The ethical principals of clinical research such as autonomy, beneficence, equipoise, and justice will be followed according to the US Office of Human Research Protections (OHRP).  All physician investigators at CBI will maintain NIH Human Participants Program Education for Research Certification (HPPERC). 

Additionally, independent certified clinical research associates (CCRA) will monitor all local research data collection and source documentation.  On site certified clinical research coordinators (CCRC) will manage research protocols and maintain ACRP continuing medical education requirements.  All gene therapy research protocols will be approved through the FDA Office of Cellular, Tissue, and Gene Therapies (OCTGT) and the NIH DNA Recombinatorial Advisory Committee (DNA RAC) to comply with a local Institutional BioSafety Committee (IBC) approval, monitoring and containment. 

The physician and clinic staff will remain fully credentialed at all times with DEA and medical board licensure, oncology certified nurses for chemotherapy infusions and advanced cardiac life support (ACLS).   Biosafety level IIB pharmacy mixing hoods will be utilized according to OSHA standards.   Electronic medical records will maintain HIPAA compliance for privacy, security, and enable medication dispensing safety guards for quality assurance.  The on-site clinical lab is CLIA certified according to clinical Good Laboratory Practices (cGLP).

The future Human Applications Laboratory (HAL) will maintain clinical Good Manufacturing Process (cGMP) for clinical grade cell therapy under FDA facility inspection.  Leukapheresis will follow American Association of Blood Bank (AABB) standard protocols with certified technicians and seek Foundation Accreditation Cell Therapy (FACT) certification.  The tumor bank and research lab will seek College of American Pathologists (CAP) certification and follow clinical Good Tissue Practices (cGTP) and American Association Tissue Banks (AATB) guidelines. 

CBI radiation and nuclear pharmacy facilities will follow Consumer Assurance of Radiologic Excellence (CARE) and FDA Center for Devices and Radiological Health (CDRH) guidelines.   Appropriate nuclear medicine/radiology certifications, isotope accountability, and appointment of a radiation safety officer (RSO) will be followed according to the Nuclear Regulatory Commission guidelines.