Ethical decision‑making in clinical research extends beyond regulations—it requires sound judgment in the face of real‑world pressures, competing priorities, and complex participant needs.
In this panel discussion, experienced clinical research professionals explored common ethical dilemmas encountered in day-to-day research operations, including challenges in informed consent, participant safety, protocol deviations, and operational constraints.
Attendees gained insight into how ethical principles are applied in practice—not just documented in SOPs. Through practical examples and open dialogue, the panel illustrated how research teams can uphold participant rights, navigate gray areas, and maintain integrity while balancing regulatory expectations and operational realities.
Upon completion of this continuing education program, participants should be able to:
Describe the role of ethical principles in guiding decision-making in clinical research beyond regulatory requirements.
Identify common ethical challenges in clinical research operations, including those related to informed consent, participant safety, and protocol
Apply practical approaches to navigate ethical dilemmas and support participant rights while balancing regulatory and operational demands. deviations.
Speakers:
Jan Hewett, JD, Senior Vice President, FDA Regulatory Advisor, Advarra
Dee Tilley, RN, CGRN, CCRC, ACRP-MDP, ACRP-PM, FACRP, Clinical Research Nurse, Mercy Health St. Vincent Medical Center
Leslie Pimentel-Byatt, MSML, MBA, CCRC, PMP, FACRP, Director, Clinical Trials Operations, University of New Mexico Hospital
Julie Ozier, Senior Vice President for IRB Review, Advarra (Moderator)
