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  • Introduction
  • Zachary M. Schrag (bio)

Research with human subjects is central to contemporary life. Read the newspaper, buy a new product, swallow a new pill, and you are consuming knowledge gathered through experiments, interviews, surveys, focus groups, or observations involving people who live next door or on the other side of the planet. Some elements of this research are highly formalized, like the four phases of clinical trials required for new drugs or medical treatment. Others are indistinguishable from daily life, as when an anthropologist interested in smoking talks to his mechanic, who is taking a cigarette break.1

Some research—medical experiments in particular—can kill. Other research can hurt, inflicting harms ranging from embarrassment to jail sentences to chronic illness. And some research, even though not materially harmful, may be ethically shocking. What hospital patient would like to wake up and be told that he had, without his consent, been subjected to an experimental procedure that had no chance of benefiting him, even if it had done no lasting harm?

Accordingly, professional associations and governments have sought for some time to control research. When and why this started is part of the story told by the authors in this issue, but by the start of the twenty-first century, the regulation of research with human subjects was a massive enterprise. Government regulators and other national bodies remain rather small, but they oversee large networks of local ethics committees—known as institutional review boards, research ethics boards, research ethics committees, or other terms—charged with overseeing individual research projects.

Though created with the best of intentions, these committees have proven controversial. As sociologist Sydney Halpern has noted, "Human subjects oversight in the US provides a striking counter-example to the often assumed [End Page 1] flexibility of hybrid regulation." In the mid-1990s, U.S. regulators began cutting research funds to universities for relatively minor violations of rules, leading to complaints even from some of the creators of the regulatory system.2 Other countries have adopted U.S. models, leading to similar structures—and similar complaints—there.

Understandings of history both shape and sustain this regulatory structure. Though many policymakers acted in response to recent events, at times they shaped rules as a way to avoid the recurrence of behavior well in the past. In the United States, for example, the current regulatory climate owes a great deal to the work, in the 1990s, of the Advisory Committee on Human Radiation Experiments. Though U.S. President Bill Clinton established the committee in response to reports of abuses that had taken place decades earlier, it and other official bodies used those abuses to justify a stricter regime of ethics review.3 Proponents of regulation continue to look back to the 1960s for evidence of the need of strict ethics review.4

Accounts of past scandals are also a key element in the training given to researchers who wish to work with human subjects and committee members who oversee them. As Maureen Fitzgerald has noted, "Most texts on research ethics and many public documents related to the ethics review of research" include an "obligatory history [involving] the presentation of a series of cases that highlight periods of ethical (or moral) crisis in society. The same cases are cited repeatedly and this body of cases is relatively small in relation to the amount of research conducted."5 Yet ethics committees around the world rely on this small set of historical knowledge.

Given the importance of history to the regulation of research with human subjects, it would be nice to have a sturdy, scholarly foundation for the stories that are told. Fortunately, many scholars—both historians and others with a good sense of history—have made a start at that, especially when it comes to the most famous cases of the mid-twentieth century, such as the Nazi medical experiments, the Tuskegee Syphilis Study, the Willowbrook hepatitis experiments, and the research underlying Tearoom Trade.6 Yet if we are to get a full history of human subjects research and the policies governing it, we must get beyond these cases to look at less prominent examples of troublesome research. And we must consider what...

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