The EPA commissioned The National Academies to provide advice on the vexing question of whether and, if so, under what circumstances EPA should accept and consider intentional human dosing studies conducted by companies or other sources outside the agency (so-called third parties) to gather evidence relating to the risks of a chemical or the conditions under which exposure to it could be judged safe. This report recommends that such studies be conducted and used for regulatory purposes only if all of several strict conditions are met, including the following: The study is necessary and scientifically valid, meaning that it addresses an important regulatory question that can't be answered with animal studies or nondosing human studies; The societal benefits of the study outweigh any anticipated risks to participants. At no time, even when benefits beyond improved regulation exist, can a human dosing study be justified that is anticipated to cause lasting harm to study participants; and All recognized ethical standards and procedures for protecting the interests of study participants are observed. In addition, EPA should establish a Human Studies Review Board (HSRB) to evaluate all human dosing studiesâ€"both at the beginning and upon completion of the experimentsâ€"if they are carried out with the intent of affecting the agency's policy-making.

In the past 30 years, the population of prisoners in the United States has expanded almost 5-fold, correctional facilities are increasingly overcrowded, and more of the country's disadvantaged populations—racial minorities, women, people with mental illness, and people with communicable diseases such as HIV/AIDS, hepatitis C, and tuberculosis—are under correctional supervision. Because prisoners face restrictions on liberty and autonomy, have limited privacy, and often receive inadequate health care, they require specific protections when involved in research, particularly in today's correctional settings. Given these issues, the Department of Health and Human Services' Office for Human Research Protections commissioned the Institute of Medicine to review the ethical considerations regarding research involving prisoners. The resulting analysis contained in this book, Ethical Considerations for Research Involving Prisoners, emphasizes five broad actions to provide prisoners involved in research with critically important protections: • expand the definition of "prisoner"; • ensure universally and consistently applied standards of protection; • shift from a category-based to a risk-benefit approach to research review; • update the ethical framework to include collaborative responsibility; and • enhance systematic oversight of research involving prisoners.

When the vast wartime factories of the Manhattan Project began producing plutonium in quantities never before seen on earth, scientists working on the top-secret bomb-building program grew apprehensive. Fearful that plutonium might cause a cancer epidemic among workers and desperate to learn more about what it could do to the human body, the Manhattan Project's medical doctors embarked upon an experiment in which eighteen unsuspecting patients in hospital wards throughout the country were secretly injected with the cancer-causing substance. Most of these patients would go to their graves without ever knowing what had been done to them. Now, in The Plutonium Files, Pulitzer Prize-winning reporter Eileen Welsome reveals for the first time the breadth of the extraordinary fifty-year cover-up surrounding the plutonium injections, as well as the deceitful nature of thousands of other experiments conducted on American citizens in the postwar years. Welsome's remarkable investigation spans the 1930s to the 1990s and draws upon hundreds of newly declassified documents and other primary sources to disclose this shadowy chapter in American history. She gives a voice to such innocents as Helen Hutchison, a young woman who entered a prenatal clinic in Nashville for a routine checkup and was instead given a radioactive "cocktail" to drink; Gordon Shattuck, one of several boys at a state school for the developmentally disabled in Massachusetts who was fed radioactive oatmeal for breakfast; and Maude Jacobs, a Cincinnati woman suffering from cancer and subjected to an experimental radiation treatment designed to help military planners learn how to win a nuclear war. Welsome also tells the stories of the scientists themselves, many of whom learned the ways of secrecy on the Manhattan Project. Among them are Stafford Warren, a grand figure whose bravado masked a cunning intelligence; Joseph Hamilton, who felt he was immune to the dangers of radiation only to suffer later from a fatal leukemia; and physician Louis Hempelmann, one of the most enthusiastic supporters of the plan to inject humans with potentially carcinogenic doses of plutonium. Hidden discussions of fifty years past are reconstructed here, wherein trusted government officials debated the ethical and legal implications of the experiments, demolishing forever the argument that these studies took place in a less enlightened era. Powered by her groundbreaking reportage and singular narrative gifts, Eileen Welsome has created a work of profound humanity as well as major historical significance. From the Hardcover edition.

From the courtrooms of Nuremberg to the battlefields of the Gulf War, Undue Risk exposes a variety of government policies and specific cases, includingplutonium injections to unwilling hospital patients, and even the attempted recruitment of Nazi medical scientists bythe U.S. government after World War II.