Forms & Guidance

Scientific Protocol

Scientific Protocol Template (DOCX)

Community-Engaged Research Protocol Addendum (DOC) 

• Guidance for Expedited Review - Retrospective Studies (PDF)

• Guidance for Community-Engaged Research

• Guidance for Exempt Review - Categories 2 and 4 (DOC)

Informed Consent

Informed Consent Template with HIPAA (eIRB) (DOCX) - Updated 11/07/2024

Informed Consent Template (eIRB) (DOCX) - Updated 11/07/2024

Informed Consent Template (ERMA) (DOCX) - Updated 11/07/2024

• Concise Summary Examples (DOCX)

• Electronic Consent Guidance (DOCX)

• Suggested Consent Language Library

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

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

• Guidance for Short Form Consent (DOCX)

Waiver of Signed Consent (ERMA Only) (PDF)

Waiver of Consent (ERMA Only) (PDF)

For suggested MUSC Local Context Language, please see the MUSC Process for Reliance on an External IRB page.

HIPAA

HIPAA Authorization (eIRB) (DOCX)

HIPAA Authorization (eIRB) - Spanish (DOCX)

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

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

HIPAA Authorization (ERMA Only) (DOCX)

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

HIPAA Waiver of Authorization (ERMA Only) (DOC)

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

Standard Paragraphs

Child and Adult FDA Regulated HIPAA (DOC)

Child and Adult FDA Regulated (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)

Certificate of Translation (PDF)

VA Addendum to MUSC IRB Continuing Review Application (DOC)

eIRB Watermark

MUSC Watermark for All Documents (DOC) 

• Instructions for use of Watermark (DOC)

Attachments (for ERMA)

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)

Miscellaneous

External Collaborator Supplement Form (DOC)

Amendments

Researcher Amendment Checklist (PDF)

Veterans Administration Forms

View Veterans Administration Forms here.

Archive to Prior IRB Form Versions

View Archive to Prior IRB Form Versions here.