IRB 250 is designed for professionals seeking to deepen their understanding of and insight into core topics related to human research protection programs (HRPPs). The curriculum also delivers an array of practical strategies for enhancing an institution’s HRPP/IRB operations via the use of best practices. This program is taught by HRPP/IRB experts who are recognized leaders in the fields of human research protections and research ethics.
IRBs face different challenges when reviewing protocols that are conducted outside their institution, whether the research is conducted across town, in another region of the United States, or internationally. This presentation will discuss concepts, regulatory requirements, and cross-cultural and ethical considerations that an IRB must consider when the research is conducted beyond the boundaries of its institution, particularly when conducted internationally. Finally, the session will offer tools and strategies for acquiring local knowledge of the research setting.
Similar to applying the exemption categories, this module will review the federal regulations governing expedited categories, including what types of research are expedited. In addition, the modules will review OHRP Guidance on expedited categories, as well as using expedited review.
The curriculum for this module will review recruiting subjects over the Internet, observation of Internet activity, and collecting data over the Internet. In addition, the module will consider IRB review issues, including risk/benefit, consent, participation by minors, and privacy and confidentiality. Finally, this module will discuss electronic data security and IRB review requirements.
The curriculum for this module aims to familiarize attendees with the ethical principles as they pertain to subpart D and the regulations. In addition, the module reviews what is sufficient pediatric expertise, pediatric risk/benefit assessment and definitions, parental permission and assent, wards of state, and subpart D documentation requirements.
George Gasparis is the president of The PEER Consulting Group, LLC. With more than 30 years of experience in the conduct, administration, review, and compliance oversight of research, Mr. Gasparis provides expert consultation for human research protection programs, institutional review boards (IRBs), and principal investigators/research teams. Before starting the consulting company, he served as the assistant vice president and senior assistant dean for research ethics from 2003 to 2012. In this capacity, he served as the executive director of the Human Research Protection Program and the IRB Office for Columbia University, Columbia University Medical Center (CUMC), and New York Presbyterian Hospital at CUMC. The Columbia IRB Office managed six IRBs that provided oversight for more than 4,500 total active protocols and more than 1,500 new protocols per year. The office also enhanced regulatory compliance through its Compliance Oversight Team and promoted educational training for researchers through comprehensive training programs.
Prior to his arrival at Columbia University in June 2003, Mr. Gasparis was the director for the Division of Assurances and Quality Improvement at the Office for Human Research Protections (OHRP). Prior to his tenure at OHRP from 1996 to 2003, he was the director of the Office of Human Research at The George Washington University (GWU) Medical Center from 1991 to 1996. In that capacity he served as the administrator for the GWU Medical Center IRB, director of the Research Pharmacy, and also served on the behavioral IRB for GWU. Mr. Gasparis also has had extensive experience with clinical trials when he was employed at the GWU Lipid Research Clinic (LRC) from 1981 to1991. During his tenure as data manager at the LRC, he managed more than 40 clinical trials, including the National Institutes of Health awards and studies for 10 different sponsors. Mr. Gasparis is a graduate of GWU. He became a Certified IRB Professional (CIP®) in 2003.
Moira Keane is the former Executive Director of the University of Minnesota, Human Research Protection Program which includes the Institutional Review Board (IRB), and the Institutional Biosafety Committee (IBC). The HRPP oversees the research of all University of Minnesota campuses which encompasses review of basic science, clinical research, and social and behavioral sciences projects conducted by faculty, staff, and students. She is actively involved in subjects protections and served as Chair of the AAHRPP Council on Accreditation, as Vice Chair of the Council on Certified IRB Professionals (CCIP), and as a member of the Secretary’s Advisory Committee on Human Subjects Protection (SACHRP) Sub Part A Sub Committee.
M.D.: This activity has been planned and implemented in accordance with ACCME® Essential Areas and Elements and Iowa Medical Society (IMS) policies. Des Moines University is accredited by the IMS to provide continuing medical education for physicians. Des Moines University designates this live education activity for a maximum of 6.0 AMA PRA Category 1 Credits™. Physicians should only claim credit commensurate with the extent of their participation in the activity.
D.O.: This activity has been planned and implemented in accordance with the essential areas and policies of the American Osteopathic Association (AOA). Des Moines University is accredited by the AOA and approves this live activity for a maximum of 6.0 hours of AOA Category 2-A CME credits.
D.P.M.: Des Moines University is approved by the Council on Podiatric Medical Education as a sponsor of continuing education in podiatric medicine. Des Moines University has approved this activity for a maximum of 6.0 continuing education contact hours.
Nursing: Des Moines University (provider #112) is approved by the Iowa Board of Nursing as an accredited provider. This activity has been reviewed and approved for a maximum of 7.2 continuing education contact hours.
Other: This live activity was designated for 6.0 AMA PRA Category 1 Credits™.
The cost to attend is $65.
If you would like to register and pay for a large group of individuals, please contact DMU CME at email@example.com or 515-271-1596.
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In Des Moines, you can experience the excitement of the city and explore rural Iowa’s charming beauty. Connecting with your peers, shopping, food and activities make great memories. This affordable, cosmopolitan city has an impressive blend of world class art and premier attractions, such as the Science Center of Iowa and the Pappajohn Sculpture Park. Miles of trails to walk or cycle allow you to see the city and the beauty of its rivers and parks ~ just steps away from the conference. Bicycles are available for rent through the BCycle program! When it comes to dining, our city offers incredible food prepared by talented chefs. You will experience some of the finest tasting pork to Tai pizza. Another added benefit is downtown’s four-mile, climate-controlled skywalk system (the largest skywalk system per capita in the world), our booming suburbs, and unique shopping in the East Village. Greater Des Moines is a growing metropolis with an array of attractions and entertainment in a setting that boasts a rich history, a thriving present and a very bright future, all while maintaining a special charm that touches all who visit. Learn more about Des Moines at the following websites:
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