Clinical Translational Research Center

  • Research Subject Advocate (RSA)

    Background and Purpose

    The research subject advocate  ensures that protection of human subjects is accorded the highest priority for studies conducted on the CTRC. The position is supported by funding from by the National Institutes of Health for CTRC programs throughout the United States.

    Activities

    • Develops and implements policies and procedures for the assurance of research subject safety
    • Monitors CTRC studies for safe conduct and regulatory compliance
    • Audits studies for regulatory compliance and conduct that is safe and ethical
    • Educates investigators and subjects regarding the appropriate conduct of human research

    How can the RSA help investigators at Cincinnati Children’s?

    • Review data and safety monitoring plans for adequacy and conformity with regulations
    • Assist the chartering of data and safety monitoring boards
    • Provide guidance on compliance with regulations concerning conduct of human research
    • Observe / monitor the consent process for  complex procedures and high-risk or  vulnerable populations

    How can the RSA help research subjects?

    • Monitor consent process and assist at making it understandable
    • Explain procedures and rights of study subjects involved in particular research protocols
    • Direct subjects toward resources for resolutions of problems or answering other questions