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Editor’s Note

The inaugural issue of Ethics & Human Research (E&HR) follows the approach of its predecessor, IRB: Ethics & Human Research, in publishing conceptual and empirical analyses on a wide range of topics related to the human research enterprise. With the new title comes an opportunity to identify new ethical, policy, and regulatory challenges that rapid developments in science, medicine, and regulatory frameworks bring to the conduct and oversight of human subjects research in the United States and elsewhere. The pieces in the issue identify several new challenges and hint at some of the unresolved issues and broader topics that merit further attention. Jill Fisher and Rebecca Walker propose adapting the ethical concepts and oversight mechanisms that are applied to research with nonhuman animals to enhance the welfare of healthy human volunteers in phase I clinical trials, improve oversight of the trials, and more critically assess their scientific value. Holly Taylor et al. and Robert Klitzman et al. explore ethical issues related to new federal policy concerning having a single institutional review board be responsible for review of multisite studies. And in a case study about Costa Rica’s moratorium on human research, Michael Householder et al. highlight the difficulties countries face in adhering to international ethical standards for human subjects research when they have a weak regulatory and ethics oversight infrastructure, particularly when studies are sponsored by foreign pharmaceutical companies.

Published on: November 7, 2018
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