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What is the difference between a central (commercial) IRB and a local institutional IRB - and which one is right for your study? Here is a clear, side-by-side explanation.
| Feature | Elemental IRB | Local / institutional IRB |
|---|---|---|
| Who operates it | Independent / commercial organization | A single university, hospital, or institution |
| Who can use it | Any qualified sponsor or investigator | Researchers affiliated with that institution |
| Multi-site studies | Single IRB of record across all sites | Each site reviews separately |
| Typical turnaround | Days (rolling review) | Weeks (scheduled board meetings) |
| Submission process | Digital portal | Varies; often institution-specific |
| Best for | Industry, CROs, multi-site, independent PIs | Single-site academic research |
A central IRB (also called a commercial or independent IRB) operates independently of any single institution and reviews research for any qualified sponsor or investigator. A local IRB is operated by a single university, hospital, or institution and reviews studies by its own affiliated researchers. Both must be OHRP registered.
Choose a central IRB for multi-site studies, when you are an industry sponsor or CRO without your own IRB, when you are an independent investigator with no institutional affiliation, or when your local IRB's schedule does not fit your timeline. Central IRBs also satisfy the NIH single IRB (sIRB) policy.
A central IRB (also called a commercial or independent IRB) is an independent organization that can review research for any qualified sponsor or investigator, regardless of institution. A local IRB is operated by a single university, hospital, or institution and reviews research conducted by its own affiliated researchers. Central IRBs are typically faster and are designed to serve as the single IRB of record for multi-site studies.
Largely, yes. The terms central IRB, commercial IRB, and independent IRB are often used interchangeably to describe an IRB that operates independently of any single institution and can review research for outside sponsors and investigators. Elemental IRB is an OHRP-registered commercial IRB that functions as a central IRB.
Use a central IRB when you run multi-site research, when you are an industry sponsor or CRO without an institutional IRB, when you are an independent investigator with no institutional affiliation, or when your local IRB's timeline does not fit your study schedule. Central IRBs also satisfy the NIH single IRB (sIRB) policy for applicable multi-site studies.
The NIH single IRB policy requires most NIH-funded, non-exempt, multi-site human subjects studies conducted in the US to use a single IRB of record rather than each site's local IRB. A central IRB like Elemental IRB can serve as that single IRB, coordinating reviews and issuing approvals for all participating sites.
Generally, yes. Central IRBs like Elemental IRB review on a rolling basis and are not tied to monthly board meeting cycles, so expedited reviews finish in 3-5 business days and full board reviews in 5-10. Local IRBs often meet on fixed schedules, which can add weeks to your timeline.
Yes. A central IRB must be OHRP registered and comply with the same federal regulations (45 CFR 46 and, for FDA-regulated research, 21 CFR 56) as any local IRB. The ethical standards and participant protections are identical - central IRBs simply add speed, multi-site coordination, and pricing transparency.