access intranet after hours circle-arrow apply blog caret circle arrow close closer look community outreach community outreach contact contact us down arrow facebook lock solid find a provider find a clinical trial find a provider find a researcher find faculty find-a-service how to apply join leadership left arrow locations logo make a gift map location maximize minimize my chart my chart notification hp notification lp next chevron right nxt prev pay your bill play previous quality and safety refer a patient request a speaker request appointment request an appointment residents corner rss search search jobs Asset 65 submit a story idea symptom checker Arrow Circle Up twitter youtube Dino Logo External Link University Logo Color University Logo Solid Health Logo Solid Arrow Right Circle Book Calendar Date Calendar Search Date Diploma Certificate Dollar Circle Donate Envelope Graduation Cap Map Pin Map Search Phone Pills Podcast

Forms & Guidance

ORI

Scientific Protocol

Forms

Scientific Protocol Template (DOCX)

Expedited Retrospective Review Protocol (DOC)

Community-Engaged Research Protocol Addendum (DOC)

Guidance

Guidance for Expedited Review - Retrospective Studies (PDF)

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 (PDF)

Exempt Application: MUSC Guidance HRPP Section 3.2 (PDF)

Expedited Application: MUSC Guidance HRPP Section 3.3 (PDF)

Full Board Application: MUSC Guidance HRPP Section 3.4 (PDF)

Continuing Review: MUSC Guidance HRPP Section 3.5 (PDF)

Approved Protocols Guidance

Click Submission Process for Links to On-Line Application

Amendment: MUSC Guidance HRPP Section 3.6 (PDF)

Protocol Deviation: MUSC Guidance HRPP Section 4.14 (PDF)

Adverse Event: MUSC Guidance HRPP Section 4.7 (PDF)

Informed Consent

Forms

Informed Content Template with HIPAA (eIRB) (DOCX) - New 05/01/2018

Informed Consent Template (eIRB) (DOCX) -  Revised 05/01/2018

Informed Consent Template (ERMA) (DOCX)

Concise Summary Examples (DOCX) - New 01/02/2018

Suggested Consent Language Library

Short Form Consent Template: English (DOC), Spanish (DOCX)

Short Form Addendum for Sub-Studies Template (Spanish Version) (DOCX)

Signature Page for use with Long Form Template (Spanish Version) (DOCX)

Waiver of Signed Consent (ERMA Only) (PDF)

Waiver of Consent (ERMA Only) (PDF)

Guidance

MUSC Guidance HRPP Section 6.1 (PDF)

MUSC Guidance HRPP Section 6.2 (PDF)

Electronic Consent Guidance (DOCX) - New 05/01/2018

MUSC Guidance HRPP Section 7.5 (PDF)

Guidance for Short Form Consent (PDF)

HIPPA

Forms

HIPAA Authorization (eIRB) (DOC)

HIPAA Authorization (eIRB) - Spanish (DOCX)

HIPAA Authorization (eIRB) - Optional Research Version (DOC)

HIPAA Authorization (eIRB) - Optional Research Version - Spanish (DOCX)

HIPAA Authorization (ERMA Only) (DOC)

HIPAA Authorization (ERMA Only) - Optional Research Version (DOC)

HIPAA Waiver of Authorization (ERMA Only) (DOC)

HIPAA De-Identification Form (ERMA Only) (DOC)

Privacy Notice

Forms

Notice of Privacy Practices (English) (PDF)

Notice of Privacy Practices (Spanish) (PDF)

Standard Paragraphs

Child and Adult FDA Regulated HIPAA (DOC)

Child and Adult Not FDA Regulated HIPAA (DOC)

Child and Adult Not FDA Regulated (DOC)

Child FDA Regulated HIPAA (DOC)

Child FDA Regulated (DOC)

Child Not FDA Regulated HIPAA (DOC)

Child Not FDA Regulated (DOC)

FDA Regulated HIPAA (DOC)

FDA Regulated (DOC)

Not FDA Regulated HIPAA (DOC)

Not FDA Regulated (DOC)

Attachments (for eIRB & ERMA)

Forms

Off-Campus Study Site (DOC)

VA Addendum to MUSC IRB Continuing Review Application (DOC)

Guidance

MUSC Guidance HRPP Section 9.1 (PDF)

MUSC Guidance HRPP Section 9.2 (PDF)

eIRB Watermark

Forms

MUSC Watermark for All Documents (DOC)

Guidance

Instructions for use of Watermark (DOC)

Attachments (for ERMA)

Forms

Human Research Conflict of Interest Disclosure (DOC)

Cover Page for Updated Investigator Brochure (DOC)

Investigational New Drug (IND) Information Sheet (Drug A) (DOC)

Late Submission Approval (IRB I and II Only) (DOC)

Marketed Drug(s) Only Information Sheet (Drug B) (DOC)

Oncology Group NCI Protocol Only Drug Information Sheet (Drug C) (DOC)

Medical device (IDE) Information Sheet (Drug D) (DOC)

PI Statement of Assurance/Signature Page (DOC)

Protocol Deviation Report Form (DOC)

Guidance

MUSC Guidance HRPP Section 1.6 (PDF)

MUSC Guidance HRPP Section 4.1 (PDF)

MUSC Guidance HRPP Section 4.2 (PDF)

MUSC Guidance HRPP Section 4.3 (PDF)

MUSC Guidance HRPP Section 4.4 (PDF)

MUSC Guidance HRPP Section 4.14 (PDF)

MUSC Guidance HRPP Section 5.1 (PDF)

MUSC Guidance HRPP Section 5.2 (PDF)

MUSC Guidance HRPP Section 5.3 (PDF)

IRB Reviewer Checklists

Forms

IRB Reviewer Checklist for Full Board Initial Application (DOC)

IRB Reviewer Checklist for Expedited Initial Application (DOC)

IRB Reviewer Checklist for Continuing Review Full Board and Expedited Protocols (DOC)

IRB Reviewer Checklist Informed Consent (DOC)

Special Subject Populations Checklist - Children (DOC)

Special Subject Populations Checklist - Cognitively Impaired or Persons Unable to Consent (DOC)

Special Subject Populations Checklist - Pregnant Women, Fetuses, Neonates (DOC)

Special Subject Populations Checklist - Prisoners (DOC)

Guidance

MUSC Guidance HRPP Section 3.3 (PDF)

MUSC Guidance HRPP Section 3.4 (PDF)

MUSC Guidance HRPP Section 3.5 (PDF)

MUSC Guidance HRPP Section 6.1 (PDF)

MUSC Guidance HRPP Section 6.2 (PDF)

MUSC Guidance HRPP Section 8.1 (PDF)

MUSC Guidance HRPP Section 8.2 (PDF)

MUSC Guidance HRPP Section 8.3 (PDF)

MUSC Guidance HRPP Section 8.4 (PDF)

MUSC Guidance HRPP Section 8.5 (PDF)

IRB Reviewer Checklists Addenda

Forms

IRB Reviewer Checklist - Department of Defense Addendum (DoD) (DOC)

IRB Reviewer Checklist - Department of Education Addendum (DOC)

IRB Reviewer Checklist - Department of Energy Addendum (DoE) (DOC)

IRB Reviewer Checklist - Department of Justice Addendum (DoJ) (DOC)

IRB Reviewer Checklist - Environmental Protection Agency (EPA) (DOC)

Veterans Administration Forms

View Veterans Administration Forms here.

Archive to Prior IRB Form Versions

View Archive to Prior IRB Form Versions here.