May 2009 Regional Meeting

Overview

PRIM&R sponsored a 2 ½-day program in San Diego, CA geared specifically toward the educational needs of institutional review board (IRB)/human research protection program (HRPP) members, administrators, and staff. This program included three highly regarded educational courses: IRB 101sm, IRB Administrator 101, and IRB 201.

IRB 101sm
Wednesday, May 6, 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 who led the course reviewed:

  • 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 that govern IRB operations

Faculty for IRB 101:

  • Susan Kornetsky, MPH, CIP
  • Jeffrey Cooper, MD, MMM

Download the IRB 101sm program.

IRB 201
Thursday, May 7, 8:30 AM-4:30 PM
IRB 201 is designed for IRB/HRPP members and staff who understand the fundamentals of IRB/HRPP operations and who are now interested in obtaining the next level of training. Participants gained the knowledge and skills needed both to serve as effective IRB/HRPP reviewers and to teach others to become effective reviewers.

The highly regarded faculty highlighted key criteria for the review of research, including:

  • Risks to participants are minimized
  • Risks are reasonable in relation to anticipated benefits
  • Selection is equitable
  • Informed consent will be sought and waivers of informed consent
  • Informed consent will be documented including waivers of documentation
  • Research plan makes adequate provisions for monitoring safety
  • Adequate provisions to protect privacy and maintain confidentiality
  • Additional safeguards for participants likely to be vulnerable to coercion or undue influence

Faculty for IRB 201:

  • Jeffrey Cooper, MD, MMM
  • Moira Keane, MA, CIP

Download the IRB 201 program.

IRB Administrator 101
Thursday, May 7, 8:30 AM-4:00 PM
Friday, May 8, 8:30 AM-12:15 PM
IRB Administrator 101 is aimed at both new administrators and those in need of a refresher course.  This course was taught by two experts in the field. These experts:

  • Identified the key components of human research protection programs
  • Examined the primary responsibilities of administrators
  • Reviewed the strategies and policies for developing and/or strengthening your institution’s HRPP

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 for IRB Administrator 101:

  • Susan Kornetsky, MPH, CIP
  • Ada Sue Selwitz, MA

Download the IRB Administrator 101 program.