IRB Overview

Our foundation is a research culture that prioritizes a commitment to the integrity of the science and efficient, ethical research conduct. This has established a reputation for performance and has allowed Sitero to develop relationships with global experts in almost any therapeutic field.

We pride ourselves on the ability to provide exemplary service with a single, consistent point of contact, on-call boards, and competitive turnaround times.

Our IRB has some of the pioneers and architects that have crafted the modern field of human research protection as well as recognized experts in their respective specialties. The caliber of our staff is unmatched with over 50 years of collective IRB experience and our Board Leadership has unparalleled background in protecting human subjects.

Accreditation and Compliance

Sitero IRB 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).

Sitero is in the process of becoming accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP).

Regardless if you’re an CRO/Sponsor who needs to have ethical, efficient review services, an investigator who has a question, or an institution who wants to develop synergies in their IRB operations, we can help.

Sitero IRB is registered with FDA and OHRP.

  • IRB Organization (IORG) Number: 011484

  • IRB Registration Number: 00013619
    (expiration date: 09/16/2025)
  • Sitero IRB’s Federalwide Assurance (FWA) Number: 00032739
    (expiration date: 09/28/2027)

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

Download Statement of Compliance