This easy-to-read reference book provides a practical approach for dealing with the legal and regulatory compliance issues involved in human research. Covering a broad range of topics, such as consent, confidentiality, subject recruitment and selection, the role of the investigator and Institutional Review Board, it offers timely and useful strategies for achieving regulatory compliance while reducing liability. In addition, insurance, quality management, accreditation, and risk management are topics examined in the book. The practical insights found in this volume are not found in other...

What Do I Say? Communicating Intended or Unanticipated Outcomes in Obstetrics will help physicians and other health care professionals improve their communication skills with patients and their family members. Written by James R. Woods, a perinatologist, and Fay A. Rozovsky, an attorney, risk management consultant, and authority on informed consent, What Do I Say? explores how to explain risk to patients, how to obtain patient consent, and how to talk with patients when adverse events occur. What Do I Say? is a comprehensive book that

• Explains consent as a...