CTSC Clinical Research Unit at MetroHealth
Research Subject Advocate
The primary responsibility of the Research Subject
Advocate (RSA)
is to ensure research subjects’ safety while participating in
GCRC-approved clinical research studies. The RSA is a resource not only for
research subjects and investigators but also for nurses and other GCRC
personnel. The RSA also acts as a link between the GCRC Advisory Committee (GAC)
and the Institutional Review Board (IRB), to ensure communication between these
two groups and to provide additional oversight and support to investigators
conducting research studies under the auspices of the GCRC.
Responsibilities of the RSA include:
- Be available
to research participants who are involved in GCRC protocols to provide
appropriate information if requested for any protocol classified as greater
than minimal risk.
- Serve as a
resource to which any concerned individual may relay information about
research subject’s safety or well being.
- Review the Data Safety Monitoring Plan
(DSMP) for each protocol and assist the GCRC Advisory Committee (GAC) in monitoring
the activity within each protocol.
- Be available as a resource for
investigators and help them develop an appropriate Data Safety Monitoring Plan (DSMP). The
RSA will also help investigators establish a Data Safety Monitoring Board (DSMB) when
necessary.
- Serve as link between the
GCRC and the IRB.
Contact Information
MetroHealth Medical Center
Judy Whitwell, RN
jwhitwell@metrohealth.org
Phone: (216)
778-5423
University Hospitals of
Cleveland
Baha Arafah, MD
Phone: (216) 844-3166
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