Office of Research Integrity Staff for Office of Research Integrity research.musc.edu
 

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

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:
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