The Quality Improvement Program (QIP) is committed to providing on-going support and education to the Harvard Longwood Campus (Harvard Chan School, HMS, HSDM) research community on a variety of research related topics. The series runs during the academic year (September-May) remotely via Zoom.
Human research training refresher credit will be available at the HLC IRBs for those who attend three or more relevant sessions in an academic year.
Learn how to determine which type of IRB determination your study will receive. This presentation will cover Not Human Subjects Research and Exemption determinations as well as when reviews are conducted on an Expedited basis vs. by the Convened IRB (“Full Board” review). Additionally, we will touch on common road blocks (and how to avoid them), FAQs, recommendations, as well as students conducting human research.
October: Emergency Preparedness and Response: Approaches to Ensure Safety and Manage Risks for Human Research
Wednesday, October 23th, 12:00 PM-1:00 PM (EST)
Presenters: Kim Serpico, Associate Director of IRB Operations, HLC IRBs
There are a myriad of emergencies that investigators face while conducting their research, from natural and man-made disasters to cyberattacks and pandemics. Even in an emergency, protecting the safety, rights, and wellbeing of research participants is the top priority for researchers and the IRB alike. This session will explore considerations for human research-related emergency preparedness plans, including approaches to ensure safety and manage risks, staying compliant while needing flexibility, communication plans, impact to study logistics, study-specific contingency planning, and more.
Were you aware that investigators have responsibilities after they obtain IRB approval? Join us at this session to discuss what you should do in order to run a compliant and organized Human Research Study. Our session will cover what documentation to maintain, recommended logs and tools to use, and other tips to help stay compliant. Bring your questions!
November: Challenges and Best Practices in Conducting Human Research Outside of the U.S.
Tuesday, November 12th, 12:00 PM – 1:00 PM (EST)
Presenters: Delia Wolf Christiani, HSPH Associate Dean for Regulatory Affairs & Research Compliance
Conducting human research internationally involves several challenges, including varying regulations, cultural and language, healthcare needs and standard of care, and scientific/ethical review infrastructure. In this session, Dr. Delia Christiani will address emerging challenges faced by researchers and share innovative approaches and best practices to promote ethical conduct of research. Participants are encouraged to bring hypothetical and/or real-life examples/cases for discussion.
Do you have an idea for an education session not listed or would you like QIP to develop a customized session for your department, lab or class? Contact Alyssa Speier at aspeier@hsph.harvard.edu for more information or to submit a topic.
