> Skip repeated content

HSS Research Institute

IRB Forms and Guidelines

Guidelines for IRB Submission

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

HIPAA Compliance Research Forms

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

 

IRB Forms

IRB Submission Requirements (last updated 2/8/18)
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 - Observational Study Informed Consent (last updated 11/13/20)
Form 10a - Interventional or Genetics Informed Consent (last updated11/13/20)
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 9/7/18)
Form 11 - Compassionate Use Checklist (last updated 4/3/18)
Form 12 - Compassionate Use Consent Template (last updated 11/14/2020)
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