2014 Webinar - Central IRBs

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Overview

The use of central institutional review boards (IRBs) is on the rise, and there is increasing pressure to conduct study review using centralized mechanisms (for example, the National Institutes of Health is now offering funding priority for the use of centralized IRB review for some grants). Research protection professionals being asked to respond to the growing mandate to use central IRBs must be educated about the different models of centralized review, the technicalities of working with a central IRB, and the implications of centralizing review. This webinar covered the following topics:

  • Central IRBs as a formal mechanism for review and the different central IRB models
    Presenters will identify the different central IRB models (e.g., share and non-share models, etc.) outlining the distinct characteristics and the respective institutional and IRB responsibilities for each model.
  • The logistics of using a central IRB, and the potential implications for your institution
    With a focus on the ways that the respective responsibilities of the institution and the central IRB need to be codified in reliance agreements, this part of the presentation will also discuss the most challenging areas of reliance agreements, such as noncompliance, adverse events, and compensation for research injury. Presenters will provide insight on setting up operations in the IRB office.
  • Benefits and costs of central IRBs
    Is using a central IRB in fact more cost-effective and efficient? Where would cost-effectiveness and efficiency manifest most prominently? Presenters will shed light on the costs and benefits of utilizing central IRB review and provide tools to conduct this assessment at your institutions.

Audience
This intermediate-level webinar was of interest to IRB chairs, directors, staff, and members, as well as institutional officials.

Faculty

Emily Chi Fogler, JD, is senior legal counsel in the Office of General Counsel at Partners HealthCare System (Boston, MA), which includes Massachusetts General Hospital and Brigham and Women’s Hospital. At Partners, she has been practicing for over ten years in the areas of human subject research, IRB, and HIPAA-related research matters, including issues arising in industry-sponsored clinical trials and in health care quality measurement and other data-sharing initiatives. Previously, she was an associate at Ropes & Gray LLP, and a law clerk to the Hon. Patti B. Saris of the U.S. District Court for the District of Massachusetts. Ms. Fogler is a graduate of Harvard Law School, where she was an executive editor of the Harvard Law Review.

Elizabeth Hohmann, MD, is IRB chair, and physician director of the Partners HealthCare Human Research Committees covering Massachusetts General Hospital (MGH) and Brigham and Women’s Hospital, two of the major teaching hospitals of Harvard Medical School in Boston, MA. She is an associate professor of medicine in the Infectious Disease Division at MGH, and has research interests in “first in human” translational research and live attenuated bacterial vaccines.

P. Pearl O'Rourke, MD, is the director of human research affairs at Partners HealthCare in Boston, MA, and is an associate professor of pediatrics at Harvard Medical School. She is responsible for the systems that support the regulatory and ethical oversight of human research and the responsible conduct of research. She is also chair of the Partners HealthCare Embryonic Stem Cell Research Oversight Committee. Dr. O'Rourke has worked as a pediatric critical care physician at Boston Children’s Hospital and at Seattle Children’s Hospital, where she was the director of the Pediatric Intensive Care Unit. She was active in clinical research in extracorporeal membrane oxygenation, liquid ventilation, high frequency ventilation, and pediatric resuscitation. From 1995 to 1996, Dr. O'Rourke completed a Robert Wood Johnson Foundation Health Policy Fellowship working for Senator Edward Kennedy. She then became the deputy director of the Office of Science Policy in the Office of the Director at NIH, where she worked on issues such as privacy, gene therapy (transfer), embryonic stem cells, and genetic discrimination. Dr. O'Rourke is a member of PRIM&R's Board of Directors, having previously served as Board chair.

Certificates of Attendance

Certificates of attendance for the Central IRBs: Models, Logistics, and Implications webinar were 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.

If you would like to receive a certificate of attendance for a previous PRIM&R educational program, please email info@primr.org or call 617.423.4112, ext.0.

CE Credit for Certified IRB Professional (CIP®) Recertification
Webinar participants holding the CIP credential who wish to apply credits from Central IRBs: Models, Logistics, and Implications 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, of which at least 15 must carry CE credits issued by a recognized accrediting body. Credits from PRIM&R webinars do not count as credits issued by a recognized accrediting body.

Additional information about CIP recertification can be found here.