The University of Iowa Human Subjects Office is hosting Public Responsibility in Medicine & Research (PRIM&R) IRB 101sm and IRB 201 conferences on August 12, 2019 and August 13, 2019. We hope you can join us for one or both conference days!
Monday, August 12, 2019 from 8:30 am – 4:30 pm (Registration begins at 7:30 am)
This is a full-day program that will provide attendees with the core concepts and fundamental knowledge needed to succeed as members of a human research protection program (HRPP) and/or an IRB. Through a series of lectures, discussions, and case studies, attendees learn:
- How the federally mandated IRB system developed within the United States
- Ethical principles underlying the federal regulations governing human subjects research
- Key components of the regulations that govern IRB operations and research activities
- Procedures for reviewing research involving human subjects
This program is ideal for those new to the field, or those interested in solidifying their understanding of the ethics and regulations governing research. It’s appropriate to those in a variety of roles - researchers and research staff, new IRB members and staff, compliance personnel, administrators, and more. The complete agenda can be found HERE. A box lunch will be provided.
IRB 201: An In-Depth Analysis of the Criteria for Review
Tuesday, August 13, 2019 from 8:30 am – 4:00 pm (Registration begins at 7:30 am)
This didactic program provides attendees with the tools and knowledge they need to become effective IRB chairs, members, or staff. This course reviews and analyzes each of the eight regulatory criteria that the IRB must consider during protocol review, examine the ethical principles that underlie these criteria, and discuss how the criteria are applied.
The specific criteria* covered are:
- Minimization of risks
- Risk-benefit relationship
- Equitable selection
- Consent process
- Consent documentations
- Data monitoring
- Privacy / confidentiality
- Vulnerable subjects
* From 45 CFR 46.111 and 21 CFR 56.111
This course has been designed for those who conduct reviews as part of a convened IRB or through the expedited procedure, and who understand the fundamentals of IRB operations. Please note that this course does not cover administrative issues. The complete agenda can be found HERE. A box lunch will be provided.
SPEAKER PROFILESJudith Birk, JD, is the director, IRBs and assistant director, HRPP, at the University of Michigan Medical School (IRBMED), an AAHRPP-accredited institution. She is responsible for daily operational oversight and regulatory compliance of the five IRBs within IRBMED. Ms. Birk serves on numerous policy, compliance, ethics, and regulatory committees in support of the University of Michigan’s HRPP. She is also responsible for developing innovations and regulatory flexibility projects to reduce regulatory burdens and increase IRB efficiencies. From 2003 to 2012, she was the director of the health sciences and behavioral sciences IRBs at the University of Michigan and has also held other positions in research and clinical support capacities at the institution.
Bruce Gordon, MD, is assistant vice-chancellor for regulatory affairs, and professor of pediatrics at the University of Nebraska Medical Center (UNMC). Dr. Gordon has been a member of the UNMC institutional review board since 1992, served as chair since 1996, and as executive chair since 2011. He has served on a variety of national committees and task forces, including the Secretary's Advisory Committee on Human Research Protections Subpart A Subcommittee. He was the first chair of the National Cancer Institute Pediatric Central IRB; currently serves on the Board of Directors for PRIM&R; has been a faculty member at every ARENA/PRIM&R national meeting since 2002; and was the co-chair for the 2009 AER Conference. He is an active participant in PRIM&R’s "At Your Doorstep" educational programs and co-developed the “Collaborating for Compliance” workshop, “IRB Chairs Boot Camp” program, and the “Vulnerable Subjects” program. Dr. Gordon is a founding member of the Collaborative Institutional Training Initiative (CITI); the author of two modules for the Human Subjects Research course; and co-developed the “Research Involving Vulnerable Subjects” course; and the author of numerous original papers, chapters, review articles, and abstracts regarding research ethics and protection of human research subjects.
If you'd like to print out a single sheet with the speakers' profiles, click HERE.
These conferences are free and open to all. Registration is capped at 150.
The registration deadline is 5 pm on Sunday, August 4, 2019. Follow the links below to register:
- Attending IRB 101 Conference ONLY (Monday, August 12, 2019)
- Attending IRB 201 Conference ONLY (Tuesday, August 13, 2019)
- Attending BOTH conferences
Let us know if you have questions or need any assistance.
Individuals with disabilities are encouraged to attend all University of Iowa-sponsored events. If you are a person with a disability who requires a reasonable accommodation in order to participate in this program, please contact the University of Iowa's Human Subjects Office in advance at 319/335-6564 or irb-outreach.uiowa.edu.
Iowa Memorial Union, Black Box Theater, 360 IMU, 125 N. Madison Street, Iowa City, IA 52242
Please Note: Area first responders and local hospitals are participating in a Johnson County Emergency Management training exercise at the Campus Recreation and Wellness Center (CRWC) between 7 am and 2 pm on Tuesday, August 13. This building is a few blocks away from the Iowa Memorial Union and may affect your travel to the conference. More information, including a map of the affected area, is available on the UI Department of Public Safety website.
- Iowa Memorial Union Parking Ramp, on North Madison Street across the street from the Iowa Memorial Union.
- North Campus Ramp, at the North end of Madison Street, by North Hall.
There are many hotels in the Iowa City/Coralville area. The ones closest to the conference site include: