Ethical & Independent Review Services (E&I)’s Institutional Review Board, through written process and policy, operates in compliance with requirements of FDA regulations 21 CFR Parts 50 and 56, HHS regulations 45 CFR 46, and International Conference on Harmonization (ICH) E6, Good Clinical Practice (GCP), and other federal, state and local laws regulating review of human subjects research, as applicable.
OHRP / FDA Registration:
Both HHS and the FDA require all IRBs working with human subjects research conducted or supported by HHS or regulated by FDA to register with the Office of Human Subject Protection (OHRP.) OHRP (45 CFR part 46, subpart E) and FDA (21 CFR 56.106)
E&I's IRB is registered with OHRP for the review of human subjects research regulated by HHS or FDA. Our registration is current and can be viewed here by simply selecting "IRB" then entering Ethical and Independent Review Services into the search field.
E&I's IRB Organization number is: 0006502
E&I's IRB Registration number (for both OHRP and FDA) is:
IRB #2 West Coast: #IRB00007807 effective through 3/9/2020
If you have questions, would like a copy of our Statement of Compliance on letterhead, or would like further information regarding IRB registration and/or FWA assurances, please
US Food and Drug Administration
Good Clinical Practices in FDA-Regulated Clinical Trials
Department of Health and Human Services (45 CFR 46)
Department of Health and Human Services (Belmont Report)