification you are currently making. Don't describe previous modifications or provide information that isn't relevant to this change. Make sure that everything in the protocol accurately reflects the plan that you anticipate putting into place once the protocol is approved.
Modification Review
Modification review follows the same process as a new protocol, as described in the Protocol Review Process section. Generally protocols follow the same review path as their original review; if the protocol was expedited or exempt initially, it will be expedited or exempt for the modification review, unless the modification changes the level of risk to participants. If risk increases, a protocol may need full board review. Likewise, if a protocol was reviewed in a full board meeting but the modification changes the protocol so that it qualifies for exemption or expedited review, it will follow that path for the modification review and future reviews unless the risk level changes again. For more information, see Protocol Review Process.