Forms & Templates
REQUIRED FOR ALL SUBMISSIONS:
- Registration Form. Please note: This is a sample form generated using the IRBNet Wizard and is provided for illustrative purposes only. Do not use this form for your submission. Instead, begin the Wizard from the Designer page in IRBNet when submitting your project to the IRB.
FORMS:
- 7B: Application for Ancillary Review of Unfunded Clinical Research
- 8-3: HIPAA Research Authorization
- 8-4: HIPAA Authorization for Psychotherapy Notes
- 8-5: Electronic Information Sheet with HIPAA Authorization for e-survey, e-interview, or e-focus group
- 8-6: Electronic Information Sheet (NO PHI / NO SIGNATURES) for e-survey, e-interview, or e-focus group
- 8-7: Information Sheet with HIPAA Authorization
- 8-8: Information Sheet (NO PHI / NO SIGNATURES)
- 8-12: SUNY RF Payment Consent
- 8-13: Assent Form (for age 7-12 years)
- 8-14: Subject Recruitment Authorization - Internal Authorization for Recruitment Contact
- 8-15: Subject Recruitment Authorization - Internal Verbal Authorization for Recruitment Contact
- 8-16: Subject Recruitment Authorization - External Authorization for Recruitment Contact
- 8-17: NYS Medical Release Form
- 8-18: HIPAA Waiver
- 8-19: Waiver of Informed Consent Requirements
- 8-20: HIPAA Authorization Form
- 8-21: Authorization for Release of Health Information to News Media and to the General Public (Media HIPAA Authorization Form)
- 11-A1: Application for Exempt Review
- 11-A1B: Application for Exempt Review - DOJ/DIJ Funded Research Only
- 11-A2: Application for Expedited or Full Review
- 11-A3: Application for External IRB Oversight
- 11-A4Guidance (How to successfully submit and get approval for Form 11-A4: Application for Determination Letter (IRB Decision Aid) for "Not Research, Not Human Research, or Institution Not Engaged in Human Research"
- 11-A4: Application for Determination Letter (IRB Decision Aid) for "Not Research, Not Human Research, or Institution Not Engaged"
- 11-A4Q: Application for an IRB Determination of "NOT Research" or "NOT Human Research" for a Quality Improvement, Quality Assurance, Performance Improvement, or Evidence Based Practice Activity
- 11-A5: Application for Expanded Access to Investigational Drug/Biologic for Treatment Use
- 11-A6: Application for HUD for Clinical Purposes
- 11-A7: Application for Independent Honest Broker Assurance Agreement
- 11-8: Exclusion of Pregnant People and/or Plans to Study Outcomes of Unexpected Pregnancies
- 11-9: Research involving Pregnant People and/or Fetuses
- 11-10: Application For Downstate Workforce Activation of Exempt Research or IRB Determinations (Not Research, Not Human Research, or Downstate Not Engaged) Approved by an (External) Reviewing IRB
- 13.2 Scientific Review Committee (SRC) Review Form
- 20-B1: Application for Acknowledgment
- 20-B2A: Application for Amendment
- 20-B2B: Application for Amendment - STAFF CHANGES ONLY
- 20-B3: Application Form for Reportable Event
- 20-B4: Application for Continuing Review/Check-In/Study Closure/Re-Activation
- 21-1: Quality Assessment Form
- 21-2: Corrective & Preventative Action Plan (CAPA) Form
- BAA Template Form
- Business Associate Agreements (BAA) Policy (HIPAA-3)
- Research Budget Form
- CMRC Review Request Form
- CMRC Reviewer and Certification Form
- Delegation of e-Signature Form
- FDA Form 1572
- HIPAA Preparatory to Research Certification Form
- Individual Investigator Agreement Form (IIA)
- IRB Reliance Agreement (IRA): Send request to: Executive Director, Human Research Protections and Quality Assurance
- IRS Form W-9
- IRS Form W-8BEN
- UHD Pathology Instructions, Forms, and Fees are posted on the UHD Pathology Research Services web site
- Research Subject Recruitment Authorization Forms
- Short Forms and Translation Certificates (see below)
- Form 13.2 Scientific Review Committee (SRC) Review Form
- Voluntary Researcher Request Form
- WCG IRB Forms
- WCG Single IRB Quote Request Form
Short Forms and Translation Certificates:
Note: Use the Short Form versions immediately below for research that must comply with the 2018 version of the Common Rule (e.g., research consents which contain a "Key Information" section)
- Short Form (Arabic)
- Short Form (Simplified Chinese)
- Short Form (Traditional Chinese)
- Short Form (English)
- Short Form (Haitian Creole)
- Short Form (Russian)
- Short Form (Spanish)
Note: Below are the translation certificates for the short forms immediately above this section. These do not need to be submitted to the IRB, but are here to be saved to the research record or to be shared with a sponsor.
- Translation Certificate for Short Form (Arabic)
- Translation Certificate for Short Form (Simplified Chinese)
- Translation Certificate for Short Form (Traditional Chinese)
- Translation Certificate for Short Form (Haitian Creole)
- Translation Certificate for Short Form (Russian)
- Translation Certificate for Short Form (Spanish)
Note: Use the versions immediately below for research previously approved research grandfathered under the pre-2018 Common Rule (e.g,. initially approved prior to January 21, 2019 or for newer research which is not subject to the Common Rule (e.g., FDA or HIPAA regulated research that is not Federally funded that use research consent forms that do not require the "key information" section.)
- Short Form (Arabic)
- Short Form (Simplified Chinese)
- Short Form (Traditional Chinese)
- Short Form (English)
- Short Form (Haitian Creole)
- Short Form (Russian)
- Short Form (Spanish)
Note: Below are the translation certificates for the short forms immediately above this section. These do not need to be submitted to the IRB, but are here to be saved to the research record or to be shared with a sponsor.
- Translation Certificate for Short Form (Arabic)
- Translation Certificate for Short Form (Simplified Chinese)
- Translation Certificate for Short Form (Traditional Chinese)
- Translation Certificate for Short Form (Haitian Creole)
- Translation Certificate for Short Form (Russian)
- Translation Certificate for Short Form (Spanish)
TEMPLATES:
- 8-1: Simple Version Informed Consent Template
- 8-2: All-In-One Version Informed Consent Template
- 8-3: HIPAA Research Authorization Template
- 8-9: Pregnancy Follow-Up Consent Template
- 8-12: SUNY RF Payment Consent
- Data Use Agreement (DUA) Template
- Downstate Protocol Template (for Downstate Investigator-Initiated research that involves a clinical intervention
- Downstate Protocol Template (Shell Only) - use for non clinical intervention and exempt research
- Downstate Protocol Template (With Guidance)- use for non clinical intervention and exempt research.
- Electronic Information Sheet (NO PHI / NO SIGNATURES) for e-survey, e-interview, or e-focus group
- Electronic Information Sheet with HIPAA Authorization for e-survey, e-interview, or e-focus group
- HIPAA Authorization for Psychotherapy Notes
- Information Sheet (NO PHI / NO SIGNATURES)
- Information Sheet with HIPAA Authorization
- Informed Consent Template (All-In-One Version)
- Informed Consent Template (Pregnancy Follow-Up)
- Informed Consent Template (Simple Version)
- NIH Behavioral and Social Clinical Trials Template
- NIH Electronic Protocol Writing Tool
- NIH/FDA Phase 2 or 3 Clinical Trial Protocol template with guidance
- Quality Assessment Program -Template Letters to PI
- Research budget template