Forms & Guidance

Research Integrity

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:

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 Consent 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 - Informed Consent to Participate in Research Policy and Procedures (PDF)

MUSC Guidance HRPP Section 6.2 - Waiver or Alteration of the Consent Process and Waiver of Consent Documentation - Policy and Procedures (PDF)

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

MUSC Guidance HRPP Section 7.5 - Research Involving Non-English-Speaking Subjects Policy and Procedures (PDF)

Guidance for Short Form Consent (PDF)

HIPAA

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 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)

Forms

Off-Campus Study Site (DOC)

VA Addendum to MUSC IRB Continuing Review Application (DOC)

Guidance

MUSC Guidance HRPP Section 9.1 - Off Campus Research Studies (PDF)

MUSC Guidance HRPP Section 9.2 - Management of Reporting Events in Multi-Site Research Studies - Policy and Procedures(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 - Communicating Conflict of Interest (COI) among IRB, ORSP and University COI Committees (PDF)

MUSC Guidance HRPP Section 4.1 - Review of Research Involving Drugs or Biological Drug Products - Policy and Procedures (PDF)

MUSC Guidance HRPP Section 4.2 - Single Emergency Use of an Investigational Drug - Policy and Procedures (PDF)

MUSC Guidance HRPP Section 4.3 -Review of Research Involving Medical Devices - Policy and Procedures (PDF)

MUSC Guidance HRPP Section 4.4 - Medical devices Risk Determination - Policy and Procedures (PDF)

MUSC Guidance HRPP Section 4.14 - Protocol Deviation - Policy and Procedures (PDF)

MUSC Guidance HRPP Section 5.1 - Principal Investigator Responsibilities - Supervision of Staff and Protection of Subjects (PDF)

MUSC Guidance HRPP Section 5.2 - Principal Investigator Responsibilities - Recordkeeping and Record Retention Requirements (PDF)

MUSC Guidance HRPP Section 5.3 - Education and Training Requirements for Individuals Involved in Human Research (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 - Expedited Research Review - Policy and Procedures(PDF)

MUSC Guidance HRPP Section 3.4 - Full Board Initial Review - Policy and Procedures (PDF)

MUSC Guidance HRPP Section 3.5 - Continuing Review and Annual status Update - Policy and Procedures (PDF)

MUSC Guidance HRPP Section 6.1 - Informed Consent to Participate in Research - Policy and Procedures (PDF)

MUSC Guidance HRPP Section 6.2 - Waiver or Alteration of the Consent Process and Waiver of Consent Documentation - Policy and Procedures (PDF)

MUSC Guidance HRPP Section 8.1 - Vulnerable Populations - General Guidelines (PDF)

MUSC Guidance HRPP Section 8.2 - Research Involving Persons with Impaired Decision Making Capability (PDF)

MUSC Guidance HRPP Section 8.3 - Research Involving Prisoners (PDF)

MUSC Guidance HRPP Section 8.4 - Research Involving Pregnant Women, Fetuses and Neonates (PDF)

MUSC Guidance HRPP Section 8.5 - Research Involving Children (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.