Alternative IRB of Record

Researchers wishing to open Phase 3 adult cooperative group oncology trials that have been approved by the National Cancer Institute Central Institutional Review Board (NCI CIRB) may submit the appropriate paperwork to the IRB-HSR. If the IRB-HSR accepts the NCI CIRB review, the NCI CIRB will become the IRB of record.

Researchers wishing to open an expanded access protocol or a Phase 1 or 2 adult cooperative group oncology trials or Phase 3 trials which cannot be opened through the CIRB or a pediatric cooperative group oncology trial may use the Western Institutional Review Board (WIRB) as the IRB of record for the trial. The PI will submit the appropriate paperwork to WIRB and the IRB-HSR.

Researchers wishing to open an expanded access protocol may use a central IRB as the IRB of record for the trial. The PI will submit the appropriate paperwork to the central IRB and the IRB- HSR.

Central IRB for NeuroNEXT Protocols (NeuroNEXT CIRB)

• NeuroNEXT CIRB Procedures
• NeuroNEXT IRB-HSR Protocol Information Form
• NeuroNEXT Investigator Agreement

National Cancer Institute Central IRB (NCI CIRB) Procedures and Forms

• NCI CIRB Procedures
• NCI CIRB Consent Form Template - UVa Local Wording
• NCI CIRB Investigator Agreement
• NCI CIRB IRB-HSR Protocol Information and Application Form
• NCI CIRB HIPAA Authorization - English
• NCI CIRB HIPAA Authorization - Spanish
• For Short Forms see: Consent Short Forms for non-English Speaking Subjects
  

Additional Information from FDA on Expanded Access

Additional Information on IRB Authorization Agreements with other outside IRB’s

*Taken from UVa IRB-HSR Research Guidance