01 · The Question
How do you answer ethics comments without creating another round of confusion?
You receive the ethics committee's review and discover a mixture of questions, requested revisions, document corrections, conditions, and perhaps one or two comments you do not fully agree with.
The temptation is to revise the application quickly, upload the new files, and write something like "All comments have been addressed." That may feel efficient from the researcher's side. From the reviewer's side, it can mean reopening several documents and trying to discover what changed.
A strong response does the opposite. It creates a clear trail from each committee comment to your answer, the resulting revision, and the exact document or section where that revision appears.
03 · What You Need to Know
Your response should function as a map of the revised study
Ethics committees need to determine whether their concerns have actually been resolved. That becomes much easier when the response package shows the relationship among the original comment, your answer, and the revised documents.
WHO's Research Ethics Review Committee provides a concrete example. Its submission guidance instructs investigators responding to review to address queries point by point in a cover memo and submit an amended protocol incorporating requested changes, with revisions marked through bolding, highlighting, or tracked changes. After approval, WHO requests a clean final protocol without those markings. These are WHO-specific procedures, but they illustrate a useful general principle: make changes visible during review and preserve a clean approved version afterward.
Start by classifying what each comment actually asks you to do
Not every committee comment requires the same response.
| Type of comment |
What it usually needs from you |
Common mistake |
| Clarification |
Explain information that is unclear or incomplete |
Changing the study when explanation alone would have resolved the question |
| Required modification |
Revise the affected procedure or document as requested, or use the permitted process to justify an alternative |
Answering the comment without changing the document |
| Additional information |
Supply the missing methodological, ethical, administrative, or supporting information |
Repeating the original wording |
| Document correction |
Correct the affected material and check related documents for the same issue |
Fixing one file while leaving contradictions elsewhere |
| Condition of approval |
Satisfy and document the specified condition according to the committee's procedure |
Assuming the study may begin before the condition is verified |
This first step prevents overreaction. A reviewer asking "Please clarify how recordings will be stored" has not necessarily instructed you to change the storage system.
Use a point-by-point response
Preserve the committee's numbering or order whenever practical. Reproduce or accurately identify each comment, then place your response immediately beneath it.
A useful response tells the reviewer four things:
What was requested
Identify the committee's comment or condition clearly.
What you did
State whether you revised, clarified, supplied information, or proposed an alternative.
Where it changed
Identify the protocol section, application field, consent form, instrument, recruitment material, or other affected document.
Why, when necessary
Explain the reasoning when the response is not self-evident or when you are proposing something different from the requested solution.
The objective is verification. A reviewer should not need detective skills to discover whether a requested change appears somewhere in a 40-page protocol.
Do not answer "Done" when the reviewer needs evidence
Consider the comment: "Please clarify what happens to audio recordings after transcription."
A response saying "Done" confirms almost nothing. A stronger response might explain that the protocol and participant information have been revised to state that recordings will be stored in the approved location, accessed only by specified personnel, and deleted at the approved stage after transcription and verification.
The exact procedure depends on the study. What matters is that the response communicates the substantive resolution and directs reviewers to the revised material.
Revise every document affected by the same change
One committee comment can propagate through the submission package.
If interview duration changes from 60 to 45 minutes, check the protocol, application, participant information sheet, consent form, recruitment advertisement, and any scheduling materials that mention duration.
If compensation changes, search every participant-facing document. If a new risk is added, review both the risk section and the consent information. If recruitment changes, check whether eligibility and contact procedures elsewhere still make sense.
Watch Out
Do not fix a contradiction by creating another contradiction. Whenever a committee comment changes a fact about the study, search the complete submission package for every other place where that fact appears.
Use tracked or highlighted revisions when the committee requests them
Reviewers often need to distinguish new material from the version they already reviewed.
WHO's submission guidance, for example, asks for requested amendments to be incorporated into the protocol and marked through bolding, highlighting, or track changes during the response stage. It requests a clean final version after approval.
Your committee may require a different convention, such as a redlined copy plus a clean copy, highlighted PDFs, a change table, or only a revised document with version numbers. Follow its format rather than creating your own elaborate color system.
Do not make unrelated changes silently
While revising the protocol, you notice another paragraph that could be improved. Then you decide to adjust an eligibility criterion, replace two interview questions, change the survey platform, and rewrite the recruitment advertisement.
Now the committee is reviewing more than its original comments.
Necessary corrections and genuinely important updates should not be hidden, but distinguish them from committee-requested revisions. If you introduce additional changes, disclose them clearly and follow the committee's requirements for reviewing them.
This is particularly important because changes to approved research may require prior review under applicable systems. OHRP's current written-procedures guidance for U.S. IRBs emphasizes procedures for reporting proposed changes and ensuring that changes to approved research are not initiated without prior IRB review and approval except where necessary to eliminate apparent immediate hazards to participants.
If you disagree, answer the ethical concern rather than ignoring the requested change
You do not need to pretend to agree with every comment.
If a requested change would materially damage the methodology, is based on a factual misunderstanding, or can be addressed through a better safeguard, explain that reasoning and propose an alternative through the committee's review process.
The key distinction is between a reasoned response and silent refusal. If you disagree with a requested ethics change, make the disagreement explicit enough for the committee to evaluate it.
Do not bury the response beneath a literature review
Some comments need evidence. That does not mean every response requires three pages of citations.
If a committee questions whether removing an item invalidates a standardized instrument, cite the instrument documentation or validation evidence relevant to that point. If the concern involves data security, explain the technical control. If it involves a regulatory requirement, identify the applicable rule or authoritative guidance.
Evidence should resolve the issue, not demonstrate that you own reference-management software.
Be especially precise when the committee imposes a condition
A condition is not merely a suggestion for improving the manuscript.
OHRP guidance distinguishes circumstances in which an IRB may approve research with conditions from situations in which it must defer approval pending further review. In conditional approval, the IRB has already been able to make the required approval determinations on the assumption that specified conditions will be satisfied. The investigator's responsive material still needs to be reviewed in the manner specified by the IRB.
WHO's Research Ethics Review Committee similarly describes conditional approval as contingent on an adequate response to the satisfaction of the reviewers or Chair, with required amendments incorporated and resubmitted.
Because terminology varies, respond to the exact conditions in your decision letter rather than assuming that "conditional approval" has one universal operational meaning.
Check whether your response deadline matters
Some committees specify how long investigators have to respond before an application closes, expires, or requires further review.
OHRP guidance notes that institutional procedures may set deadlines for investigators to submit responsive materials after an IRB requests changes or clarifications. A prolonged delay can also mean that new information relevant to risk or approval determinations needs to be disclosed when the researcher eventually responds.
Check your own committee's timeline. Do not assume an ethics application waits indefinitely in suspended animation.
Conduct a final cross-document audit before resubmitting
After answering every comment, temporarily stop reading the response letter and inspect the revised study as a whole.
Check:
- study title and identifiers;
- participant numbers and eligibility;
- recruitment procedures;
- study procedures and duration;
- risks and safeguards;
- potential benefits;
- compensation;
- consent procedures;
- data collection and retention;
- contact information;
- document dates and version numbers.
A response can address every comment individually and still leave the revised submission internally inconsistent.
07 · A Quick Checklist
Check your response package before resubmission
Before responding to ethics committee comments, check:
Every committee comment or condition has a corresponding point-by-point response.
Each response states what was changed, clarified, supplied, or proposed instead.
The response identifies the revised document and location when a change was made.
All documents affected by the same substantive change have been updated consistently.
Tracked, highlighted, clean, or redlined copies follow the committee's required submission format.
Any disagreement is explained explicitly and supported with relevant reasoning or evidence.
Additional changes not requested by the committee are identified rather than silently inserted.
Document titles, dates, and version numbers clearly distinguish the revised files from earlier drafts.
You have checked the response deadline and understand what further committee confirmation is required before research may proceed.
