New York Biologics holds two IRB approvals for residual specimen collection: one from Western IRB (WIRB) and the other from Ethical & Independent Review Services (EIRS). These external IRB approvals provide a waiver of informed consent on collection protocols for de-linked and de-identified specimen collection(s). These approvals resolve patient confidentiality issues that would otherwise require patient informed consent agreements. The IRB’s are renewed annually and have existed since 2001.
FDA Blood Registration confirms the ability for New York Biologics to provide blood center derived materials: such as: RBC Units and WBC Units, Test Negative Normals, Allo Ab samples.
We are a registered broker permitted to work with Blood Centers and sell direct to the Invitro Diagnostics Industry.
- Western IRB
- Ethical & Independent Review Services
- FDA Registration