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.

In his fascinating new book, Jonathan D. Moreno investigates the deeply intertwined worlds of cutting-edge brain science, U.S. defense agencies, and a volatile geopolitical landscape where a nation's weaponry must go far beyond bombs and men. The first-ever exploration of the connections between national security and brain research, Mind Wars: Brain Research and National Defense reveals how many questions crowd this gray intersection of science and government and urges us to begin to answer them. From neuropharmacology to neural imaging to brain-machine interface devices that relay images and sounds between human brains and machines, Moreno shows how national security entities seek to harness the human nervous system in a multitude of ways as a potent weapon against the enemy soldier. Moreno charts such projects as monkeys moving robotic arms with their minds, technology to read the brain’s thought patterns at a distance, the development of "anti-sleep" drugs to enhance soldiers’ battle performance and others to dampen their emotional reactions to the violence, and advances that could open the door to "neuroweapons"—virus-transported molecules to addle the brain. "As new kinds of weapons are added to the arsenal already at the disposal of fallible human leaders," Moreno writes, "we need to find new ways to address the problem"--of the ethical military application of so powerful and intimate a science. This book is the first step in confronting the quandaries inherent in this partnership of government and neuroscience, serves as a compelling wake-up call for scientists and citizens, and suggests that, with imagination, we might meet the needs of both security and civil liberty.

Timely and provocative essays on bioethical questions brought to the forefront by the bioterrorist threat. The war on terrorism and the threat of chemical and biological weapons have brought a new urgency to already complex moral and bioethical questions. In the Wake of Terror presents thought-provoking essays on many of the troubling issues facing American society, written by experts from the fields of medicine, health care policy, law, political science, history, philosophy, and theology. One of the first potential casualties of catastrophic circumstances is civil liberties. In the past, medical experiments conducted for national security purposes have violated ethical standards, and this book questions whether current policy provides sufficient safeguards against further abuses. It also focuses on public health issues, offering contrasting views on the extent to which civil authorities should be allowed to restrict freedom of movement in the name of national security and debating whether aggressive public health interventions improve public confidence and cooperation or detract from them. A major area of concern is preparedness for future terrorist attacks. Chapters are devoted to ethical issues involved in the development, distribution, and rationing of vaccines and antidotes; resource allocation and medical triage; the moral duties of emergency health workers and other first responders; and the obligations of private entities such as managed care organizations and pharmaceutical companies. Contributors also address the implications of terrorism for our health insurance system and the role of genetic advances in bioterrorism. Underlying all of these issues, the authors argue, is the need to maintain a spirit of social solidarity, which can in turn only be achieved if preparations are publicly acknowledged and generally regarded as both prudent and fair.