A Kaplan EduNeering course

This course addresses the role, responsibilities and regulatory requirements of Institutional Review Boards (IRBs) / Independent Ethics Committees (IECs) in protecting the rights and welfare of human research subjects.  This course reviews the regulations, guidelines, ICH GCP and the EU Directive to provide a better understanding of the relationship between the IRB/IEC, sponsor/monitor and investigator/subjects.  Upon completing this course, IRB/IEC members, investigators and sponsors/CROs will understand their obligations in relation to the IRB/IEC and will be able to ensure that policies and procedures developed for compliance will protect and safeguard the research subjects.

Topics include:
      ·          Development of the ethical review system in place today
      ·          Membership/Procedures
      ·          Review and Approval
      ·          Responsibilities
      ·          Vulnerable subjects
      ·          Noncompliance
      ·          Compliance resources