October 2011 Regional Meeting

Overview

On October 25-26, 2011, PRIM&R offered three highly acclaimed educational programs: Institutional Review Board (IRB) 101sm, IRB Administrator 101, and What Does it Mean to Represent the Community?.

These courses were held in conjunction with the 2011 Community Engaged Research (CEnR) Conference: Communication in Community-Engaged Research. Co-sponsored by the Journal of Empirical Research of Human Research Ethics, the University of Houston Hobby Center for Public Policy, was held October 27-28 at the University of Houston. Attendees chose to attend the following programs:

Institutional Review Board (IRB) 101sm
Tuesday, October 25, 2011
IRB 101 featured a series of lectures, interactive discussions, and case studies. The faculty member who led 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

View a sample agenda.

Faculty:

  • Susan Fish, PharmD, MPH
  • Robert Levine, MD

IRB Administrator 101
Tuesday, October 25 - Wednesday, October 26
IRB Administrator 101was a one and a half-day program, specifically geared toward both new administrators and those in need of a "refresher" course. The faculty taught attendees to:

  • Identify the key components of HRPPs
  • Examine the primary responsibilities of administrators
  • Develop strategies and policies that will strengthen an 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

View a sample agenda.

Faculty:

  • Ada Sue Selwtiz, MA
  • Susan Kornetsky, MPH

What Does it Mean to Represent the Community?
Wednesday, October 26
What Does it Mean to Represent the Community? was a full-day program that focused on the role of non-scientific and unaffiliated members (community members) on institutional review boards (IRBs). The morning session provided a review of the history of research, how abuse has shaped federal regulations governing human subjects research, and current accepted practice. In the afternoon, attendees participated in an exploration of the different communities engaged in research and how those communities impact the development and execution of research, including the role of the institutional, scientific, and communities. Special emphasis was placed on providing attendees with specific strategies for non-scientists reviewing protocols.

The highly-acclaimed faculty leading this course reviewed:

  • The basic regulatory requirements with which all IRBs must comply
  • The historical events that precede the regulatory requirements and how the requirements are modeled after the ethical principles of the Belmont Report
  • A model for understanding the role of the non-scientist and/or unaffiliated member on the IRB and managing that role
  • The other communities that impact the work of the IRB, including the role of the institutional community, the subject community, the scientific community, and the regulatory community

View a sample agenda.

Faculty:

  • Gigi McMillan
  • Don Workman, PhD