Accreditation and Compliance

PrimeIRB 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 (including but not limited to OHRP, FDA, EPA, ICH GCP as specific to IRB review, and the ethical principles underlying the involvement of human subjects in research (including The Belmont Report, Nuremberg Code, Declaration of Helsinki).

PrimeIRB is fully accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP).

 

PrimeIRB is registered with FDA and OHRP.

 

  • IRB Organization (IORG) Number: IORG0010252
  • IRB Registration Number: IRB00012178

Please note that the IRB registration number applies for both FDA and OHRP registrations.

  • PrimeIRB’s Federalwide Assurance (FWA) Number: FWA00030021