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Navigating the Regulatory Maze When Proposing Study Visits in Participant Homes (D08)

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Mitchell Parrish, JD, RAC, CIP – H Clinical ### 25716###Speaker###President###H Clinical###
Speaker: Mitchell Parrish, JD, RAC, CIP – H Clinical
@@@ Brenda Ruotolo, CIP – Columbia University in the City of New York ### 10698###Speaker###Associate Vice President for Human Research Protection###Columbia University in the City of New York###
Speaker: Brenda Ruotolo, CIP – Columbia University in the City of New York
@@@ Natalie M. Klein, PhD, CIP – DHHS Office for Human Research Protections ### 1135058###Resource Person###Director, Division of Policy and Assurances###DHHS Office for Human Research Protections###
Resource Person: Natalie M. Klein, PhD, CIP – DHHS Office for Human Research Protections
D08
Never Let a Crisis Go to Waste: Lessons Learned from the COVID-19 Pandemic for Clinical Research

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Ann Johnson, PhD, MPH, CIP – University of Utah ### 298549###Speaker###Director, Institutional Review Board & Human Research Protection Program###University of Utah###
Speaker: Ann Johnson, PhD, MPH, CIP – University of Utah
@@@ Walter L. Straus, MD, MPH – Moderna ### 11111###Speaker###Vice-President | Safety###Moderna###
Speaker: Walter L. Straus, MD, MPH – Moderna
@@@ Kevin B. Bugin, MS, PhD, RAC – Office of New Drugs, CDER/FDA ### 1483809###Speaker###Deputy Office Director###Office of New Drugs, CDER/FDA###
Speaker: Kevin B. Bugin, MS, PhD, RAC – Office of New Drugs, CDER/FDA
New Guidelines for Human Stem Cell-Related Research—Implications for IRBs and Institutions (D09)

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Insoo Hyun, PhD – Harvard Medical School ### 1402289###Speaker###Director of Research Ethics###Harvard Medical School###
Speaker: Insoo Hyun, PhD – Harvard Medical School
@@@ Rosario Isasi, JD, MPH – University of Miami ### 1402290###Speaker###Research Associate Professor of Human Genetics###University of Miami###
Speaker: Rosario Isasi, JD, MPH – University of Miami
@@@ Jeremy Sugarman, MD, MPH, MA – Johns Hopkins University ### 10037###Speaker###Harvey M. Meyerhoff Professor of Bioethics and Medicine###Johns Hopkins University###
Speaker: Jeremy Sugarman, MD, MPH, MA – Johns Hopkins University
D09
NIH's New Data Management and Sharing Policy—How Academic Medical Centers Can Prepare for January 2023 (F09)

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Taunton Paine, M.A./M.Sc. – National Institutes of Health ### 1402308###Speaker###Director, Scientific Data Sharing Policy Division###National Institutes of Health###
Speaker: Taunton Paine, M.A./M.Sc. – National Institutes of Health
@@@ Sara M. Samuel – University of Michigan ### 1402307###Speaker###Informationist, Taubman Health Sciences Library###University of Michigan###
Speaker: Sara M. Samuel – University of Michigan
@@@ Cindy Danielson, PhD – National Institutes of Health ### 1452437###Resource Person###Associate Director, Systems Integration, OER Office of Research Reporting and Analysis###National Institutes of Health###
Resource Person: Cindy Danielson, PhD – National Institutes of Health
F09