March 2012 Regional Meeting

Overview

On March 22-23, 2012, PRIM&R offered three highly acclaimed educational programs: Institutional Review Board (IRB) 101sm, IRB Administrator 101, and IRB 201. These programs took place at the Boston Westin Waterfront Hotel in Boston, MA.

IRB 101sm
Thursday, March 22, 8:15 AM-4:00 PM
IRB 101sm featured a series of lectures, interactive discussions, and case studies. The faculty members leading 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

Learn more by viewing the agenda.

Faculty:

  • Elizabeth Bankert, MA
  • Dean Gallant

IRB Administrator 101
Thursday, March 22, 8:30 AM-4:00 PM Friday, March 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 members:

  • 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.

Faculty:

  • Susan Z. Kornetsky, MPH
  • Ada Sue Selwitz, MA

IRB 201
Friday, March 23, 8:30 AM-4:00 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.

Faculty:

  • Jeffrey Cooper, MD, MMM
  • Susan Fish, PharmD, MPH