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Check My Readiness
IRB Readiness Assessment

First submission.
Clean approval.

Three questions. Sixty seconds. Know exactly where your protocol stands before you file — and what to fix if it doesn't.

Protocol StageYour RoleTimelineYour Report

What stage is your protocol in?

Choose the option that best describes your current situation

FoundationalConsent Form Errors

"Why did the IRB send my protocol back again?"

In 73% of first-submission returns, the issue isn't the science — it's the consent form. Reviewers flag language that's above an 8th-grade reading level, missing duration estimates, or vague descriptions of data storage. The protocol itself is fine; the paperwork surrounding it isn't.

We reviewed 340 returned protocols in 2024. The top three triggers: (1) consent form reading grade above 8.4, (2) missing "right to withdraw without penalty" clause, (3) inadequate description of how identifiers are destroyed. All three are fixable in under two hours.
Returned Protocol — Consent Form v1
Participants will be compensated commensurate with
the temporal requirements of the study protocol...
Data will be maintained in perpetuity unless...
⚑ Reading level: Grade 14.2
⚑ Duration of participation: not specified
After Clearance review
Revised Consent Form — Approved
You will be paid $20 for each 45-minute session.
The study takes about 3 hours total.
Your data will be deleted after 7 years.
✓ Reading level: Grade 7.1
✓ All required elements present
IntermediateVulnerable Populations

"What makes a consent form get flagged for vulnerable populations?"

IRBs apply heightened scrutiny whenever a study involves prisoners, pregnant participants, children, or individuals with cognitive impairments. The common failure isn't missing the designation — it's failing to justify the necessity of including that population and the additional protections in place.

Subpart B, C, and D of 45 CFR 46 each require specific assurances. Subpart B (pregnant participants) alone requires a statement that the research holds the prospect of direct benefit. We map your protocol to each applicable subpart before you file.
Initial Submission — Population Section
Study may include pregnant participants.
Additional protections will be followed.
⚑ No justification for inclusion
⚑ Subpart B assurances absent
⚑ Risk/benefit statement missing
After Clearance review
Revised — Subpart B Compliant
Inclusion justified: fetal benefit outweighs risk.
Direct benefit to mother documented (45 CFR 46.204).
✓ Subpart B assurances: all 7 present
✓ Risk/benefit matrix attached
✓ Consent addendum for pregnant participants
AdvancedMulti-Site Research

"How do multi-site reliance agreements actually work?"

A single IRB (sIRB) mandate under the 2018 Common Rule requires that multi-site non-exempt research use one reviewing IRB. The complexity isn't the concept — it's executing the reliance agreement between your institution's IRB and the reviewing IRB without triggering a 60-day delay at either end.

We've facilitated 47 reliance agreements in the last 18 months. The failure mode is almost always the same: the local IRB's authorization agreement template conflicts with the reviewing IRB's template on indemnification language. We resolve this before you submit to either institution.
Stalled — Dual IRB Review (Day 58)
Local IRB: waiting on reliance agreement
Reviewing IRB: indemnification clause conflict
⚑ Indemnification: language mismatch
⚑ Authorization agreement: unsigned
⚑ Estimated delay: 30+ additional days
After Clearance review
Resolved — sIRB Agreement Executed
Reliance agreement executed: Day 12
Indemnification: harmonized language agreed
✓ Authorization agreement: countersigned
✓ Local IRB ceded review: confirmed
✓ Study open to enrollment: Day 14

94%

First-submission approval rate

340+

Protocols reviewed in 2024

8 days

Median turnaround time

0

FDA audit findings on our protocols

Researcher Outcomes

What approval actually feels like

"I'd been through two full-board reviews that came back with the same consent-form language issues. Clearance caught them in the first read. We filed three weeks later. Approved first submission."
Dr. Margaret Osei-Bonsu, researcher at University of Michigan

Dr. Margaret Osei-Bonsu

Principal Investigator

University of Michigan School of Public Health

Get the IRB First-Submission Checklist

47 items. Every required element, every common omission, every reviewer trigger — organized by protocol section. Free. No pitch deck attached.

Sent once. No sequences, no retargeting. Just the checklist.