Is the University of Delaware Violating the Federal Law on Human Subject Research?
October 31, 2007
by Kelly Sarabyn
A core part of the University of Delaware’s residential life program focuses on finding the most effective method for behavioral and thought reform. As covered in the FIRE press release
, the University’s own research agenda
, and previous posts
, the University’s residential life program requires its students to undergo experimental thought-reform “treatments.” The University assesses and tracks the efficacy of their various “treatments” through pre- and post-treatment surveys, one-on-one interviews and behavioral observation. Unfortunately, it conducts this research without informing its students that they are being used as subjects in a massive reeducation experiment.
The federal law governing research on human subjects
was first passed in 1974 after the public became aware of the government’s Tuskegee Syphilis Study. One of the law’s overriding purposes, as described in the accompanying Belmont Report, is to ensure that government agencies conducting research treat individuals as “autonomous agents.” “To show lack of respect for an autonomous agent,” the report explains
, “is to repudiate that person’s considered judgments” or “to deny an individual the freedom to act on those considered judgments.”
As it acknowledges
, the University of Delaware is legally bound by federal law regulating research on human subjects. The law requires school officials to obtain the approval of its Institutional Review Board (IRB) and the informed consent of all human subjects prior to commencing any human subject research.
The University of Delaware’s Office of Residence Life is at least superficially aware of the legal issues involved. It states in its Research Agenda
that those who wish to transform “assessment results” gathered from the residential “treatment” program into “publication-quality” reports “need to discuss such plans in advance with the Director or Associate Director to make sure all human subject protocols have been followed.” Not only do they admit their research is intentionally not rigorous enough for publication, they also imply that their “treatments” will have to follow the human subject law only if somebody seeks to publish the “results.” In fact, however, the research’s lack of publication is irrelevant to whether the research is governed by the human subject law. The law applies to any human subject research, which is defined as any “systematic investigation” designed to gather “generalized knowledge” involving human subjects (§46.102 Definitions, D).
The University of Delaware’s school-wide guidelines regarding the human subject law make it clear that any research that goes “beyond the diagnostic and therapeutic needs of the subject” is regulated by the law. This includes activities categorized by the school as “training” and “development.”
The Residence Life memo concerning the residential “treatment” programs recognizes that “our tools designed to examine educational techniques will require advance approval” by its IRB. However, it follows this up by committing to “further training on human subject regulations,” raising the question of whether the approval was acquired prior to the instigation of their “treatment” program. The memo also claims that the parts of its program which are “primarily educational in nature” are “fully exempt” from the law. Unfortunately, not much of its “treatment” program falls into this benign category.
The “treatment” program is riddled with human subject research. Its “action based research,” which it claims is exempt from the human subject research law because it lacks generalized conclusions, includes “developing an understanding of the students’ behavioral changes in reaction to RL [Residence Life] educational strategies.” Although the memo claims that “action based research” does not produce any generalized conclusions, it says the staff is free to “conduct summative, research style studies” alongside the “action based research.” The report itself calls for generalized research to be conducted alongside the “action based research” by the “research team,” using “validity controls and question precision necessary to reach broader conclusions.” (4-5)
The “treatment” program is designed to study and determine the best way to change students’ behaviors, values and beliefs. This does not fall under the “normal educational practice” exception to the law. As a result, Delaware should have obtained approval from its IRB and informed consent from all its residential students. If it has not done so, its program is likely a manifest violation of federal law governing the use of human subjects. This would not be entirely surprising, as the law was designed to ensure that state actors respect the autonomy of citizens—a task the University of Delaware clearly has difficulty completing.