DIA 2017 Annual Meeting

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-17-570-L04-P; CME 1.25; IACET 1.25; RN 1.25

On the final days of the outgoing administration, the Office of Human Subject Protections posted sweeping changes to federal regulations regarding human subjects research. The first substantive changes to human subjects research regulation in nearly 30 years! While the changes are focused at federal funding agencies, the implications for industry are enormous. New consenting requirements, new IRB requirements, requirements to post final consent forms to clinical trials.gov and a host of other changes will impact research operations, protocol design, and clinical trial implementation across the industry.

This late breaking session will explore all changes and give practical tips to sponsors on how to address the change.

Learning Objectives

Discuss the basics of the new requirements; Explain the history and rationale for the changes; Identify how to activate programs and systems to prepare for the new requirements.

Chair

James Riddle, MS

Speaker

Perspective From the Office of Human Subject Protection
Laura Odwazny

Common Rule Changes: Impact on Industry
James Riddle, MS