Research Subject Advocate

The Research Subject Advocate (RSA) of the CRU is responsible for guarding the welfare of research participants during all phases of research activity to include study design, participant recruitment and enrollment, and research intervention and data collection.  Accordingly, the RSA Program assists research subjects as well as members of the CRU research team.

Specific functions include:

  • Assisting research investigators with protocol design, to include inclusion/exclusion criteria, recruitment plans, risk/benefit analyses and subject compensation.
  • Assisting research investigators with the formulation and creation of Data and Safety Monitoring Plans (DSMPs) and Data and Safety Monitoring Boards (DSMBs).
  • Auditing studies to ensure compliance with human subjects’ protections regulations.
  • Monitoring adverse events.
  • Evaluating conflict of interest disclosures.
  • Facilitating research ethics training for all key study personnel.
  • Witnessing or assisting the informed consent process.
  • Providing study information to research subjects.

Services offered
Please contact the RSA Program office for assistance with protocol and data safety monitoring plan preparation, or concerns you may have about research participation and human research regulations.  All protocols must be reviewed and approved by the RSA Program, as well as the General Advisory Committee (GAC) and the CCF Institutional Review Board (IRB), before the research project may begin.

We advise you submit your CRU application first, rather than your IRB application.  By submitting your protocol to the CRU first, your protocol, consent form and Data Safety Monitoring Plan will be reviewed and red-lined by the Research Subject Advocate.  The RSA is 100% focused on research ethics and research subject protections.  By making the changes suggested by the Research Subject Advocates, usually your documents will satisfy IRB research ethics requirements.

All adverse events (AE) must be reported yearly to the Clinical Research Unit Research Subject Advocate (RSA)

Useful Links
IRB forms, instructions, templates & suggested language
(http://portals.ccf.org/irb/Forms,InstructionsandHIPAAForms/tabid/7673/Default.aspx)

PRISM readability toolkit (good for alternative word suggestions- starting on p. 40) http://www.grouphealthresearch.org/capabilities/readability/ghchs_readability_toolkit.pdf

Readability Formula (to check the grade level of text)
http://www.readabilityformulas.com/free-readability-formula-assessment.php

FDA www.fda.gov
NIH www.nih.gov
OHRP www.hhs.gov/ohrp
Belmont Report http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm



Publication Acknowledgement

All publications resulting from the utilization of CTSA resources are required to credit the CTSA grant by including the NIH funding acknowledgement and must comply with the NIH Public Access Policy. All researchers should cite grant UL1TR000439, as follows: " This publication was made possible by the Case Western Reserve University/Cleveland Clinic CTSA Grant Number UL1TR000439 from the National Center for Advancing Translational Sciences (NCATS), a component of the National Institutes of Health. Its contents are solely the responsibility of the authors and do not necessarily represent the official view of NCATS or NIH."
For more information please visit http://publication.nih.gov/