The ethics of anonymous chart reviews

Janusz Kaczorowski and John Sellors question the ethics of an anonymous chart review. Their concern seems to be the apparent inconsistency in our approach to obtaining consent: we obtained consent from physicians to participate in the study and from patients before their telephone interview but we did not obtain consent for patient chart reviews.1 Our approach is entirely consistent with the Tri-Council Policy Statement on Ethical Conduct for Research Involving Humans, which states that researchers must obtain consent for physician participation in studies and for patient telephone interviews but not for chart reviews.2 Section 3, paragraph C, states that “secondary use of data refers to the use in research of data contained in records collected for a purpose other than the research itself. Common examples are patient or school records or biological specimens, originally produced for therapeutic for educational purposes, but now proposed for use in research. The issue becomes of concern only when data can be linked to individuals … in the published reports.”2

The College of Physicians and Surgeons of Ontario regularly performs chart audits in physicians' offices in an effort to ensure quality of care and patient safety. Hospitals are not only permitted but are obliged to perform chart audits to ensure quality of care and continuous quality improvement. Physicians are encouraged by their professional associations to carry out chart reviews on their practices. In none of these scenarios is patient consent requested.

Our study was designed to determine whether an outreach facilitation would improve the provision of evidence-based preventive care in family practice. We ensured that no data could be linked back to the 4600 patients in 46 practices whose charts were audited. Chart audit with feedback to the physician is a very effective way to change physician practice patterns. Requiring patient consent for anonymous chart audits would be expensive and complex. It would have a negative impact on the science from a societal perspective, and it is not clear what gain would be afforded in terms of patients' rights.

Rules on research ethics are designed to protect patients from harm. If these rules are to be changed, we should ensure that the changes would benefit patients and do no harm.