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. 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 (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 aline.baday@nychhc.org) Posted 5/6/15 Protocol Elements Checklist Posted 12/27/2022 HIPAA 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
