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. 2013 Winter;41(4):829-40, Table of Contents.
doi: 10.1111/jlme.12093.

Subversive subjects: rule-breaking and deception in clinical trials

Rebecca Dresser  1
Affiliations

Subversive subjects: rule-breaking and deception in clinical trials

Rebecca Dresser. J Law Med Ethics. 2013 Winter.

Abstract

Research subjects do not always conform to research requirements. When their personal interests conflict with the demands of participation, some subjects surreptitiously break the rules. These subjects are subversive--they undermine the research endeavor. In rejecting the restrictions research imposes, subversive subjects diminish the value of research results. From one vantage point, subversive subjects engage in unethical behavior. They create risks to themselves and others; they also disregard ethical responsibilities to adhere to research agreements and tell the truth. At the same time, subversive subjects expose ethical problems in the design and conduct of clinical trials. Features of the research environment create fertile ground for subject subversion. Intensified policing and guidance are two common strategies for reducing subject subversion, but collaborative reforms are more consistent with the partnership model of clinical research.

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References

    1. Epstein S. Impure Science: AIDS, Activism, and the Politics of Knowledge. Berkeley: University of California Press; 1996. at 204. - PubMed

    1. Researcher Kenneth Shulz observed that because requirements like randomization “annoy human nature,” people involved in research may be tempted to evade those requirements. See Schulz KF. Subverting Randomization in Controlled Trials. Journal of the American Medical Association. 1995;274(18):1456–1458.

    1. Smith DL. Patient Nonadherence in Clinical Trials: Could There Be a Link to Postmarketing Patient Safety? Drug Information Journal. 2012;46(1):27–34. at 28.
    1. Shumaker SA, Dugan E, Bowen DJ. Enhancing Adherence in Randomized Controlled Clinical Trials. Controlled Clinical Trials. 2000;21(5):226S–232S. at 226S. - PubMed

    1. Some rule violations have a more serious impact on research findings than do other violations. But any violation of a rule designed to strengthen the validity of data presents a threat to study quality.

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