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Wednesday, June 21 • 2:00pm - 3:15pm
#346: Understanding the New Common Rule and Its Impact to Industry

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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


Speakers
avatar for Laura Odwazny

Laura Odwazny

Senior Attorney, Office of Human Subject Protection, Office of General Counsel, Department of Health and Human Services
Laura M. Odwazny is a Senior Attorney with the Office of the General Counsel, U.S. Department of Health and Human Services. Throughout her 17 years at HHS, Ms. Odwazny's primary client has been the Office for Human Research Protections, which interprets and enforces the HHS prote... Read More →
avatar for James Riddle

James Riddle

Vice President of Client Services, Kinetiq, a Division of Quorum IRB
James Riddle, MCSE, CIP, CPIA Kinetiq Vice President, Client Services Served as Assistant Director at the Fred Hutchinson Cancer Research Center and has over 15 years of experience leading human subject protection programs. He has served as a site visitor for AAHRPP, is a faculty... Read More →

Wednesday June 21, 2017 2:00pm - 3:15pm
N426b McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
  05: Regulatory, Forum
  • format json
  • Featured Topics Academic Clinical Researcher,Patient Centric
  • Credit Type ACPE, CME, IACET, RN
  • Tags Forum