In this presentation, Robert Romanchuk, Vice Chair at Schulman IRB, seeks to simplify the HUD topic, distinguishing humanitarian devices from investigational devices and drugs and identifying key issues and best practices in the review and use of HUDs.
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- Robust Q&A with webinar presenter
- Online archive of all recorded webinars
Schulman is committed to sharing our experience and expertise with the research community, promoting professional development, discussion and collaboration.
Webinar presentations offer expert content on a variety of IRB-related topics, including industry trends, regulatory details and IRB processes.
Schulman’s webinars are a great way to support existing training programs. Certificates of attendance are available for each live presentation. The webinars may be eligible for continuing education credits—check with your individual certifying organization for more information.
Luke Gelinas, Petrie-Flom Center/Harvard Catalyst Fellow in Clinical Research Ethics at Harvard Law School, discusses a practical framework for evaluating offers of payment and provides guidance on challenging ethical and regulatory issues involved in paying research subjects.
Schulman IRB’s Biosafety Officer Daniel Eisenman discusses the IBC’s role in ensuring research involving genetic engineering is conducted safely and responsibly.
Michele Russell-Einhorn, VP of Human Subject Protection Services and Institutional Official at Schulman IRB, discusses recent federal initiatives for single IRB review and their impact on the way sponsors, CROs and institutions conduct research.
Schulman IRB Vice Chair Nathan Lee discusses the specific OHRP and FDA regulations regarding research in pediatric populations and their impact on proposed pediatric research.
Product Safety Analyst Tricia Henson discusses the drug and device documents that must be submitted to the IRB during initial review and throughout the study.
IRB Member Danielle Macario delves into the various regulatory paths for devices, how those paths impact the regulations devices are subject to, and IRBs review device studies.
Presenters measure the NPRM’s changes against historical events and personal experiences to determine whether these updates provide improved human subject protections.
In this webinar, Eli Alford, COO at Schulman IRB, discusses how to thoughtfully use and report metrics in clinical research.
This webinar explores how IRBs review this type of recruitment material and the basics of using digital and social media in recruiting study participants.
Andrea Bidwell, IRB member at Schulman IRB, reviews the regulatory definitions of research, research involving human subjects, exempt research and expedited research.
In this webinar, Michael Linke, IRB Chair at the University of Cincinnati, describes the experience of establishing the NIH StrokeNet Central IRB.
Ernest Prentice, Institutional Official at the University of Nebraska Medical Center, reviews the evolution of ethics & regulation in human research.