Writing clinical research protocols : ethical considerations / Evan G. DeRenzo and Joel Moss.

Amsterdam ; Boston : Elsevier/Academic, [2006], ©2006.

xix, 300 pages ; 23 cm

Includes bibliographical references (p. 273-280) and index.

Includes web resources.

Introduction to the art and science of clinical research -- What you need to know about clinical research ethics -- What you need to know about the regulation of clinical research -- Designing a clinical research study -- Selecting subjects for clinical studies -- Risks and benefits in clinical research -- Recruiting subjects -- Informed consent -- Privacy and confidentiality -- The "ethics" section -- Procedures and methods -- Statistics, data collection and management, and record keeping -- Use of human biological materials -- Special issues raised by evolving areas of clinical research -- Case histories : learning from experience.