Late in the summer of 1999, federally funded human subjects research at the University of Illinois at Chicago (UIC) was suspended by order of inspectors from the National Institutes of Health (NIH) Office for Protection from Research Risks (OPRR).
Hundreds of research efforts, including my own Youth and Religion Project, were stopped dead in their tracks. The federal inspectors had found UIC human subjects protection measures to be in serious disarray—understaffed, underfunded, and neglected by senior administrators—and they documented several cases of abuse by UIC researchers, particularly in medical and psychiatric fields. The suspension was to remain in effect until OPRR, now called the Office for Human Research Protections, determined that UIC's human subjects research procedures had been satisfactorily overhauled and its Institutional Review Boards (IRBs) reconstituted. The ultimate sanction in the hands of OPRR was its authority, in the case of noncompliance, to revoke federal grants. To say that demonstrating compliance captured the immediate attention of senior administrators at UIC is to understate in the extreme.
The crisis reverberated far beyond the research labs and administrative offices that were its proximate cause. First of all, a single "multiple project assurance" contract between UIC and the federal government links compliance in all federally funded projects at the university, so not only was the offending medical and psychiatric research shut down but so also was innocent social and behavioral research. Second, senior UIC officials, in their sedulous effort to demonstrate compliance with the federal inspectors, extended the suspension to all research, whether funded by federal agencies or, like mine, private foundations, indeed whether funded or not. Research on even master's theses and doctoral dissertations in the sociology department was thus temporarily crippled.
At the time of this writing (October 2000), the pressing crisis has passed. NIH has certified UIC's revised human subjects procedures, and research has been up and running, under stringent new rules, for months. Yet social scientists across the country should pay heed to the UIC experience. Here are three lessons.
What happened at UIC will likely happen elsewhere, soon. In Congressional testimony given in June 1998, George Grob, Department of Health and Human Services Deputy Inspector General for Evaluation and Inspections, pointed to the systemic national problem of an overworked IRB system monitoring increasing research efforts. He also called attention to the built-in conflict of interest created when units that are responsible for protection of research subjects are also responsible for increasing research funding. Dr. Grob recommended more attention to monitoring compliance, and UIC proved to be one case where the enhanced scrutiny found just the kinds of problems he predicted. Social scientists cannot afford to ignore human subjects issues wherever they may exist on their campuses.
Human subjects regulations are often ill-suited to social science research. By federal definition, a "human subject" is a living individual about whom a researcher gathers identifiable private information through interaction with that person. This definition largely exempts several forms of non-interactive research but is mute on the interactions, organizations, communities, and cultures that interest social scientists.
The regime of enhanced scrutiny was largely motivated by abuses in medical research, where very serious harm can be done. Much effort has been invested to ensure that the consent of subjects is truly informed, potential harm carefully weighed, and unavoidable risks shared equitably across groups in our society. It is salutary that social scientists are being asked to consider the principles of respect for persons, beneficence, and justice developed in the 1979 Belmont Report that support human subjects regulations. We are enjoined to bear in mind that the people we encounter in our research are human beings and not research fodder, to give thought to the harm our research can do, and to ensure that those we interview and observe are not chosen simply for the ease with which they can be induced to cooperate. Yet so pervasive is the medical research model in these regulations that social scientists are constantly reminded to think about their informants as if they were patients. We must contend with elaborate forms that ask, in effect, whether there isn't an alternative to the drug we are about to administer to our subjects, how soon before treatment begins the "informed consent" (i.e., the subject's signature) will be secured, and whether the research unduly neglects or targets prisoners or pregnant women.
This "patient" orientation is a particularly galling problem for those of us who conduct qualitative or "ethnographic" field research on living communities. Most qualitative sociologists presuppose that relationships are essential to persons, who are thereby not isolable, as patients are, and that interactions are essential foci of sociological analysis. Most of us practice an emergent style of research, where the questions addressed in the research change as the research proceeds. Many of us reject the dualistic principle that alienates us from the social world that we both study and inhabit. But human subjects regulations require us to imagine that when we observe people's interactions, as I do when I observe worship in a church, we are doing something akin to inspecting a patient's medical record. Worse yet, when we interview people for an hour or more to find out what their religious activity means to them, we are supposed to think of the entire conversation as comparable to a "treatment" and identify potential complications in advance to gain interviewees' informed consent. In this way, we are asked to forget that the interview is a conversation we engage in with another human being. Thereby, at least one of the ethical goals of human subjects regulations—respect for persons—has been deeply subverted.
Pressure to demonstrate regulatory compliance threatens to eclipse the kind of ethical reflection necessary for social scientists. Researchers are more and more impelled to ask not "What should I do to respect people's rights while advancing knowledge?" but "What must I do to satisfy the watchdogs?" Rhetoric from administrators eager to demonstrate compliance may well be framed in the elevated language of ethics. "Research at [UIC] may only be carried out in accord with the highest ethical standards"—so begins one document. Yet implementation descends quickly to the level of requiring signatures on lengthy, legalistic informed consent documents. Dire warnings are issued that even research not subject to IRB oversight "may be subject to other pertinent federal, state, or local laws and university rules or policies." I have seen little evidence that researchers are encouraged to apply their personal, religious, or, more to the point, professional ethical principles and scruples. (The American Sociological Association, for example, has its own quite elaborate code of ethics.) That medically inspired human subjects regulations pertain only to individuals and that the protections offered protect the privacy of guilty, as well as of innocent individuals, have been largely ignored. Ethical reflection demands recognition of the fact that social science research often focuses not on individuals but collectivities and cultures, whose integrity and interests should be protected without unduly censoring research. We should also consider the possibility that human subjects protection may shield the powerful from scrutiny because the subject's informed consent is required to delve into their affairs. Protection from risk in the case of most medical research, however, presupposes that the research subject is helpless, often desperate, and inclined to regard the physician-researcher as just short of divine.
Social scientists must discuss procedures that will protect society without unnecessarily hindering our legitimate research interests. If we do not address these issues squarely, we acquiesce in undermining the culture of inquiry and sacrificing respect for the persons we enlist in our research.
R. Stephen Warner is Professor of Sociology at the University of Illinois at Chicago and Director of the Youth and Religion Project there. The views he expresses in this article are his own and not those of the University of Illinois at Chicago or the Youth and Religion Project.
