Suchergebnisse

The untold history of America's mid-twentieth-century program of hepatitis infection research, its scientists' aspirations, and the damage the project caused human subjects From 1942 through 1972, American biomedical researchers deliberately infected people with hepatitis. Government-sponsored researchers were attempting to discover the basic features of the disease and the viruses causing it, and to develop interventions that would quell recurring outbreaks. Drawing from extensive archival research and in-person interviews, Sydney Halpern traces the hepatitis program from its origins in World War II through its expansion during the initial Cold War years, to its demise in the early 1970s amid an outcry over research abuse. The subjects in hepatitis studies were members of stigmatized groups—conscientious objectors, prison inmates, the mentally ill, and developmentally disabled adults and children. The book reveals how researchers invoked military and scientific imperatives and the rhetoric of a common good to win support for the experiments and access to recruits. Halpern examines the participants' long-term health consequences and raises troubling questions about hazardous human experiments aimed at controlling today's epidemic diseases

Today's parents routinely consult pediatricians for care of sick youngsters, information on child development, and advice on problems of child management. Yet only a hundred years ago, special medical services for children barely existed. During the intervening century, physicians defined a new field and built occupational structures that established pediatrics as a permanent division of medical practice. Professor Halpern traces the development of American pe

Research physicians face intractable dilemmas when they consider introducing new medical procedures. Innovations carry the promise of preventing or curing life-threatening diseases, but they can also lead to injury or even death. How have clinical scientists made high-stakes decisions about undertaking human tests of new medical treatments? In Lesser Harms, Sydney Halpern explores this issue as she examines vaccine trials in America during the early and mid-twentieth century.Today's scientists follow federal guidelines for research on human subjects developed during the 1960s and 1970s. But lo

AbstractNew governance scholars see hybrid regulation as a means for achieving regulatory flexibility and responsiveness. The US system for overseeing human subjects research embodies three dimensions of hybridity: it brings together governmental and non‐governmental controls; it combines central and local authority; and it engages a multiplicity of policy actors. Yet this system became rigid 20 years into its development. Sources of rigidity included shifts in the regulatory environment, temporal constriction in the range policy participants, and risk aversion on the part of non‐governmental institutions charged with implementing federally mandated controls. This article explores the implications of these institutional dynamics for the relationship between hybridity and regulatory responsiveness. It also examines possibilities for renewed flexibility generated by the recent advent of both accreditation and regulatory innovation by university research administrators.