Office of Human Research Affairs

Forms

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

DOCUMENT	DOWNLOAD LINK
Key Information Section FAQ	1/16/2019
Key Information Template	12/01/2018
Key Information Samples	Comparative Effectiveness Study (12/01/2018)
	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 aline.baday@nychhc.org)	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 SingleIRB@einsteinmed.org 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.)	5/18/19
Individual Investigator Agreement	2/27/19