• Sci Eng Ethics · Dec 2010

    Comment

    Clinical study reflections: another view: Commentary on: "Raising suspicions with the Food and Drug Administration: detecting misconduct".

    • Patricia Spitzig.
    • The Public Sector Consortium, Cambridge, MA, USA. pas@public-sector.org
    • Sci Eng Ethics. 2010 Dec 1; 16 (4): 705-11.

    AbstractFederal 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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