Research

IRB Forms and Guidelines

Guidelines for IRB Submission

Guidelines for IRB Submission
Guidelines for Requesting Registry Data for Research Proposals
Flow Diagram for Review of Clinical Research
Guidelines for Randomized Controlled Trials
Guidelines for Observational Studies
IRB Submission Tips

HIPAA Compliance Research Forms

Determining HIPAA Waiver Requirements
Request for Waiver of HIPAA Authorization
HIPAA Research Authorization Form
Request for Waiver/Alteration of Informed Consent
Request for Reviews Preparatory for Research
Oral HIPAA Authorization Script

IRB Forms

Form 1 - Initial Application (last updated 6/24/14)
Form 1A - Instructions for Form 1 (last updated 2/03/09)
Form 2 - Request for Exemption (last updated 8/6/13)
Form 4 - Retrospective Chart Review for Clinical Research (Last update 5/17/2013)       
Form 5 - Registry Proposal (last updated 6/24/14)
Form 5a - Research Proposal for Conducting Registry Research (last updated 8/14/13)
Form 6 - INTERNAL Human Subjects Adverse Event Report Cover Sheet (last updated 2/3/06)
Form 6a - EXTERNAL Safety Report Submission Cover Sheet (last updated 5/16/06)
Form 7 - Continuing Review Application (last updated 4/7/14)
Form 8 - Internal Use
Form 9 - Internal Use
Form 10 - Research Informed Consent (last updated 2/14/13)
Form 10a - Genetics Informed Consent (last updated 3/7/12)
Form 10b - Assent for Adolescents (last updated 9/25/07)
Form 10c - Anonymous/Confidential Survey Consent Script (last updated 10/18/05)
Form 10d - Short Form, Informed Consent (last updated 10/18/05)
Form 10d - Short Form, Informed Consent Spanish (last updated 10/18/05)
Form 10d - Short Form, Informed Consent Simplified Chinese (last updated 10/18/05)
Form 10d - Short Form, Informed Consent Russian (last updated 10/18/05)
Form 10d - Short Form, Informed Consent French (last updated 11/29/11)
Form 10d - Certification of  Russian Translation (last updated 10/18/05)
Form 10e - Registry Informed Consent Form (last updated 3/24/10)
Form 11 - Compassionate Use Checklist (last updated 8/15/05)
Form 12 - Emergency Use Checklist (last updated 9/2/05)
Form 13 - Clinical Trial Directory Form (last updated 6/07/10)
Protocol Deviation Form (last updated 12/19/05)

Investigator Finanical Interest Disclosure Guidelines & Form

Financial Interest Disclosure Form

Risks Language for Imaging

Risks Language for Imaging

Check List for Elements of Informed Consent

Check List for Elements of Informed Consent

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