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George Washington University Committee on Human Research Institutional Review Board GUIDANCE ON MEDICAL RECORDS RESEARCH VS. CASE REPORTING IN THE CLINICAL SETTING Events and experiences occurring in the clinical setting, involving the treatment of patients with unique diseases or conditions, often lead to broader research questions. These questions may result in a formal research protocol. At most academic institutions, including GWU, medical students and residents are encouraged to identify and present unique clinical cases to their peers as part of the educational process. In addition, these individuals are urged to submit these clinical cases as case reports for publication in medical journals or presentation at medical/scientific meetings. When an individual contemplates reporting on such events/experiences, it is sometimes difficult to determine whether the reporting constitutes retrospective medical records research or case reporting. Making the correct determination at the onset is imperative because systematic review of medical records requires prospective IRB approval before accessing, collecting and analyzing the data. Case reporting activities, however, do not. Given this difficulty, the GWU IRB has developed the following list, which differentiates between research related elements/activities and case reporting elements/activities. Purpose Starting Point Patient Type Patient Benefits Patient Risks Patient Consent Data Collection End Point Intervention Used Testing/Analysis Intended Result Research Case Reports Develop or contribute to generalizable Contribute to treatment of a patient(s) with knowledge by testing a formal hypothesis a unique disease/condition while developing information for medical education purposes A prospectively designed, formal written A unique disease or condition discovered research hypothesis during routine medical care Any patient, including vulnerable subjects Non-vulnerable patients. If a case report is as defined in 45 CFR 46 Subparts B – D to include a vulnerable patient, seek IRB guidance before proceeding May not benefit patient Will benefit patient May put patient at risk with little or no Will not put patient at risk without some potential benefit anticipated benefit Must be obtained in accord with federal May not agree/consent to the standard of regulations, unless waived by the IRB care treatment in a formal manner Formal systematic collection in accordance Informal collection; limited to data on a with established protocol patient or small group of patients Evaluate drug/biologic/device data or Cure or control the unique disease or answer research question condition A drug, biologic, device not yet approved Standard of care; approved drugs, biologics for the use being studied and/or devices Validity of the hypothesis Success of the treatment provided Publication or presentation of the formal Publication or presentation of anecdotal hypothesis findings; share findings with peers Medical Records Research vs. Case Reporting Guidance February 2004