NEW IRB LOCATION IS HARBORVIEW OFFICE TOWER, ROOM 601, MSC 857.

Chair IRB I: Dorothea Jenkins, MD & Kathryn Magruder, PhD
Chair IRB II: Susan Sonne, PharmD
Chair IRB III: David N. Lewin, MD
Interim Program Manager: Vicki McGillivray  

Human Research Review Application

TABLE OF CONTENTS
I	How to Submit to the IRB:
		Instructions for Submitting Applications IRB Forms HIPAA Forms IRB Fees Protocol Guidelines Good Clinical Practice Review Checklist
II	Responsibilites When Using Human Subjects in Research
		Who must submit for IRB review Principal Investigator, Employees, Students, and Staff Institutional Review Board for Human Research (IRB) University Administration
III	MUSC Guidelines For Human Research
		Study Monitor Access to Research Participant's Study and Medical Records
		Databases: IRB Approval & HIPAA Authorization
		Elements of Electronic Data Protection Plan
		Use of Cell Lines Obtained from Commercial Sources
		Adverse Events
		Research involving Human Embryonic Stem Cells, Germ Cells, and Stem Cell-derived Test Articles
		Stem Cell Information: FAQs
		Informed Consent
	Types of Review
		Exempt Review Categories Expedited Review Categories Full Board Review Categories
IV	Federal Wide Assurance (FWA) Compliance with DHHS Regulations for the Protection of Human Research Subjects
V	Deadlines
		Deadlines How to determine which IRB to contact
VI	IRB Policies and Procedures
		Table of Contents
VII	Links
		HIPAA Links
VIII	Tutorials and Training
		Clarification on the CITI Human Subjects Training
		November 5th Memorandum - Further Clarification
		Research Coordinator Development Course (RCDP)
	Collaborative IRB Training Initiative (CITI)
		University of Miami Course REQUIRED
	Human Participation Protection Education for Research Teams
	Most Common Areas of Non-Compliance