Ready-to-recruit" or "Ready-to-consent" populations? - Informed consent and the limits of subject autonomy. " Qualitative Inquiry 13(6

This paper queries the pharmaceutical industry’s concept of “ready-to-recruit ” populations by examining its recruitment strategies for clinical trials and the types of human subjects who participate in these drug studies. The argument is that the pharmaceutical industry has profited from a system comprised of what can more aptly be characterized as ready-to-consent populations, meaning populations who do not have better alternatives than participation in clinical trials. Further, through qualitative research, this paper aims to highlight some of the limitations of current U.S. federal regulation and to show how these limits signal problems that are not normally discussed in the medical ethics literature about research on human subjects. It does this by examining the impotence of informed consent – both as a concept and as a practice – in light of recruitment strategies and the structural reasons motivating individuals to participate in clinical trials. During the past two decades, human subjects research has developed into a full-fledged industry with a global presence. Human subjects are needed to test the safety and efficacy of new pharmaceutical products before those drugs or devices can be marketed to the genera