Study Documents

Applications (New and Continuing Renewals)
Application for New Submission
Request to Rely on External IRB Form
Continuing Renewal Study Ceded to an External IRB Application
Continuing Renewal Application – LBH IRB
Humanitarian Use Device (HUD) Application
HUD Renewal Application
Application for Exempt Research or QI
Application for Expanded Access

Helpful Checklists for Study Submissions
New Submission Checklist
Continuing Renewal Submission Checklist  
Amendment Submission Checklist

Informed Consent/Assent Form Templates
Informed Consent Form Template
Assent Form for Children 7 to 10 Years of Age Template
Assent Form for Children 11 to 17 Years of Age Template
Subject Short Consent Form Template
Informed Consent/Parental Permission Form Template 

Humanitarian Use Device (HUD) Forms
Humanitarian Use Device (HUD) Application
HUD Renewal Application
Humanitarian Device Consent and Privacy Authorization Form

Waiver of Disclosure for Use of Protected Health Information (PHI) in a Research Study
HIPAA Authorization Form- Investigator Sponsored Research
HIPAA Authorization Form- Outside Sponsored Research

Annual Reporting Forms
Significant Interest Disclosure Questionnaire
SAE & SRs Annual Report

Additional Forms
Delegation of Responsibility Form
Human Gene Transfer/Recombinant DNA Research Form
Unanticipated Problem/Adverse Event Form
Informed Consent Exception Request
Translation Certification Form
Medicare Coverage Analysis
Noncompliance Report Form
Disclosure - Use of De-Identified Data - Materials for Research