How to Prepare an IRB Submission
Assemble a submission the board can act on without a round of clarification requests.
What a how-to is not
A how-to is SPEQ’s practitioner method, not a procedure. It does not replace your own SOP, it is not a validated approach, and the judgement calls in it belong to your quality unit.
An institutional review board is not a formality between a protocol and a first participant. It is the body that decides whether risks are reasonable against anticipated benefits, whether selection of participants is equitable, and whether the consent process is adequate. Submissions stall for procedural reasons far more often than ethical ones — a missing version number, an advertisement nobody submitted, a form that contradicts the protocol.
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Assemble the full package the board will review
Protocol, consent documents, investigator brochure or device description, recruitment materials, participant-facing questionnaires and diaries, and the investigator’s qualifications. Recruitment material is the most commonly omitted item and the most commonly cited, because it reaches participants before anything else does.
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Version and date every document
Each document needs a version and a date, and the submission must state which versions it covers. Boards approve specific versions, so an unversioned document cannot be approved in a way anyone can later verify — and the site cannot prove which text was in use on a given day.
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State the risk determination and justify it
Describe the risks, how they are minimised, and why they are reasonable in relation to anticipated benefits and the knowledge expected to result. This is the board’s statutory question; a submission that describes procedures without addressing it forces the board to do the analysis for you.
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Address vulnerable populations explicitly, or say why none are involved
Where participants may have limited capacity to consent or may be susceptible to coercion, describe the additional safeguards. Silence reads as an omission rather than as absence, and it is the fastest route to a deferral.
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Describe recruitment, compensation, and the consent process
How participants are identified and approached, what they are paid and on what schedule, and who conducts the consent discussion. Compensation structured so that most of it is paid only on completion can be read as undue influence to remain in a trial.
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Plan for continuing review and reporting from the start
Know what the board requires and when — periodic continuing review at an interval it sets, prompt reporting of unanticipated problems involving risks to participants or others, and notification of deviations that increase risk. Approval that lapses because a continuing review was late suspends the trial at the site.
- !Recruitment materials used but never submitted, so the first thing a participant sees was never reviewed.
- !Documents submitted without version and date, making it impossible to evidence which text was approved.
- !Vulnerable-population safeguards left unaddressed rather than explicitly ruled out.
- !Continuing review treated as a reminder rather than a deadline, so approval lapses mid-enrolment.
How to Prepare an IRB Submission: frequently asked questions
Common questions on prepare an irb submission.
What is the board actually deciding?
Whether risks to participants are minimised and reasonable in relation to anticipated benefits and the knowledge expected to result, whether selection is equitable, whether consent will be sought and documented adequately, and whether the data will be monitored for safety. A submission organised around those questions moves faster than one organised around your document list.
Does a protocol amendment always need prior approval?
A change may not be implemented before review and approval except where necessary to eliminate an apparent immediate hazard to a participant. That exception is narrow, it is reported promptly afterwards, and it is not a route for changes that are merely urgent to the schedule.
What has to be reported between reviews?
Unanticipated problems involving risks to participants or others, serious or continuing non-compliance, and any suspension or termination. The threshold is not "serious adverse event" — many serious events are anticipated and reported through the safety route instead, while an unanticipated problem may involve no adverse event at all.