September 2009 Regional Meeting

Overview

On September 21-24, PRIM&R offered four highly acclaimed educational programs: IRB 101sm, IRB Administrator 101, IBC Basics, and Essentials of IACUC Administration. These courses were geared specifically to meet the educational needs of IRB/HRPP, IBC, and/or IACUC members, administrators, and staff.

IRB 101sm
Monday, September 21, 8:30 AM–4:00 PM
IRB 101sm was a full day program that featured a series of lectures, interactive discussions, and case studies. The two experienced PRIM&R faculty members leading this course reviewed:

  • The development of the federally mandated IRB system 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 that govern IRB operations

Faculty:
  • Leonard Glantz, JD
  • Susan Kornetsky, MPH, CIP

Download the IRB 101 program.

IBC Basics
Tuesday, September 22, 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).

Taught by expert staff  from from the National Institutes of Health Office of Biotechnology Activities (NIH OBA), along with institutional biosafety professionals and other members of the IBC community, IBC Basics brought clarity to a high-stakes and often murky area of research 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

The target 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. 

Faculty:

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

Download the IBC Basics program.

IRB Administrator 101
Tuesday, September 22, 8:30 AM–4:00 PM
Wednesday, September 23, 8:30 AM–12:15 PM

IRB Administrator 101 was a one and a half-day program, specifically geared toward both new administrators and those in need of a refresher course. Two highly experienced administrators in the field:

  • Identified the key components of HRPPs
  • Examined the primary responsibilities of administrators
  • Developed strategies and policies that will strengthen your institution’s HRPP

The faculty for IRB Administrator 101 also highlighted key administrator tasks such as:

  • 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
  • Susan Kornetsky, MPH, CIP

Download the IRB Administrator 101 program.

Essentials of IACUC Administration
Wednesday, September 23, 12:45–5:45 PM
Thursday, September 24, 8:00 AM–5:30 PM

Essentials of IACUC Administration was a one and a half-day program, which provides 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.Two expert administrators:

  • 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.