Alternatives are offered for consideration: (1) use of more precise terms, for example, distinctions between participant/patient, doctor/researcher, and therapy/research); (2) developing different rules for social research, particularly qualitative methods involving no treatment and/or "minimal risk"; (3) insisting regulators focus on treatment when making decisions and contemplating rules; (4) developing realistic attitudes about what regulation of any kind can do; and (5) engaging in and encouraging passive rebellion, i.e., rejecting local systems in favor of federal standards for exemption from IRB processes when studies involve only "minimal risk."

An analytical device, (SINS) Structures, Institutionalizations, Naturalizations, Simulations, was developed. Through utilization of (SINS), each term or portion of text can be viewed as a social Structure at various levels of operation (from widely held beliefs to regional, local, and individual ones), and/or as an Institutionalization of Structures, or ways these Institutionalizations become Naturalized in the lives of individuals, or, finally, in the Simulations created with increased detachment of structures (regulations) from the lifeworld (the research environment).

Underlying theoretical support is found in Marx, Horkheimer, Adorno, Schutz, and Baudrillard. The work of constructionists is also employed, including Goffman, Mead, Berger and Luckmann. Additionally, the ideas of Foucault, Habermas, Derrida, and Lyotard are utilized, in particular discursive formations and relationships of power (Foucault), cultural reproduction and instrumental technical reasoning (Habermas), deconstruction, particularly language (Derrida), and performativity (Lyotard). More recent applications of ideas in this vein are found in the critical management studies of Deetz, Alvesson, Manning, and others; these works serve as models for the present study.

This organizational communication study involves critical analysis/ideology critique of regulation, and deconstruction and resistance readings of texts produced by the human subjects regulation system in the U.S. This regulatory organization includes federal government agencies and local entities called Institutional Review Boards (IRBs). Information related to the historical development of the IRB system is provided, along with analyses of federal and local systems and the relationships among the regulators, researchers, and the researched. Textual data include IRB application forms, the Human Research Subject Protection Act of 1997, and several reports from executive, legislative, and administrative entities.