Applied Ethics in Today’s Clinical Research Landscape

Jan Hewett, JD
Senior Vice President, FDA Regulatory Advisor
Advarra

Jan Hewett joined Advarra as the Senior Vice President, FDA Regulatory Advisor in May 2025. Prior to joining Advarra, Jan served as Regulatory Counsel (Policy) at the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) – Office of Compliance (OC) – Office of Scientific Investigations (OSI) for ten years. Jan has also served as the Director of the Yale University Human Research Protection Program for three years and the Assistant Director and Director, University of Michigan Institutional Review Board (IRBMED) from 2004 – 2012. She has also served as a Senior Grants and Contracts Officer in Research and Technology Development Services (RTDS) at Georgetown University, and as Supervisor of Research Operations at the Lombardi Cancer Center at Georgetown. In addition, while at Georgetown, Jan was also a Phase I Clinical Research Nurse Specialist in Oncology, and Clinical Research Nurse Coordinator in the General Clinical Research Center (GCRC) in the Department of Pharmacology – Division of Clinical Pharmacology. an has served as a consumer representative member of the U.S. Food and Drug Administration’s Nonprescription Drugs Advisory Committee (NDAC) and has presented nationally and internationally on human research protection regulations. Trained as a registered nurse in her native Australia, Jan received her B.S.N. from Georgetown University School of Nursing and her J.D. from the University of Michigan Law School. She is co-author on a number of peer-reviewed articles in the areas of medicine, medical law, research results, Institutional Review Board, and Human Research Protection Program operations and regulatory requirements.

Dee Tilley, RN, CGRN, CCRC, ACRP-MDP, ACRP-PM, FACRP
Clinical Research Nurse
Mercy Health St. Vincent Medical Center

Dee Tilley, RN, CGRN, CCRC, ACRP-MDP, ACRP-PM, FARCP is a clinical research nurse for Bon Secours Mercy Health St. Vincent Medical Center. She has more than 25 years of research experience in Phase I-IV clinical trials, with a special interest in infectious disease, gastroenterology, and rare diseases. She obtained her CCRC certification in 2006, her ACRP-MDP subspecialty designation in 2019, and her ACRP-PM subspecialty designation in 2021. Dee received an associate degree in Nursing from the University of Toledo. She first became involved with ACRP by writing items for the CCRC exam in 2013, served as a committee member for the CCRC exam from 2014 to 2020 (including time as the committee Chair from 2018 to 2020), and participated in the creation of the ACRP-MDP exam. She is also certified with the Society of Gastrointestinal Nurses (SGNA) since 1991, was the founding president of the Maumee Bay Chapter of SGNA, and initiated the annual Gut-Together educational conference. She is dedicated to the process and oversight of ACRP.

Leslie Pimentel-Byatt, MSML, MBA, CCRC, PMP, FACRP
Director, Clinical Trials Operations
University of New Mexico Hospital

Leslie Byatt, MSML, MBA, PMP, CCRC, serves as Director of Clinical Trials Operations at University of New Mexico Hospitals, bringing over 30 years of clinical research leadership and project management experience. Her diverse background includes developing clinical trials administrative programs from the ground up, opening clinical research sites in Panama City, Panama, and serving in leadership roles at UNM Cancer Center as New Mexico Minority NCORP grant administrator and study activation/regulatory operations manager. Leslie’s project management expertise spans complex site operations and comprehensive program development. She collaborates with private practices, public hospitals, and academic sites to drive industry change and advance diversity in clinical trials. Leslie has contributed to multiple publications and abstracts on clinical trial operations and diversity, and served leadership roles with ASCO’s Clinical Research Committee, the Association of Cancer Institutes’ Steering Committee, and serves as a member of ACRP’s board of trustees.

Moderator: Julie Ozier, Senior Vice President for IRB Review, Advarra