May 2012 Regional Meeting

Overview

On May 22-24, 2012, PRIM&R offered three acclaimed educational programs: IRB Administrator 101, What Does it Mean to Represent the Community?, and IRB 201. These programs took place at Washington University in St. Louis, MO.

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

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

The faculty 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

Learn more by viewing the agenda for IRB Administrator 101.

Faculty:

  • Elizabeth Bankert, MA
  • Susan Kornetsky, MPH

What Does It Mean to Represent the Community?
Wednesday, May 23, 8:30 AM-5:00 PM
What Does It Mean to Represent the Community? was a full-day program that focused on the role of institutional review board (IRB) non-scientific, unaffiliated members (community members) in the review process. The skilled faculty guided participants in their exploration of the community’s role in research ethics. During this program, attendees:

  • Reviewed the history of research ethics and identify how abuse has shaped federal regulations governing human subjects research
  • Discussed various issues in ethical decision making
  • Explored what it means to be a community member, and who community members represent
  • Learned about the various roles and responsibilities with an IRB

Learn more by viewing the agenda for What Does It Mean to Represent the Community?.

Faculty:

  • Emily Anderson, PhD
  • Gigi McMillan
  • Don Workman, PhD

IRB 201
Thursday, May 24, 8:30 AM-4:30 PM
IRB 201 was designed for human research protections program (HRPP)/IRB members and staff who understand the fundamentals of HRPP/IRB operations and who are interested in obtaining the next level of training. Participants gained the knowledge and skills required both to serve as effective reviewers and to teach others to become effective reviewers.  During this course, the faculty reviewed the key criteria for the review of research, including:

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

Learn more by viewing the agenda for IRB 201.

Faculty:

  • David A. Borasky, Jr., MPH, CIP
  • Susan Kornetsky, MPH