Total IRB Statement of Compliance

Total IRB provides ethical review and support services to principal investigators (PIs), institutions, contract research organizations (CROs), and sponsors of human subjects research. FDA-regulated studies are reviewed in accordance with the regulations outlined in the Title 21 of the Code of Federal Regulations (CFR) Parts 50-56, International Conference on Harmonization (ICH), and Good Clinical Practices (GCP), as applicable. Non-FDA regulated studies are reviewed under the provisions Title 45 CFR 46, International Conference on Harmonization (ICH) and Good Clinical Practices (GCP), as applicable.

Total IRB also reviews in compliance with other applicable federal and state laws and regulations governing IRBs and research with humans. Total IRB is registered with the Office for Human Research Protections (OHRP) as IRB00006968, enabling the review of HHS - supported or - conducted human subjects research under the Federal Assurance (FWA) of a submitting body. If you have questions or need further information, please do not hesitate to contact us.