Office of Research Integrity

IRB Forms

Form

Guidance

Scientific Protocol

 Scientific Protocol Template (Word Document) 
Expedited Retrospective Review Protocol (Word Document)Gudance for Expedited Review - Retrospective Studies
 Community-Engaged Research Protocol AddendumGuidance for Community-Engaged Research

Application Initial Submission Guidance - click Submission Process for Links to On-Line Application

 
Not Human Research Application
MUSC Guidance HRPP Section 3.1
 
Exempt Application
MUSC Guidance HRPP Section 3.2
 
Expedited Application
MUSC Guidance HRPP Section 3.3
 
Full Board Application
MUSC Guidance HRPP Section 3.4

Approved Protocols Guidance - click Submission Process for Links to On-Line Application

 
Continuing Review
MUSC Guidance HRPP Section 3.5
 
Amendment
MUSC Guidance HRPP Section 3.6
 
Protocol Deviation
MUSC Guidance HRPP Section 4.14
 
Adverse Event
MUSC Guidance HRPP Section 4.7

Informed Consent

 

Informed Consent Template (eIRB)
Standard Informed Consent Guide

MUSC Guidance HRPP Section 6.1
MUSC Guidance HRPP Section 6.2
 Guidelines for Research Involving DNA 
 Guidelines and Consent for Tissue Collection - Autopsy pdf 
 Waiver of Signed Consent (ERMA Only) pdf word 
 Waiver of Consent (ERMA Only)pdf word 

HIPAA

 HIPAA Authorization (eIRB)
HIPAA Authorization (ERMA Only)
 
 HIPAA Waiver of Authorization (ERMA Only) 
 HIPAA De-Identification Form (ERMA Only) 

PRIVACY NOTICE

Notice of Privacy Practices (English)
Notice of Privacy Practices (Spanish)

Attachments (for eIRB and ERMA)

 Off-Campus Study SiteMUSC Guidance HRPP Section 9.1
MUSC Guidance HRPP Section 9.2
 VA Addendum to MUSC IRB Continuing Review Application 

eIRB Watermarks

Instructions for use of Watermark
(Word Documents Only)
 for Informed Consent Documents
 for All Other Documents

Attachments (for ERMA)

 Human Research Conflict of Interest Disclosure MUSC Guidance HRPP Section 1.6
 Cover Page for Updated Investigator Brochure  
 Investigational New Drug (IND) Information Sheet (Drug A) MUSC Guidance HRPP Section 4.1
MUSC Guidance HRPP Section 4.2
 Late Submission Approval (IRB I and II Only)  
 Marketed Drug(s) Only Information Sheet (Drug B)MUSC Guidance HRPP Section 4.1
MUSC Guidance HRPP Section 4.2
 Medical device (IDE) Information Sheet (Drug D) MUSC Guidance HRPP Section 4.3
MUSC Guidance HRPP Section 4.4
 Oncology Group NCI Protocol Only Drug Information Sheet (Drug C) MUSC Guidance HRPP Section 4.1
MUSC Guidance HRPP Section 4.2
 PI Statement of Assurance/Signature Page MUSC Guidance HRPP Section 5.1
MUSC Guidance HRPP Section 5.2
MUSC Guidance HRPP Section 5.3
 Protocol Deviation Report Form MUSC Guidance HRPP Section 4.14
 Request for Expedited Review MUSC Guidance HRPP Section 3.3

IRB Reviewer Checklists

 IRB Reviewer Checklist for Full Board Initial ApplicationMUSC Guidance HRPP Section 3.4
 IRB Reviewer Checklist for Expedited Initial ApplicationMUSC Guidance HRPP Section 3.3
 IRB Reviewer Checklist for Continuing Review Full Board and Expedited ProtocolsMUSC Guidance HRPP Section 3.3
MUSC Guidance HRPP Section 3.5
 IRB Reviewer Checklist Informed ConsentMUSC Guidance HRPP Section 6.1
MUSC Guidance HRPP Section 6.2
MUSC Guidance HRPP Section 6.3
 Special Subject Populations Checklist - ChildrenMUSC Guidance HRPP Section 8.1
MUSC Guidance HRPP Section 8.5
 Special Subject Populations Checklist - Cognitively Impaired or Persons Unable to ConsentMUSC Guidance HRPP Section 8.1
MUSC Guidance HRPP Section 8.2
 Special Subject Populations Checklist - Pregnant Women, Fetuses, NeonatesMUSC Guidance HRPP Section 8.1
MUSC Guidance HRPP Section 8.4
 Special Subject Populations Checklist - PrisonersMUSC Guidance HRPP Section 8.1
MUSC Guidance HRPP Section 8.3

IRB Reviewer Checklist Addenda

 IRB Reviewer Checklist - Department of Defense Addendum (DoD) 
 IRB Reviewer Checklist - Department of Education Addendum 
 IRB Reviewer Checklist - Department of Energy Addendum (DoE) 
 IRB Reviewer Checklist - Department of Justice Addendum (DoJ) 
 IRB Reviewer Checklist - Environmental Protection Agency (EPA) 

Veterans Administration Forms