A broad critical review of national policies on biomedical research - human, epidemiologic, clinical trials, genetic, reproductive, etc.

It is widely assumed that informing prospective subjects about the risks and possible benefits of research not only protects their rights as autonomous decisionmakers, but also empowers them to protect their own interests. Yet interviews with patient‐subjects conducted under the auspices of the Advisory Committee on Human Radiation Experiments suggest this is not always the case. Patient‐subjects often trust their physician to guide them through decisions on research participation. Clinicians, investigators, and IRBs must assure that such trust is not misplaced.

Written from the combined perspectives of a physician, lawyer, and social scientist, this book is the first reference work to provide a concise and practical overview of informed consent. Topics include the ethical theories and history of the principle of informed consent, all legal requirements for practitioners, and suggesions for making the interaction between doctor and patient clinically meaningful.

Drug companies are moving their research from academic medical centers to physicians’ private offices. The shift brings in more subjects, and could mean faster and better results. It also changes the physician's relationship to patients, dangles monetary lures in front of physicians, and could produce subjects who don't understand what they're participating in and results that are unreliable.

The discussion about complementary and alternative medicine is sometimes rather heated. “Quackery!” the cry goes. A large proportion “of unconventional practices entail theories that are patently unscientific.” “It is time for the scientific community to stop giving alternative medicine a free ride. There cannot be two kinds of medicine — conventional and alternative. There is only medicine that has been adequately tested and medicine that has not, medicine that works and medicine that may or may not work.” “I submit that (...) if these treatments cannot withstand the test of empirical research, … then we have wasted a lot of time and effort. The time has been wasted on all the people who have spent years learning falsehoods about acupuncture points and the principles of homeopathy. And the patients have wasted their time, money, and efforts receiving treatments that were not what they were represented to be or were harmful.”. (shrink)

Like the National Commission and the President's Commission, the Advisory Committee on Human Radiation Experiments was formed to carry out specific ethical tasks. Yet the committee also had an “openness” mission, a charge to investigate allegations that the U.S. government secretly exposed Americans to environmental releases of radiation. Eighteen months later—and after sixteen public meetings, more than 200 interviews, and the review of about 400,000 documents—the committee delivered a 925‐page report to the president.