Table of Contents
Is the University of Delaware Violating the Federal Law on Human Subject Research?
A core part of the University of Delaware鈥檚 residential life program focuses on finding the most effective method for behavioral and thought reform. As covered in the FIREpress release, the University鈥檚 own research agenda, and previous posts, the University鈥檚 residential life program requires its students to undergo experimental thought-reform 鈥渢reatments.鈥 The University assesses and tracks the efficacy of their various 鈥渢reatments鈥 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 was first passed in 1974 after the public became aware of the government鈥檚 Tuskegee Syphilis Study. One of the law鈥檚 overriding purposes, as described in the accompanying Belmont Report, is to ensure that government agencies conducting research treat individuals as 鈥渁utonomous agents.鈥 鈥淭o show lack of respect for an autonomous agent,鈥 , 鈥渋s to repudiate that person鈥檚 considered judgments鈥 or 鈥渢o deny an individual the freedom to act on those considered judgments.鈥
As , 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鈥檚 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 鈥渁ssessment results鈥 gathered from the residential 鈥渢reatment鈥 program into 鈥減ublication-quality鈥 reports 鈥渘eed to discuss such plans in advance with the Director or Associate Director to make sure all human subject protocols have been followed.鈥 Not only do they admit their research is intentionally not rigorous enough for publication, they also imply that their 鈥渢reatments鈥 will have to follow the human subject law only if somebody seeks to publish the 鈥渞esults.鈥 In fact, however, the research鈥檚 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 鈥渟ystematic investigation鈥 designed to gather 鈥済eneralized knowledge鈥 involving human subjects (搂46.102 Definitions, D).
The University of Delaware鈥檚 school-wide guidelines regarding the human subject law make it clear that any research that goes 鈥渂eyond the diagnostic and therapeutic needs of the subject鈥 is regulated by the law. This includes activities categorized by the school as 鈥渢raining鈥 and 鈥渄evelopment.鈥
The Residence Life memo concerning the residential 鈥渢reatment鈥 programs recognizes that 鈥渙ur tools designed to examine educational techniques will require advance approval鈥 by its IRB. However, it follows this up by committing to 鈥渇urther training on human subject regulations,鈥 raising the question of whether the approval was acquired prior to the instigation of their 鈥渢reatment鈥 program. The memo also claims that the parts of its program which are 鈥減rimarily educational in nature鈥 are 鈥渇ully exempt鈥 from the law. Unfortunately, not much of its 鈥渢reatment鈥 program falls into this benign category.
The 鈥渢reatment鈥 program is riddled with human subject research. Its 鈥渁ction based research,鈥 which it claims is exempt from the human subject research law because it lacks generalized conclusions, includes 鈥渄eveloping an understanding of the students鈥 behavioral changes in reaction to RL [Residence Life] educational strategies.鈥 Although the memo claims that 鈥渁ction based research鈥 does not produce any generalized conclusions, it says the staff is free to 鈥渃onduct summative, research style studies鈥 alongside the 鈥渁ction based research.鈥 The report itself calls for generalized research to be conducted alongside the 鈥渁ction based research鈥 by the 鈥渞esearch team,鈥 using 鈥渧alidity controls and question precision necessary to reach broader conclusions.鈥 (4-5)
The 鈥渢reatment鈥 program is designed to study and determine the best way to change students鈥 behaviors, values and beliefs. This does not fall under the 鈥渘ormal educational practice鈥 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鈥攁 task the University of Delaware clearly has difficulty completing.
Recent Articles
FIRE鈥檚 award-winning Newsdesk covers the free speech news you need to stay informed.