Providing Restricted Access to an Electronic Medical Record for Research Monitoring.

As hospital systems and healthcare institutions adopt electronic medical records (EMRs), this creates a new challenge in the normal conduct of clinical research. When protected health information (PHI) is stored in an EMR, there is inherent risk that general access to these systems for source verification purposes could allow research monitors to also have access to the PHI of non-study participants.

Regulatory Support Improves Subsequent IRB Approval Rates in Studies Initially Deemed Not Ready for Review: A CTSA Institution's Experience.

We evaluated the impact of a regulatory support service (known as the Regulatory Knowledge and Support [RKS] program), part of the Medical University of South Carolina's Clinical and Translational Science Award, on the success of Institutional Review Board (IRB) applications that have previously been deemed by the IRB to be Not Ready for Review (NRR). At the time of this evaluation, 77 studies had been deemed NRR, 53 of which came from trainees and junior faculty. All the applications that received regulatory support either received IRB approval or were deemed to not be research, and therefore did not require IRB review.