Klote Medical Research Advisors, LLC
Great Falls, VA
Molly Klote, MD is the President & CEO of Klote Medical Research Advisors, LLC. She is the former Director of the US Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP). Dr. Klote is a proud graduate of James Madison University in Virginia where she graduated with a degree in Computer Information Systems and through ROTC was commissioned in the US Army as a military intelligence officer. She then attended the Uniformed Services University of the Health Sciences in Maryland, where she earned her medical degree and became an Army doctor. Dr Klote had a distinguished 30 year career in the US Army including a tour in Iraq. Her final assignment in the Army was as the Director of the Army Human Research Protections Office in the Office of the Army Surgeon General. In this capacity, she oversaw all Army policy and compliance related to academic, biomedical, socio-behavioral, and engineering human research. After retirement from the Army Dr Klote joined the Office of Research & Development at the Veterans Health Administration (VHA) Central Office where she served as a Senior Executive overseeing research policy, regulatory, and education for the the largest integrated healthcare system in the United States. At VHA, she oversaw the implementation of a single electronic research management system at 110 medical centers, oversaw the creation of the community panel of the Central IRB, and created an electronic determination aid. Additionally, Dr. Klote has served as an Instiutional Official, directed two major research program offices, chaired three Institutional Review Boards, led a Research Scientific Review Board, and has particpated in two clinical trials. She held the CIP certification during the time she was eligible to do so.
B02 - Navigating the New Frontier: IRB Challenges with Complex Innovative Trial Designs
Friday, November 7, 2025
1:45 PM - 3:00 PM ET