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OFFICE OF HUMAN SUBJECTS RESEARCH

Institutional Review Board

109.8 Organization Policy on Monitoring the Consent Process and Research Procedures in Ongoing Research

August 2010

The Organization grants to the JHM IRBs the authority to observe the consent process of an ongoing study as part of its continuing review responsibility.    Observation of the consent process may be delegated to the OHSR Compliance staff.   Compliance staff may observe consent processes, observe ongoing research procedures, interview research staff and participants, and evaluate study records as needed.

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