Institutional Review Board

Forms

Applications | HIPAA | Informed Consent | Other Forms | Grants & Contracts | Emergency Use | Single IRB/Reliance Agreements 

 

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

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 
Standard HIPAA Data Use Agreement Revised 2003  
Authorization for Publication of Case Report Revised 2/4/13 

 

Consent

Document  Download Link
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 02/09/17 
iRIS Consent/HIPAA Authorization for Expedited/Minimal Risk Studies Revised 02/09/17 
iRIS Consent/HIPAA Authorization for Biobanking Studies (studies that have no underlying research component) Revised 04/11/16 
iRIS Assent (for enrollment of 7-12 year old participants) Revised 04/11/16 
iRIS Oral Consent Script (for survey studies ONLY, generally only permitted for telephone-based studies) Revised 04/11/16 
Glossary of Terms for use in Preparing Informed Consent Documents Posted 1/13 
Humanitarian Use Device (HUD) – Consent for Use in Clinical Care/Treatment (non-research use) Posted 04/11/16 
Short Forms (For enrolling unexpectedly encountered non-English speaking subjects.) Available upon request.
 See the Informed Consent Guidelines.
Epic language for Consent Documents approved prior to March 2015 See the Use of Epic in Research Guidlines  

 


Other Forms

Document  East Campus IRB
(formerly Einstein CCI)
 
West Campus IRB
(formerly Montefiore IRB)
 
Please note, the use of paper forms ended with the migration of "pre-iRIS" studies to iRIS.
Learn more about Migration and iRIS, the Einstein IRB's new paperless application system.
AE Log Revised 6/21/16 
Deviation Log Revised 8/16/13 
Amendment (For non-iRIS Exempt studies only) Revised 10/3/03  Revised 5/3/08 
Final Close-out (only for pre-iRIS studies that haven't had activity in iRIS)   Revised 11/14/14 
Office of Biotechnology Request for Approval of an Outgoing MTA Revised 5/16/2017  
Office of Biotechnology Request for Approval of an Incoming MTA or DUA Revised 9/19/11 
HHC STAR form (replaces the HHC-641)
First time users must register (follow link at right, then click "Register for an Account" (on left).
Effective 1/19/15 
HHC STAR Guidance (for questions, contact walter.vazquez@nbhn.net) Posted 5/6/15 
NBHN Research Revised 5/1/09 
NBHN Assurance Revised 10/22/09 

   

Grants & Contracts

Document  Revised
Grant Application (for uploading into Cayuse) 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 04/11/16 
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 04/11/16 
Final Report for the Emergency use of an Investigational Drug or Biologic 5/8/03 

   

Single IRB/Reliance Agreements

*If you are requesting that Einstein serve as the Lead IRB for more than one external site, please contact us prior to submitting your study in iRIS.* 

Questions about the use of a single IRB, SMART IRB, IRB Choice, or collaboration with individual investigators outside of Einstein/Montefiore? 

Email us at SingleIRB@einstein.yu.edu or call us at 718-430-2237 and ask to speak with someone about reliance agreements or the use of single IRBs. 

The Einstein IRB reviews requests to rely on external IRBs (including the SMART IRB and IRB Choice) on a protocol-specific, case-by-case basis, once those requests have been submitted to us in iRIS. We encourage researchers to contact the Einstein IRB as soon as possible (and prior to submitting grants) to discuss the feasibility and process for ceding arrangements between institutions. We also remind researchers to familiarize themselves with the reporting requirements of both Einstein/Montefiore and the external IRB, since PIs will usually need to provide information and ongoing reports to both institutions. 

Document  Revised 
Reliance Request Information Sheet
(Contains information regarding what must be submitted to the Einstein IRB, gives you a better sense of the process, and must be included with all ceding requests in iRIS.) 
5/15/17 
IRB Authorization Agreement 5/3/17 
Individual Investigator Agreement 5/30/17 
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