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Abstract: Ethics guidelines and commentary suggest that a central function of research ethics committees is to assess the scientific merit of the protocols they review. However, some commentators object to this role, and evidence suggests that the assessment of scientific merit is a significant source of confusion and animosity between ethics committees and clinical investigators.… Read more
ETHICS & HUMAN RESEARCH
Abstract: The U.S. Public Health Service’s sexually transmitted disease (STD) experiments in Guatemala are an important case study not only in human subjects research transgressions but also in the response to serious lapses in research ethics. This case study describes how individuals in the STD experiments were tested, exposed to STDs, and exploited as the… Read more
Abstract: Contrary to the revised Common Rule, and contrary to the views of many bioethicists and researchers, we argue that broad consent should be sought for anticipated later research uses of deidentified biospecimens and health information collected during medical care. Individuals differ in the kinds of risk they find concerning and in their willingness to… Read more
Abstract: In September 2007, the inspector general of the U.S. Department of Health and Human Services delivered a searing indictment of the oversight system in the United States for research with human subjects. Officials at the Food and Drug Administration (FDA) were inspecting fewer than 1 percent of sites where FDA-regulated products were being tested… Read more