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Human Subjects Research RegulationPerspectives on the Future$
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I. Glenn Cohen and Holly Fernandez Lynch

Print publication date: 2014

Print ISBN-13: 9780262027465

Published to MIT Press Scholarship Online: January 2015

DOI: 10.7551/mitpress/9780262027465.001.0001

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Democratic Deliberation and the Ethical Review of Human Subjects Research

Democratic Deliberation and the Ethical Review of Human Subjects Research

(p.157) 10 Democratic Deliberation and the Ethical Review of Human Subjects Research
Human Subjects Research Regulation

Govind Persad

The MIT Press

This chapter explains the concept of democratic deliberation and considers its implications for ethical review of human subjects research. Democratic deliberation is an ethical principle relatively new to research ethics. It involves a public exchange of ideas within and across groups of ordinary citizens, experts, and political representatives, and requires participants to engage actively with one another, to offer reasons that are acceptable and intelligible to their interlocutors, and to revise their decisions as new information and new perspectives come into view.Incorporating democratic deliberation into human subjects research would recommend greater inclusion of participants in the review process. This might be achieved by seating participants or their advocates on IRBs, and by otherwise involving them on advisory committees overseeing research. Such inclusion of research participants would follow the model of advisory committees elsewhere in the health care system, which include patients and other stakeholders. It would also counsel against exempting public benefits research, such as experimentation with Medicare and Medicaid benefits, from ethical review.

Keywords:   Deliberation, Deliberative democracy, Participants, Participatory inclusion, Public benefits, IRBs, Advisory committees, Human subjects, Clinical research

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