The IRB is not assessing whether your study is good. It is assessing whether it is safe
Applications get returned for the same handful of reasons, and almost none of them are about research quality. Consent language that a participant could not follow, vague data handling, recruitment that looks coercive, and answers that do not match the protocol.
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The IRB asks narrow questions, and wide answers get returned
A reviewer wants to know what will happen to a participant, what could go wrong, and what you will do about it. Restating your research rationale where the form asks about risk reads as not having understood the question, and it is one of the most common causes of a second round.
Consent documents fail most often on reading level. They are written in the language of the proposal, which is the language of your discipline, and the person signing is not in your discipline. Plain language is not a courtesy here, it is the standard being applied.
Data protection answers fail on vagueness. Data will be stored securely says nothing. Where, in what form, encrypted how, who has access, for how long, and destroyed when. Those six answers take a paragraph and prevent a whole round of correspondence.
- Review category identified correctly before you submit
- Consent documents written at a readable level
- Data handling answered specifically, not generically
- Recruitment materials checked for anything that reads as pressure
What a review covers
Your own institution's forms, against your own protocol
- Whether your answers match your protocol and each other
- Consent form language, completeness and reading level
- Risk assessment: identified, proportionate, and mitigated
- Data security, retention and destruction, answered concretely
- Recruitment and compensation, checked for undue influence
Four recurring reasons
Consent that is not readable
Written at doctoral reading level for participants who are not doctoral students. Reviewers check this specifically, and rewriting it in plain language is usually a short job.
Risk dismissed rather than assessed
There are no risks to participants is almost never true. Interviews about difficult topics carry distress risk, and workplace studies carry confidentiality risk. Naming and mitigating beats denying.
Vague data handling
Securely, appropriately, safely. Each of these will generate a follow-up question. Specifics take one paragraph and save two weeks.
Protocol and form disagree
The form says twenty participants, the proposal says thirty. Reviewers read both, and any mismatch means a modification request regardless of which number is right.
Before you submit, and after a modification request
Send the draft application and your protocol
Both, because the most common single problem is disagreement between them and it is invisible if we only see one.
Consistency check
Numbers, procedures, timelines and inclusion criteria compared across every document you are submitting, including recruitment materials.
Consent and recruitment language
Read as a participant would read it, and graded where the language is too technical, where a required element is missing, or where an incentive could read as pressure.
Risk and data, made specific
Every generic answer flagged, with the specific question the reviewer will ask if it stays generic.
If it comes back, work through the response
A modification request is normal and not a judgment on your study. We help you read what is actually being asked, which is often narrower than it first appears.
The application is yours to make
- We do not complete or submit your IRB application.
- We do not write your consent documents or protocol.
- We do not correspond with your IRB or your institution.
- We do not advise you on how to avoid review or reduce your review category.
- We read what you have drafted and tell you where a reviewer will stop.
Nothing here is legal advice or a substitute for your institution's guidance. Your IRB office is the authority on its own process, and it is usually far more helpful to ask them early than to guess. Read the full policy.
Frequently Asked Questions
It depends on your institution and your review category. Exempt and expedited reviews are typically much faster than full board review, which may only meet monthly. Ask your IRB office for current timelines and build the answer into your dissertation timeline rather than hoping.
Your IRB decides, not you. Minimal-risk studies with adults using anonymous surveys often qualify for exempt or expedited review. Vulnerable populations, sensitive topics, deception or anything more than minimal risk usually go to full board. Guessing low and being wrong costs you a cycle.
Almost certainly yes if it is research involving human subjects and you intend to publish or submit it. Familiarity with participants does not remove the requirement, and it can add a coercion concern your application needs to address.
No. Modification requests are routine and most applications get at least one. Read it as a list of specific things to fix rather than as a rejection, and answer each point directly rather than rewriting broadly.
No. Recruiting or collecting data before approval is a serious compliance problem, and data collected that way usually cannot be used. It is one of the few mistakes here that can genuinely end a study.
You submit a modification request and wait for it to be approved before making the change. Changes to procedure, population, instruments or consent all normally require this, and implementing first is treated the same way as collecting without approval.
Send the draft application and the protocol
We will tell you where a reviewer will stop, which answers are too generic to pass, and where your documents disagree with each other.
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