August 2013

JHM requires investigators to submit all proposed human subjects research applications for JHM IRB review.  Submissions must occur through the electronic IRB application system (eIRB).  eIRB applications must contain all material required for the IRB to make the determinations required under DHHS and FDA regulations.  eIRB resides on a secure computer network controlled by JHM.  Access to the eIRB system is controlled by the Office of Human Subjects Research (OHSR).  Access to eIRB is limited to individuals on a need to know basis. All staff of the JHM OHSR and all members of the JHM IRBs must sign a confidentiality agreement as part of their IRB activities. All non-OHSR staff granted access to the eIRB system must agree to abide by the confidentiality terms stated when access is granted. Information and uploaded documents obtained and reviewed as part of IRB functions are treated as confidential.  The information will not be discussed or disclosed outside of the JHM review process.