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.

Undue Risk is an unprecedented and chilling history of the use of human subjects in atomic, biological, and chemical warfare experiments by the U.S. government from World War II to the present. Jonathan Moreno, a senior researcher on the president's special commission, goes where few researchers have gone before, exploring secret government documents which reveal a plethora of government experiments. He exposes startling details of experiments like those involving the exposure of soldiers to atomic blast fallout and secret LSD and mescaline experiments. From the courtrooms of Nuremberg to the battlefields of the Gulf War, Undue Risk exposes a variety of government policies and specific cases, including plutonium injections to unwilling hospital patients, and even the attempted recruitment of Nazi medical scientists by the U.S. government after World War II. New to the paperback edition, this exciting read covers recent objections by U.S. military personnel to required anthrax vaccinations and new developments in government policies on experiments involving vulnerable human subjects.

""Impromptu Man captures the remarkable impact of a singular genius, J.L. Moreno, whose creations-the best-known being psychodrama-have shaped our culture in myriad ways, many unrecognized. The record will be set straight for all time by this can't-put-down biography, a tribute by Jonathan D. Moreno to his father's masterly legacy." -DANIEL GOLEMAN, author of Emotional Intelligence: Why It Can Matter More Than IQ J.L. Moreno (1889-1974), the father of psychodrama, was an early critic of Sigmund Freud, wrote landmark works of Viennese expressionism, founded an experimental theater where he discovered Peter Lorre, influenced Martin Buber, and became one of the most important psychiatrists and social scientists of his time. ?? A mystic, theater impresario and inventor in his youth, Moreno immigrated to America in 1926, where he trained famous actors, introduced group therapy, and was a forerunner of humanistic psychology. As a social reformer, he reorganized schools and prisons, and designed New Deal planned communities for workers and farmers. Moreno's methods have been adopted by improvisational theater groups, military organizations, educators, business leaders, and trial lawyers. His studies of social networks laid the groundwork for social media like Twitter and Facebook. ?? Featuring interviews with Clay Shirky, Gloria Steinem, and Werner Erhard, among others, original documentary research, and the author's own perspective growing up as the son of an innovative genius, Impromptu Man is both the study of a great and largely unsung figure of the last century and an epic history, taking readers from the creative chaos of early twentieth-century Vienna to the wired world of Silicon Valley. Jonathan D. Moreno, called the "most interesting bioethicist of our time" by the American Journal of Bioethics, is a professor at the University of Pennsylvania and a Senior Fellow at the Center for American Progress. "--

"A major figure argues that the creation of bioethics was dependent on the rise of the post-WWII liberal democratic order and muses on the fate of the field, should that order fall"-- Provided by publisher.