The Iceberg of IRB Delays: What You Don’t See Is What’s Costing You Time
By Jenna Levenson PhD, RN, MS
You see the IRB submission, but I see the iceberg under the surface.
And that iceberg…
It’s what’s silently sinking your timeline.
Most biotech and research teams treat the Institutional Review Board (IRB) process like a simple checklist:
Submit protocol - DONE
Attach consent - DONE
Wait for approval – DONE
But here’s the reality: that wait is often 6–12 weeks longer than it needs to be—and the reasons are rarely technical. They're strategic.
Let’s unpack what most teams don’t see (but I always look for).
The Real Reasons IRB Reviews Get Stuck
“We submitted everything. Why is it still under review?”
If I had a dollar for every time I heard this from a frustrated trial sponsor...
Most delays aren’t caused by missing forms or IRB backlogs. They come from:
Overly complex or redundant protocols
Consent forms that confuse rather than clarify
Lack of patient-centric language or engagement
Unaddressed questions about recruitment or risk mitigation
You can have rock-solid science—and still lose months waiting for IRB revisions. Why?
Because your documents might be speaking the language of data, but the IRB needs the language of clarity, ethics, and human impact.
The One Tweak That Can Save You Months
Here’s where I make the difference.
When I review IRB packages before submission, I am not just checking boxes. I:
Translate complex science into accessible language for community IRBs
Simplify consent forms to reduce perceived risk
Rework protocols to clearly show how participants are protected
Highlight patient engagement strategies the IRB actually cares about
Think of it like a “Clarity Review”—and in nearly every case, it reduces approval timelines by weeks if not months.
Because here’s the part no one tells you:
IRBs aren’t rejecting your science.
They’re rejecting your communication and that results in:
Burned budget on idle sites
Delayed patient enrollment
Slower investor updates
Missed grant or milestone deadlines
Time lost at the IRB stage ripples across your entire trial lifecycle.
And the worst part?
Most of these delays are preventable.
Your De-Risking Roadmap Starts Here
If your team is planning a multicenter trial, navigating protocol amendments, or prepping a grant submission—this is the moment to get proactive.
Don't let IRB timelines be a black box. Let’s find the inefficiencies before they freeze your progress.
If you would like a quick audit of your current IRB submission plan, Let’s Talk and get your trial approved—and moving—faster.