Her name was Henrietta Lacks, but scientists know her as HeLa. She was a poor Southern tobacco farmer, yet her cells--taken without her knowledge--became one of the most important tools in medicine. The first "immortal" human cells grown in culture, they are still alive today, though she has been dead for more than sixty years. HeLa cells were vital for developing the polio vaccine; uncovered secrets of cancer and viruses; helped lead to in vitro fertilization, cloning, and gene mapping; and have been bought and sold by the billions. Yet Henrietta Lacks is buried in an unmarked grave. Her family did not learn of her "immortality" until more than twenty years after her death, when scientists began using her husband and children in research without informed consent. The story of the Lacks family is inextricably connected to the dark history of experimentation on African Americans, the birth of bioethics, and the legal battles over whether we control the stuff we are made of--From publisher description.

All investigators funded by the National Institutes of Health are now required to receive training about the ethics of clinical research. Based on a course taught by the editors at NIH, Ethical and Regulatory Aspects of Clinical Research is the first book designed to help investigators meet this new requirement. The book begins with the history of human subjects research and guidelines instituted since World War II. It then covers various stages and components of the clinical trial process: designing the trial, recruiting participants, ensuring informed consent, studying special populations, and conducting international research. Concluding chapters address conflicts of interest, scientific misconduct, and challenges to the IRB system. The appendix provides sample informed consent forms. This book will be used in undergraduate courses on research ethics and in schools of medicine and public health by students who are or will be carrying out clinical research. Professionals in need of such training and bioethicists also will be interested.

This book analyzes the major issues of research ethics through a careful review of the treatment in official policies on research ethics developed throughout the world (especially North America, Western Europe, and the Pacific Rim). Among the issues covered are animal research, research on human subjects, epidemiological research, genetic research, reproductive research, research on vulnerable subjects, clinical trials, drug approval and the research process, and research on women and minorities. Brody also evaluates the content and the methods of developing these policies in light of his philosophical position of pluralistic casuistry. This is the only book that analyzes all the major issues in research ethics. It is the only book which deals with these issues from an international perspective rather than just a US perspective. Major official policies from important research-intensive countries are reprinted in the appendix (close to 200 plates of otherwise difficult material).