2013 Webinar: Quality Assurance/Quality Improvement

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Overview

This webinar provided information about the progression of quality assurance/quality improvement (QA/QI) study reviews, beginning with the selection of the study or focus for review, continuing through the process of reviewing the institutional review board (IRB) or the investigator, and concluding with possible uses for the results.

Topics for discussion included:

  • Introducing different types of QA/QI reviews and selecting studies for site visits:
    Presenters focused on the role of the IRB in general or topic-specific reviews and the responsibilities of the investigator and research staff in routine and for-cause site visits.
  • Reviewing the IRB:
    Our speakers discussed when review of the IRB should be conducted, and what specifically needs to be reviewed, by whom, and how frequently.
  • Reviewing the investigator:
    What happens during a site visit? Presenters covered investigator interviews, record reviews, exit briefings, and opportunities for investigator education, and other research compliance areas.
  • Assessing and handling the results:
    Our speakers discussed lessons learned and ways to use the feedback from completed reviews to improve the human research protection program (HRPP) as a whole.

Audience

This special webinar may be of interest to individuals working in human subjects protections, specifically, in QA/QI, HRPPs, and IRBs.

Faculty

Kristen Burt, JD
Kristen Burt is the interim director of the Michigan State University human research protection program (HRPP). Kristen has performed case management of human research projects, led MSU’s application processes to AAHRPP, and coordinated institutional review board (IRB) education programs since joining the MSU IRB office in 2001. Ms. Burt currently leads policy and planning initiatives within the office of regulatory affairs and is presently serving as the director of the HRPP. Kristen Burt obtained a BS in human biology and a BA in general business administration from Michigan State University (MSU) and a JD from the MSU College of Law.

Eunice Yim Newbert, MPH
Eunice Yim Newbert has served as manager of the Education and Quality Improvement Program (EQuIP) at Boston Children’s Hospital since the program’s establishment in 2003. Her responsibilities include initiating and overseeing EQuIP’s efforts, which aim to ensure the protection of human subjects through the ongoing review and education of all research sectors at Boston Children’s Hospital, including the principal investigator and research staff, the IRB, and the human subject. Newbert began her career as a clinical research coordinator at the University of Chicago Medical Center in Chicago, IL, and at the Asthma Research Center with BWH in Boston, MA. After receiving her master’s degree in public health with a concentration in epidemiology and biostatistics, she worked as a senior research associate for Prevention Sciences, Inc. before finally joining Boston Children’s Hospital.

Certificates of Attendance

Certificates of Attendance for the QA/QI: Study Review from Conception to Completion webinar were made available at the conclusion of the webinar. To access the certificate, you must first complete the online evaluation. Such certificates are useful for obtaining continuing education (CE) credits (not Continuing Medical Education credits) from professional associations. Note that guidelines concerning CE credits may differ, and you should consult the appropriate professional association representative for further guidance.

CE Credit for Certified IRB Professional (CIP®) Recertification 
Webinar participants holding the CIP credential who wish to apply credits from QA/QI: Study Review for Conception to Completion toward CIP recertification may submit the Certificate of Attendance they received upon completing the online evaluation as documentation of their participation. Participation in this 90-minute webinar counts as 1.5 CE credit hours.

For recertification by CE, CIPs must complete 30 documented hours of continuing education. At least 15 of the 30 hours must either carry credits issued by a recognized accrediting body or have received advanced recognition from the Council for Certification of IRB Professionals (CCIP). Credits from PRIM&R webinars have received such advance recognition, and may be counted towards these 15 hours.

Additional information about CIP recertification can be found here.