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 has been phased out. Learn more about iRIS, the Einstein IRB's new paperless application system.

 

HIPAA

Note: The iRIS consent form templates include HIPAA language (so separate HIPAA Authorization forms are not needed for studies using consents prepared from the iRIS templates).

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  Download Link
Child Assent (for 7-12 year old participants) Revised 5/04 
Sample Recruitment Letter Revised 6/19/03  
Informed Consent Note Revised 11/16/05 
iRIS Consent/HIPAA Authorization for Full Board/Greater than Minimal Risk Studies Revised 11/20/13 
iRIS Consent/HIPAA Authorization for Expedited/Minimal Risk Studies Revised 11/20/13 
Glossary of Terms for use in Preparing Informed Consent Documents Posted 1/13 
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)
 
Conflict of Interest (COI) Disclosure Form Revised 8/5/13 
Patient Information Confidentiality Agreement (PICA) Revised 10/1/08 
Reportable Event Form* Revised 8/16/13 
Reportable Event Follow-Up Report* Revised 8/16/13 
Protocol Exception Request Form* Revised 8/16/13 
AE Log Revised 8/16/13 
Deviation Log Revised 8/16/13 
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)
Progress Report* Use PATS only
(for approved exceptions: Revised 9/3/03)
Revised 10/1/08 
Final Close-out* Use PATS Progress Report Form only Revised 10/9/13 
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 (Note: form can now be saved with data)
NBHN Research Revised 5/1/09 
NBHN Assurance Revised 10/22/09 

*For non-iRIS studies only. (For iRIS studies, use the forms in iRIS.)

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 
Click here to log in