Ancillary Reviews Some studies involve activities that require specialized review outside of the IRB. For example, when a study involves the transfer of gene material into humans, the protocol must undergo review by the Einstein Institutional Biosafety Committee (IBC). We refer to these as Ancillary Reviews, or Committee Reviews. Some ancillary reviews affect subject safety; therefore the IRB cannot approve a study until the ancillary review is complete. The research team is responsible for applying to the ancillary committee or reviewing applicable policies to ensure compliance with institutional requirements. If the ancillary review impacts subject safety or the ability to conduct the research successfully, the IRB will require proof of the ancillary committee’s determination as part of the application for initial review. The list below is separated into three sections to assist you in understanding how the requirement will affect your IRB application and review process. The following committee approvals are required before the IRB may review a study: Committee Name Required For Contact Einstein Institutional Biosafety Committee (IBC) Any research involving the transfer of gene material, complementary DNA, full length genes, RNA, or oligonucleotides into humans Dr. D.Y. Goldstein 718.920.2149 Cancer Center Protocol Review and Monitoring Committee (PRMC) Any Montefiore Einstein research involving a primarily cancer patient population. Note: Studies receiving “expedited” review by the PRMC may be reviewed by the IRB prior to PRMC approval, but IRB approval will not be issued until after the PRMC approves. prmc@montefiore.org 718.379.6861 The following committee approvals are required before the IRB may issue an approval on a study: Committee Name Required For Contact Clinical Research Center Protocol Review Committee (CRC PRC) Any research utilizing the CRC facilities Elizabeth Catro 718.920.5126 Vishwa Niranjan 718.430.2763 Radiation Safety Committee (RSC) Any research involving radiation or radioisotopes beyond standard clinical care at Montefiore Einstein Manyu Chen 718.920.5012 Radiation Safety Committee (RSC) at Jacobi Any research involving radiation or radioisotopes beyond standard clinical care at Jacobi Lionel Zuckier 718.9187.4897 Hazardous Materials Committee Any research involving Acutely toxic materials (e.g., arsenic, cyanide), Neurotoxic materials (e.g., MPTP), Carcinogens (e.g., ENU, MNU, formaldehyde, azoxymethane), Mutagens/teratogens (e.g., BrdU), Heavy metals (e.g., mercury, cadmium, chromium, silver, lead), Other chemicals that may be toxic to target organs (e.g., streptozotocin, carbon tetrachloride), Chemotherapy agents (e.g., mitoxantrone, 5-FU), Waste anesthetic gases (e.g., isoflurane, halothane), Other regulated chemicals (e.g., EPA P-list or U-listed, OSHA toxic and hazardous substances), or if unsure email. ehs@montefiore.org 718.920.7600 Occupational Health Services at Montefiore COVID research involving Montefiore associates (or their data) as a target population Fran Ganz-Lord or Michaela Catalano ohs@montefiore.org The following committee approvals are required before the study may begin.: Committee Name Required For Contact Embryonic Stem Cell Research Oversight (ESCRO) Committee Any research on gametes and blastocysts, including human embryonic stem cell research (hESC). Please note that ESCRO review may lead to modifications of the research protocol. Melissa Epstein 718.430.2237 Magnetic Resonance Research Center (MRRC) Committee Any research involving the MRRC facility, prior to initiation the MRRC component of the study. Please note that MRRC review may lead to modifications of the research protocol. Luda Slobodskaya 718.430.3323 NBHN Research Protocol Working Group (RPWG) and HHC Any research involving HHC/NYMA/NBHN/JMC/NCB personnel, facilities, and/or resources. Howard Nadel 718.918.7070