OHRP Policies

• MCG OHRP Human Research Protections Program (HRPP) posted 4/26/2007
  • Introduction
  • What is Research?
  • What is a Human Subject?
  • What are Human Derived Materials?
  • What Regulations Do We Have to Follow?
  • Institutional Roles and Responsibilities
  • Organizational Leadership, Authority, Structure and Function of the  Human Research Protection Program
  • MCG Office of Human Research Protection
  • Human Research Protection Program Educational Requirements
  • Institutional Review Boards
  • Communication and Relationships with Other Institutions/Sponsors
  • Medical College of Georgia Departments
  • Consent for the Treatment of Minors in Georgia
  • Institutional Role in Complaints and Allegations of Potential Non-Compliance
  • Institutional Responsibilities and Policies Regarding Conflict of Interest
  • Required Education
  • What is an Institutional Review Board (IRB)?
  • What is a Privacy Board?
  • What are the Roles and Responsiblities of Research Team Members?
  • What is a Principal Investigator?
  • What is a Faculty Sponsor?
  • What is a Sub-Investigator?
  • What is a Study Coordinator?
  • Research Conducted with Investigators That Do Not Have an Affliation with MCG, MCGHI or the Charlie Norwood Charlie Norwood VA Medical Center
  • Research Conducted with Other Institutions or Performance Sites
  • Research Conducted in an International Setting

 

• Research Team Member SOPs posted 3/3/08
  • SOP 01- Standard Operating Procedure for SOPs
  • SOP 02- Informed Consent
  • SOP 03- Investigational Drug Handling
  • SOP 04- Regulatory Documentation
  • (Monitoring/Auditing Log)
  • SOP 05- IRB Selection
  • SOP 06- Procedures for Using Chesapeake Research Review, Inc.
  • SOP 07- Procedures for Using the Human Assurance Committee
  • SOP 08-Under Construction
  • SOP 09-Under Construction
  • SOP 10-Under Construction
  • SOP 11-Under Construction
  • SOP 12-Clinical Research Conducted in Campus Facilities
  • SOP 13-Investigational Device Accountability
  • Sample Device Accountability Log
  • Research SOP's-FAQ

 

• IRB Policies
  • Human Assurance Committee (HAC) Policies
  • Chesapeake Research Review, Inc. (CRRI) Policies
  • National Cancer Institute Central IRB (CIRB)

 

• MCG Administrative Policies Related to Human or Human Derived Materials Research
  
• Clinical Trials Proposals posted 12/27/2007
• Policy on Human Assurance Committee Review for Non-MCG Entities posted 12/27/2007

MCGHI Process

• Process for Obtaining Printed Documents from the MCG Health, Inc. Electronic Medical Record posted 7/22/2009