Receiving comments or revision requests from an Institutional Review Board (IRB) is a normal part of the research review process. For researchers, however, an IRB revision request can sometimes feel overwhelming—especially when several changes are requested or when the reasoning behind a comment is not immediately clear.
Understanding how to respond effectively to reviewer comments is especially important when working with Solutions IRB, where the application itself must serve as the primary, stand-alone record of the study. Here’s what researchers should know when responding to IRB reviewer comments and submitting revisions.
Why Does the IRB Request Revisions?
The purpose of IRB review is to protect the rights, safety, and welfare of research participants. During review, the IRB evaluates areas such as the study design, risks and benefits, recruitment procedures, informed consent process, privacy and confidentiality protections, and the overall experience of participants.
If the IRB identifies something that needs clarification or modification, the researcher may receive a request for revisions.
A revision request does not necessarily mean there is something fundamentally wrong with the study. Often, the IRB simply needs clearer language, additional detail, or updates to ensure that participant protections are fully and accurately described.
Read Every Comment Carefully
The first step is to read the entire revision request before making changes. Avoid immediately editing documents based on individual comments without considering how the requested change affects the study as a whole.
Some comments may be straightforward, while others may require careful interpretation.
If a comment is unclear, do not guess. Researchers should contact the IRB for clarification rather than making changes that may not fully address the concern.
Make All Protocol Changes Directly in the Application (Required)
When submitting revisions to Solutions IRB, it is essential that all changes to the study protocol are made directly within the IRB application itself.
The application is the authoritative source of record for your study and must clearly and accurately reflect:
- Study procedures
- Recruitment methods
- Eligibility criteria
- Consent process
- Data collection methods
- Risk/benefit descriptions
- Any other protocol-related elements
The application should be able to stand alone without relying on attached documents to understand how the study is conducted. Reviewers must be able to read the application and fully understand the study without needing to cross-reference external files.
Attached documents (such as consent forms, recruitment materials, or instruments) support the application—but they do not replace it. If there is a discrepancy between the application and an attachment, the application will be considered the primary source.
Respond to Each Comment Individually
Researchers should provide a clear, point-by-point written response to every IRB reviewer comment. This response document should explain:
- What was changed
- Where the change was made in the application
- What documents were updated (if applicable)
For example:
IRB Reviewer Comment: Please clarify how participants will be recruited.
Researcher Response: The recruitment procedures have been updated directly in the IRB application under the “Recruitment” section to specify that participants will be recruited via email invitation sent through departmental listservs. The recruitment email attachment has also been updated to reflect this change.
This format allows reviewers to quickly verify that the application itself has been updated appropriately.
Keep the Application and Attachments Consistent
One of the most important parts of the revision process is ensuring consistency between the IRB application and all supporting documents.
For example, if you update the time commitment for participants, that change must be reflected:
- Directly in the IRB application (required)
- In the consent form
- In recruitment materials
- In any participant-facing documents
However, the application must always be the most complete and accurate description of the study. Attachments should match—but the application should not depend on them for clarity.
Explain Changes When Necessary
In your written response document, briefly explain what was changed and why. If you disagree with a requested revision, provide a clear, professional justification supported by your study design or ethical considerations.
The goal is not to argue, but to ensure the IRB understands how participant protections are being addressed.
Do Not Make Unrelated or Untracked Changes
When revising your submission, only make changes that are necessary to address IRB comments or improve accuracy and participant protection.
Avoid making unrelated edits that are not documented in your response, as this can create confusion during review.
If you determine that additional substantive changes are needed beyond the requested revisions, contact the IRB before making those updates.
Review the Entire Submission Before Resubmitting
Before resubmitting your revised application, carefully review the full submission package.
Ask yourself:
- Have all IRB comments been addressed in the response document?
- Have all protocol changes been made directly in the application?
- Does the application fully and clearly describe the study on its own?
- Do all attachments match the updated application?
- Are there any inconsistencies between documents?
- Is the response document clear and easy to follow?
A complete and consistent submission helps prevent additional revision cycles.
IRB Revisions Are Part of the Review Process
IRB comments and revision requests are a normal and expected part of the review process. They help ensure that research is clearly described and that participant protections are fully addressed.
For researchers working with Solutions IRB, it is especially important to remember that the IRB application is the central document of record. While supporting materials are important, the application must always provide a complete, stand-alone description of the study.
By carefully addressing each comment, updating the application directly, maintaining consistency across documents, and providing a clear written response, researchers can make the revision process more efficient and transparent for everyone involved.
At Solutions IRB, our experienced team works closely with researchers throughout the review process to help ensure submissions are clear, complete, and aligned with ethical research standards.