Forms for Investigators and Research Teams

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.


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 (effective January 21, 2019) Revised 12/05/18
Consent/HIPAA Authorization for Full Board/Greater than Minimal Risk Studies Revised 03/16/2021
Consent/HIPAA Authorization for Expedited/Minimal Risk Studies Revised 09/06/2023
Consent/HIPAA Authorization for Biobanking Studies (studies that have no underlying research component) Revised 12/08/17
Assent (for enrollment of 7-12 year old participants) Revised 03/16/2021
Oral Consent Script (for survey studies ONLY, generally only permitted for telephone-based studies) Revised 06/20/2018
Consent/HIPAA Authorization for Exempt Studies Revised 03/16/2021
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.
Sample Study Schedule Posted12/01/2018
Sample Risk Table Posted 12/01/2018
Sample Study Flow Chart Posted 01/17/2019

Emergency Use Consent Templates

Document Download Link
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

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 Download Link
AE Log Revised 6/21/16
Deviation Log Revised 8/16/13
International Research Protocol Addendum Revised 4/17/2020
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
Protocol Elements Checklist Posted 12/27/2022


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

Document Download Link
Authorization Form - English Revised 11/05
Authorization Form - Spanish Revised 8/8/07
HIPAA Information Sheet - English Revised 7/9/03
HIPAA Information Sheet - Spanish Revised 7/9/03
Authorization for Publication of Case Report Revised 2/4/13
Spanish Authorization for Publication of Case Report Revised 2/4/13