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Elemental IRB is an independent commercial IRB delivering expert ethical oversight with approvals in 5-10 business days. Transparent pricing starting at $750. No hidden fees. OHRP registered and FDA compliant.
A commercial IRB (also called an independent IRB or central IRB) is a for-profit institutional review board that operates independently from any single academic institution. Available to any qualified researcher or sponsor nationwide.
5-10 day approvals vs 4-8+ weeks. Transparent pricing from $750. Rolling review (no monthly meeting wait). Digital portal with real-time tracking. Multi-site sIRB support.
Fastest approvals in the industry, completely transparent pricing, OHRP registered and FDA compliant, industry-specialized reviewers, digital portal with real-time tracking, and rolling review.
A commercial IRB (also called an independent or central IRB) is a for-profit review board that operates independently from any academic institution. Unlike university IRBs that primarily serve their own researchers, commercial IRBs are available to any sponsor or investigator nationwide. They typically offer faster turnaround, transparent pricing, and rolling review schedules rather than fixed monthly board meetings.
Yes. Elemental IRB is fully registered with the Office for Human Research Protections (OHRP). Our registration is recognized for federally funded and non-federally funded human subjects research, and our approvals are valid under 45 CFR 46, 21 CFR 56, and the revised Common Rule.
Expedited reviews are typically completed in 3–5 business days. Full board reviews take 5–10 business days. We review on a rolling basis, so there is no waiting for a monthly board meeting cycle. Multi-site studies have custom timelines based on the number of sites and complexity.
Expedited review starts at $1,500. Full board review is $4,000. Multi-site and complex studies have custom pricing — contact us for a quote. All prices include unlimited minor amendments, annual continuing review, and ongoing support. There are zero hidden fees.
We review a wide range of research including pharmaceutical and drug studies, dietary supplement clinical trials, medical device studies, cosmetic and skincare studies, behavioral and social research, wellness product trials, and software/technology research. Our expert panel includes specialists in each domain.
Yes. Elemental IRB is structured to function as the IRB of record for multi-site studies, satisfying the NIH single IRB policy for applicable research. We coordinate site-specific reviews and issue approval letters for each participating institution.
Standard submission documents include the research protocol, informed consent form(s), investigator credentials (CV/resume), study instruments (surveys, questionnaires), and any recruitment materials. Full-board reviews may also require an Investigational Device Exemption (IDE) or Investigational New Drug (IND) application if applicable. Our portal guides you through the exact requirements for your study type.
Yes. Unlimited minor protocol amendments are included in your review fee at no additional cost. Minor amendments include changes to consent language, recruitment materials, and non-substantive protocol updates. Major amendments that require substantial re-review are $500 flat.
Annual continuing review is included in your original review fee. We track your study timeline and notify you before renewal is due. Continuing review involves submitting an annual progress report, which our team reviews and processes within 3–5 business days.
Currently, Elemental IRB only reviews US-based research studies with US participants. We do not currently accept international protocols or studies conducted outside the United States.
Elemental IRB was purpose-built to solve the frustrations researchers have with legacy commercial IRBs: slow turnarounds, opaque pricing, and poor communication. We offer 5–10 day approvals (vs. 2–4 week industry average), fully transparent upfront pricing (no surprise invoices), and a modern digital portal with real-time tracking. See our dedicated comparison pages for a detailed breakdown.
Yes. Elemental IRB operates in full compliance with FDA regulations under 21 CFR 56 (IRB regulations) and 21 CFR 50 (protection of human subjects). Our approvals are recognized by the FDA for regulated research including IND studies and IDE studies.