On January 19, 2017, the Office of the Federal Register published a revised Federal Policy for the Protection of Human Subjects, marking the first significant changes to the Federal Policy for the Protection of Human Subjects, or "Common Rule," since 1991. These changes will have important and wide-reaching implications for the human subjects research enterprise. However, the Rule arrives under a cloud of uncertainty: A new presidential administration takes over the reins of the federal government on January 20, and it is unclear whether they will use available avenues to overturn the new Rule. Whether or not the new Rule survives long enough to be implemented, the issues it addresses are important to the future of the research oversight community.
Free for PRIM&R members and available at a discounted rate of $30 and $60 for individual and group nonmembers, respectively, this webinar will provide an overview of the critical changes presented in the Rule as well as an explanation of the rulemaking process and the various possible outcomes.
Attendees will have the opportunity to participate in a virtual Q&A session with the presenters at the conclusion of the webinar, and all registrants will receive a recording of the webinar within one week of the broadcast.
What will I learn?
After attending this webinar, attendees will:
Who should attend?
This webinar will benefit anybody who works in human subjects research.
For more information about the revised Common Rule, please visit PRIM&R's Common Rule webpage.
P. Pearl O'Rourke, MD, is the director of human research affairs at Partners HealthCare, 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).
Heather H. Pierce, JD, MPH, is the senior director for science policy and regulatory counsel at AAMC. In this role , she serves as AAMC's staff leader for scientific regulatory issues including clinical research, conflicts of interest, evidence-based regulation, and collaborations among industry, government, and academia in biomedical research. She is also the program leader for the AAMC's Forum on Conflict of Interest in Academe and for Convey, the AAMC's global financial interest disclosure system. Ms. Pierce is a member of PRIM&R's Board of Directors, Executive Committee, and Public Policy Committee, and regularly speaks at national forums on issues related to the protection of human subjects, conflicts of interest, scientific misconduct, and the regulation of research. She has served on ad hoc committees and task forces convened by organizations including the IOM, The Pew Charitable Trusts, the National Dialogue on Healthcare Innovation, and PRIM&R. Prior to joining AAMC, Ms. Pierce was an attorney in the Health Care Group of the law firm of Ropes & Gray LLP in New York. Her regulatory practice focused on medical research and clinical care. She received her law degree from New York University and her MPH in Health Law from Boston University.
Certificates of attendance will be made available at the conclusion of the webinar. To access the certificate, you must first complete the online evaluation. Such certificates are useful for obtaining continuing education (CE) credits (not Continuing Medical Education credits) from professional associations. Note that guidelines concerning CE credits may differ, and you should consult the appropriate professional association representative for further guidance.
CE Credit for Certified IRB Professional (CIP®) Recertification
Webinar participants holding the CIP® credential who wish to apply credits from this webinar toward CIP® recertification may submit the Certificate of Attendance they received upon completing the online evaluation as documentation of their participation. Participation in this 90-minute webinar counts as 1.5 CE credit hours. Additional information about recertification can be found here.
If you have additional questions about webinar recordings, please contact us by phone (617.303.1876) or via email.