Case Reports

“Research is an undertaking intended to extend knowledge through a disciplined inquiry or systematic investigation.TCPS2

Generally speaking, writing a report of a unique or interesting clinical case would not fall within the definition of research requiring REB review per the second edition of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2). This would be the case to the extent that these reports are simply anecdotal accounts of individual cases.   

The writing and/or publication of individual case reports may raise issues related to privacy and confidentiality and related to consent of the subject of the case report, which a clinical care provider must consider. Guidance related to issues such as these may be sought from a privacy officer of the responsible data custodian, or from the REB as a starting point for further referral. 

Case Reports Requiring REB Review

Where a physician seeks to use data collected for non-research (clinical) purposes in order to answer a research question, it is considered ‘secondary use of information not intended for research;’ as such, it falls within the definition of research and would require REB review. An example would be the analysis of 3 or more case reports to answer a specific research question.

TCPS 2 provides guidance regarding secondary use of identifiable information for research purposes within Articles 5.5 and 5.6.

 

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