May 2013 Regional Meeting

Overview

On May 15-17, 2013, PRIM&R offered three educational programs:  Institutional Review Board (IRB) Administrator 101, Consent: Processes, Criteria, and Considerations for Obtaining Informed Consent, and IRB 201: An In-Depth Analysis of the Criteria for Review. These programs were hosted by Wake Forest School of Medicine in Winston-Salem, North Carolina.

IRB Administrator 101
May 15, 2013: 8:30 AM - 4:00 PM
May 16, 2013: 8:30 AM - 12:30 PM
IRB Administrator 101 is a one and a half day program, specifically geared toward new administrators, those in need of a “refresher” course, and anyone interested in learning more about IRB operations. The curriculum for IRB Administrator 101 includes the identification of the key components of human research protection programs (HRPPs), an examination of the primary responsibilities of administrators, and a review of strategies and policies for developing and/or strengthening an institution’s HRPP.

For more information, please view the agenda.

Faculty:

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

Consent: Processes, Criteria, and Considerations for Obtaining Informed Consent
May 16, 2013: 8:30 AM – 4:30 PM
Consent: Processes, Criteria, and Considerations for Obtaining Informed Consent provided participants with an opportunity to understand the distinction between the process of informed consent and the documentation requirements for the consent form. Regulatory requirements and regulatory flexibility were emphasized in order to empower participants to use all available options for achieving informed consent in a manner that reduces participant and researcher burden. Special topics addressed included: parental permission, assent of research participants, exceptions to informed consent, and cross-cultural issues. Participants had an opportunity to apply their new-found knowledge through case studies and an interactive working session.

For more information, please view the agenda.

Faculty:

  • Moira Keane, MA, CIP
  • Daniel K. Nelson, MSc, CIP

IRB 201: An In-Depth Analysis of the Criteria for Review
May 17, 2013: 8:30 AM - 4:30 PM
IRB 201 provided the knowledge needed to become experienced IRB chairs, members, and staff. This educational program included information directly relevant to IRB chairs, members, and staff who conduct reviews as part of a convened IRB or through the expedited procedure. This course was designed for IRB members and staff who understand the fundamentals of IRB operations and are now interested in obtaining the next level of training. By attending IRB 201 participants gained the knowledge and skills they need to both serve as effective IRB reviewers and teach others to become effective IRB reviewers. For more information, please view the agenda.

Faculty:

  • Elizabeth Bankert, MA
  • Jeffrey Cooper, MD, MMM

Certificates of Attendance

Certificates of Attendance for IRB Administrator 101, Consent: Processes, Criteria, and Considerations for Obtaining Informed Consent, and IRB 201: An In-depth Analysis of the Criteria for Review were provided upon completion of the program evaluation. Such certificates are useful for obtaining continuing education (CE) credits (not continuing medical education credit) from professional associations. Note that guidelines around CE credits may differ, and you should consult the appropriate professional association representative for further guidance.

IRB 201 participants holding the Certified IRB Professional (CIP®) credential and wish to apply credits from IRB 201 toward CIP recertification  may submit the Certificate of Attendance as documentation of participation. Participation in this program counts as 6.5 CE credit hours.

Credit hours per program:
IRB Administrator 101: 9.75 CE Hours
Informed Consent: 6.5 CE Hours
IRB 201: 6.5 CE Hours