Academic journal article
By Heimer, Carol A.; Gazley, J. Lynn
Law & Society Review , Vol. 46, No. 4
Sociolegal scholars suggest that regulatory encounters often are occasions for displaying a surface compliance decoupled from day-to-day practice. Yet ethnographic data from five highly regulated HIV clinics show that regulatory encounters open opportunities both for ritualism and-surprisingly-for transcending ritualism. Using a theatrical analogy, we argue that improv performance is the technology that enables regulatory inspectors and clinic staffto transcend ritualism. As regulatory encounters unfold, clinics' carefully prepared performances sometimes change into more cooperative interactions where inspectors and regulatees hash out details about how rules will be applied and even work together on reports for the regulators' supervisors. By "performing together," regulatory inspectors gain access to the clinic's backstage where they can assess clinic workers' deeper conformity to ethical and scientific norms. But such joint performances are less likely where cultural divides and material scarcity make it difficult for clinic staffto gain inspectors' trust.
In 2009, the FDA began the process of disqualifying Chicago HIV specialist Dr. Daniel Berger as a clinical researcher, charging that he had "failed to protect the rights, safety and welfare of subjects under [his] care, repeatedly or deliberately submitted false information to the sponsor and repeatedly or deliberately failed to comply with the cited [federal] regulations, which placed unnecessary risks to human subjects and jeopardized the integrity of data."1 The infractions were serious: forged or missing signatures; falsified records of physical examinations, electrocardiograms, and laboratory results; enrolling of patients without adequate checks on their eligibility; and disappearance of over two hundred tablets of investigational drugs. Ultimately Berger proved that the fraud was traceable to a research coordinator who was embezzling research subjects' stipends. But Berger had not adequately supervised the employee's work and had failed to uncover his criminal record in pre-employment screening. After months of negotiations, the FDA agreed that Berger could continue conducting drug studies, with the stipulation that an outside monitor review his work.
So how was the fraud uncovered? In 2008 and 2009, a clinical trials monitor noted anomalies in signatures on consent forms and other documents and reported these findings to the FDA, which began an investigation. Here the irregularities were paired with and concealed by forged signatures, making them relatively easy to uncover in routine monitoring. But noncompliance may not always occur in tandem with surface irregularities and may not be visible unless a monitor can secure access to the "backstage" of a clinic's operation. It is the process and effects of getting backstage that this article explores.
Seemingly detached from the serious work of science and treatment, the regulatory encounters we discuss entail arcane rules and endless paperwork. Such regulatory work is just the place where we might expect ritualistic adherence to the "letter of the law." In fact, though, the stakes are very high and regulatory encounters can move well beyond ritualism, as Berger and his research coordinator learned. Clinical research and treatment programs are multimillion dollar enterprises. Without assurance of ethical and scientific integrity in data collection, clinical trial results cannot withstand FDA scrutiny, jeopardizing patients' access to safe and effective drugs and therapies. For government and industry sponsors, regulatory inspections provide crucial evidence that they have invested in scientifically and ethically sound research. And as Berger's case illustrates, researchers' and clinics' access to future research and treatment funding depends on demonstrated compliance with regulations. Mostly the stakes of regulation remain as background in the encounters between monitors and clinic workers. But episodically, clinic staffworried about how they could continue vital work if they lost funding and monitors reflected on their pride in ensuring the integrity of important medical research. …