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  • Title: Clinical study reflections: another view: Commentary on: "Raising suspicions with the Food and Drug Administration: detecting misconduct".
    Author: Spitzig P.
    Journal: Sci Eng Ethics; 2010 Dec; 16(4):705-11. PubMed ID: 21052860.
    Abstract:
    Federal regulations are the minimum requirements for conducting clinical studies. Some innovation would improve the situation of many involved in these studies, including: study subjects, those who monitor studies, and clinical investigators as well as Institutional Review Boards. Respecting patient and whistle-blower input; appreciating research staff contributions; and implementing a systems and partnership approach would foster quality and advance clinical research.
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