As an ethical guide, E&I applies the principles found in the Belmont Report.
Ethical and Independent Review Services, LLC (E&I), and its IRBs, operate in compliance with the regulations found in the Common Rule. In addition, as applicable, E&I applies the regulations of the United States Food and Drug Administration as described in 21 CFR Parts 50 and 56, and the International Conference on Harmonisation Good Clinical Practice Guidelines. E&I may apply regulatory flexibility in the review on non-regulated studies.
OHRP / FDA Registration:
Any institution engaged in non-exempt human subjects research that is conducted or supported by any agency of the U.S. Department of Health and Human Services (HHS), that institution must have an OHRP-approved assurance of compliance with the HHS regulations (45 CFR 46.103) for the protection of human subjects.
The institution obtains an assurance, the IRB does not.
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: 00006502
E&I's IRB Registration number (for both OHRP and FDA) is:
IRB #2 West Coast: #IRB00007807 effective through 09/07/2013
If you have questions 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)