TY - CHAP M1 - Book, Section TI - Clinical Trials A1 - Iyer, Aarthi B. A1 - Poppenk, Jessica Huening A1 - Francis, Michelle A2 - Quang, Tony S. A2 - Taft, Michelle S. A2 - Beriwal, Sushil PY - 2022 T2 - Understanding the Principles and Practice of Legal Oncology AB - Medical malpractice lawsuits are a common domain among plaintiff’s attorneys in clinical care. While human subjects research does contain some parallels to clinical care, litigation in clinical trials has stemmed from an array of legal claims including lack of informed consent, products liability, fraud, battery, infliction of emotional distress, breach of patients’ rights protected by state law, violation of federal regulations, and violation of civil rights protected under the constitution.1 Layering on top of the actual claims is the breadth of individuals and institutions against which lawsuits have been commenced. Cases have been brought against universities, academic medical centers, hospital systems, investigators, clinical trial sponsors, institutional review board (IRB) members, and bioethicists.2,3 SN - PB - McGraw Hill Education CY - New York, NY Y2 - 2024/04/16 UR - hemonc.mhmedical.com/content.aspx?aid=1191393117 ER -