The Center for Bioethics and the Human Research Protection Program together offered this Zoom-based event where panelists reflected on how their teams have navigated the conduct, oversight, or support of human research during the COVID-19 pandemic, and how their experiences may promote practical improvements in human subjects protections or signal changes in the post-pandemic environment. Followed by their presentations, there was a Q and A.
Assessing Capacity to Consent and Obtaining Informed Consent Remotely
Abbey Staugaitis, RN, MSN, CCRC, Program Manager, ACRC, U of MN SIREN HUB Manager, StrokeNet RCC 18 Program Manager, Dept of Emergency Medicine, U of MN
FDA Guidance Regarding Emergency Use Authorizations and the Use of Investigational Products During the Pandemic
Harvey M. Arbit, PharmD, MBA, President and CEO of Arbit Consulting, a firm that provides drug and medical device regulatory strategy and support for industry, academia, and investigator-initiated clinical research. He is adjunct professor at the University of Minnesota, College of Pharmacy, and adjunct professor at Albany College of Pharmacy and Health Sciences.
Engaging Non-English Speaking Participants and Families Remotely
Idolly F. Oliva, MBA, Director Language Services, M Health Fairview