These forms may only be used when a retrospective medical record review study is being proposed. The study must only propose to review pre-existing medical records. Pre-existing means the medical records are collected prior to this research use for a purpose other than the proposed research, and the only information accessed in the medical records must be present at the time the Existing Medical Record Review (EMRR) Application Facesheets are submitted to the HRPP via the web.
In addition, the proposed study must also satisfy the criteria outlined in the EMRR Research Plan including that there will be no contact with subjects, the study is minimal risk, and the criteria for both waiver of consent and waiver of individual HIPAA authorization can be satisfied. More information about these criteria can be found in the Research Plan.
Proposed studies that involve the following would not qualify for the use of the EMRR forms: Collection of data from sources other than medical records such as other UCSD/RCHSD IRB-approved protocols; collection and submission of subject identifiable information/protected health information (PHI) to non-UCSD/RCHSD sites; and/or receipt of subject identifiable informaiton/PHI from non-UCSD/RCHSD sites.
Instructions for submitting an EMRR Application can be found on the EMRR Application Facesheets.
EMRR Application Facesheets can be found at https://irb.ucsd.edu/SOMfacesheets_EMRR.pdf.
EMRR Research Plan can be found at https://irb.ucsd.edu/EMRR_RP.docx.