May 2005 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. Although its authority to observe the consent process has not yet been exercised, the JHM IRB may do so in the future. 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. |