Accreditation and Compliance
Advarra is organized and operates in compliance with the U.S. 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 Office of Human Research Protection [OHRP], Food and Drug Administration [FDA], Environmental Protection Agency [EPA], International Council of Harmonization [ICH] good clinical practice [GCP] as specific to institutional review board [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 Registration Number: 00000971
Please note the IRB registration number applies for both FDA and OHRP registrations and covers all general, therapeutically focused and country-specific panels. - FWA number: 00023875.
Advarra’s Federalwide Assurance (FWA) has been approved by OHRP.
