What Does An IRB Do?

Quick Fix Summary

Need IRB approval fast? Submit your research protocol to your institution’s IRB office. Expect 2–4 weeks for review. Skip this step? Your study might not get published—and you could break federal rules.

What’s Happening

An Institutional Review Board (IRB) is basically a required safety net. It’s a committee that reviews research involving human participants to make sure everything’s ethical, safe, and follows the rules—think 45 CFR Part 46 and 21 CFR Part 56. And yes, they still answer to the U.S. Department of Health and Human Services’ Office for Human Research Protections (OHRP) as of 2026.

Step-by-Step Solution

1. Figure out if your study even needs IRB review.
   • Ask yourself: Does this count as "research involving human subjects"? Check the OHRP guidance to be sure.
   • Working with FDA-regulated stuff—like drugs, devices, or biologics? Then IRB review is mandatory under 21 CFR Part 56.
2. Pick the right review type for your study.

   Review Type	When to Use It	How Long It Takes
   Exempt	Minimal risk studies (think anonymous surveys or looking back at old medical records)	Around 2 weeks
   Expedited	Studies with no more than minimal risk (like simple blood draws or noninvasive procedures)	About 2–3 weeks
   Full (Convened)	Higher-risk studies (interventions, working with vulnerable groups, etc.)	3–6 weeks—or even longer

3. Get your submission ready.
   • Fill out your IRB application through your institution’s portal (IRBNet or Cayuse IRB are common ones).
   • Gather these documents:
     • A short summary of your protocol
     • Informed consent forms
     • Materials for recruiting participants
     • Tools for collecting data
     • An investigator brochure (if your study involves drugs or devices)
   • Don’t forget a risk-benefit breakdown and—if you’re working with vulnerable groups—a solid justification for why it’s necessary.
4. Hit submit.
   • Log into your institution’s IRB portal (usually something like https://[your-institution].irbportal.edu).
   • Go to New Study → Create Initial Submission.
   • Upload everything and fill out the online form.
   • Click Submit. You’ll get a confirmation email with a reference number.
5. Deal with IRB feedback.
   • Keep an eye on your inbox—IRB comments usually arrive within 5–10 business days.
   • Fix whatever they flag and resubmit through the portal.
   • Use track changes or a response letter to show exactly what you changed.
6. Wait for the verdict.
   • Approval? You’ll get a stamped consent form and an official approval letter.
   • Denied? You can appeal or revise and try again.
   • Save that approval letter—you’ll need it for grants and publications later.

If This Didn’t Work

• Double-check for mistakes. Did you miss a required field? Forget to upload a document? Common slip-ups include missing signatures or using an outdated consent template.
• Ask for a pre-review. Many institutions hold IRB office hours or let you submit materials early for feedback.
• Push for faster review if you’re in a hurry. Time-sensitive study? Contact the IRB chair or compliance officer to ask about an expedited review.

Prevention Tips

• Start early. Submit your application 6–8 weeks before you plan to start collecting data—especially if you need a full-board review.
• Use the templates your institution already approved. It’ll cut down on revision rounds and speed things up.
• Take the required training. Complete human subjects research training (like CITI Program) every 3 years—CITI requires it.
• Stay updated on the rules. OHRP and FDA guidelines change, especially around digital health and remote data collection (they’ve evolved a lot since 2020).
• Keep everything documented. Save emails, submission dates, reviewer comments, and revised materials—you’ll thank yourself later.