IRB Home Page

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

WEBPAGE UPDATE(May 13, 2009): Hyperlinks to pdfs activated and Table of Contents numbering corrected
WEBPAGE UPDATE (April 29, 2009): April 29th Veatch Presentation "Human Research Protection Program Accreditation Site Visit - Principal Investigator and Research Study Team Update"pdf; New Section X - Subscribe to Clinical Research Listservs
WEBPAGE UPDATE (April 28, 2009): April 28th Lanier Presentation "Human Research Protection Program Overview of Significant Enhancements for AAHRPP Accreditation" pdf
WEBPAGE UPDATE (April 14, 2009): April 14th Malcolm Presentation AAHRPP update pdf
WEBPAGE UPDATE (March 16, 2009): Guidelines for Research Involving Cancer Patients, the Hollings Cancer Center or any research addressing cancer

TABLE OF CONTENTS
I	How to Submit to the IRB:
		Instructions for Submitting Applications IRB and 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
	3/16/09	Research Involving Cancer Patients, the Hollings Cancer Center or any research addressing cancer
		Human Research Protection Program (HRPP)
		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
	NEWS:	Deadlines How to determine which IRB to contact
VI	IRB Policies and Procedures
	NEWS	Human Research Protection Program (HRPP) Program Guide (effective November 1, 2008, revised February 13, 2009)
		Downloadable pdf version of HRPP Program Guide
VII	Links

		HIPAA Links
VIII	Tutorials and Training
	NEWS:	Letter from Drs. Lanier and Malcolm: Continuing Education for those Involved in Human Subjects Research
		HRPP Program Guide Section 4.3 Education and Training Requirements for those Involved in Human Research
		Clarification on the CITI Human Subjects Training
		November 5th Memorandum - Further Clarification
	Collaborative IRB Training Initiative (CITI) REQUIRED
	Core Clinical Research Training
	Human Participation Protection Education for Research Teams

IX	AARHPP Updates
	April 14th 2009 Update - Clinical Research Community April 28th 2009 Update - Clinical Research Community April 29th 2009 Update - PI and Research Study Team

X	Clinical Research Listservs

	We use two listservs to communicate important IRB information, one to the investigators, the other to the contacts identified by the investigators. These listservs are only used for information important to your project and only when necessary. If you wish to join one of these listservs, click on the listserv to send an email to Dr. Veatch. Once subscribed, you will receive a confirmation email. clinicalresearchpis clinicalresearchcontacts Stephen M. Lanier, Ph.D. Robert Malcolm, M.D. Lynn M. Veatch, Ph.D. Associate Provost for Research Director, Office of Research Integrity Special Projects to the APR

Last Update
9/23/08