How Will I Be Protected

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  • Learn how you can participate in clinical trials - National Institutes of Health
    The safety and well-being of patients participating in clinical trials are protected by the informed consent process, as well as regulations in place by the Institutional Review Boards (IRB), the U.S. Food and Drug Administration (FDA), and Scientific Review Committees (SRC).
    • IRBs ensure that clinical trials are ethical and your rights, such as confidentiality, are protected. They monitor progress and review results during the trial. Moffitt’s IRBs are independent committees made up of doctors, statisticians, and community members. All U.S. clinical trials must have IRB approval based on high standards of scientific integrity and protection of all participants. 

    • The FDA oversees clinical trials that are testing new medicines or medical devices. They review trial proposals before any testing on patients is done and ensure studies have proper informed consent and protection for participants. 

    • SRC review is a requirement of the National Cancer Institute as part of our Comprehensive Cancer Center designation. Scientific review is required for all clinical interventional studies that involve cancer, cancer prevention, or survivorship. A review by the SRC ensures: 
      1.        A clear research question 
      2.        A proper research design 
      3.        Sound and doable methods 
      4.        Qualifications of the research team 
      5.        Adequate sample size 
      6.        The validity of the statistical analysis plan
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