Download case reporting in the clinical setting

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