Informed Consent

Informed Consent

In many respects, the history of informed consent began with the Nazi extermination camps and the dreadful violence perpetrated on their inmates and, above all, the reduction of their bodies to “objects” in the hands of experimenters devoid of humanity. That such horrors should never happen again was the unanimous conviction of public opinion worldwide after World War II. It was for this reason that the Nuremberg Code was formulated in 1947 and the Helsinki Declaration was signed by the World Medical Association in 1964 (Dingwall, 2006; Hoeyer, Dahlager, & Lynöe, 2005).

Only in subsequent decades did the idea arise that these declarations of principle could be translated into a single instrument—namely informed consent—for doctors and health care practitioners (Beauchamp & Childress, 2001). Because, as Arthur Kleinman (1997) writes, Westerners tend to be monotheist outside religious contexts as well, the enterprise of informed consent rapidly became the new moral deity: the fetish, some would say, of a secularized and individualized society. It expressed the distrust widely aroused by an expert system as esoteric and complex as medicine (Giddens, 1990) and perhaps also the crisis of trust that traverses contemporary social systems.

Put very simply, the notion of informed consent is grounded primarily on the principle of individual autonomy and secondarily on that of beneficence (Oeye, Bjelland, & Skorpen, 2007). It states the obligation to furnish the potential participants in a research study or experiment with detailed information (preferably in written form) on the purpose, duration, and methods of the research. Moreover, the risks and benefits deriving from participation in the study and the treatments must be honestly described. And guarantees must be given as to absolute confidentiality and the respondent's right to withdraw his or her consent at any time (Marshall, 2003). The correct application of the principle of informed consent is enforced by the myriad “ethical committees” charged with its enforcement.

Successful ideas travel far (Czarniawska & Joerges, 1995); “greater than the tread of mighty armies is an idea whose time has come,” said Victor Hugo (quoted by Czarniawska & Joerges, 1995). The informed consent regulatory system [Page 444]has thus rapidly become a “universal fashion” through an isomorphic process that has reached the four corners of the world (Dingwall, 2006). From biomedicine, it has quickly spread into social research, where it has progressively increased the number of domains falling under its control (Katz, 2007). It has done so with all the unintentional consequences that inevitably accompany “translation processes” of this kind (Czarniawska & Joerges, 1995). “The translation model” has been introduced in the sociological analysis of social and organizational change by the French sociologist Bruno Latour. Latour contrasts the traditional “diffusion” model with the translation model. He wrote that “watching ideas travel, we observe a process of translation, not one of reception, rejection, resistance or acception.”

In this chapter, I review some of the stages of this journey. I begin with the effects of the migration of the idea of informed consent into interview research, and into social research in general. I then measure its efficacy in the place where it first arose, namely, biomedicine. I conclude with an examination of the alternative conceptions of protecting research participants.

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