REGULATING CREATIVITY: RESEARCH AND SURVIVAL IN THE IRB IRON CAGE[dagger]

Article excerpt

INTRODUCTION

When universities receive federal funding to conduct research, they make a number of promises to the U. S. Government. They promise, of course, to carry out a plan of research, and they promise to do so in a fiscally responsible manner. When the research involves human subjects, they also promise to ensure that the rights and welfare of human subjects who participate in this research are adequately protected through an Institutional Review Board ("IRB") mechanism. IRB review is a requirement of a university's Federal- Wide Assurance ("FWA") contract with the government,1 which binds it to administer any federal research funds it receives by federally mandated standards. At first glance it seems self-evident that institutional efforts to protect human subjects in compliance with these regulations can only be a good thing. At most universities, however, the reach of the IRB mission as well as its bureaucracy has now superseded by far the visions of the designers. Universities in the United States are replete with regulatory systems and bureaucracies, covering everything from grant accounting and accreditation to fire codes.2 Among them, however, the IRB system is the only one that has the direct power to stop, delay, or change the character of research, the most prized product in the university system. IRBs have disrupted student careers, set back tenure clocks, and blunted the essence of many intellectual traditions. Facing demands that spiral to the level of sheer impracticality, faculty and students at many institutions face a stark choice: to conduct innovative research in their fields or to meet the requirements of their institutions' IRBs.

Nor is there any persuasive evidence that research subjects' rights or welfare have benefited, overall, in exchange for this damage. From our own experience, which we document below, we know that there are specific instances in which IRB panel members spot potential risks for subjects that are overlooked by investigators. Since no other research regulatory system in history has ever approached the U.S. IRB system in scale or in the kinds of demands it makes, however, meaningful controlled comparisons are out of the question. Indeed, as far as we know, no credible assessments have been conducted that could determine whether IRB review actually protects people or in what ways.

The specter of IRB sanction pervades all that students and faculty do in fields deemed to be IRB-relevant. IRB offices are the institutional executors of concern for human research subjects by the U.S. government, the financial lifeblood of most universities. Yet in enacting what they see as their responsibility of ethical oversight of research, they affect everything from imagining a study's scope and significance to the choice of words in a survey. It is little wonder that many researchers, fearing not just obstacles to their own research but the suspension of all federal funding to their university, appear to lead lives either of resentful compliance with IRB or of fearful avoidance of it.

The purview of IRB control has expanded broadly as well as deeply. IRB has been generalized from the medical world to a wide range of social science and, in some cases, humanities research.3 The major American professional scholarly associations, in their ethics statements, tend to urge their members to obtain IRB approval as a matter of professional ethics.4 Although most approved FWAs are in the U.S., IRBs have inserted themselves into the research codes of one or more institutions in nearly all countries in the world.5 And although most educational institutions with IRBs are universities or medical research organizations, a growing number of high schools, though they do not appear to have formal FWAs, have been drawn into IRB requirements,6 or at least the language of IRB compliance, through an organization called Science Service, which sponsors the International Science and Engineering Fair program. …