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  • Global Research Ethics

    Overview of Quintiles’ Council on Research Ethics (CORE)

    Quintiles chartered the Council on Research Ethics as one central, global Council to monitor implementation of Quintiles’ Corporate Policy on “Ethics, Compliance and Quality,” and standard practices and procedures designed to oversee ethical issues in the conduct of research. CORE monitors evolving global ethical standards affecting research, taking into consideration the varied phases of research and the regions within which Quintiles is involved in research activities. The CORE is responsible for recommending solutions to ethical issues related to research with a focus on the advancement of ethical and professional conduct during research with human participants.

    CORE Membership

    The CORE is composed of several members, broadly representative of the different areas, both geographically and functionally, within which Quintiles is involved in various types of research. The CORE members have backgrounds and appropriate professional competency necessary to review Quintiles’ research policies and standard procedures with respect to ethical principles of research. CORE members possess knowledge or expertise in areas that can include medical, regulatory, legal, quality assurance, clinical trial operations, product ownership, marketing, and post-approval research. CORE also includes independent members, such as a respected local Minister and an expert in global health policy. CORE is lead by Quintiles‘ Regulatory Counsel, the Head of Global Quality Assurance, and the Chief Medical and Scientific Officer.

    Additional Guidance for Ethical Conduct of Research 

    PhRMA Principles
    Belmont Report
    FDA Regulations Relating to Good Clinical Practice and Clinical Trials
    International Conference on Harmonisation – Good Clinical Practice Consolidated Guidance
    The Nuremberg Code
    The Common Rule
    European Medicines Agency
    EU Clinical Trials Directive