Advarra® is organized and operates in compliance with the US federal regulations (including, but not limited to 21 CFR Parts 50 and 56, and 45 CFR Part 46), various guidelines as applicable (both domestic and international, including but not limited to OHRP, FDA, EPA, ICH GCP as specific to IRB review, Canadian Food and Drug Regulations, the Tri-Council Policy Statement 2, and CIOMS), and the ethical principles underlying the involvement of human subjects in research (including The Belmont Report, Nuremberg Code, Declaration of Helsinki).
Advarra is fully accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP).
Advarra’s IRB is registered with FDA and OHRP.
- IRB Organization (IORG) Number: 0000635
- IRB Registration Number: 00000971
Please note that the IRB registration number applies for both FDA and OHRP registrations and covers all general, therapeutically focused and country-specific panels.
Advarra’s Federalwide Assurance (FWA) has been approved by OHRP. Advarra’s FWA number is 00023875.