Office of Human Research Affairs


Applications | HIPAA | Informed Consent | Key Information | Other FormsEmergency 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. 


Please note, the use of paper application forms has been phased out. Learn more about iRIS, the Einstein IRB's new paperless application system.




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  
Spanish Authorization for Publication of Case Report Revised 2/4/13 
Authorization for Publication of Case Report Revised 2/4/13 



Document  Download Link
Sample Recruitment Letter Revised 6/19/03  
Informed Consent Note Revised 11/16/05 
Summary of Consent Document Changes for 2018 Final Rule (now effective January 21, 2019) Revised 12/05/18 
iRIS Consent/HIPAA Authorization for Full Board/Greater than Minimal Risk Studies Revised 12/05/2018  
iRIS Consent/HIPAA Authorization for Expedited/Minimal Risk Studies Revised 12/05/2018 
iRIS Consent/HIPAA Authorization for Biobanking Studies (studies that have no underlying research component) Revised 12/08/17 
iRIS Assent (for enrollment of 7-12 year old participants) Revised 12/08/17 
iRIS Oral Consent Script (for survey studies ONLY, generally only permitted for telephone-based studies) Revised 06/20/2018 
iRIS Consent/HIPAA Authorization for Exempt Studies Posted 06/20/2018 
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 06/20/2018 
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  
Sample Study Schedule      Posted12/01/2018 
Sample Risk Table Posted 12/01/2018 
Sample Study Flow Chart Posted 01/17/2019 


Key Information Section for Consent Documents

Key Information Section FAQ 1/16/2019  
Key Information Template 12/01/2018 
Key Information Samples
 Placebo-Controlled Trial (12/01/2018) 
 Healthy Volunteer (12/01/2018) 
 Biobank (12/01/2018) 
 Nonmedical Research - Video Game (12/01/2018) 
 Nonmedical Research – Relaxation & Academic Outcomes (12/01/2018)   


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 
International Research Protocol Addendum Revised 4/17/2020 
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 
Radiation Exposure Form Revised 5/1/2018 
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 Posted 5/6/15 
NBHN Research Revised 5/1/09 
NBHN Assurance Revised 10/22/09 


Emergency Use Consent Templates

Document  Revised 
ICD Template for Emergency Use of an Investigational Device 04/11/16 
ICD Template for Emergency Use of an Investigational Drug or Biologic 04/11/16 


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 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 Form
(Contains information regarding what must be submitted to the Einstein IRB, gives you a better sense of the process, and must be completed as a first step in any IRB reliance arrangement.)   
Individual Investigator Agreement  2/27/19  
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