September 2008 Regional Meeting

Overview

On September 15-18, PRIM&R sponsored  a four day program geared specifically to meet the needs of Instituitonal Review Board (IRB)/ Human Protection Program (HRPP), Instiutional Animal Care and Use Committee( IACUC), and Institutional Biosafety Committee (IBC) members, administrators, and staff.   This program included four highly acclaimed educational programs: IRB 101sm, IRB Administrator 101, IBC Basics, and Essentials of IACUC Administration.

IRB 101sm
Monday, September 15, 8:30 AM–4:00 PM
IRB 101smcovered the ethics, history, and federal regulations related to the conduct of biomedical and social science research on human subjects. Through a series of lectures, interactive discussions, and case studies, IRB/HRPP members, administrators, clinical investigators, and research staff were taught:

  • How the federally mandated IRB system developed within the United States
  • The underlying ethical principles and procedures for reviewing research involving the protection of human subjects
  • The key components of the regulations which govern IRB operations

Faculty:

  • Bruce Gordon, MD
  • Don Workman, PhD

Download the IRB 101 program.

IBC Basics
Tuesday, September 16, 8:30 AM–5:00 PM
IBC Basics: An Introduction to the NIH Guidelines and the Oversight of Recombinant DNA Research was a full day course on the history, function, and administration of Institutional Biosafety Committees (IBCs). The audience for this course included IBC members and staff, research administrators, biosafety officers, regulatory affairs officers, members and staff of institutional oversight committees, such as IRBs and IACUCs, and others interested in the oversight of recombinant DNA research.

Delivered by expert staff from the National Institutes of Health (NIH) Office of Biotechnology Activities (OBA) , along with institutional biosafety professionals and other members of the IBC community, IBC Basics promoted the professional development of those associated with IBCs, by providing an opportunity to:

  • Learn about the NIH OBA, the content of the NIH Guidelines for Research Involving Recombinant DNA Molecules, and the history of IBCs
  • Understand the range of responsibilities that IBCs have under the NIH Guidelines
  • Work through case studies designed to clarify federal expectations with regard to biosafety review and surveillance of recombinant DNA and related research
  • Examine the relationship of IBCs to IRBs and IACUCs in terms of their respective purviews, roles, and responsibilities
  • Network with colleagues to share ideas about best practices, resources, innovative approaches, and possible collaborations

Faculty:
  • Kathryn L. Harris, PhD, RBP
  • Allan C. Shipp, MHA

Download the IBC Basics program.

IRB Administrator 101
Tuesday, September 16, 8:30 AM–4:00 PM
Wednesday, September 17, 8:30 AM–12:15 PM
IRB Administrator 101 was a 1½ day program, specifically geared toward both new administrators and those in need of a "refresher" course. Taught by two highly experienced administrators in the field, IRB Administrator 101 included:

  • Identification of the key components of human research protection programs
  • Examination of the primary responsibilities of administrators
  • A review of the strategies and policies for developing and/or strengthening your institution’s human research protection program

IRB Administrator 101 highlighted key administrator tasks including:

  • Advising principal investigators, research staff, IRB chair and members, and institutional officials
  • Managing protocol review
  • Recordkeeping and reporting
  • Handling allegations and complaints
  • Developing policies and procedures
  • Managing staff and infrastructural needs
  • Serving liaison functions
  • Providing/overseeing education
  • Conducting quality improvement or assurance reviews
  • Coordinating "off-site" administrative agreements

Faculty:
  • Elizabeth Bankert, MA
  • Ada Sue Selwitz, MA

Download the IRB Administrator 101 program.

Essentials of IACUC Administration
Wednesday, September 17, 12:45–5:30 PM
Thursday, September 18, 8:00 AM–5:30 PM

Essentials of IACUC Administration was a 1½ day program that provided Institutional Animal Care and Use Committee (IACUC) administrators and support staff, as well as training and compliance personnel, with an overview of how to effectively manage an animal care and use program. This course

  • Reviewed the key components of an integrated program
  • Examined the primary responsibilities of administrators
  • Discussed strategies for creating a culture that assures the humane care and use of animals while facilitating their use in research and teaching

Faculty:
  • Molly Greene
  • Marky Pitts

Download the Essentials of IACUC Administration program.