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 05/11/2023

Informed Consent Template (eIRB) (DOCX) - Updated 05/11/2023

Informed Consent Template (ERMA) (DOCX) - Updated 05/11/2023

Concise Summary Examples (DOCX)

Suggested Consent Language Library

Short Form Consent Template: English (DOCX), Spanish (DOCX) - Updated 6/15/2023

Short Form Addendum for Sub-Studies Template (Spanish Version) (DOCX) - Updated 09/22/2022

Waiver of Signed Consent (ERMA Only) (PDF)

Waiver of Consent (ERMA Only) (PDF)

Electronic Consent Guidance (DOCX)- Updated 04/26/2023

Guidance for Short Form Consent (DOCX) - Updated 09/22/2022

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

HIPAA

HIPAA Authorization (eIRB) (DOCX)- Updated 08/09/2022

HIPAA Authorization (eIRB) - Spanish (DOCX) - Updated 08/09/2022

HIPAA Authorization (eIRB) - Optional Research Version (DOCX)- Updated 08/09/2022

HIPAA Authorization (eIRB) - Optional Research Version - Spanish (DOCXX) - Updated 08/09/2022

HIPAA Authorization (ERMA Only) (DOCX) - Updated 08/09/2022

HIPAA Authorization (ERMA Only) - Optional Research Version (DOC) - Updated 08/09/2022

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) - New 09/22/2022 

VA Addendum to MUSC IRB Continuing Review Application (DOC)

eIRB Watermark

MUSC Watermark for All Documents (DOC)

MUSC Watermark for All Remote/Relying Site Documents

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)

Veterans Administration Forms

View Veterans Administration Forms here.

Archive to Prior IRB Form Versions

View Archive to Prior IRB Form Versions here.