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Description
Pragmatic Clinical Trials (PCTs) challenge traditional research ethics by intentionally integrating research and clinical care, prompting unique ethical and regulatory considerations. This webinar explores the distinct ethical paradigm governing PCTs compared to conventional clinical research, rooted in foundational principles like those outlined in the Belmont Report and Common Rule. The webinar also examines key issues including informed consent, data and safety monitoring, and data sharing, as well as institutional factors impacting PCT implementation. The webinar is designed for clinical and regulatory professionals seeking to balance ethical standards with the practicalities of achieving meaningful, real-world outcomes through clinical research.
Audience
Compliance Professionals, Faculty, IBC Administrators, Postdocs, Research Administrators, Students
Meet the Presenter
Stephanie Morain, PhD, MPH – Johns Hopkins University
Stephanie Morain is the Dracopoulos Rising Professor at the Berman Institute of Bioethics and Associate Professor in the Department of Health Policy and Management at the Johns Hopkins Bloomberg School of Public Health. Her research focuses on ethical issues when research is embedded into clinical care.
Challace Pahlevan-Ibrekic, MBE, CIP – Northwell Health
Challace Pahlevan-Ibrekic directs regulatory affairs for the Institute of Health System Science at Northwell Health. She oversees research compliance and champions ethical research practices, including pragmatic research and implementation science. With expertise in IRB leadership and policy, she ensures compliant research innovation.
