2016 Webinar: Tools, Templates, and Checklists for Streamlining IRB Protocol Review

View the webinar recording:


Overview

One of the primary responsibilities of the IRB administrator is to facilitate and streamline protocol review, in accordance with federal requirements for protecting human subjects. With the right tools, templates, and checklists, administrators can do so efficiently and in compliance with applicable regulatory requirements.

Using examples from typically challenging areas of protocol review, the presenters will demonstrate how to identify, develop, and successfully implement targeted tools, templates, and checklists. Areas that were covered included:

  • Screening of protocols upon receipt to determine submission completeness and the level of review required
  • Facilitating IRB member reviews
  • Using meeting minutes to document IRB determinations. [Consideration will be given to the new jointly released draft guidance from FDA and DHHS on IRB meeting minutes]
  • Developing IRB correspondence to communicate IRB inquiries or determinations

What will I learn?

After attending this webinar, attendees were able to:

  • Take advantage of tools, templates, and checklists to improve the protocol review process, and adapt pre-existing tools to fit their institution’s needs
  • Understand the benefits and shortcomings of using checklists and templates in the IRB review process

Who should attend?

This intermediate-level webinar benefited IRB administrators who facilitate the review of biomedical and/or social, behavioral, and educational research (SBER) and wish to capitalize on the use of tools for developing systematic, defensible review processes at their institutions.

Faculty

Sharon FreitagSharon Freitag began her career as a researcher with the Government of the Northwest Territories (GNWT). She was instrumental in the development of the NWT Cancer Registry. Subsequently, Sharon became the health statistician for the GNWT, where she was responsible for the operations of the Community Health Management Information System. In 2000, Sharon joined the University Health Network in Toronto as a research assistant responsible for recruitment and data collection on a large multi-center study. In 2003, Sharon joined St. Michael’s Hospital in the newly created role of Research Ethics Coordinator. In 2008, Sharon was elected to the board of directors of the Canadian Association of Research Ethics Boards (CAREB) and served as president from 2010 to 2012. Sharon has also been involved with PRIM&R, serving on a number of committees. In 2010, Sharon was appointed director of the Research Ethics Office. Sharon represented CAREB at the Senate hearings on Canada’s Clinical Trial Infrastructure, and Canadian General Standards Board development of standards for REBs reviewing clinical trials. In 2012, Sharon was appointed chair of the CIHR External Advisory Committee for the Streamlining of Health Research Ethics Review in support of the Strategy for Patient Oriented Research. Sharon is also a member of the Clinical Trials Ontario Research Ethics Advisory Group and of the Canadian Clinical Trials Coordinating Centre Advisory Group. Sharon graduated with a BSc from the University of Alberta, majoring in genetics. She has also completed training at Rotman School of Management, University of Toronto.

Megan Kasimatis SingletonMegan Kasimatis Singleton, JD, MBE, CIP, is the associate director of the IRB at the University of Pennsylvania (UPenn). In this role she is responsible for oversight and direction of the staff that support Penn's nine IRBs; serves as a regulatory representative during the convened meetings; and assists in the development and presentation of educational initiatives for IRB staff, members, and the research community. She also serves as the IRB liaison to the University's Conflicts of Interest Standing Committee and the HIPAA research privacy officer. Ms. Singleton is a licensed attorney in Pennsylvania. She earned her law degree from Temple University and her Masters in Bioethics from UPenn.

Certificates of Attendance

Certificates of attendance will be 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.

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 this webinar 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.

Contact Information

If you have additional questions about webinar archives, please contact us by phone (617.423.4112, ext. 1876) or via email.