Ethical Review Boards

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. Topics in this course include: Development, Membership/Procedures, Review and Approval, Post-Approval Responsibilities, Vulnerable Subjects, Noncompliance, and Compliance Resources. After completing this course, learners will be able to recognize their obligations in relation to the IRB/IEC and the policies and procedures that were developed to protect and safeguard research subjects.

After this course learners will be able to recognize the key events that helped establish the ethical review system. recognize the membership requirements of an irb/iec and the procedures these groups must follow with regard to approval of clinical research. identify the additional protections put in place for various types of vulnerable subjects. identify how fda will enforce noncompliance to established regulations for irb/iecs.