IN PRINT

IN PRINT: Against One-Size-Fits-All Research Ethics September-October 2010

Against One-Size-Fits-All Research Ethics

Published in The Hastings Center Report (see link to full article in gray box below).

By Michelle N. Meyer

James W. Fossett and Michelle N. Meyer

ABSTRACT: When the federal government funds research on human beings, researchers must follow regulations known as the “Common Rule” intended to protect their human subjects. Many observers believe the range of activities covered by the Common Rule under the label “human subjects research” has become unwieldy. It has long been thought, for example, that biomedical research on people’s bodies should not necessarily be treated on par with behavioral research in which subjects are merely asked to respond to surveys. Recent increases in other methods of conducting research, such as biobanking (research on stored biological samples) and Internet-based research (in which investigators recruit and interact with subjects online) have renewed objections to the Common Rule’s one-size-fits-all approach to research ethics.



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The full article is published in the September-October 2010 issue of The Hastings Center Report, 40 Hastings Ctr. Rep. 10 (2010).
© 2010 The Hastings Center. Reprinted by permission.

Kennedy Institute of Ethics Journal

A more nuanced approach is overdue.

This short column, written for a technical audience, explores the possibility that in some research contexts, investigators and subjects should be permitted to reach voluntary, informed agreements about certain aspects of their relationship — in lieu of government regulation. It does so by considering the National Institutes of Health’s “Guidelines for Human Stem Cell Research” as an example of both the promise of a more nuanced approach to research ethics and the peril of failing to achieve such nuance. The NIH guidelines seek to ensure that the federal government funds human embryonic stem cell research only where the embryo was donated by, and with the voluntary, informed consent of, in vitro fertilization patients who no longer needed the embryos for reproductive purposes. Under the prevailing interpretation of the Common Rule, such IVF patients do not constitute “human subjects,” since the embryos constitute already existing, deidentified tissues. As a result, the Common Rule does not apply, and neither the IVF patient’s consent to nor their knowledge of research on the embryos is required. When a tissue source’s only interest is in privacy, this rule is defensible. But when the source objects to the kind of research being conducted, deidentification is irrelevant. By requiring IVF patients’ consent to controversial stem cell research despite the fact that their embryos are not linked to them, the guidelines implicitly recognize that research diversity requires regulatory diversity.

Yet one of the first decisions made under the NIH guidelines amounts to a disappointing retreat to research ethics dogma. The NIH declined to fund research on several scientifically valuable hESC lines because embryo donors were required to waive any legal claims they might have arising from the research. The guidelines, designed specifically for this context, say nothing about such exculpatory language; however, the Common Rule prohibits it. Although a ban on exculpatory language is a sensible rule in many research contexts, it is not clear that this is the case in the context of embryo donation, for reasons the column discusses.

About the Rockefeller Institute of Government

The Nelson A. Rockefeller Institute of Government, the public policy research arm of the State University of New York, conducts fiscal and programmatic research on American state and local governments. It works closely with federal, state, and local government agencies nationally and in New York, and draws on the State University’s rich intellectual resources and on networks of public policy academic experts throughout the country.