2011 Webinar: PRIMR's Primer on the ANPRM

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Overview

The Department of Health and Human Services (DHHS) posted proposed changes to the 'Common Rule,' and accepted public comments through September 26, 2011. To help ensure that institutions were aware of the intricacies of the Advance Notice of Proposed Rulemaking (ANPRM), PRIM&R offered a webinar titled PRIM&R's Primer on the ANPRM. This webinar was offered live on Thursday, July 28, with a recorded broadcast on Wednesday, August 10. Both presentations were hosted by, and featured a live question-and-answer session with, P. Pearl O'Rourke, MD, PRIM&R board member and director of human research affairs at Partners HealthCare Systems.

This webinar featured an overview of ANPRM proposals for consideration, including:

  • Creating mandatory standards for data security and information protection 
  • Eliminating the requirement for annual continuing review for some research 
  • Requiring informed consent for research using identifiable or de-identified biospecimens 
  • Expanding the types of research that can be exempted from institutional review board (IRB) review
  • Improving informed consent forms 

Audience

This webinar was of interest to everyone working in human subjects protections.

Faculty

Pearl O'Rourke, MD
Dr. O’Rourke is the director of human research affairs at Partners HealthCare System, Inc in Boston and an associate professor of pediatrics at Harvard Medical School. She is responsible for the systems that support the regulatory and ethical oversight of human research and the responsible conduct of research. She is also chair of the Partners Healthcare System embryonic stem cell research oversight (ESCRO) Committee. Pearl has worked as a pediatric critical care physician at the Children's Hospital, Boston and at the Children's Hospital, University of Washington, Seattle, where she was the director of the pediatric intensive care unit. She was active in clinical research in extracorporeal membrane oxygenation (ECMO), liquid ventilation, high-frequency ventilation, and pediatric resuscitation. In Seattle she served many years as a member of the IRB. Pearl has also been involved in international medical care, serving in China and Indonesia with Project HOPE. In 1995-1996, Pearl received a Robert Wood Johnson Health Policy fellowship and worked for the late Senator Edward M. Kennedy. Following this fellowship, she became the deputy director of the office of science policy in the office of the director at the NIH where she worked on issues such as privacy, gene therapy (transfer) embryonic stem cells, and genetic discrimination.