VCOM Institutional Policy and Procedure Manual

Edward Via College of Osteopathic Medicine

Policy Order No.: R004A6 Effective Date: March 1, 2008

Signature on File ____________________________ Dixie Tooke-Rawlins, D.O. Dean and Executive Vice President

Signature on File ____________________________ James F. Wolfe, Ph.D. President ___________________________________________________________________________________________ Addendum to VCOM IRB Policy No. R004 VCOM IRB Guidance on Research Limited to Retrospective Medical Record Reviews ____________________________________________________________________________________ 1. P URPOSE The purpose of this policy is to define the College’s guidelines regarding retrospective research studies. Research studies involving the retrospective review, collection and analysis of medical record information are descriptive studies that ordinarily seek to evaluate relationships between one or more biomedical, treatment, and/or demographic variables and one or more outcome measures in patients. Data may include a wide range of information from the medical record (e.g., results o flab tests, nursing and physician notes, summary reports). Because this is research, College IRB oversight is required in accordance with the Federal Policy regulations (45 CFR Part 46) governing human subject protections. Further, because the research involves medical records, compliance with the HIPAA Privacy Rule [46 CFRT Part 160; Part 164 (subparts A,E)] is required. There are several different approaches to the conduct of retrospective medical record research studies that can be approved by the College IRB. This involves the recording of medical information, without identifiers, by or under the oversight of a Principal Investigator (PI) who would normally have access to this information by virtue of his/her patient care responsibilities. An investigator may personally review medical records and abstract relevant data from the medical records if ALL of this following conditions are met: 1. All medical records to be accessed for study are currently in existence at the time of the IRB submission. 2. The desired medical record data is recorded by the investigator in such a way that the respective patients cannot be identified (i.e., by the investigator or others) either directly or indirectly via linkage codes assigned to the data. This means that the investigator cannot record names, social security numbers or any other patient identifiers and link this information to the data set. As a consequence, the resulting research data set is necessarily completely anonymous . For that reason, once the information has been extracted from the medical record, it 2. R ECORDING OF U NIDENTIFIABLE M EDICAL I NFORMATION