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Regulatory Knowledge & Support

Human Research Subject Advocate (RSA)

Research Subject Advocates (RSAs) work closely with CCTSI investigators in study design, approval, and oversight. We maintain an appropriate level of independence in order to monitor and ensure the safety of research participants. RSAs provide training and education for research participants, parents, investigators and co-investigators, study coordinators, and CTRC staff members.

Our Mission

  • To promote and facilitate safe and ethical conduct of human research
  • Participant advocacy:
    • Ensure participants understand clinical research, the risks involved, and their rights as volunteers
    • Protect participant's rights before, during and after their participation
    • Act as a confidential consultant between research participants and researchers
  • Provide a reporting pathway to institutional officials that is free of conflict of interest
  • Resolution of problems based on ethical and safety concerns
  • Development of policy regarding research ethics, participants’ rights, and research safety at the institutional level

For Investigators we provide:

  • Assistance with ethical protocol design for CTRC applications
  • Support to achieve participant safety
  • Help write informed consent forms conforming with COMIRB required language
  • Help with development and implementation of Data and Safety Monitoring Plans (DSMP)
  • Help create a Data and Safety Monitoring Board

Report all adverse events in studies supported by CCTSI resources that are serious, unexpected, and related to participation in research to the local site Research Subject Advocate (RSA).

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