Rethinking the Ethics of Research

Karen Maschke, associate for ethics and science policy at the Hastings Center, observes on the opposite page that all of the feature articles in this issue of the Report contemplate major changes to the ethical standards that govern research conducted on human subjects. The first two articles, by David Orentlicher and Lynn Jansen, ask whether informed consent, at least as it has been understood, is always necessary, and the third, by David Wendler, proposes that the way risks have been understood for certain kinds of research is inadequate. In asking whether informed consent is always necessary, the first two articles are in effect asking whether "coercive" methods of recruiting new subjects should sometimes be tolerated, or at least whether "coercion" is sometimes understood too broadly. This question recurs in an essay by Jennifer Hawkins and Ezekiel Emanuel, who argue that people who think about human subjects research often see coercion where none exists.

Two of the departments also take up questions about research. Jeremy Sugar-man, in Policy & Politics, examines the developing debate over whether American researchers who run trials in foreign countries should adhere to the host country's requirements rather than to U.S. requirements, and a set of commentators from Vanderbilt University and the Department of Defense's Uniformed Services University of the Health Sciences argue in Perspective that scientific researchers generally need more training, and ongoing training, in the responsible conduct of research.

These contributions to the Report reflect a recent trend in bioethics to reconsider some of the basic elements of the ethics of research on human subjects. One of the articles is prompted by an article in 2003 by Franklin Miller and Howard Brody that challenged the accepted wisdom on whether it is important for the experimental treatment and the treatment to which it is compared to stand in "clinical equipoise," meaning that reasonable experts disagree about which treatment is best. Most commentators have held that clinical equipoise must obtain if a trial is to be ethical. In effect, Miller and Brody held that much of the literature on the ethics of clinical research was mistaken. And last year in the Report, a team of authors led by Ezekiel Emanuel argued that a frequently accepted requirement for research conducted in foreign countries—namely, that the experimental intervention, if proven effective, be available in the country that hosted the research—is mistaken.

The accepted wisdom on human subject research ethics is apparently not quite settled. A few years ago, there was a trend toward more stringent protection of research subjects, with the federal government temporarily closing down some universities' medical research pending investigations of the universities' adherence to federal regulations for the protection of research subjects. But now the federal government seems to have backed off, and some commentators are leaning toward the view that the protections for subjects are too heavy-handed or are applied in clumsily sweeping ways, thereby getting in the way of good science. And throughout, there appears to be a growing belief that some of the cornerstone concepts of the ethics of human subjects research, whether or not they provide adequate protections, are in need of rethinking.