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Run credible, claim-ready clinical research on dietary supplements and nutraceuticals. Elemental IRB delivers expedited review from $1,500 with reviewers who understand supplement substantiation.
Any study collecting data from human participants - including clinical substantiation trials for supplements and nutraceuticals - requires independent IRB oversight. IRB-approved human research is the gold standard for the competent and reliable scientific evidence the FTC expects behind structure/function claims.
Substantiation trials, biomarker and efficacy studies, tolerability and safety studies, and consumer perception research that involves human subjects.
Most supplement studies are minimal-risk and qualify for expedited review at $1,500 in 3-5 business days. Higher-risk designs receive full board review at $4,000 in 5-10 business days, with pricing published upfront.
Yes. Any research involving human participants - including clinical substantiation trials for dietary supplements, nutraceuticals, and functional ingredients - requires review by an Institutional Review Board to protect participants and produce credible, publishable, claim-ready data. IRB approval is also expected by most journals, retailers, and certification bodies.
Most supplement substantiation studies qualify for expedited review at $1,500 (3-5 business days). Higher-risk protocols that require full board review are $4,000 (5-10 business days). Minor amendments and annual continuing review are included; major amendments are a flat $500.
An IRB does not approve marketing claims - that is governed by the FTC and FDA. But IRB-approved human research is the foundation of credible substantiation. A well-designed, ethically reviewed clinical trial provides the competent and reliable scientific evidence the FTC expects behind structure/function and other claims.
Expedited review is completed in 3-5 business days and full board review in 5-10 business days, measured from the point your submission is confirmed complete. Elemental IRB reviews on a rolling basis, so there is no wait for a monthly board meeting.
Yes. Our reviewer panels include members with experience in nutrition, dietary supplements, and consumer-health research, so your protocol is evaluated by people who understand structure/function study designs, biomarker endpoints, and supplement safety profiles.
A research protocol, informed consent form(s), the PI's CV, study instruments (surveys, questionnaires, biomarker plans), recruitment materials, and a one-time indemnification agreement. Product safety information such as a Certificate of Analysis is helpful for safety review.