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.

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.

In recent decades, American medicine has become increasingly politicized and politics has become increasingly medicalized. Behaviors previously seen as virtuous or wicked, wise or unwise are now dealt with as healthy or sick--unwanted behaviors to be controlled as if they were health issues. The modern penchant for transforming human problems into diseases and judicial sanctions into treatments, replacing the rule of law with the rule of medical discretion, leads to the creation of a type of government social critic Thomas Szasz calls pharmacracy. Medicalizing troublesome behaviors and social problems is tempting to voters and politicians alike: it panders to the people by promising to satisfy their needs for dependence on medical authority and offers easy self-aggrandizement to politicians as the dispensers of more and better health care. Thus, the people gain a convenient scapegoat, enabling them to avoid personal responsibility for their behavior. The government gains a rationale for endless and politically expedient wars against social problems defined as public health emergencies. The health care system gains prestige, funding, and bureaucratic power that only an alliance with the political system can provide. However, Szasz warns, the creeping substitution of pharmacracy for democracy--private medical concerns increasingly perceived as requiring a political response--inexorably erodes personal freedom and dignity. Pharmacracy: Medicine and Politics in America is a clear and convincing presentation of this hidden danger, all too often ignored in our health care debates and avoided in our political contests.