Research

IRB Forms and Guidelines

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
 

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

IRB Submission Requirements (last updated 11/4/2016)
IRB Submission Tips (last update 11/4/2016)
Template for Patient Recruitment Letter and Telephone script
Form 5a - Research Proposal for Conducting Registry Research (last updated 8/14/13)
Form 5A.1 - Foot & Ankle Steering Committee Applicants ONLY
Form 5A.2 - ARJR Registry Research Request Form
Form 10 - Research Informed Consent (last updated 2/14/13)
Form 10a - Genetics Informed Consent (last updated 9/28/16)
Form 10b - Assent for Adolescents (last updated 7/11/16)
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 2/23/16)
Form 10d - Short Form, Informed Consent French (last updated 2/23/16)
Form 10d - Certification of  Russian Translation (last updated 10/18/05)
Form 10e - Registry Informed Consent Form (last updated 3/7/12)
Form 11 - Compassionate Use Checklist (last updated 11/22/16)
Form 12 - Compassionate Use Consent Template (last updated 10/28/2016)
Form 13 - Emergency Use Checklist (last updated 9/2/05)
Form 14 - Clinical Trial Directory Form (last updated 6/07/10)
 

Investigator Financial 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