The inaugural issue of Ethics & Human Research, January — February 2019

The journal’s name change “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.” Topics authors are invited to explore include human research with somatic and germline genome editing techniques, stem cell interventions, and neurological drug and device interventions; and research involving the use of digital platforms for collecting, storing, and sharing individuals’ personal data. The pieces in the inaugural issue identify several new challenges and hint at some of the unresolved issues and broader topics that merit further attention.

In their article (Advancing Ethics and Policy for Healthy-Volunteer Research through a Model-Organism Framework), Jill A. Fisher and Rebecca L. 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. They note that the confinement and monitoring of human research participants in these trials “invite questions of how to regulate those environments, respectfully engage with participants, and provide for their comfort and welfare.” The authors are at the University of North Carolina at Chapel Hill.

Two articles explore ethical issues related to new federal policies requiring that a single institutional review board (IRB) review multisite studies. In their analysis of public comments submitted in response to the Department of Health and Human Services’ proposed single-IRB mandate, Holly Taylor and colleagues at Johns Hopkins University found that support for the rule was limited. (Public Comments on the Proposed Common Rule Mandate for Single IRB Review of Multisite Research). Holly A. Taylor, Stephan Ehrhardt, Ann-Margret Ervin

The study by Robert Klitzman et al., the first to examine how single IRBs perceive needs for local knowledge, reveals several challenges. The authors, who are from Columbia University and the University of Massachusetts in Worcester, found that interview respondents “identified four potentially relevant types of local knowledge: about culture and linguistics, about geography and socioeconomics, about the researchers, and about the institutions.” They point out, “While a recent, commonly used, standardized single?IRB form asks three basic questions about local information, our findings suggest potential needs for additional information and, thus, have important implications for practice, policy, and research.” (Local Knowledge and Single IRBs for Multisite Studies: Challenges and Solutions).

Robert Klitzman, Ekaterina Pivovarova, Alexandra Murray, Paul S. Appelbaum, Deborah F. Stiles, Charles W. Lidz

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. The provide recommendations for how this small developing nation can move forward responsibly as a leader in human research for the region. The authors are from Case Western Reserve University and the University of Costa Rica. (Reviving Human Research in Costa Rica). Michael Householder, Ana Laura Solano-López, Derby Muñóz-Rojas, Suzanne M. Rivera

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For more information, contact:

Susan Gilbert, Director of Communications

The Hastings Center

845-424-4040 x244

[email protected]

(Editor’s Note: Widening the Lens)

Karen J. Maschke