Understanding the Revised Common Rule

Description:

Ending five and a half years of rulemaking and speculation, the US Department of Health and Human Services (HHS) and 15 other Federal Agencies released a final revision of the Federal Policy for the Protection of Human Subjects, or "Common Rule," on January 19, 2017. These are the first revisions to the Common Rule since it was promulgated in 1991. What are the implications of these revised regulations for IRB program operations? What changes need to be made in administrative processes and procedures to promote compliance with the new Federal Policy? This interactive program will provide a practical, hands-on journey through the revised regulations, allowing participants to not only review the changes to the Rule but to discuss and identify best practices for implementation.

Audience:

This course is targeted for various audiences, including

  • IRB administrators
  • IRB Chairs, Vice Chairs, and members
  • Research administrators

The content is appropriate for those new to the topic as well as those with knowledge or experience in implementing the Common Rule.

Learning Objectives:

  • Develop an understanding of the revised Common Rule
  • Identify areas for administrative change and discuss strategies for applying the new requirements

Format:

Understanding the Revised Common Rule is offered in a half-day format. The content is effective as a stand-alone workshop, or can be offered in conjunction with any of our other AYD offerings, including IRB 101sm, IRB 201, IRB 250, Putting Together the HRPP Puzzle, Responsible Conduct of Research: Concepts and Cases, Establishing an Effective Research Ethics Education Program, and Ethical Study Design is Good Science.