Institutional Review Board

Forms

Applications | HIPAA | Informed Consent | Other Forms | Grants & Contracts | Emergency Use 

 

NOTE: The forms below are being updated on an ongoing basis. In the meantime, references to "Committee on Clinical Investigations," "CCI," or "MMC IRB" refer to the Einstein IRB. New and recently revised forms have "Revision" dates highlighted in yellow. 

Applications

Document  East Campus IRB
(formerly Einstein CCI) 		 West Campus IRB
(formerly Montefiore IRB) 
Please note, the use of paper application forms is being phased out. Learn more about iRIS, the Einstein IRB's new paperless application system.
Exempt Application Use iRIS only
Expedited Application Use iRIS only
Full Review Application Use PATS only
See below for additional
Addenda & Checklist
See below for additional
Addenda & Checklist
Full Review Checklist Revised 7/20/12   Revised 7/20/12 
Full Review Application Addenda  East Campus IRB
(formerly Einstein CCI) 		 West Campus IRB
(formerly Montefiore IRB) 
  - Biohazard/Gene Transfer Revised 12/17/11 
  - COI Disclosure Use PATS printout or
Revised 3/25/02 		 Revised 5/3/08 
  - Drug/Device Use PATS only Revised 5/21/10 
  - Drug Storage Waiver Use PATS only Revised 10/1/08 
  - Human Specimens Use PATS only Revised 5/24/10 
  - IND Exemption Request Revised 10/26/11 
  - Investigational Device Use PATS only Revised 5/21/10 
  - Ionizing Radiation/Isotopes Use PATS only Revised 9/25/08 
  - Ionizing Radiation Exposure Form Revised 5/11/09 
  - Nursing Revised 4/14/06 
  - OCT New Study Activation Revised 9/30/11 
  - Patient Information Confidentiality Agreement Revised 10/1/08 
  - Placebo   Revised 6/17/02 

 

Copies of Individual Application Sections

Document  East Campus IRB
(formerly Einstein CCI) 		 West Campus IRB
(formerly Montefiore IRB) 
Approvals Page Use PATS printout Revised 2/6/07 
PI Assurances Use PATS printout or Revised 12/19/05   Revised 2/6/07 

 

HIPAA

Document  East Campus IRB
(formerly Einstein CCI) 		 West Campus IRB
(formerly Montefiore IRB) 
Authorization Form - English Use PATS printout or Revised 11/05  Revised 11/05 
Authorization Form - Spanish Use PATS printout or Revised 11/05  Revised 8/8/07 
HIPAA Information Sheet - English Revised 7/9/03 
HIPAA Information Sheet - Spanish Revised 7/9/03 
Request for Waiver/Alteration or Exemption from HIPAA Authorization and Informed Consent Use PATS only Revised 10/12/04  
Standard HIPAA Data Use Agreement Revised 2003  
Authorization for Publication of Case Report Revised 2/4/13 

 

Consent

Document  East Campus IRB
(formerly Einstein CCI) 		 West Campus IRB
(formerly Montefiore IRB) 
Adult (for 18+ participants) Use PATS only Revised 7/22/08 
Adult/Parent/Teen (for adults, parents, and 13-17 year old participants) Revised 12/20/08 
Child Assent (for 7-12 year old participants) Revised 5/04 
Sample Oral Consent Script Revised 4/23/07 
Sample Recruitment Letter Revised 6/19/03  
Informed Consent Note Revised 11/16/05 
Short Forms (For enrolling unexpectedly encountered non-English speaking subjects.) Available upon request.
 See the Informed Consent Guidelines.

 

Other Forms

Document  East Campus IRB
(formerly Einstein CCI) 		 West Campus IRB
(formerly Montefiore IRB) 
Advertisement Revised 10/30/07  Revised 6/23/10 
ResearchMatch Posting Revised 12/2/11 
Amendment Use PATS only
(for approved exceptions: Revised 10/3/03)		 Revised 5/3/08 
Amendment
(Exempt studies)		 Under development
(use the forms above in the interim)
Protocol Deviation Revised 7/19/12 
Adverse Event/Reportable Event Use PATS only Revised 11/19/10 
Progress Report Use PATS only
(for approved exceptions: Revised 9/3/03)		 Revised 10/1/08 
Final Close-out Use PATS only Revised 8/2/07 
Office of Biotechnology Request for Approval of an Outgoing MTA Revised 7/27/07   
Office of Biotechnology Request for Approval of an Incoming MTA or DUA Revised 9/19/11   
HHC-641 Revised 5/03 
NBHN Research Revised 5/1/09 
NBHN Assurance Revised 10/22/09 

 

Grants & Contracts

Document  East Campus IRB
(formerly Einstein CCI) 		 West Campus IRB
(formerly Montefiore IRB) 
Grant Application (for uploading into Cayuse) Revised 3/13/13   

 

Emergency Use - Device

Document  Revised 
Request for Emergency Use of an Investigational Device 5/8/03 
ICD Template for Emergency Use of an Investigational Device 5/8/03 
Final Report for the Emergency Use of an Investigational Device 5/8/03 

 

Emergency Use - Drug/Biologic

Document  Revised 
Request for Emergency Use of an Investigational Drug or Biologic 5/8/03 
ICD Template for Emergency Use of an Investigational Drug or Biologic 5/8/03 
Final Report for the Emergency use of an Investigational Drug or Biologic 5/8/03 
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