May 2006 Regional Meeting

Overview

PRIM&R sponsored a 2½ day program that was geared specifically to the educational needs of the IRB member, administrator, and staff. The program included two existing and highly acclaimed educational courses: IRB Administrator 101and IRB 201. Registrants had the option to attend the entire course from May 1-3, or to select only one of the educational programs being offered.

IRB Administrator 101
Monday, May 1, 12:00 – 4:00 PM
Tuesday, May 2, 8:30 AM–4:00 PM
IRB Administrator 101 is 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, IRB Administrator 101 includes:

  • Identification of the key components of human research protection programs
  • Examination of the primary responsibilities of administrators
  • A review of the strategies and policies for developing and/or strengthening your institution’s human research protection program

IRB Administrator 101 highlights 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

Download the IRB Administrator 101 Program.

IRB 201
Wednesday, May 3, 8:30 AM – 4:00 PM
IRB 201 has been designed for IRB members and staff who understand the fundamentals of IRB operations and who are now interested in obtaining the next level of training. Participants gain the knowledge and skills needed both to serve as effective IRB reviewers and to teach others to become effective IRB reviewers. Note that this course does not cover administrative issues.
IRB 201 highlights 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

Download the IRB 201 Program.

Faculty

  • Jeffrey A. Cooper, MD, MMM
  • Helen McGough, MA, CIP
  • Ada Sue Selwitz, MA