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General Clinical Research Center

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Research Subject Advocate

Background and Purpose

  • The Research Subject Advocate insures that protection of human subjects is accorded the highest priority for studies conducted on the GCRC. The position is supported by funding from by the National Institutes of Health for GCRC Programs throughout the U.S.

Activities

  • Develops and implements policies and procedures for the assurance of research subject safety.
  • Monitors GCRC 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 CCHMC?

  • 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 studies complex procedures, high risk, or specific 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 towards resources for resolutions of problems or answering other questions.

How to Reach the RSA

Jennie Noll, PhD
Associate Professor of Pediatrics
Division of Behavioral Medicine and Clinical Psychology 
Telephone: (513) 636- 9922
Email: jennie.noll@cchmc.org