2015 Webinar: PRIM&R's Primer on the NPRM

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Sixteen federal government departments and agencies, including the Department of Health and Human Services, issued a Notice of Proposed Rulemaking (NPRM) on the federal policy for the protection of human subjects. This NPRM, published in the Federal Register on September 8, 2015, proposes the first revisions to the “Common Rule” since its publication in 1991. Learn how this will affect your job and what you’ll need to do in the upcoming months to appropriately respond to these changes.

What will I learn?

During this webinar, presenters Heather H. Pierce, JD, MPH, PRIM&R board member and senior director for science policy and regulatory counsel in scientific affairs at the Association of American Medical Colleges (AAMC) and P. Pearl O’Rourke, MD, PRIM&R board member and director of human research affairs at Partners HealthCare Systems, Inc., will give an overview of the critical changes proposed in the NPRM, including:

  • Expansion of the categories of research exempt from institutional review board (IRB) review
  • Changes to the informed consent process
  • Mandate that multi-site research studies rely on a single IRB
  • Expansion of the scope of the rule to cover all clinical trials conducted at any US institution receiving federal funding for non-exempt human subjects research, regardless of funding sources
  • Changes to the requirements for continuing review
  • Consent requirements for the use of stored biospecimens
  • Limitation of the use of waivers or alterations of consent for research involving biospecimen
  • Calibration of the level of review to the level of risk involved in research

Who should attend?

Everyone who needs to learn how the changes to the Common Rule will impact their human research protection program or the work of their IRB.

Background information

Since the Department of Health and Human Services (DHHS) released for public comment an Advance Notice of Proposed Rulemaking (ANPRM), titled Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators in 2011, there has been considerable debate and discussion about the appropriate regulation of human subjects research. In December 2014, the National Institutes of Health (NIH) issued a request for comments on its "Draft NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research," which influenced the development of the ANPRM into the proposed rule. Continuing analysis of the NPRM can be found on Ampersand.


Heather Pierce(2)Heather H. Pierce, JD, MPH, PRIM&R board member and senior director for science policy and regulatory counsel in scientific affairs at the Association of American Medical Colleges (AAMC). Ms. Pierce serves as AAMC’s leader on issues related to conflicts of interest, human subjects protection, regulatory compliance, and interactions between industry, government, and academia in biomedical research. Prior to joining AAMC, Heather was an attorney in the health care group of the law firm of Ropes & Gray LLP in New York. Her practice focused on regulatory compliance issues including research with human subjects, medical information privacy and security, and fraud and abuse counseling. She worked with a wide range of clients including academic medical centers, hospitals, universities, and pharmaceutical and device manufacturers. She earned her juris doctor at New York University and her master’s degree in public health at Boston University. Prior to becoming a lawyer, Heather worked in development and public education for an academic medical center and as a freelance writer.  

Pearl ORourke WebinarP. Pearl O’Rourke, MD, PRIM&R board member and director of human research affairs at Partners HealthCare Systems, Inc. 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 human embryonic stem cell research. Dr. O’Rourke’s career began as a pediatric critical care physician at Boston Children’s Hospital, and then as the director of the Pediatric Intensive Care Unit at Children’s Hospital, University of Washington. She did clinical research in extracorporeal membrane oxygenation, liquid ventilation, high frequency ventilation, and pediatric resuscitation. Following a Robert Wood Johnson Health Policy fellowship working for Senator Edward Kennedy from 1997 to 2000, she was the deputy director of the Office of Science Policy in the Office of the Director at the National Institutes of Health, where she worked on issues such as privacy, gene therapy (transfer), embryonic stem cells, and genetic discrimination. Dr. O’Rourke has been actively involved with PRIM&R as both a member and past chair of the Board of Directors, and as a member of the AER Conference Core Conference Planning Committee (CCPC). She currently serves as the co-chair of the 2015 AER Conference CCPC.


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Free to PRIM&R Members
Nonmember - $180  

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Group registration is for two or more individuals. This is a cost-effective option for institutions where a number of individuals are viewing the webinar; individuals do not all have to be in the same location. It is the responsibility of the person whose name is used to register the group to distribute the login information to his/her colleagues and to share the link to the webinar evaluation with the other members of the group. Only one member of the group needs to be a PRIM&R member in order to receive the member group rate. 

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