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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Ethics & Human Research (E&HR)

Published/Released on January 24, 2019 | Posted by Admin on January 25, 2019 / , ,

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Editor’s note:
The inaugural issue of Ethics & Human Research (E&HR) marks an exciting milestone in The Hastings Centers’ 40‐year history of publishing a journal that focuses on the ethical, regulatory, and policy issues related to research with humans. Like its predecessor, IRB: Ethics & Human Research, E&HR will publish conceptual and empirical analyses on a wide range of topics related to the human research enterprise.

The journal’s name change conveys to the global community of authors and readers that E&HR is not solely about issues related to institutional review boards (IRBs) in the United States. The title shift provides 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. Along with publishing work that investigates new challenges, E&HR aims not only to draw attention to unresolved issues but also to broaden the scope of issues for investigation and analysis in the field of human research ethics. The pieces in this inaugural issue identify several new challenges and hint at some of the unresolved issues and broader topics that merit further attention.

In the lead article, about phase I clinical trials with healthy volunteers, 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 such trials, improve oversight of the trials, and more critically assess their scientific value. For example, using a “model‐organism” approach to advance the ethical framework for phase I healthy‐volunteer trials would draw attention to shared structural features of animal and human research. As is the case with animal subjects, human participants in healthy‐volunteer trials are typically confined at a research facility. Participants in these trials cannot leave the study site during the duration of the trial—which can last 24 hours or more—unless they withdraw from the study. While animal research regulations require adherence to specific health and welfare conditions for the confinement of animals used in research, the authors point to gaps in ethics and regulatory standards on these matters for the confinement of healthy human volunteers in phase I trials.

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