This session explores the intersection of research compliance and billing ethics, focusing on what it truly takes to ensure informed consent regarding patient care costs in clinical research. We will examine how well Clinical Research Coordinators (CRCs) understand and explain cost obligations to participants, including when to address questions themselves versus when to involve other experts. The discussion will clarify what the informed consent form (ICF) and Medicare Coverage Analysis (MCA) actually communicate, how subject‑injury language and potential financial risks are conveyed, and whether IRBs fully grasp these implications for participants. Attendees will leave with practical strategies to clearly articulate cost responsibilities and educate patients without discouraging study enrollment.
• Tanisha LaVeck - Clinical Research Financial Analyst - Holy Cross Hospital – Research Department
• Karen (Kaye) Mottola - Senior Program Manager - Boston Medical Center
• Whit Sanders - Manager Clinical Research - Mercy Research