Office of Human Research Affairs

Administrative Approvals for IRB Applications

A protocol cannot be approved by the Einstein IRB unless the appropriate administrative approvals are provided. Use the list below to determine the appropriate signatures required on the Signature Page of the application.

The Department Chairperson is responsible for the first level of review of research proposals. Only the Chairperson or a designee specifically appointed by the Chairperson may sign in his/her absence. The Chairperson must inform the Einstein IRB, in writing, of the designee.

See below for required committee approvals and the list of people authorized to sign applications.

Position Title	Signature Required For
Principal Investigator	All applications
PI’s Department Chairperson	All applications
Division Chief	Department of Medicine studies
Division Director	Jacobi Surgery studies
Department Chairperson	Each department involved in the work outlined in the protocol when the test/procedure is beyond standard clinical care and is performed only for research purposes
Medicine Chief of Service	All research involving Medicine In-patients at MMC (Weiler or Moses)
Director of Nursing at MMC	MMC Oncology protocols that involve the nursing staff Nursing students conducting nursing research
Chairman of Radiology	Tests/procedures that are beyond standard clinical care and involve resources of the department of Radiology
Montefiore: Chairman of Radiology NBHN: Chairman of Nuclear Medicine	Tests/procedures that are beyond standard clinical care and involve resources of the department of Nuclear Medicine
Chairman of Radiology	MRI’s that are beyond standard clinical care
Pharmacy Director	All research involving drugs, whether approved or investigational
Chairman of Pathology	Any research protocol in which: Tests/procedures are performed that are beyond standard clinical care and involve resources of the clinical Laboratory. Resources of the Pathology department will be utilized. Tissue specimens for research will be obtained as part of a clinical procedure performed for the purpose of diagnosis or treatment. Specimens obtained for research purposes must come from specific tissue (i.e. it is important that there be histological confirmation that the correct tissue has been obtained). NOTE: Research protocols in which samples of presumably normal tissue will be analyzed only for their chemical content (e.g. drug levels, biomarkers, etc), but there is no need for histological confirmation of tissue type, do not require prior review by Pathology before submission to the IRB. When a PI selects this option, the IRB reviewer must concur with the decision that histological confirmation is not required.
Director, Clinical Pathology	Any research protocol in which body fluid samples are obtained from the Clinical Pathology Lab
Director, hFTR	All studies involving material from the Einstein hFTR.
Director, Catheterization Laboratory	All studies involving catheterizations at Weiler
Director, Diabetes Research and Training Center	All research being funded by the DRTC Grant
Director, Sound View Throggs Neck (SVTN)	All research taking place at SVTN
Executive Director, Division of Substance Abuse (DOSA)	All research involving the DOSA facilities or population
Chairman, Emergency Medicine	Any research originating in the Emergency Department
Director, Clinical Research Center (CRC)	All research involving drugs, whether approved or investigational, that will be stored in the CRC
Administration, Burke Hospital	Burke Hospital as a research site or department for the PI
YU Schools
Dean, Yeshiva College	All research involving Yeshiva College students or faculty
Dean, Stern College	All research involving Stern College students or faculty
Director, Syms School of Business	All research involving Syms School of Business students or faculty
Provost	All YU Research
Dean, Azrieli	All research involving Azrieli students or faculty
Dean, Ferkauf	All research involving Ferkauf students or faculty
Ferkauf IRB Representative	All research involving Ferkauf students or faculty
Dean, Wurzweiler	All research involving Wurzweiler students or faculty
Director, Doctoral Program, Wurzweiler	All research involving Wurzweiler students
Dean, Katz	All research involving Katz students or faculty
Dean for Students, Einstein	Any research involving Einstein medical students as key personnel
Dean for Students, Einstein	Any research targeting Einstein medical students as research subjects

Required Committee Approvals: 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.)	Rutvi Patel (718-379-6861)

Required Committee Approvals: 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 Castro (718-920-5126) or Vishwa Niranjan (718-430-2763)
Radiation Safety Committee (RSC)	Any research involving Radiation or Radioisotopes beyond standard clinical care at Einstein/Montefiore.	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 (718-918-4897)
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.	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

Required Committee Approvals: 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)	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)