Guidances Relating to Compliance, Laws & Regulations

FDA vs. OHRP Regulations

• Significant differences between the regulations

• HIPAA Requirements for Case Reports

• Investigator Non-Compliance with IRB Approved  Human Subjects Research

Maryland Law

• Maryland law pertaining to research
• Enrolling foster children in research (Baltimore City)
• Maryland Reporting Obligations that May Apply to Investigators or Other Members of the Research Team
  Reporting Obligations under Maryland Law

• JHM IRB Routine Monitoring Visits
• Compliance Monitor Information Session - Spring 2006 
• Compliance Monitor Information Session - Fall 2006 
• Compliance Monitor Information Session - Spring 2007

•  Regulatory Definitions

Reporting to JHM and OHRP/FDA

• Reporting to the Institution and Government Agencies
  IRB report of investigator’s serious and continuing non-compliance, or suspension or termination of study