IRB Forms

	Form	Guidance
Scientific Protocol
	Scientific Protocol Template (Word Document)
	Community-Engaged Research Protocol Addendum	Guidance 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
	Waiver of Signed Consent (ERMA Only)
	Waiver of Consent (ERMA Only)
HIPAA
	HIPAA Authorization (eIRB) HIPAA Authorization (ERMA Only)
	HIPAA Waiver of Authorization (ERMA Only)
	HIPAA De-Identification Form (ERMA Only)
Attachments (for eIRB and ERMA)
	Off-Campus Study Site	MUSC 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 Application	MUSC Guidance HRPP Section 3.4
	IRB Reviewer Checklist for Expedited Initial Application	MUSC Guidance HRPP Section 3.3
	IRB Reviewer Checklist for Continuing Review Full Board and Expedited Protocols	MUSC Guidance HRPP Section 3.3 MUSC Guidance HRPP Section 3.5
	IRB Reviewer Checklist Informed Consent	MUSC Guidance HRPP Section 6.1 MUSC Guidance HRPP Section 6.2
	Special Subject Populations Checklist - Children	MUSC Guidance HRPP Section 8.1 MUSC Guidance HRPP Section 8.5
	Special Subject Populations Checklist - Cognitively Impaired or Persons Unable to Consent	MUSC Guidance HRPP Section 8.1 MUSC Guidance HRPP Section 8.2
	Special Subject Populations Checklist - Pregnant Women, Fetuses, Neonates	MUSC Guidance HRPP Section 8.1 MUSC Guidance HRPP Section 8.4
	Special Subject Populations Checklist - Prisoners	MUSC 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

Office of Research Integrity

Institutional Review Board for Human Research

IRB Forms

Form

Guidance

Scientific Protocol

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

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

Informed Consent

HIPAA

Attachments (for eIRB and ERMA)

eIRB Watermarks

Attachments (for ERMA)

IRB Reviewer Checklists

IRB Reviewer Checklist Addenda

Veterans Administration Forms