Principles of IRB Review: Ensuring Both Ethical Review and Regulatory Compliance
This webinar will discuss how IRBs can review research to fulfill the regulatory requirements as well as conduct appropriate and complete ethical review of research protocols. Many examples will be provided distinguishing between what must be done to fulfill the regulatory requirements and what should be done for ethical review. For example, having and completing a checklist may fulfil and even document compliance with regulations, but have the content of those items on the checklist been adequately discussed and issues resolved? The discussion will include issues related to the composition of the IRB, conduct of IRB meetings, criteria for approval of research, evaluation of an individual protocol and voting. In addition other HRPP functions will be discussed including education, evaluation of IRB members and staff, quality improvement and annual review of the HRPP/IRB. Attendees will learn the issues to consider to ensure complete review of protocols, optimal IRB function, regulatory compliance and fulfillment of ethical responsibilities for the protection of human subjects in research.