May 2008 Regional Meeting

Overview

On May 5-7, PRIM&R sponsored a 2 ½-day program that geared specifically to the educational needs of Institutional Review Board (IRB)/Human Research Protection Program (HRPP) members, administrators, and staff.  This program included three highly acclaimed educational courses: IRB 101sm, IRB Administrator 101, and IRB 201.

IRB 101smMonday, May 5, 8:30 AM–4:00 PM
IRB 101sm covered 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 learned:

  • 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 for IRB 101sm:

  • Elizabeth Banket, MA
  • Jeffrey Cohen, PhD, CIP

Download the IRB 101sm program.

IRB 201
Tuesday, May 6, 8:30 AM–5:00 PM
IRB 201 was a one-day workshop 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.  IRB 201 highlighted key criteria for 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 Cohen, PhD, CIP
  • Bruce Gordon, MD

Download the IRB 201 program.

IRB Administrator 101
Tuesday, May 6, 8:30 AM–4:00 PM
Wednesday, May 7, 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, this course:

  • 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 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 for IRB Administrator 101:

  • Elizabeth Bankert, MA
  • Susan Z. Kornetsky, MPH, CIP

Download the IRB Administrator 101 program.