109.8 Organization Policy on Monitoring the Consent Process and Research Procedures in Ongoing Research
May 2025
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 Monitoring staff or the Research Participant Advocate. Delegated OHSR representatives may observe consent processes, observe ongoing research procedures, interview research staff and participants, and evaluate study records as needed.