Acad Med 2021 Sep 21. Epub 2021 Sep 21.
D.F. Stiles is vice president, Research Operations, and policy and chief operating officer, Office of the Executive Vice President for Research, Columbia University, New York, New York; ORCID: https://orcid.org/0000-0001-9845-6804. B.L. Ruotolo is associate vice president, Human Research Protection, Columbia University, New York, New York. H. Kim is associate vice president, Clinical Trials, Columbia University, New York, New York. J. Cho is associate director, Regulatory Science, Clinical Trials Office, Columbia University, New York, New York. P.S. Appelbaum is Elizabeth K. Dollard Professor of psychiatry, medicine, and law, Department of Psychiatry, Columbia University Irving Medical Center, New York, New York; ORCID: https://orcid.org/0000-0002-1940-0042. N.S. Green is professor, Department of Pediatrics, and associate dean, Faculty Operations, Columbia University Irving Medical Center, New York, New York; ORCID: https://orcid.org/0000-0002-9877-1561.
By March 2020, New York City became the early epicenter of the COVID-19 pandemic in the United States. Consequently, Columbia University, with its large portfolio of human subjects research, had to address the challenges of protecting thousands of research participants and research staff from potential exposure to COVID-19 while facilitating essential biomedical research, especially pandemic-related studies. The authors describe, from the perspective of Columbia's research administration leadership, how the university and its primary teaching hospital ramped down-and later ramped up-human subjects research, and reflect on the lessons learned. Read More